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. Reproduction of all or part of this report is strictly prohibited without prior written permission from Bayer HealthCare. 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 Clinical Trial Results Synopsis Study Sponsor: Bayer HealthCare Study Number: ( ) Study Phase: I Study Design Description NCT Official Study Title: Investigator-blinded, randomized, cross-over, multiple dose phase-1 study on safety and pharmacokinetics of topically applied Azelaic acid foam, 15% compared to Azelaic acid gel, 15% in subjects with papulopustular rosacea Therapeutic Area: Dermatology Test Product Name of Test Product: Name of Active Ingredient: Dose and Mode of Administration: Azelaic acid foam, 15% (BAY ) Azelaic acid (AzA) 75 mg AzA (0.5 g foam) per application, twice-daily applications (i.e., in morning and evening) corresponding to 150 mg AzA per day once daily application on day 7 The AzA foam, 15% corresponding to the size of a walnut was used per application in a non-occlusive fashion for the entire facial area (cheeks, chin, forehead, and nose) and was rubbed in gently until disappearance. Reference Therapy/Placebo Reference Therapy: Azelaic acid gel, 15% (Finacea gel, BAY ) Dose and Mode of Administration: 75 mg AzA (0.5 g gel) per application, twice-daily applications (i.e., in morning and evening) corresponding to 150 mg AzA per day, once daily application on day 7. The AzA gel, 15% corresponding to 2.5 cm (1 inch) of gel formulation was to be used per application in a non-occlusive fashion for the entire facial area (cheeks, chin, forehead, and nose) and was to be rubbed in gently until disappearance. Duration of Treatment: For each application period, treatment duration was of seven days. Studied period: Date of first subject s first visit: 31 JAN 2011 Date of last subject s last visit: 14 MAR 2011 Premature Study Suspension / Termination: Substantial Study Protocol Amendments: No The study was conducted according to the integrated protocol Version 2.0 dated 16 NOV 2010, which incorporated Amendment 01. No changes to the study conduct or measurements were implemented after the start of the study. Amendment No. 1 dated 16 NOV 2010 introduced the following changes: An intensified blood sampling regimen was implemented which Page 1 of 9

3 included an additional 12 hours post-dose sample on Day 1 and blood sampling up to 36 hours post-dose on Day 7 of both periods. Baseline sampling scheme was added before second period and additional pharmacokinetic (PK) blood samples were collected up to 12 hours on Day 1 of both periods for AzA baseline concentration. Study population was modified to include subjects with moderate rosacea to be consistent with the upper range of severity of the proposed indication and to exclude subjects with papulopustular rosacea, who required systemic treatment. The inclusion criteria with regard to the Investigator s Global Assessment (IGA) score and the number of inflammatory lesions was re-confirmed on Day 1 of the second period, and the subjects were withdrawn if inclusion criteria was no longer fulfilled. The washout period between the two periods was extended up to 14 days. Study Center(s): This study was conducted at three centers in the United States. Methodology: This was an ambulatory, investigator-blinded, randomized, cross-over, Phase 1 multi-centric clinical study. The study comprised a screening phase (Day 30 to Day 3), first period (Day 2 to Day 7), washout period (5-14 days), and second period [Day 2 to Day 7/end of study (EOS)]. The two treatment periods had a 3 day assessment of baseline levels of AzA and its metabolite pimelic acid (PA), followed by an application of the study drug twice daily for 7 days during each period. The total number of visits per subject was 13 including the screening and EOS visit. Depending on the interval between the screening and Visit 1 and the length of the washout phase, the study duration per subject was days. On Visit 3 before the first application of the study drug, the subjects were randomized to the following treatment sequences: Treatment sequence 1: First period: AzA foam, 15%, second period: AzA gel, 15% Treatment sequence 2: First period: AzA gel, 15%, second period: AzA foam, 15% Subjects were asked to maintain a usage diary, in which they recorded the date and time of medication application. Pharmacokinetic (PK) assessments were done by collecting blood samples during both the treatment periods in the following sequence: on Days 2 and 1 for baseline concentration measurement additional blood samples 1, 2, 3, 4, 6, 9, and 12 hours post-baseline on Day 1 pre-morning dose and 12 hours post-dose sample on Day 1 single pre-morning dose sample on Days 5 and 6 pre-morning dose and 1, 2, 3, 4, 6, 9, 12, 24, and 36 hours Page 2 of 9

4 post-dose sample on Day 7 Safety (adverse events [AEs] including serious AEs [SAEs], local cutaneous AEs) was assessed at all study visits (except screening). Safety was also assessed by recording vital signs (blood pressure, heart rate) at each visit. Medical/surgical history and prior and concomitant therapy were also recorded. Laboratory tests like urine pregnancy test and serology for human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV) were done only at screening. Indication/Main Inclusion Criteria: The status of rosacea, i.e., IGA score, number of inflammatory lesions (papules and/ or pustules), was again assessed on Days 1 and 7 of the first and second periods. Indication Papulopustular rosacea Main inclusion criteria Diagnosis of moderate papulopustular rosacea, defined as IGA score of moderate or severe and a minimum of 15 and no more than 50 inflammatory lesions (papules and/or pustules), and persistent erythema with or without telangiectasia Free of any clinically significant disease, which could interfere with the study Male and female subjects aged 18 years Body mass index (BMI) of kg/m 2 with a body weight between 50 and 130 kg (between 110 and 286 pounds) Signed written informed consent before any study-related activities are carried out Willingness of subject to follow all the study procedures Study Objectives: Overall: Assessment of PK of AzA after repeated dermal application of AzA foam, 15% and AzA gel, 15% in subjects with papulopustular rosacea. Assessment of safety of AzA foam, 15% after repeated dermal application in subjects with papulopustular rosacea. Comparison of PK of AzA foam, 15% and AzA gel, 15% after repeated dermal application in subjects with papulopustular rosacea. Evaluation Criteria: Safety: Adverse events: All AEs were assessed and documented by investigator according to their seriousness, intensity (mild, moderate, or severe), frequency, causal relationship with the study drug, action taken on the investigational drug, and outcome of the event. Each AE was classified using the Medical Dictionary for Regulatory Activities (MedDRA; Version 13.1). In case of cutaneous AE, an additional assessment was made by the investigator: Local reaction, i.e., occurring at application site (yes/no). If Page 3 of 9

5 yes, the localization was documented and specified (face, scalp, intertriginous, extremities, trunk, other). Duration, i.e., transient: occurs and subsides within 60 minutes after onset of the AE or persistent: subsides after more than 60 minutes after onset of AE. Other safety variables: Vitals such as blood pressure and heart rate were measured at every visit. Any significant deviations from the reference range were duly noted. Pharmacokinetics: Primary PK variable: Baseline corrected AUC0-12h: Area under the plasma level time curve (AUC) from start of the respective treatment until the time point of 12 hours was calculated to assess the systemic exposure of AzA and PA. It was evaluated after repeated dose of either foam or gel (depending on the treatment arm) from the blood samples on Day 7 of both the application periods. Secondary PK variables: Original (non-corrected) AUC0-12h for AzA and PA for pre-treatment phase and after repeated dose interval After repeated dose, the non-corrected and baseline-corrected AUC0-36h Original (non-corrected) and baseline-corrected Cmax for AzA and PA and corresponding Tmax values after repeated dose Baseline morning concentrations (Visits 1, 2, and 3 of the first period and Visits 7, 8, and 9 of the second period) were compared with pre-dose morning concentrations after repeated dose on Days 5, 6, and 7 of both the periods Effect of topical application of AzA foam, 15% and AzA gel, 15% on endogenous levels of AzA and PA were evaluated, comparing Cmax and AUC0-12h obtained pre- and post-dose. Statistical Methods: Data was evaluated using the following analysis sets: Full analysis set (FAS): All subjects who were randomized and had investigational product dispensed. Per protocol set (PPS): The PPS was a subset of the FAS. The PPS included all the subjects of FAS except those with major protocol deviations and those who discontinued the study prematurely. Safety: Safety was analyzed using the FAS. Data on safety and assessment of rosacea was reported using descriptive statistics. Pharmacokinetics: The PK analysis (both primary and secondary variables) was performed for the FAS and PPS. Descriptive statistics (number [N], mean, standard deviation, median, quartiles) was used to describe the PK variables. For the original and plasma concentration values used for the calculation of the AUC0-12h (dosing interval), the individual and mean plasma-concentration vs. time curves were plotted by Page 4 of 9

6 Number of Subjects: treatment using both linear and semi-logarithmic scale. In addition, the log values of baseline-corrected PK parameters AUC0-12h and Cmax were analyzed using an analysis of variance (ANOVA) including sequence, subject (sequence), and period and treatment effects. For baseline-corrected AUC0-12h, Hodges-Lehmann estimates of difference and 90% confidence interval for Test vs Reference mean were used. Based on above analyses, point estimates (least-square means) and exploratory 90% confidence intervals for the ratio "AzA foam, 15%/AzA gel, 15%" of AUC0-12h and Cmax of AzA and PA was calculated by re-transformation of the logarithmic data using the intra-individual standard deviation of the ANOVA. Percentage change of selected PK parameters (AUC0-12h and Cmax values) between pre-treatment and post-treatment was also calculated. The effect of topical application of foam and gel preparations on endogenous AzA and PA levels was evaluated by comparing parameters (Cmax, AUC0-12h) obtained pre- and post-treatment. Planned: 24 subjects Analyzed: 21 subjects Results Summary Subject Disposition and Baseline Study Results A total of 73 subjects were screened and 24 subjects with moderate papulopustular rosacea were enrolled in the study. Twenty-one subjects completed the clinical part of the study. The FAS comprised 24 subjects and the PPS comprised 21 subjects. Disease severity was similar at the start of the two respective treatment phases; thus, no clinically relevant differences between the treatment groups/treatment phases were noted. For all 21 subjects included in the PPS, full compliance measured by number of actually applied applications of the investigational drug, as documented in the patient diary [100% of anticipated doses), was reached. In the FAS, full compliance was reached for 91.7% (22 of the 24 subjects) of the subjects. Results Summary Safety Adverse events A total of 32 treatment-emergent AEs (TEAEs) were reported in 9 subjects (37.5%) during all treatment phases. Of these, 18 AEs occurred in the AzA foam, 15% treatment phase and 14 AEs occurred in the AzA gel, 15% treatment phase. Adverse events assessed as related to the investigational product were reported in 5 subjects (20.8%) in the AzA foam, 15% treatment phase and in 5 subjects (21.7%) in the AzA gel, 15% treatment phase. These AEs were local cutaneous events: application site discolouration, dryness, erythema, pain, pruritus, rosacea, and seborrhoea. No other cutaneous and systemic AEs were treatment related. All AEs assessed as related to the investigational product were mild in intensity for both the treatment phases. One subject experienced deterioration of his pre-existing condition of rosacea such that he no longer met the inclusion criteria at the beginning of the second treatment phase of the study and was discontinued from further study participation at that time. The worsening of the subject s pre-existing condition of rosacea was judged as an AE which showed a reasonable causal relationship to the study drug. Page 5 of 9

7 No subject died, and no SAEs were reported during the study. All reported AEs were treatment-emergent, and there were no systemic AEs. Local site tolerability as assessed by the frequency and type of the study drug-related cutaneous AEs were comparable between the AzA foam, 15% group and the AzA gel, 15% group. Other Safety Variables No pregnancies were reported for any female subject or any female partner of a male study subject during the conduct of this study. Serology tests (HIV, HBV, HCV) and pregnancy tests were negative for all randomized subjects. In subjects who failed screening, there were also no positive pregnancy tests and no positive HBV tests, while one screening-failure subject had a positive HCV test, and another screening-failure subject had a positive HIV test. No deviations were recorded while monitoring vital signs during the study. Results Summary Pharmacokinetics In this study, for both treatments the analytes AzA and its metabolite PA in rosacea subjects were higher compared to measurements done at the time period before start of treatment. Across both treatments, lower values were observed for foam compared to gel. The maximum occurring AzA plasma concentration under a standardized diet obtained from rosacea subjects without treatment (before start of a treatment period) was ng/ml, while the maximum occurring AzA plasma concentration in rosacea subjects treated with AzA foam, 15% was ng/ml. The maximum observed mean concentration for the rosacea subject population occurring during the treatment period with AzA foam, 15% (Day 7, 12 hour value: ng/ml) also were within this range. After start of treatment, the uncorrected mean values of the plasma concentrations of both the analytes (AzA and PA) increased for AzA foam, 15% and AzA gel, 15%. At Day 7, the uncorrected mean concentrations for AzA foam, 15% of both the analytes were lower compared to AzA gel, 15% with the exception of the 36 hours after last treatment application time point. After baseline correction, the mean values of the Day 7 AzA and PA concentrations were always lower for AzA foam, 15% compared to AzA gel, 15%. The plasma levels for the analytes tended to vary significantly between the individuals and also intra-individually over time. The key PK parameters AUC0-12h, AUC0-36h, and Cmax (uncorrected as well as baseline corrected) were obtained for the analyte AzA as well as for its metabolite PA. Endogenous concentrations were assessed by the variable BASELINE, defined as the median of baseline morning concentrations on Days 2, 1, and 1 (pre-dose). Page 6 of 9

8 The following tables briefly summarize the key parameters: Table 1: Summary of pharmacokinetic parameters for analyte Azelaic Acid Table 2: Summary of pharmacokinetic parameters for analyte Pimelic Acid Page 7 of 9

9 Table 3: Summary of pharmacokinetic analysis (point estimates) The variable EQUIL was defined as the median of pre-dose morning concentrations on Days 5, 6, and 7. Each of these variables was calculated separately for each treatment period. The key PK parameters AUC(0-12h), AUC(0-36h), and Cmax show lower values for the AzA foam, 15% compared to AzA gel, 15%. This can be seen for the baseline-corrected as well as the uncorrected parameters for both the analytes. Uptake of exogenic AzA is indicated by the baseline-corrected AUC(0-12h) values for both the treatments. The mean of the variable EQUIL was higher than the mean of the variable BASELINE for both the analytes and treatments, also indicating uptake of exogenous AzA. The increase, however, was lower for AzA foam, 15% compared to AzA gel, 15%. For the primary PK parameter baseline-corrected AUC0-12h of the analyte AzA, statistical analysis revealed a ratio of (90% confidence interval ) for AzA foam, 15% compared to AzA gel, 15%, thus excluding the point of no difference for AzA foam, 15% compared to AzA gel, 15%. Statistical analysis confirmed that there was lower systemic burden of AzA under the treatment with AzA foam, 15%, versus the treatment with AzA gel, 15%. The same was observed for the secondary PK parameters AUC0-36h and Cmax of the analyte AzA and AUC0-12h, AUC0-36h, and Cmax for the analyte PA. As described above, all evaluated PK data obtained in this study, including the primary endpoint baseline-corrected AUC0-12h, demonstrated that the occurring plasma levels of AzA and PA after treatment with AzA foam, 15% were not higher, but appeared to be even lower than the occurring plasma levels that were observed after treatment with AzA gel, 15%. However, these results should be interpreted bearing in mind that the Page 8 of 9

10 measured plasma levels are not only dependent on other external sources such as nutritional factors, but probably also on endogenous sources. Therefore, a relatively high volatility of these naturally occurring plasma levels also in untreated subjects should be taken into consideration. This is supported by the observed increase in plasma concentrations from Day 7, 24 hours to Day 7, 36 hours. The maximum AzA concentration observed for AzA foam, 15% was lower compared to the maximum concentration observed during pre-treatment. Conclusion(s) The present study concluded that treatment with AzA foam, 15% did not result in a higher systemic burden of AzA or PA when compared to the AzA gel, 15%. Results of the study confirmed the historical data that mean AzA plasma levels stay within the endogenous range after topical application. Both administered drug formulations appeared to be safe and equally well tolerated. Publication(s): None at the time of report creation. Date Created or Date Last Updated: 09 JUL 2015 Date of Clinical Study Report: 12 MAR 2013 Page 9 of 9

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