Target date to recruit patients agreed? Target range. maximum. minimum. Date. 5 Agreed 26/01/ /11/2015 Recruitment Finished.
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1 No REC Reference IRAS No Title Target number of agreed? Target range minimum Target range maximum Target date to recruit agreed? Planned Recruitment end date Total no of recruited at the agreed target date Total no of recruited study actually closed to recruitment at STH Reason for closure to recruitment at STH 1 10/H1307/ A Compassionate Use Open-Label Study of Anti IL-5 (Mepolizumab) Treatment in Subjects with Hypereosinophilic Syndrome Agreed 1 1 Agreed 01/01/ /01/2016 Recruitment Finished 2 11/LO/ LUX Head & Neck 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 with stage III, IVa, or IVb locoregionally advanced head and neck squamous cell carcinoma. Agreed 5 5 Agreed 26/01/ /11/2015 Recruitment Finished International non-randomized, single arm, long-term follow-up study of with uncontrolled 3 12/LO/ hypertension A randomised, multicentre, open-label Phase III study to evaluate the efficacy and safety of Trastuzumab Emtansine versus Trastuzumab as adjuvant therapy for with 4 12/LO/ HER2-positive primary breast cancer Agreed Agreed 31/01/ /09/2016 Recruitment Finished Agreed 3 3 Agreed 30/04/ /01/2016 Recruitment Finished Efficacy and Safety of AM-101 in the Treatment of Acute Peripheral 5 13/EE/ Tinnitus 3 (TACTT3) 6 13/LO/ Agreed 3 5 Agreed 30/06/ /07/2016 Recruitment Finished A Phase II Simon Two Stage Efficacy Study of Intracerebral CTX0E03 DP in Patients with Stable Paresis of the Arm Following an Ischaemic Stroke. Agreed 2 4 Agreed 05/08/ /08/2016 Recruitment Finished
2 A randomized, double-blind, parallelgroup, 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 7 13/LO/ treatment of overactive bladder. CALM-NET: A Phase IV, Multicentre, Open label, Single Group Exploratory Study to Assess the Clinical Value of 8 13/LO/ Enumeration of Circulating Tumour 9 13/NI/ Agreed 8 8 Agreed 13/03/ /02/2016 Recruitment Finished Agreed 4 4 Agreed 22/07/ /07/2016 Recruitment Finished A randomised, double-blind, placebo controlled, multicentre trial to measure the oral corticosteroid-sparing effect of lebrikizumab in with severe corticosteroid dependent asthma - VOCALS Agreed 7 7 Agreed 02/02/ /02/2016 Recruitment Finished A Phase III randomized, 3-arm, open label, multicenter study of LGX818 plus MEK162 and LGX818 monotherapy compared with vemurafenib in with unresectable or metastatic BRAF 10 13/SC/ V600 mutant melanoma Study of Oral Pacritinib versus Best Available Therapy in Patients with Thrombocytopenia and Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis (PERSIST-2) 11 14/EM/ Agreed 3 3 Agreed 31/03/ /10/2015 Recruitment Finished Agreed 3 4 Agreed 01/01/ /02/2016 Recruitment Finished 12 14/EM/ An open-label, multicenter study to provide with chronic heart failure and reduced ejection fraction access to LCZ696 following participation in PARADIGM-HF Agreed 2 2 Agreed 29/02/ /02/2016 Recruitment Finished
3 Prospective, randomized, placebocontrolled, double-blind, multicenter, parallel-group, 24-week study to assess the efficacy, safety and tolerability of macitentan in subjects with inoperable chronic 13 14/LO/ thromboembolic pulmonary Agreed 2 2 Agreed 18/03/ /03/2016 Recruitment Finished 14 14/LO/ /LO/ A Phase 3, Randomized, Placebo- Controlled, Double-Blind Study of Oral MLN9708 Maintenance Therapy in Patients with Multiple Myeloma Following Autologous Stem Cell Transplant - Millennium A Multi-center, Prospective, Randomized, Controlled Trial of Endobronchial Valve (EBV) Therapy vs. Standard of Care (SoC) in Heterogeneous Emphysema Agreed 3 3 Agreed 01/12/ /03/2016 Recruitment Finished Agreed 5 10 Agreed 30/06/ /06/2016 Recruitment Finished 16 14/LO/ /LO/ /NW/ Long term, multicenter, single-arm, open-label extension study of the MERIT-1 study, to assess the safety, tolerability and efficacy of macitentan in subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) Study : Albiglutide versus Placebo in Subjects with new- onset type 1 diabetes mellitus 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 with peripheral neuropathic pain of diabetic origin treated with pregabalin or gabapentin Agreed 1 1 Agreed 27/06/ /05/2016 Recruitment Finished Agreed 3 3 Agreed 26/05/ /05/2016 Recruitment Finished Agreed 7 7 Agreed 15/03/ /03/2016 Recruitment Finished
4 Comparative testing of Transfix Vacuum blood collection tubes and Cytochex blood collection tubes for FDA 510 (k) submission 19 14/NW/ A phase 3 randomized, double-blind study assessing the efficacy and safety of pf and 20 14/SC/ adalimumab in combination with 21 14/SC/ 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 Agreed Agreed 25/02/ /02/2016 Recruitment Finished Agreed 1 4 Agreed 28/02/ /02/2016 Recruitment Finished Agreed 5 5 Agreed 31/10/ /04/2016 Recruitment Finished A Phase 3b, Multi-center, Randomized-withdrawal, Placebocontrolled, Double-blind, Parallelgroup 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 22 14/SS/ Kidney Disease 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 with 23 14/WM/ type 2 diabetes mellitus. (THEMIS) 24 14/WS/ 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 Not Agreed 5 Available / 5 Not Agreed /01/2016 Recruitment Finished Agreed Agreed 03/06/ /05/2016 Withdrawn By Sponsor Agreed Agreed 30/06/ /03/2016 Recruitment Finished
5 A Phase 2, Randomized, Placebo Controlled, Double Blind, Proof of concept Study of the Efficacy and Safety of PF in Subjects 25 14/YH/ with Huntington s disease 26 15/EM/ A Multi Center, Open Label Study Evaluating the Safety, Tolerability, and Efficacy of Pridopidine in Patients with Huntington s Disease (Open PRIDE HD) Agreed 4 10 Agreed 19/02/ /03/2016 Recruitment Finished Agreed 0 3 Agreed 30/07/ /02/2016 Recruitment Finished 27 15/LO/ Safety and Efficacy of Brimonidine Posterior Segment Drug Delivery System in Patients with Geographic Atrophy Secondary to Age-related Macular Degeneration. Agreed 8 10 Agreed 09/09/ /09/2016 Recruitment Finished 28 15/LO/ ARMOR3-SV A Phase 3, randomised, open label, multicentre, controlled study of Galeterone compared to Enzalutamide in men expressing androgen receptor splice variant-7 mrna (AR-V7) metastatic (M1) castrate resistant prostate cancer (CRPC). Effects of ODM-109 on respiratory function in with ALS. A randomised, double blind, placebocontrolled, cross-over, 3 period, multicentre study with open-label 29 15/LO/ follow-up extension /LO/ An Open-Label, Multicenter Clinical Trial with Nivolumab (BMS ) Monotherapy in Subjects with Advanced or Metastatic Squamous Cell (Sq) Non-Small Cell Lung Cancer (NSCLC) who Have Received at Least One Prior Systemic Regimen for the Treatment of Stage IIIb/IV SqNSCLC Agreed 0 0 Agreed 31/12/ /07/2016 Withdrawn By Sponsor Agreed 5 10 Agreed 31/07/ /07/2016 Recruitment Finished Agreed 9 9 Agreed 15/06/ /06/2016 Recruitment Finished
6 An open-label, multi-center, nonrandomized Phase Ib study to investigate safety and tolerability of radium Ra 223 dichloride (BAY ) administered in combination with paclitaxel in cancer subjects with 31 15/LO/ bone lesions. Agreed 2 4 Agreed 28/02/ /02/2016 Recruitment Finished 32 15/NW/ A Phase 3, Randomized, Doubleblind, 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. Agreed 5 8 Agreed 30/04/ /04/2016 Recruitment Finished 33 15/NW/ /SC/ A Prospective Observational Trial to Evaluate the Correlation of T-SPOT Response to CMV Infection and T cellmediated Acute Graft Rejection. The PROTECT Study. Agreed Agreed 31/01/ /09/2016 Recruitment Finished A randomised, double-blind, placebocontrolled, phase 3 trial of doxorubicin plus olaratumab versus doxorubicin plus placebo in with advanced or metastatic soft tissue sarcoma. Agreed Agreed 30/06/ /05/2016 Withdrawn By Sponsor 35 15/SC/ A Randomized, double blind, placebocontrolled, phase 3 study to assess the efficacy and safety of KRN23 in adults with x-linked hypophosphotaemia (XLH). Agreed 6 6 Agreed 30/06/ /06/2016 Recruitment Finished
7 A Randomized, Open-label, Phase 3 Study Assessing Safety and Efficacy in Subjects with Relapsed and Refractory Multiple Myeloma Receiving Once-weekly Carfilzomib Compared to Twice-weekly Carfilzomib in Combination with Dexamethasone /WM/ /YH/ Acceptability study on Nutricomp Drink Plus in adult Agreed 4 5 Agreed 30/08/ /08/2016 Recruitment Finished Agreed Agreed 31/10/ /10/2015 Recruitment Finished 38 15/YH/ 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 with atopic dermatitis. Agreed 0 5 Agreed 01/12/ /12/2015 Recruitment Finished 39 15/YH/ /EM/ Multi-center, Open-Label, Randomized, Two-Arm, Parallel- Group Study to Assess Efficacy and Safety of Envarsus Compared with Tacrolimus Used as Per Current Clinical Practice in the Initial Maintenance Setting in De Novo Kidney Transplant Patients The BAHA Attract System with Cochlear BAHA 5 SuperPower. Agreed 4 4 Agreed 30/08/ /07/2016 Recruitment Finished Agreed 3 5 Agreed 30/07/ /09/2016 Recruitment Finished 41 GTAC 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 tumourbearing pleural cavity (intrapleural) in with inoperable malignant pleural mesothelioma Agreed Agreed 26/09/ /09/2016 Recruitment Finished
Target date to recruit patients agreed? Target range minimum. Target range maximum. Agreed 1 1 Agreed 01/01/ /01/2016 Recruitment Finished
No REC Reference IRAS No Title Target number of patients agreed? Target range minimum Target range maximum Target date to recruit patients agreed? Planned Recruitment end date No of patients recruited
Target date to recruit patients agreed? Target range minimum. Target range maximum
No REC Reference IRAS No Title Target number of patients agreed? Target range minimum Target range maximum Target date to recruit patients agreed? Planned Recruitment end date Total no of patients recruited
Min number of patients agreed to be recruited. Max number of patients agreed to be recruited
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