Clinical Study Synopsis

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1 Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace the advice of a healthcare professional and should not be considered as a recommendation. Patients should always seek medical advice before making any decisions on their treatment. Healthcare Professionals should always refer to the specific labelling information approved for the patient's country or region. Data in this document or on the related website should not be considered as prescribing advice. The study listed may include approved and non-approved formulations or treatment regimens. Data may differ from published or presented data and are a reflection of the limited information provided here. The results from a single trial need to be considered in the context of the totality of the available clinical research results for a drug. The results from a single study may not reflect the overall results for a drug. The following information is the property of Bayer HealthCare AG. Reproduction of all or part of this report is strictly prohibited without prior written permission from Bayer HealthCare AG. Commercial use of the information is only possible with the written permission of the proprietor and is subject to a license fee. Please note that the General Conditions of Use and the Privacy Statement of bayerhealthcare.com apply to the contents of this file.

2 Test Product Study Sponsor: Study Number: Study Phase: Official Study Title: Clinical Trial Results Synopsis Study Design Description Bayer HealthCare AG, Consumer Care IIa Therapeutic Area: Dermatology Name of Test Product: Name of Active Ingredient: Dose and Mode of Administration: Reference Therapy/Placebo NCT Double-blind, randomized, dose escalation study of the efficacy and safety of ZK ointment in concentrations of 0.01%, 0.03% and 0.1% over 4 weeks in patients with Atopic Dermatitis Mapracorat (ZK , BAY ) ZK The study drug to be applied topically as a thin layer in a non-occlusive way, in a dose depending on the concentration of ZK ointment (0.01%, 0.03%, and 0.1%) and the body surface area to be treated (2%, 6%, 15%, and 30%) once daily in morning. Reference Therapy: Vehicle ointment Dose and Mode of Administration: Vehicle ointment to be applied topically as a thin layer in a non-occlusive way, in a dose depending on the body surface area to be treated (2%, 6%, 15%, and 30%) once daily in the morning. Duration of Treatment: Subjects continued treatment for a minimum of 2 weeks and up to a maximum of 4 weeks. Studied period: Date of first subjects first visit: 15 JUL 2009 Date of last subjects last visit: 26 MAR 2010 Premature Study Suspension / Termination: Substantial Study Protocol Amendments: No None Study Center(s): The study was conducted in three centers in South Africa. Methodology: This was a multicenter, randomized, double-blind, vehiclecontrolled, dose escalation study of different concentrations of ZK This was an ambulatory study in which subjects were randomized to four treatment groups (0.01%, 0.03%, and 0.1% ZK ointment, and vehicle ointment [control]). Each subject was administered once daily double-blind topical applications of one of the four assigned treatments, respectively. The Subjects were treated in four sequential groups of 2%, 6%, 15 %, and 30% body surface area affected with atopic dermatitis (AD).Escalation to Page 1 of 10

3 the next sequential body surface area to be treated group was allowed depending on safety and tolerability data from the previous group. Study duration per subject was a maximum of 18 weeks with a screening visit (Visit 1) within 12 weeks prior to the first application of the study drug (baseline visit [Visit 2]). screening and baseline visits may coincide. Treatment period was a minimum of 2 weeks and up to 4 weeks with baseline visit and three weekly visit intervals (Visits 3, 4, and 5). A follow-up period consisted of 2 weeks, also called End-of-Study visit or Visit 7 (2 weeks after application of the last dose of the study medication [End of study medication visit or Visit 6]). A subject diary (paper booklet) was used to help the subject follow directions of the clinical study protocol. Subjects kept the diary after screening until the End-of- Study visit (Visit 7). The efficacy variables, clinical signs of AD at target lesions (representative and maximum), and the Investigator's Global Assessment (IGA) of the target area were evaluated at all visits. Pictures of the target lesions were taken before the study medication started (baseline visit) and at Visits 4, 6, and 7. Blood sampling to evaluate the pharmacokinetic (PK) parameters was done at the baseline visit, and at Visits 3, 4, 5, and 6. Safety variables included recording of adverse events (AEs) at the baseline visit, and at Visits 3-7. Vitals, ECG, and blood chemistry were also evaluated. Indication/ Main Inclusion Criteria: Treatment with the study medication was stopped in case the investigator made the assessment that the area treated clinically no longer showed any sign of inflammation (IGA score 0). Indication: Atopic dermatitis Main inclusion criteria: Signed written informed consent before any study-related activities were carried out Male or female subject aged 18 to 55 years at screening. Females either using an accepted effective method of contraception or of non-childbearing potential (i.e., postmenopausal - one year without menstrual period, tubal ligation, or hysterectomy). Males agreed not to father a child during participation in the study. Diagnosis of AD according to Hanifin and Rajka criteria. Static IGA score of 2 or 3 corresponding to mild to moderate AD at start of treatment. Body surface area affected by AD lesions: 5%-40% at start of treatment. Clinical signs of inflammation (i.e., erythema, infiltration/papulation, excoriation, and lichenification) at target Page 2 of 10

4 Study Objectives: lesion scored 4. Wash-out periods to be observed before start of the treatment: At least 3 months had passed since any systemic interferon, immunomodulating, or immunosuppressive treatment. At least 1 month had passed since any use of systemic AD therapy, e.g., systemic corticosteroids, cyclosporine A, azathioprine, mycophenolate mofetil, or phototherapy. At least 2 weeks had passed since any local AD therapy, e.g., corticosteroids or topical immunomodulators. At least 2 weeks had passed since systemic antibiotics. Willingness of the subjects to follow all the study procedures. Willingness of the subjects to avoid excessive exposure of diseased areas to natural or artificial sunlight. Subjects need to be literate in order to complete the diary. Primary: To assess the severity of AD at the maximum target lesion based on clinical signs of inflammation (i.e., erythema, infiltration/papulation, excoriation, and lichenification) assessed by the investigator after administration of ZK %, 0.03%, and 0.1% ointment and its vehicle. Evaluation Criteria: Secondary: To assess the severity of AD at the representative target lesion based on clinical signs of inflammation assessed by the investigator after administration of ZK %, 0.03%, and 0.1% ointment and its vehicle. To assess the severity of AD at the target area based on the IGA assessed by the investigator after administration of ZK %, 0.03%, and 0.1% ointment and its vehicle. To evaluate the safety and tolerability of ZK ointment when applied in concentrations of 0.01%, 0.03%, and 0.1% to the increased body surface areas. To assess the systemic exposure to ZK after topical, non-occlusive application of ZK %, 0.03%, and 0.1% ointment to the increased body surface areas. To assess the dose-response relationship of ZK after topical, non-occlusive application of concentrations of 0.01%, 0.03%, and 0.1% to the increased body surface areas. Efficacy (Primary): Eczema severity index (ESI): The ESI in the maximum target lesion (maximum target lesion is a lesion with the maximum severity of AD in the target area of a particular subject). The ESI is based on the clinical signs of AD (erythema,infiltration/papulation, excoriation, and lichenification). The ESI was calculated as the sum of the scores of the four clinical signs of AD at a given visit. The primary time point for the analysis of the ESI was the End-of-study medication visit. Clinical signs of inflammation at target lesion was graded on a Page 3 of 10

5 scale of 0 to 3 (severe) (0 = none, 1 = mild, 2 = moderate, 3 = severe, half-steps allowed). Efficacy (Secondary): The ESI in the respresentative target lesion (Representative target lesion is a lesion representing the average severity of AD in a particular subject) Combined end-point ESI (maximum and respresentative target lesion): the clinical signs of AD (erythema, infiltration/papulation, excoriation, and lichenification) in the target lesions. IGA of the target area: IGA was assessed up to 4 weeks and consisted of a 6-point scale ranging from totally clear (0) to very severe disease (5). Safety: Safety parameters included AEs, local tolerability, safety laboratory (urine pregnancy test), electrocardiogram (ECG), vital signs, physical examination, serology, and drug and alcohol screening. Each AE was classified using the Medical Dictionary for Regulatory Activities (MedDRA, Version 11.0). Pharmacokinetics: The PK parameters included ZK serum concentrations and PK variables including the area under curve (AUC) for estimation of exposure. Statistical Methods: Efficacy was evaluated for two subject data sets, the full analysis set (FAS), and the per protocol set (PPS). All the subjects who were randomized and had investigational product dispensed were included into the FAS. The PPS was a subset of the FAS. The subjects with major protocol deviations and subjects who discontinued the study prematurely were excluded from the PPS. The primary analysis set for evaluation of the efficacy variables was the FAS. Additionally, the efficacy variables were analyzed for the PPS. Safety analyses were performed using the FAS data. All the subjects' data were presented in the individual subject listing. Efficacy (Primary): The following hypothesis was tested: H0: The mean ESI is equal in all treatment groups HA: The mean ESI is not equal in all treatment groups The primary time point for analysis of the primary efficacy variable was the end-of-study medication - usually values 4 weeks after Page 4 of 10

6 start of treatment, or if the subject prematurely discontinued the treatment, the last available data (last observation carried forward [LOCF] value) approach was carried. For subjects with lack of efficacy data post-baseline, the baseline value was analyzed. The treatment concentration effect for the ESI was investigated by analysis of variance (ANOVA) with the treatment concentration as a factor. A two-sided 0.05 significance level was used. Point estimates and 95% confidence intervals for pairwise differences in least square means between treatment groups was obtained from the ANOVA. Efficacy (Secondary): At each visit after baseline, the nominal scores and the grouped change from the baseline (improved, no change, worsened) was considered for the clinical signs of AD and the IGA. A subject was considered improved in an efficacy variable if the score at the visit was at least 2 half-steps better compared to the score at the baseline, not changed if the score was within ± 1 half-step compared to baseline, and worsened if the scores at a post-baseline visit was at least 2 half-steps worse compared to the baseline. For the ESI, the nominal values and the change from baseline were analyzed. Change from the baseline was defined as the difference between the baseline and an interim visit (Change = Baseline Interim visit). All efficacy analyses were provided by treatment group. Efficacy data for individual time points were replaced using the LOCF approach. Baseline values were carried forward, if appropriate. All the original and derived efficacy parameters as well as population characteristics were described using summary statistics. Subgroup analyses with regard to sex and age (<35 years/ 35 years) were considered. Subgroup analyses were performed for the ESI, for the clinical signs of AD, and for IGA at the End-of-Study Medication (Visit 6). Safety: All the AEs were coded using the MedDRA Version 11.0 and were evaluated under these codes. In addition, the incidence of cutaneous AEs was analyzed. Contraceptive methods and pregnancy test results were listed by the subject. All available vital signs (including height and weight); all available biochemistry (hematology and urinalysis data); and ECG data are listed by the subject and summarized using descriptive statistics by treatment group and visit. Absolute relative frequencies for abnormal low, normal, and abnormal high values (only for biochemistry and hematology parameters) were also summarized. Descriptive statistics for change from the baseline were also presented. Prior and concomitant medication were coded according to Page 5 of 10

7 Version 6.08 of the World Health Organization-Drug Reference List and the Anatomical Therapeutic Chemical classification system. Serology data were listed and summarized using absolute relative frequencies. Pharmacokinetics: The concentration-time data were analyzed by population PK modeling. An individual measure of exposure (e.g., area under concentration curve) was estimated using the developed PK model PK analysis. Number of Subjects: Planned: 64 subjects (16 subjects per sequence, 4 subjects per treatment) Screened: 118 subjects Results Summary Subject Disposition and Baseline Randomized and analyzed: 62 subjects allocated to four treatment groups in a 1:1:1:1 ratio 15 subjects in the 0.01% ZK treatment arm 16 subjects in the 0.03% ZK treatment arm 16 subjects in the 0.1% ZK treatment arm 15 subjects in the vehicle treatment arm Study Results A total of 64 male or female subjects with mild to moderate AD (IGA score of 2 or 3, and 5%-40% affected body surface area) were planned for inclusion in the study. Of the 62 subjects randomized and analyzed, 54 subjects (87.1%) completed the study (11 subjects in the 0.01% ZK treatment arm, 13 subjects in the 0.03% ZK treatment arm, 15 subjects in the 0.1% ZK treatment arm, and 15 subjects in the vehicle treatment arm). One subject (vehicle treatment group) was additionally excluded from the originally defined PPS[a] due to quantifiable ZK PK concentrations detected after database lock and unblinding, and the population was defined as PPS[b]. Sixty-two subjects (52.5%) were included in the FAS, 51 subjects (82.26%) were included in the PPS[a], and 50 subjects (80.65%) in the PPS[b]. In the FAS, the mean age of the subject was 30.0 years (range: 18-54) with the number of females being 42 and the number of males being 20. The mean height and weight of the subjects was cm (range: ) and 74.0 kg (range: ), respectively. The majority of subjects (49 [79.03%]) were white, and 23 (37.10%) and 15 (24.19%) subjects were categorized as black and Asian race groups, respectively. No subjects were of Hispanic or Latino ethnicity. After a 3-month extension period for recruitment, subject recruitment was terminated after 62 subjects due to exhaustion of the AD subject pool. Results Summary Efficacy Primary efficacy variables: ESI: The primary analysis of the FAS population for the primary variable ESI score at the maximum target lesion showed that the ESI remained constant at approximately 6 units from screening to start of study medication (Visit 2). After start of study medication, the ESI decreased in all treatment groups from Visit 2 to Visit 4 (Week 2). Notable Page 6 of 10

8 improvements were observed for the 0.1% ZK treatment group followed by the 0.03% ZK treatment group. The mean value for the 0.01% ZK treatment group was to some extent higher compared to other treatment groups at baseline and remained above other treatment groups including vehicle during the treatment phase. The most notable change in mean values was observed in the 0.1% ZK treatment group during the treatment phase; however, further improvement was not noted after Visit 4. After 2 weeks of follow-up, there were no apparent differences between the treatment groups. The differences between the treatment groups were not statistically significant at any time point. Also for the PPS populations, the mean ESI decreased, especially between Visit 2 (baseline visit) and Visit 4 (Week 2). However, the 0.01% ZK treatment group reached approximately the effect of the 0.1% ZK treatment group. This difference in the populations can be explained by the exclusion of the subjects who prematurely discontinued the study due to cutaneous AEs. In the 0.01% ZK treatment group, three subjects discontinued due to cutaneous AEs (one case of worsening of AD and two cases of burning skin), whereas in the 0.03% ZK treatment group only one subject and in the other two treatment groups (0.1% ZK and vehicle) no subject discontinued due to cutaneous AEs. Secondary efficacy variables: The ESI in the representative target lesion: The mean ESI for the FAS population at screening and baseline visits for the representative target lesion was approximately 5 units for all the treatment groups (approximately 1 unit lower compared to the values observed for the maximum target lesion). After start of the study medication, the ESI decreased in all treatment groups. However, most notable results were observed for the 0.1% ZK treatment group at the end of the study medication; the differentiation between the treatment groups was not as pronounced as observed for the maximum target lesion. This might be due to the somehow lower starting point. Especially when comparing the mean change from baseline, no differences were observed between the 0.03% ZK , 0.01% ZK , and the vehicle treatment groups. Differences between treatments groups in mean ESI at the representative target lesion were not statistically significant at any time point for the FAS. Combined end-point ESI (maximum and respresentative target lesion): The reductions observed for the combined endpoint ESI (maximum target lesion and representative target lesion) was the sum of small changes observed in all signs of the ESI. All signs of AD - erythema, infiltration/papulation, excoriation, and lichenification - contributed to the overall effect observed in the treatment groups. For no sign of AD, a worsening or no effect was observed. IGA: All subjects in the FAS in all treatment groups had IGA scores of mild or moderate at the screening and baseline visits. The number of subjects with mild IGA was twice as high in the 0.03% and the 0.1% ZK treatment groups compared to the 0.01% ZK and the vehicle treatment group; however, differences were not statistically significant. Notably after start of study medication, the percentage of subjects assessed as clear or almost clear at Visit 3 was highest in the 0.1% ZK treatment group (50% in the 0.1% ZK treatment group), compared to 37.5% in the 0.03% ZK treatment group, 33.3% in the 0.01% ZK treatment group, and 13.3% in the vehicle treatment group. During treatment with the study medication, the percentage of subjects with clear or almost clear IGA reached over 60% in the 0.03% Page 7 of 10

9 ZK and the 0.1% ZK treatment groups. In contrast, the percentage of subjects with clear or almost clear IGA in the 0.01% ZK treatment group reached 40% at Visit 4 and did not show any further increase. In the vehicle treatment group, 46.7% of the subjects had a clear or almost clear IGA at the end of treatment. The planned statistical analyses for differences between the treatment groups of all IGA scores were not statistically significant for the FAS population at any treatment visit. The analyses of the PPS[a] and the PPS[b] set for all secondary efficacy endpoints need to be interpreted carefully due to the exclusion of subjects who discontinued the study treatment due to cutaneous AEs. No trends or statistically significant differences were observed during subgroup analyses. Results Summary Safety Mean treatment and study durations were generally comparable between treatment groups. Overall, 103 AEs were observed during this study. The majority of reported AEs were considered treatment-emergent AEs (TEAEs; 97 out of 103). The severity was mild to moderate and the outcome was "recovered completely" for the majority of TEAEs. Out of the 97 TEAEs, 41 incidences were considered drug-related. Seventy-one (71) out of the 97 incidences of TEAEs were reported in the three ZK treatment groups, compared with 26 incidences in the vehicle treatment group. Incidences of TEAEs were evenly distributed between all the ZK groups and the vehicle treatment group. Almost all drug-related incidences of TEAEs were cutaneous events (38 of the 41 TEAEs reported). Among the three drug-related non-cutaneous TEAEs were two events of headache (0.1% and vehicle) and an event of loss of appetite (vehicle). The incidence of drug-related cutaneous TEAEs - vehicle: 9 events, 0.01% ZK : 12 events, 0.03% ZK : 6 events, 0.1% ZK : 11 events - did not show an increase with increase of the study drug concentration. All cutaneous drug-related TEAEs were considered as local events (i.e., occurring at the application site) with the exception of one event of worsening of AD in the 0.03% ZK treatment group. No deaths were reported during this study. Only two (3.23%) subjects reported serious adverse events (SAEs); both the events occurred in subjects in the 0.03% ZK treatment group and were considered to be unrelated to the study medication and study conduct. The most commonly reported System Organ Class (SOC) of the non-cutaneous TEAEs was "Infections and infestations" (11 [23.4%] subjects in the ZK treatment groups and 9 [53.3%] subjects in the vehicle treatment group). Within this SOC, the preferred terms nasopharyngitis and upper respiratory tract infection had an incidence of 10% in at least one treatment group. The most commonly reported cutaneous TEAE was pruritus (9 [19.1%] subjects in the ZK treatment groups and 4 [26.7%] subjects in the vehicle treatment group). In total, 7 (11.29%) subjects (3 [20.0%] subjects in the 0.01% ZK treatment group, 3 [18.8%] subjects in the 0.03% ZK treatment group, and 1 [6.3%] Page 8 of 10

10 subject in the 0.1% ZK treatment group) were withdrawn from the study due to AEs. These events include the two unrelated SAEs described above and further two events not related to the study treatment. Among the three related events were two cases of burning skin (both in the 0.01% ZK treatment group) and one event of pain of skin (0.01% ZK treatment group). Physical examinations were at least performed for the following body systems/organs: ears, eyes, nose and throat, head, neck, lungs, heart, abdomen, kidneys, lymph nodes, vascular state, skin / dermatological, musculoskeletal, and neurological. All randomized subjects (62 [100%]) reported at least one medical history; a total of 268 events. As expected, all (62 [100%]) randomized subjects had a medical history of skin and subcutaneous tissue disorders, which mostly comprised dermatitis atopic (56 [90.32%] subjects), with the remaining six (9.68%) subjects diagnosed with eczema. Immune system disorders were reported by 54.84% of subjects, and respiratory, thoracic and mediastinal disorders by 53.23% of subjects. All subjects enrolled into the study tested negative for Hepatitis B virus surface antigen (HBsAg), Human immunodeficiency virus (HIV), and Hepatitis C virus (HCV). All subjects tested negative for alcohol at screening, however, alcohol testing was not reported in 15 subjects. No clinically relevant changes in biochemistry variables, hematology variables, urinalysis variables, vital signs, or ECGs were observed during the study. No case of pregnancy was reported. The safety profile indicates that all three formulations of ZK (0.01%, 0.03%, and 0.1% ) were equally well tolerated by all subjects. Results Summary Pharmacokinetics Wide variability in ZK concentration was demonstrated across subjects at each of the sampling time points and for each ZK concentration and body surface area treated. Based on mean concentration data, systemic availability generally increased with increased ZK concentration from 0.01 to 0.1%. Exposure also appeared to increase with increase in body surface area treated from 2% to 30%; however, there was considerable variability in PK across visits. Clear outliers that were observed may also be skewing the mean data, as a number of concentrations are pharmacokinetically implausible. Contamination of the blood sample by the skin application area is the most plausible explanation for outliers and high fluctuations within subjects between visits. In subjects in whom body surface areas as high as 30% were treated, the possibility of clothing and other surfaces becoming contaminated and leading to further contact cross-contamination also can not be excluded. Furthermore, concentrations prior to dose that were higher than post-dose indicate possible contamination by the study staff performing PK sampling. In future, procedures to avoid contamination should be optimized. Conclusion(s) This clinical study was analyzed in an exploratory manner. Even though statistical significance was not observed, notable improvements in ESI at the maximum target Page 9 of 10

11 lesion were observed for the 0.1% ZK treatment group followed by the 0.03% ZK treatment group. The ESI was also observed to decrease in all treatment groups at the representative target lesion. In addition, 50% of subjects in the 0.1% ZK treatment group, compared to 37.5% in the 0.03% ZK treatment group, 33.3% in the 0.01% ZK treatment group, and 13.3% in the vehicle treatment group presented with clear or almost clear IGA after 1 week of treatment. The safety profile indicates that 0.01% ZK , 0.03% ZK , and 0.1% ZK were equally well tolerated by all the subjects. Publication(s): None Date Created or Date Last Updated: 21 MAR 2014 Date of Clinical Study Report: 06 SEP 2010 Page 10 of 10

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