Date of end of Recruitment Window at STH. Target No of Patients. No REC Ref Title

Transcription

1 o REC Ref Title Target o of Patients Date of end of Recruitment Window at STH Trial Status Target Met 1 06/MRE12/ /MRE04/ /MRE01/68 A randomised, double-blind, placebo-controlled, multicentre, Phase II study of oral lapatinib in combination with concurrent radiotherapy and cisplatin versus radiotherapy and cisplatin alone, in subjects with Stage III and IVA,B Squamous Cell Carcinoma of the Head and eck (SCCH) 6 06/01/2009 Closed - In Follow Up Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses 1 30/10/2012 ALTTO - A randomised, multicentre, open-label, Phase III study of adjuvant lapatinib, trastuzumab, their sequence and their combination in patients with HER2/ErbB2 positive primary breast cancer 25 14/01/2010 Closed - In Follow Up 4 07/H0405/70 An Open label, single arm, extension study to evaluate the long term safety and sustained efficacy of Denosomab (AMG162) in the treatment of postmenopausal osteoporosis. Protocol /04/ /MRE09/ /H0605/65 Phase I/II/II Pharmacokinetic and Outcome Study of Recombinant Factor IX Product, IB1001, in Subjects with Hemophilia B 3 30/04/2011 Closed - In Follow Up A phase III, randomised, open-label, 3-arm study to determine the efficacy & safety of Lenalidomide (Revlimid) plus low dose Dexamethasone when given until progressive disease or for 18 four-week cycles versus the combination of Melphalan, Prednisolone & Thalidomide given for 12 six-week cycles in patients with previously untreated Multiple Myeloma who are either 65 years of age or older or not candidates for stem cell transplantation. 6 31/12/2010 Closed - In Follow Up

2 7 09/H0301/5 A PHASE 3, MULTICETER, RADOMIZED, DOUBLE-BLID, PLACEBO- COTROLLED, PARALLEL-GROUP STUD OF THE EFFICAC AD SAFET OF LEALIDOMIDE (REVLIMID ) AS MAITEACE THERAP FOR PATIETS WITH B-CELL CHROIC LMPHOCTIC LEUKEMIA FOLLOWIG SECOD- LIE THERAP 6 30/04/ /H0402/ /H0405/44 A Multinational, multicentre, open label single assignment extension of the MS-LAQ-301 (ALLEGRO) study to evaluate the long term safety tolerability and effect on disease course of daily oral laquinamod 0.6mg in subjects with relapsing multiple sclerosis 5 30/11/2010 Closed - In Follow Up A randomised double blind placebo-controlled trial of eratinib (HKI-272) after Trastuzumab in women with early-stage HER-2/neu overexpressed/amplified breast cancer 10 10/10/2011 Closed - In Follow Up 10 09/H0502/84 A randomised double-blind, placebo-controlled study of Everolimus in combination with Exemestane in the treatment of postmenopausal women with estrogen receptor positive locally advanced or metastatic breast cancer who are refractory to Letrozole or Anastrozole 6 24/12/ /H0406/106 ORCHARRD - Ofatumumab versus Rituximab Salvage Chemoimmunotherapy followed by ASCT in relapsed or refractory DLBC 7 30/11/ /S0703/ /H1002/ /H/0009 Freedom 304: TDE-PH-304: An Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension 5 30/04/2011 Closed - In Follow Up A randomised, double-blind, placebo-controlled, multi-centre Phase 3 study of Denosumab as adjuvant treatment for women with early-stage breast cancer at high risk of Recurrence (D-CARE) 20 30/07/2012 Closed - In Follow Up MiroCam endoscopy of the small bowel in patients with GI bleeding/iron deficiency Anaemia and findings at upper and lower GI endoscopy of unclear bleeding potential 20 01/01/2017 Open /A 15 09/H0505/94 A Dose Blind Multicenter Extension study to Determine the Long Term safety and Efficacy of Two doss of BG00012 Monotherapy in Subjects with Relapsing Remitting Multiple Sclerosis 2 31/10/2010 Closed - In Follow Up

3 16 10/H1003/ /H0406/ /H0904/49 A multinational, multicenter, randomized, parallel-group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) injection 40 mg administered three times a week compared to placebo in a doubleblind design (GALA Study), protocol numbers MS-GA /04/2011 Closed - In Follow Up MARIAE - A randomised, 3 arm, multicentre, Phase III study to evaluate the efficacy and the safety of T-DM1 combined with pertuzumab or T-DM1 combined with pertuzumab-placebo (blinded for pertuzumab), versus the combination of trastuzumab plus taxane, as first line treatment in HER2-positive progressive or recurrent locally advanced or metastatic breast cancer (MBC) 10 15/02/2012 Closed - In Follow Up A single arm, open-label, multicentre study evaluating the long-term safety and tolerability of 0.5 mg fingolimod (FT720) administered orally once daily in patients with relapsing forms of multiple sclerosis (CFT720D2399) 11 01/08/2011 Closed - In Follow Up 19 10/MRE09/30 Multi-centre, open-label, extension study to evaluate the long-term efficacy and safety of oral tolvaptan tablet regimens in subjects with Autosomal Dominant Polycystic Kidney Disease (ADPKD) 1 24/11/ /H1307/91 A Compassionate Use Open-Label Study of Anti IL-5 (Mepolizumab) Treatment in Subjects with Hypereosinophilic Syndrome 1 01/01/2016 Open 21 09/H1211/72 An Extension Protocol for Multiple Scerosis Patients Who Participated in Genzyme Sponsored Studies of Aletmuzumab 17 01/08/ /IR02/45 A Phase-3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study To Compare Efficacy and Safety of Pomalidomide in subjects With Myeloproliferative eoplasm-associated Myelofibrosis and Red Blood Cell-Transfusion-Dependence 5 30/03/2012 Closed - In Follow Up

4 23 GTAC177 A Phase I study of the safety, tolerability and biological effect of single and repeat administration of the selectively replication-competent herpes virus HSV1716 into the tumour-bearing pleural cavity (intrapleural) in patients with inoperable malignant pleural mesothelioma 12 31/12/2015 Open /A 24 11/WM/0048 A phase 3, randomised, doubleblind, placebo controlled, multicentre study of the efficacy and safety of four 12 week treatment cycles (48 weeks total) of Epratuzumab in Systemic Lupus Erythematosus subjects with moderate to sever disease (Embody 1) 2 31/12/ /LO/ /H0903/ /AL/ /H0604/ /SC/0169 A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of atalizumab on Reducing Disability Progression in Patients with Secondary Progressive Multiple Sclerosis 12 30/04/2013 Closed - In Follow Up A Multicenter, Open-label, Extension Study to Evaluate the Long-term Safety and Efficacy of Daclizumab High ield Process (DAC HP) Monotherapy in Subjects with Multiple Scleosis Who Have d Treatment in Study 205MS202 (SELECTIO) 205-MS /11/2011 Closed - In Follow Up Exenatide Study of Cardiovascular Event Lowering Trial (EXSCEL) A Randomized, Placebo Controlled Clinical Trial to Evaluate Cardiovascular Outcomes After Treatment with Exenatide Once Weekly in Patients with Type 2 Diabetes Mellitus /05/2015 Closed - In Follow Up A European Randomised Phase 3 Study To Assess The Efficacy And Safety Of Tookad Soluble For Low Risk Localised Prostate Cancer Compared To Active Surveillance 20 25/04/2013 Randomized, Multicenter, DoubleBlind, Phase 3 Trial Comparing the Efficacy of Ipilimumab in Addition to Paclitaxel and Carboplatin versus Placebo in Addition to Paclitaxel and Carboplatin in Subjects with Stage IV/Recurrent onsmall Cell Lung Cancer (SCLC) 5 30/06/2014 Closed - In Follow Up

5 30 11/LO/0954 LUXHead & eck 2; A randomised, doubleblind, placebo controlled, phase III study to evaluate the efficacy and safety of afatinib (BIBW 2992) as adjuvant therapy after chemoradiotherapy in primary unresected patients with stage III, IVa, or IVb locoregionally advanced head and neck squamous cell carcinoma. 5 28/03/2015 Suspended 31 11/ AL/ /ES/ /SS/0018 E7080- A multicentre, randomised double-blind placebo-controlled phase 3 trial of E7080 in I-refractory differentiated thyroid cancer 2 01/12/2012 Closed - In Follow Up The Effect of Dulaglutide on Major Cardiovascular Events in Patients with Type 2 Diabetes: Researching Cardiovascular Events with a Weekly Icretin in Diabetes (REWID) APHIIT BIG 4-11/BO25126: A randomized multicenter, double-blind, 24 21/06/2013 Closed - In Follow Up placebo-controlled comparison of chemotherapy plus trastuzumab plus placebo versus chemotherapy plus trastuzumab plus pertuzumab as adjuvant therapy in patients with operable HER2-positive primary breast cancer 5 16/07/2013 Closed - In Follow Up 34 11/E/0226 Multi-centre, randomized, double-blind, placebo-controlled, parallelgroup, 9 month, equivalence trial comparing the efficacy and safety and tolerability of GTR (Synthon BV) to Copaxone (Teva) in subjects with relapsing remitting multiple sclerosis followed by an open-label 15 month GTR treatment part evaluating the long-term GTR treatment effects 13 28/02/ /LO/ /LO/1921 THERESA Study - A Phase III randomised, multicentre, two-arm, openlabel trial to evaluate the efficacy of T-DM1 compared with treatment of Physician s Choice in patients with HER2-positive metastatic breast cancer who have received at least two prior regimens of HER2-directed therapy 3 04/12/2012 Closed - In Follow Up PERTAI Study - A randomised, two-arm, open-label, multicentre Phase II trial assessing the efficacy and safety of pertuzumab given in combination with trastuzumab plus an aromatase inhibitor in first line patients with HER2-positive and hormone receptor-positive advanced (metastatic or locally advanced) breast cancer 3 03/11/2014 Closed - In Follow Up

6 37 12/LO/ /SC/ /EM/ /EE/ /EE/ /I/ /WS/ Trial Evaluating Safety and Efficacy of 8GP in Haem A (Pathfinder 2) 2 01/02/2013 Closed - In Follow Up Phase II/III partial randomized, open label trial using BA for the prophylaxis and treatment of bleeding in severe Haemophilia A (PROTECT VIII) 3 01/10/2013 A randomized, double-blind, placebo-controlled, event-driven trial of quarterly subcutaneous canakinumab in the prevention of recurrent cardiovascular events among stable post-myocardial infarction patients with elevated hscrp (CATOS) 8 01/01/2015 Closed - In Follow Up Protocol I1F-MC-RHBA A Multicenter, Randomized, Double-Blind, Placebo - Controlled Study Comparing the Efficacy and Safety of L to Etanercept and Placebo in Patients with Moderate-to-Severe Plaque Psoriasis The BEACO Study (Breast Cancer Outcomes with KTR-102: A Phase /12/2013 Closed - In Follow Up open-label, randomised multicentre study of MKTR-102 versus treatment of Physician s Choice (TPC) in patients with locally recurrent or metastatic breast cancer previously treated with an anthracycline, a taxane and capecitabine 5 24/07/2013 Closed - In Follow Up A randomised, double-blind, placebo controlled, multicentre trial to measure the oral corticosteroid-sparing effect of lebrikizumab in patients with severe corticosteroid dependent asthma - VOCALS 7 31/05/2016 Open /A A prospective randomized comparison of the BioFreedom Biolimus A9 Drug Coated Stent versus the Gazelle Bare Metal Stent in Patients at High Risk for Bleeding (Leaders free) 15 30/03/2014 Closed - In Follow Up 44 12/EM/0291 Randomized, Double-blind, Placebo-controlled Phase 3 Study of Ibrutinib (PCI-32765), a Bruton's Tyrosine Kinase (BTK) Inhibitor, in combination with Bendamustine and Rituximab (BR) in Subjects with Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (The 'HELIOS' Trial) 4 01/02/2014 Closed - In Follow Up

7 45 12/WS/ /SC/ /LO/1351 A Dose-Frequency Blinded, Multicenter, Extension Study to Determine the Long-Term Safety and Efficacy of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis 3 26/06/2013 An open-label randomised Phase III trial of BMS versus Docetaxel in previously treated advanced or metastatic squamous cell non-small cell lung cancer (SCLC) 10 30/08/2013 Closed - In Follow Up MO28231 TDM1 Safety Study - A multicentre, single arm study of Trastuzumab Emtasine (TDM1) in HER2 positive locally advanced or metastatic breast cancer patients who have received prior anti HER2 and chemotherapy based treatment. 8 31/10/2013 Closed - In Follow Up 48 12/W/0521 A randomised, double blind, placebo-controlled, multiple dose, phase 2b, 24 week trial followed by an open label extension of C , an anti-il-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to anti-tfa biologics 5 30/11/ /W/0722 Efficacy, safety, and tolerability of oral GRT6005 versus morphine sulfate PR in subjects with chronic moderate to severe pain related to cancer. 4 29/01/ /LO/ /W/ /SC/0092 A randomised, multicentre, open-label Phase III study to evaluate the efficacy and safety of Trastuzumab Emtansine versus Trastuzumab as adjuvant therapy for patients with HER2-positive primary breast cancer who have residual tumour present pathologically in the breast or axillary lymph nodes following preoperative therapy. KATHERIE 3 07/01/2016 Closed - In Follow Up A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by an active treatment period, to evaluate the efficacy, safety and tolerability of daily oral administration of laquinimod 0.6 mg and 1.2 mg in subjects with relapsing remitting multiple sclerosis (RRMS). COCERTO 5 01/02/2015 Closed - In Follow Up A multicenter, randomized, double blind parallel group placebocontrolled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis 5 31/01/2015 Closed - In Follow Up

8 53 13/LO/0219 GS6624 in Subjects with Idiopathic Pulmonary Fibrosis (RAIIER) 4 30/06/2015 Closed - In Follow Up 54 13/LO/ /LO/ /WS/0300 PRESET - Prevention of recurrence in early-stage, node-positive breast cancer with low to intermediate HER2 expression with euvax treatment 6 23/02/2015 Closed - In Follow Up International non-randomized, single arm, long-term follow-up study of patients with uncontrolled hypertension 12 31/01/2015 Closed - In Follow Up A randomised, double blind, placebo controlled, parallel group study to evaluate the effect of SAR236553/REG727 on the occurrence of cardiovascular events in patients who have recently experienced an acute coronary syndrome 25 01/12/2015 Closed - In Follow Up 57 12/LO/ /W/0002 An observer-blind study to evaluate immunogenicity and safety of GSK Biologicals Herpes Zoster vaccine GSK A in adults =18 years of age with solid tumours receiving chemotherapy. Prospective, randomised, controlled investigation comparing the safety 5 30/09/2013 Closed - In Follow Up and performance of Surgical Haemostat 2g Applicator with FLOSEAL Hemostatic Matrix as an adjunctive haemostat in cardiac surgery and thoracic aortic surgery. 17 Open /A 59 13/ES/ /LO/0073 A study evaluating the efficacy and safety of Botox and solifenacin in patients with overactive bladder and urinary incontinence. 4 01/05/2014 A Multicenter Single-arm Extension Study to Describe the Long-term Efficacy and Safety of AMG 416 in the Treatment of Secondary Hyperparathyroidism in Subjects With Chronic Kidney Disease on Hemodialysis 2 29/05/ /H/0498 An Open, Phase I, Exploratory Study of MTL-005 Radiosensitization in Patients With Advanced Carcinoma of the Head and eck: Part 1 to Evaluate Safety in a Dose Escalation Design in Patients Indicated for Palliative Radiotherapy, Part 2 to Evaluate Safety and Efficacy in a Dose- Escalation Design in Patients Indicated for Cisplatin Chemoradiotherapy - MOREX 8 31/05/2016 Open /A

9 62 13/W/0193 Efficacy and safety of a single TRUS-guided intraprostatic injection of X in patients with BPH/LUTS not adequately controlled by medical therapy with a-blockers. 5 26/11/ /W/0064 The I.PACT Global Clinical Study for the Treatment of Comprehensive Superficial Femoral and/or Popliteal Artery Lesions Using the I.PACT Admiral Drug-Eluting Balloon (I.PACT Global) 80 31/03/2014 Withdrawn 64 13/W/0215 PEARL - A double blind, randomised, placebo controlled Phase II study to assess the efficacy of recprame + AS15 Antigen-Specific Cancer Immunotherapeutic as adjuvant therapy in patients with resected PRAMEpositive, non-small cell lung cancer 5 11/07/ /WM/ /EE/ /W/ /WA/ /LO/ /LO/0671 A double-blind, randomised, placebo-controlled, multicentre study assessing the impact on major cardiovascular events of additional LDL-C lowering with AMG145 therapy when used on top of a high dose statin in patients with coronary artery disease. FOURIER 10 01/04/2015 Closed - In Follow Up BOTOX Prophylaxis in Chronic Migraine: Postauthorization Observational Study 8 28/02/2014 An open-label phase IIIb study of riociguat in patients with in-operable CTEPH, or recurrent or persisting PH after surgical treatment who are not satisfactorily treated and cannot participate in any other CTEPH trial 4 01/02/2014 A Randomized, Double-Blind, Phase III Study of the Efficacy and Safety of Gemcitabine in Combination With TH-302 Compared With Gemcitabine in Combination With Placebo in Previously Untreated Subjects With Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma (MAESTRO) 2 30/06/2014 Closed - In Follow Up Efficacy and safety of FIAsp compared to insulin aspart both in combination with insulin detemir in Adults with type 1 Diabetes. 6 16/12/2013 Closed - In Follow Up A Multicenter, Open-Label, Extension Study to Evaluate the Long-Term Safety and Efficacy of BIIB019, Daclizumab High ield Process (DAC HP), Monotherapy in Subjects With Multiple Sclerosis Who Have d Study 205MS /02/2014 Closed - In Follow Up

10 71 13/EM/0248 A study of the effect of OC on signs & symptoms in subjects with moderate to severe atopic dermatitis: a randomised double blind placebo controlled parallel group study. 5 31/05/ /W/ /EM/ /W/ /LO/ /W/ /LO/0036 A two part study to assess the safety, tolerability, pharmacokinetics and pharmacodynamic effects of multiple doses of QBM076 in patients with COPD A Phase 2, Dose-Finding, Randomized, Parallel-Group, Double-Blind, 9 01/10/2015 Withdrawn Placebo-Controlled Study, Evaluating the Safety and Efficacy of Pridopidine 45 mg, 67.5 mg, 90 mg and mg Twice-Daily versus Placebo for Symptomatic Treatment in Patients with Huntington s Disease Phase /06/2015 Closed - In Follow Up A Phase 2/3, multi-centre, open-label, randomised study of weekly nab - Paclitaxel in combination with Gemcitabine or Carboplatin, compared to Gemcitabine/Carboplatin, as first line treatment in subjects with ER, PgR, and HER2 negative (triple negative) metastatic breast cancer - TACIT 7 01/02/2018 Closed - In Follow Up A phase II, multicentre, randomised, double-blind, parallel group, placebocontrolled, dose-finding study to evaluate the safety and efficacy of three different oral doses of MT-1303 administered for a period of 24 weeks in subjects with relapsing-remitting multiple sclerosis EXTESIO 5 31/05/2014 Closed - In Follow Up Randomised, double-blind, dose-finding Phase II study to assess the efficacy of APD403 in the prevention of nausea and vomiting caused by cisplatin- or anthracycline/cyclophosphamide (AC)-based chemotherapy 7 30/01/2015 A Phase 3, Randomized, Open Label Study Investigating the Efficacy of the BiTE? Antibody Blinatumomab Versus Standard of Care Chemotherapy in Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL) (TOWER Study) 1 01/03/2016 Open 78 13/H/0320 A phase III, randomized, double-blind, placebo controlled study to assess the efficacy and safety of lebrikizumab in patients with uncontrolled asthma who are on inhaled corticosteroids and a second controller medication. Lavolta I/II 1 10/12/2014 Closed - In Follow Up

11 79 13/LO/ /EE/0312 CALM-ET: A Phase IV, Multicentre, Open label, Single Group Exploratory Study to Assess the Clinical Value of Enumeration of Circulating Tumour Cells (CTCs) to Predict Clinical Symptomatic Response and Progression Free Survival in Patients receiving Deep Subcutaneous Administrations of 4 29/02/2016 Open Efficacy and Safety of AM-101 in the Treatment of Acute Peripheral Tinnitus 3 (TACTT3) 10 19/02/2016 Open /A 81 14/H/0005 An Individualized treatment approach for EldeRly patients: A randomized, controlled study in type 2 diabetes Mellitus (IMPERIUM) 5 05/11/ /LO/ /LO/ /SC/ /EM/ /EM/0460 A randomized, double-blind, parallel-group, placebo and active controlled, multicenter study to evaluate the efficacy, safety and tolerability of combinations of solifenacin succinate 5mg and mirabegron 25 and 50mg compared to slifenacin succinate and mirabegron monotherapy in the treatment of overactive bladder. 8 13/03/2015 Closed - In Follow Up A Phase IIIb, randomized, open-label study of the safety and efficacy of dolutegravir/abacavir/lamivudine once daily compared to atazanavir and ritonavir plus tenofovir/emtricitabine once daily in HIV-1 infected antiretroviral therapy naïve women 2 29/09/2014 Closed - In Follow Up A Phase III randomized, 3-arm, open label, multicenter study of LGX818 plus MEK162 and LGX818 monotherapy compared with vemurafenib in patients with unresectable or metastatic BRAF V600 mutant melanoma 3 31/05/2015 Open An exploratory, 12 week, randomised, partially double-blinded, placebocontrolled, parallel group trial to explore the effects of once daily treatments of orally inhaled tiotropium + olodaterol fixed dose combination or tiotropium (both delivered by the Respimat inhaler), 3 29/01/2015 KAITLI A randomised, multicentre, open-label, Phase III trial comparing Trastumzumab plus Pertuzumab plus a taxane following anthracyclines versus Trastuzumab Emtansine plus Pertuzumab following anthracyclines as adjuvant therapy in patients with operable HER2-positive primary breast cancer 7 22/05/2015 Closed - In Follow Up 87 14/H/0052 A Phase 2b, Randomised, Double-Blind, Placebo Controlled Dose-Ranging Study of the Efficacy and Safety of ALV003 Treatment in Symptomatic Celiac disease Patients Maintained on a Gluten Free Diet. 5 30/09/2014

12 88 14/H/0167 Tolerance and Acceptabiltiy Evaluation of AMES DELIGHT 0 16/12/ /W/ /EM/ /WM/ /EM/0129 A double-blind, randomised, placebo-controlled, phase II study to evaluate ProCervix efficacy to clear HPV 16 and HPV 18 infection in women with normal cytology or ASCUS/LSIL 2 17/10/2014 Mepolizumab vs. Placebo as add-on treatment for frequently exacerbating COPD patients characterized by eosinophil level 6 25/07/2015 Withdrawn A multinational, randomised, double blind, placebo controlled trial to evaluate the effect of ticagrelor 90mg twice daily on the incidence of cardiovascular death, myocardial infarction or stroke in patients with type 2 diabetes mellitus. (THEMIS) 20 03/06/2016 Open /A A Phase 2/3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled (Part A) And Double-Blind, Double-Dummy, Active-Controlled (Part B), Parallel Group Study To Evaluate The Efficacy And Safety Of Rpc1063 Administered Orally To Relapsing Multiple Sclerosis Patients 3 17/02/2015 Closed - In Follow Up 93 13/LO/ /WS/ /EE/ /EM/0404 A Phase II Simon Two Stage Efficacy Study of Intracerebral CTX0E03 DP in Patients with Stable Paresis of the Arm Following an Ischaemic Stroke. 4 31/03/2016 Open /A A phase 3, multicentre, open label, randomised trial of nab-paclitaxel plus Gemcitabine versus Gemcitabine alone as adjuvant therapy in subjects with surgically resected pancreatic adenocarcinoma Multicentre, Randomised, DoubleBlind, Placebo Controlled, Phase 3 Trial 10 30/06/2016 Open /A of Fulvestrant (Faslodex ) With or Without PD (Palbociclib) ± Goserelin in Women with Hormone Receptor Positive, HER2 egative Metastatic Breast Cancer Whose Disease Progressed After Prior Endocrine Therapy. PALOMA 1 15/07/2014 Closed - In Follow Up A multicenter, prospective, randomized, open label study to assess the effect of serelaxin versus standard of care in acute heart failure (AHF) patients - RELAX EU 10 01/04/2015 Withdrawn

13 97 14/LO/ /LO/ /W/ /E/ /EM/0186 Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel-group, 24-week study to assess the efficacy, safety and tolerability of macitentan in subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) A Randomized, Double-Blind, Parallel-Group, Active-Controlled, Multicenter 2 01/10/2016 Open /A Study to Evaluate the Long-Term Safety and Efficacy of Combination of Solifenacin Succinate with Mirabegron Compared to Solifenacin Succinate and Mirabegron Monotherapy in Subjects with Overactive Bladder 5 31/08/2016 Closed - In Follow Up Comparative testing of Transfix Vacuum blood collection tubes and Cytochex blood collection tubes for FDA 510 (k) submission 18 Open /A Pressure controlled Intermittent Coronary Sinus Occlusion as an adjunct to PCI in acute coronary syndrome. An observational study evaluating the effect of PICSO treatment concomitant to ppci in patients with anterior non ST-segment Elevation Myocardial Infarction or following ppci in STsegment Elevation Myocardial Infarction. A Randomized Controlled Phase 3 Study of Oral Pacritinib versus Best 12 31/03/2016 Open /A Available Therapy in Patients with Thrombocytopenia and Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis (PERSIST-2) 3 01/01/2018 Open /A /SC/0100 Assessment of Anatomical and Functional Outcomes in Patients Treated with Ocriplasmin for Vitreomacular Traction/Symptomatic 6 31/03/ /LO/ /LO/ /H/0005 Hypertrophic Cardiomyopathy Study - Phase 2 study to evaluate the safety and efficacy of a novel compound, GS-6615 on Exercise Capacity in Subjects with Symptomatic Hypertrophic Cardiomyopathy 4 30/06/2016 Open /A A Prospective, Interventional Pharmacokinetic and Safety Study of DTG/ABC/3TC in Pregnant Women 0 30/09/2015 A Phase 3 Confirmatory Study Investigating The Efficacy And Safety Of Dupilumab Monotherapy Administered To Adult Patients With Moderate - To severe Atopic Dermatitis 5 31/07/2015 Closed - In Follow Up

14 106 14/LO/0566 A randomised, doubleblind, parallel group, placebo controlled multicentre Phase III study to assess the efficacy and safety of olaparib versus placebo as adjuvant treatment in patients with germline BRCA1/2 mutations and high risk HER2 negative primary breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy 3 30/11/2017 Open /A /W/1294 A Phase III, multi-center, double-blind, placebo controlled, randomized withdrawal study of LCI699 following a 24 week, single-arm, open-label dose titration and treatment period to evaluate the safety and efficacy of LCI699 for the treatment of patients with Cushing s disease who are candidates for medical therapy. 2 13/05/2016 Open /A /LO/ /LO/ /LO/ /EE/ /LO/1328 A Multicenter Phase 3 Randomized, Open-Label Study of Bosutinib versus Imatinib in Adult Patients with ewly Diagnosed Chronic Phase Chronic Myelogenous Leukemia BFORE 3 31/08/2015 Closed - In Follow Up Open-label, single-arm extension study to the double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg FT720 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis (STH15105 Extension) 8 01/09/2014 Study : Albiglutide versus Placebo in Subjects with new- onset type 1 diabetes mellitus 4 01/11/2015 Suspended /A A 6-month, prospective, randomized, multicenter, placebo controlled safety study of oto-104 given at 3-month intervals by intratympanic injection in subjects with unilateral Meniere s Disease followed by a 6- month open-label extension 10 01/10/2015 Closed - In Follow Up A multicentre, randomized, double-blind, parallel group, active-controlled study to evaluate the efficacy and safety of LCZ696 compared to valsartan, on morbidity and mortality in heart failure patients (HA Class II-IV) with preserved ejection fraction 6 31/03/2016 Open /A

15 113 14/LO/1513 GS-US : A Randomized, Open Label, Phase 4 Study Evaluating the Renal Effect of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF or other Tenofovir DF-containing Regimens (Ritonavir-boosted Atazanavir plus Emtricitabine/Tenofovir DF) or Efavirenz/Emtricitabine/Tenofovir DF compared to Ritonavir-boosted Atazanavir plus Abacavir/Lamivudine in Antiretroviral Treatment-naïve HIV-1 Infected Adults with egfr =70 ml/min 1 30/12/ /H/ /SC/ /LO/2182 A Phase 2, Randomized, Placebo Controlled, Double Blind, Proof of concept Study of the Efficacy and Safety of PF in Subjects with Huntington s disease 4 19/02/2016 Open /A EPOCH: Protocol TS-102: A phase 3 clinical trial evaluating Therasphere in patients with metastatic colorectal carcinoma of the liver who have failed first line chemotherapy 3 01/02/2016 Open /A STOP-HCC TS-103 A phase 3 clinical trial of intra-arterial TheraSphere in the treatment of patients with unresectable hepatocellular carcinoma 2 30/01/2018 Open /A /H/1090 The QUIET-1 Study: A Balanced Randomised Placebo Controlled Doubleblind Phase IIa Study to Investigate the Efficacy and Safety of AUT00063 Versus Placebo in Subjective Tinnitus 10 08/10/2015 Closed - In Follow Up /SS/1048 A Phase 3b, Multi-center, Randomized-withdrawal, Placebo-controlled, Double-blind, Parallel-group Trial to Compare the Efficacy and Safety of Tolvaptan (45 to 120 mg/day, split dose) in Subjects with Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due to Autosomal Dominant Polycystic Kidney Disease 5 Open /A /H/0188 Acceptability study on utricomp Drink Plus in adult patients 15 31/10/ /E/1079 RELIEVE 1 - A randomised, double-blind, placebo-controlled study to evaluate the efficacy of two different dose levels of Orvepitant (10 and 30 mg) compared with placebo on EGFRi-induced intense pruritus in oncology subjects 4 30/06/2015 Closed - In Follow Up

16 121 14/SC/ /EM/ /H/1141 A phase 3 randomized, double-blind study assessing the efficacy and safety of pf and adalimumab in combination with methotrexate in subjects with moderately to severely active rheumatoid arthritis who have had an inadequate response to methotrexate A Double-Blind, Placebo Controlled, Multicenter Study to Assess the 1 28/02/2016 Open /A Effect of Evolocumab on Cognitive Function in Patients with Clinically Evident Cardiovascular Disease and Receiving Statin Background Lipid Lowering Therapy: A Study for Subjects Enrolled in the FOURIER (Study ) Trial Evolocumab (AMG 145) 1 31/03/2015 Closed - In Follow Up A phase II randomized, double-blind, placebo-controlled trial of radium- 223 dichloride versus placebo when administered to metastatic HER2 negative hormone receptor positive breast cancer with bone metastases treated with hormonal treatment background therapy 4 01/06/2016 Open /A /EM/ /E/ /LO/ /SC/ /H/0140 A Phase II Randomised, Double Blind, Placebo Controlled, Multicentre Study of VS-6063 in Subjects With Malignant Pleural Mesothelioma 1 01/09/2015 Closed - In Follow Up A phase iii, multicenter, randomized, double-masked, sham-controlled study to assess the efficacy and safety of Lampalizumab administered intravitreally to patients with Geographic atrophy secondary to Agerelated macular degeneration A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study of Oral 4 30/09/2016 Open /A ML9708 Maintenance Therapy in Patients with Multiple Myeloma Following Autologous Stem Cell Transplant - Millennium 3 01/12/2016 Open /A A Multicenter, Randomized, Double Blind, Placebo controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Dapagliflozin as an Add on to Insulin Therapy in Subjects with Type 1 Diabetes Mellitus 5 31/10/2015 Open EDIF - Effect of ivabradine versus placebo on cardiac function, exercise capacity, and neuroendocrine activation in patients with Chronic Heart Failure with Preserved left ventricular Ejection Fraction An 8-month, randomised double-blind, placebo controlled, international, multicentre study 5 30/06/2015

17 129 15/H/0003 ZI - Randomized, Doubleblind, Multicenter, Phase III Study Comparing the Efficacy and Safety of Retosiban Versus Atosiban Therapy for Women in Spontaneous Preterm Labor 6 01/07/2016 Open /A /W/1328 A 16 Week Randomized, Double Blind, Placebo Controlled, Parallel Group, Multicentre Study Evaluating the Efficacy and Safety of Intranasal Administration of 100, 200 and 400 µg of Fluticasone Propionate Twice a Day (BID) Using a ovel BiDirectional Device in Subjects with Bilateral asal Polyposis Followed by an 8 Week Open Label Extension - AVIGATE I - Phase to Assess Safety 5 01/04/ /EE/ /LO/ /LO/1370 TOPAZ: A long-term follow-up study for Multiple Sclerosis patients who have completed the alemtuzumab Extension Study (CAMMS03409 STH15866) 15 01/07/2016 Closed - In Follow Up A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Capecitabine and Cisplatin With or Without Ramucirumab as First-line Therapy in Patients With Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (RAIFALL) Long term, multicenter, single-arm, open-label extension study of the 5 31/12/2017 Open /A MERIT-1 study, to assess the safety, tolerability and efficacy of macitentan in subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) 2 01/03/2017 Open /A /SS/ /W/ /LO/0337 A Phase 2, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Study of GS-4997 in Subjects with Pulmonary Arterial Hypertension 2 14/10/2015 Closed - In Follow Up A 4 week phase 2a, multicentre, randomised, doubleblind, placebocontrolled add-on study into safety, tolerability and efficacy of 200 mg t.i.d. of PL37 in patients with peripheral neuropathic pain of diabetic origin treated with pregabalin or gabapentin 10 15/03/2016 Open /A A randomized, double-blind, placebo-controlled, prospective, multicenter, parallel group study to assess the safety and efficacy of macitentan in patients with portopulmonary hypertension 2 01/06/2016 Open /A

18 137 15/H/ /LO/ /LO/ /H/ /LO/0443 A prospective, multicenter, single-arm, open-label, Phase 4 study to evaluate the effects of macitentan on Right ventricular remodeling in Pulmonary ArterIal hypertension assessed by cardiac magnetic resonance imaging - REPAIR 0 30/04/2016 Open /A A Phase 3 Multicenter, Double-Blind, Randomized, Active Comparator- Controlled Clinical Trial to Evaluate the Safety and Efficacy of Doravirine (MK-1439) 100 mg Once Daily Versus Darunavir 800 mg Once Daily plus Ritonavir 100 mg Once Daily, Each in Combination with TRUVADA or EPZICOM/KIVEXA, in Treatment-aïve HIV-1 Infected Subjects 1 30/09/2015 Safety and Efficacy of Brimonidine Posterior Segment Drug Delivery System in Patients with Geographic Atrophy Secondary to Age-related Macular Degeneration. 8 30/08/2016 Open /A An open label extension study to investigate the long term safety, tolerability and efficacy of PF in subjects with Huntington's disease who previously completed study A /10/2017 Open /A OPTIMISSM: Safety and Efficacy of Pomalidomide, Bortezomib and Lowdose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma /12/2017 Open /A /H/ /H/ /LO/0691 An open-label study of Dupilumab in patients with atopic dermatitis who participated in previous Dupilumab clinical trials. 5 30/06/2016 Open /A A phase 3, randomized, double-blind, placebo-controlled study investigating the efficacy and safety of multiple Dupilumab dose regimens administered as monotherapy for maintaining treatment response in patients with atopic dermatitis. 0 01/12/2015 Closed - In Follow Up An Open-Label, Multicenter Clinical Trial with ivolumab (BMS ) Monotherapy in Subjects with Advanced or Metastatic Squamous Cell (Sq) on-small Cell Lung Cancer (SCLC) who Have Received at Least One Prior Systemic Regimen for the Treatment of Stage IIIb/IV SqSCLC 9 30/04/2016 Open /A

19 145 15/W/0319 A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of LX4211 as Adjunct Therapy in Adults Patients with Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control with Insulin Therapy. 5 30/04/2016 Open /A /WS/ /LO/ /H/ /LO/1117 Multicenter, randomized, double-blind, double-dummy, activecomparator, event-driven, superiority phase III study of secondary prevention of stroke and prevention of systemic embolism in patients with a recent Embolic Stroke of Undetermined Source (ESUS), comparing rivaroxaban 15 mg once daily with aspirin 100 mg (AVIGATE ESUS) 20 01/12/2016 Open /A A Multi-center, Prospective, Randomized, Controlled Trial of Endobronchial Valve (EBV) Therapy vs. Standard of Care (SoC) in Heterogeneous Emphysema 5 Multi-center, Open-Label, Randomized, Two-Arm, Parallel-Group Study to 30/06/2016 Open /A Assess Efficacy and Safety of Envarsus Compared with Tacrolimus Used as Per Current Clinical Practice in the Initial Maintenance Setting in De ovo Kidney Transplant Patients 4 30/08/2016 Open /A An open-label, multi-center, non-randomized Phase Ib study to investigate safety and tolerability of radium Ra 223 dichloride (BA ) administered in combination with paclitaxel in cancer subjects with bone lesions. 2 31/12/2015 Open /A /LO/ /LO/ /W/0592 Effects of ODM-109 on respiratory function in patients with ALS. A randomised, double blind, placebo-controlled, cross-over, 3 period, multicentre study with open-label follow-up extension. ExplorerTM3 A multi-centre, randomised, placebo controlled, double 5 31/03/2016 Open /A blinded, multiple dose trial investigating safety, pharmacokinetics and pharmacodynamics of concizumab administered subcutaneously to haemophilia A subjects. Trial ID: /03/2017 Open /A A randomised, double-blind, double-dummy, placebo-controlled, parallelgroup multi-centre clinical proof-of-principle trial in adult subjects with newly diagnosed type 1 diabetes mellitus investigating the effect of C and liraglutide on preservation of beta-cell function. 3 18/04/2017 Open /A