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Statistical Analysis Plan (SAP) Clinical Development QAW039/Fevipiprant CQAW039A2314 / NCT03215758 A 52-week, multicenter, randomized, double-blind, placebo controlled study to assess the efficacy and safety of QAW039 when added to existing asthma therapy in patients with uncontrolled severe asthma Statistical Analysis Plan (SAP) Author: , Trial Statistician Document type: SAP Amendment 2 Document status: Final Release date: 26-Aug-2019 Number of pages: 61 Property of Novartis For business use only May not be used, divulged, published or otherwise disclosed without the consent of Novartis Novartis For business use only Page 2 SAP 26-Aug-2019 (10:13) CQAW039A2314 Novartis For business use only Page 3 SAP 26-Aug-2019 (10:13) CQAW039A2314 Table of contents Table of contents......................................................................................................... 3 1 Introduction................................................................................................................. 7 1.1 Study design.................................................................................................... 7 1.2 Study objectives and endpoints....................................................................... 8 Primary objective(s).................................................................................................... 8 Secondary objectives .................................................................................................. 8 9 2 Statistical methods .................................................................................................... 10 2.1 Data analysis general information................................................................. 10 2.1.1 Population..................................................................................... 10 2.1.2 Study day...................................................................................... 10 2.1.3 Baseline definition........................................................................ 10 2.1.4 Post-baseline measurement .......................................................... 12 2.1.5 Change from baseline................................................................... 12 2.1.6 Study completion and last contact................................................ 12 2.1.7 Visit remapping and assessment windows ................................... 12 2.2 Analysis sets.................................................................................................. 13 2.3 Patient disposition, demographics and other baseline characteristics........... 13 2.3.1 Patient disposition ........................................................................ 13 2.3.2 Background and demographic characteristics.............................. 14 2.3.3 Medical History............................................................................ 15 2.4 Subgroup of interest...................................................................................... 15 2.5 Treatments (study treatment, rescue medication, concomitant therapies, compliance)................................................................................................... 16 2.5.1 Study treatment / compliance ....................................................... 16 2.5.2 Prior, concomitant and post therapies .......................................... 17 2.6 Analysis of the primary objective ................................................................. 18 2.6.1 Primary endpoint .......................................................................... 18 2.6.2 Statistical hypothesis, model, and method of analysis ................. 21 2.6.3 Handling of missing values/censoring/discontinuations .............. 24 2.6.4 Supportive/sensitivity analyses .................................................... 25 2.7 Analysis of the key secondary objectives ..................................................... 26 2.7.1 Key secondary endpoints.............................................................. 26 2.7.2 Statistical hypothesis, model, and method of analysis ................. 27 2.7.3 Handling of missing values/censoring/discontinuations .............. 28 2.7.4 Supportive/sensitivity analysis for secondary endpoints.............. 29 29 Novartis For business use only Page 4 SAP 26-Aug-2019 (10:13) CQAW039A2314 29 30 31 31 31 31 34 34 34 34 2.9 Safety analyses.............................................................................................. 35 2.9.1 Adverse events (AEs)................................................................... 35 2.9.2 Laboratory data............................................................................. 36 2.9.3 Other safety data........................................................................... 41 43 44 2.12 Interim analysis............................................................................................. 44 3 Sample size calculation............................................................................................. 44 47 48 48 50 50 51 6 Appendix................................................................................................................... 51 6.1 Imputation rules ............................................................................................ 51 6.1.1 AE date imputation....................................................................... 51 6.1.2 Prior and Concomitant medication date imputation..................... 53 6.2 Statistical models .......................................................................................... 55 6.2.1 Primary analysis ........................................................................... 55 6.2.2 Key secondary analysis ................................................................ 57 6.3 Background asthma therapy.......................................................................... 58 6.3.1 Prednisone equivalent OCS doses................................................ 58 6.4 Rule of exclusion criteria of analysis sets..................................................... 59 7 Reference .................................................................................................................. 60 Novartis For business use only Page 5 SAP 26-Aug-2019 (10:13) CQAW039A2314 List of abbreviations ACQ Asthma Control Questionnaire AE Adverse event ALP Alkaline Phosphatase ALT Alanine aminotransferase AM ante meridiem ANCOVA Analysis of covariance AQLQ+12 Asthma Quality of Life Questionnaire for 12 years and above AR(1) Autoregressive model of order 1 AST Aspartate aminotransferase ATC Anatomical Therapeutic Classification AUC Area Under the Curve bid bis in diem/twice a day BMI Body Mass Index CM Concomitant Medication CSR Clinical Study Report DAR Drug administration record DMC Data Monitoring Committee DSPP Development Safety Profiling Plan ECG Electrocardiography eCRF Electronic Case Report Form FAS Full Analysis Set FEV1 Forced Expiratory Volume in 1 second HRQOL Health-Related Quality of Life ICS Inhaled Corticosteroid IDR Idiosyncratic drug reaction IgE Immunoglobulin E ImmunoCAPR Specific IgE test IRT Interactive Response Technology JRS Japan Respiratory Society LABA Long-acting Beta-agonist LAMA Long-acting muscarinic antagonist LTRA Leukotriene Receptor Antagonist MAR Missing at random MedDRA Medical Dictionary for Drug Regulatory Affairs MID Minimally Important Difference MMRM Mixed Model Repeated Measures OCS Oral corticosteroids PK Pharmacokinetics PM post meridiem PPS Per-Protocol Set PRO Patient-reported Outcomes QD Qua’que di’e / once a day PT Preferred Term Novartis For business use only Page 6 SAP 26-Aug-2019 (10:13) CQAW039A2314 QoL Quality of Life QTcF Fridericia QT correction formula RAN Randomized set RAST Radioallergosorbent test SABA Short acting β2-agonist SAE Serious adverse event SAF Safety set SAP Statistical Analysis Plan SCR Screened set SD Standard Deviation SGLT Sodium glucose transporter SGOT Serum glutamic oxaloacetic transaminase SMQ Standardised MedDRA Queries SOC System Organ Class SOC Standard of care TBL Total bilirubin TFLs Tables, Figures, Listings Th2 Type 2 helper T ULN Upper Limit of Normal Novartis For business use only Page 7 SAP 26-Aug-2019 (10:13) CQAW039A2314 1 Introduction Data will be analyzed by the sponsor according to the data analysis section 9 of the study protocol which is available in Appendix 16.1.1 of the CSR. Important information is given in the following sections and details will be provided, as applicable, in Appendix 16.1.9 of the CSR. 1.1 Study design This study uses a randomized, multicenter, double-blind, placebo-controlled parallel-group study design in which QAW039 or placebo is added to GINA steps 4 and 5 asthma therapy (Figure 1-1). The study will include: a Screening epoch of up to 2 weeks to assess eligibility; a Run-in epoch of approximately 2 weeks and a maximum of 6 weeks to collect baseline data for efficacy variables and compliance with the Electronic Peak Flow/ eDiary device (if a patient experiences an asthma exacerbation during the run-in epoch, the run-in epoch must be extended to 6 weeks to permit for resolution of the asthma exacerbation before randomization. The run-in epoch should only be extended beyond 2 weeks (+/- 5 days) for an asthma exacerbation.); a Treatment epoch of 52 weeks; a Follow-up epoch of 4 weeks, investigational and drug-free, following the last dose of study drug. Note: only applicable for patients not participating in the safety study CQAW039A2315.Popu;at Figure 1-1 Study design Upon completion of the run-in epoch, all patients
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