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Clinical Trials Appendix

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Clinical Trials Appendix Clinical Trials Appendices List of abbreviations AE Adverse Events IAR Infusion Associated Reaction QNM Every N Months APO Apolipoprotein IC Investigator’s Choice QOL Quality Of Life BOR Best Overall Response IGA Investigator’s Global Assessment RECIST Response Evaluation Criteria in Solid Tumors BW Body Weight IMID Immunomodulatory Drug SAE Serious Adverse Events CB Clinical Benefit ITT Intent To Treat SBP Systolic Blood Pressure CNS Central Nervous System LP Lipoprotein SDMT Symbol Digit Modalities Test CR Complete Response MRI Magnetic Resonance Imaging SMPG Self Monitored Plasma Glucose CRR Complete Response Rate MTD Maximum Tolerated Dose SSD Study Start Date CT Computed Tomography N Number TC Total Cholesterol CV Cardiovascular NC Nasal Congestion/obstruction TEAE Treatment Emergent Adverse Events DE Data Expected NNT Number Needed to Treat TSS Total Symptom Score DCR Disease Control Rate OS Overall Survival TG Triglycerides DLT Dose-Limiting Toxicity ORR Overall Response Rate TTP Time To Progression DOD Duration Of Disease PD Pharmacodynamics TTR Time To Response DOR Duration Of Response PI Proteasome Inhibitor TX Treatment DPP4 Dipeptidyl peptidase 4 PFS Progression-Free Survival VGPR Very Good Partial Response EASI Eczema Area and Severity Index PK Pharmacokinetic FPC Fasting Plasma Glucose PPG Postprandial Glucose HbA1c Hemoglobin A1c PRO Patient Reported Outcome IAE Incidence of Adverse Events QNW Every N Weeks 2 Immuno-inflammation Diabetes Dupilumab (anti-IL4Rα mAb) Oncology Cardiovascular Asthma (1/3) Rare Diseases Rare Blood Disorders MS, Neuro, Gene therapy Vaccines Study Description Patients Design Endpoints Status Continuation of Phase 3 750 • Primary: TEAEs: % of patients • SSD: Aug. 2018 LIBERTY • Patients with asthma who completed the reporting TEAs, event rates per • DE: 2022 ASTHMA Continuation of TRAVERSE treatment period in the previous 100 patient-year TRAVERSE evaluating Dupilumab safety in dupilumab asthma clinical study Patients with Asthma (Long LTS12551 term follow-up) • Open-label, Single group assignement LPS15023 NCT03620747 LIBERTY Phase 3 354 • Primary: N of patients • SSD: June 2018 ASTHMA • Open-label experiencing any TEAE • DE: 2021 Long term safety and tolerability • 1 year of Tx • Secondary: Severe asthma EXCURSION (1 year) of dupilumab in exacerbation events, change in pediatric patients with asthma % predicted FEV1, in absolute FEV1, in FVC, FEF, dupilumab LTS14424 who participated in a previous dupilumab asthma clinical study concentrations, anti-dupilumab NCT03560466 Ab, eosinophils, Ig, IgE 3 Immuno-inflammation Diabetes Dupilumab (anti-IL4Rα mAb) Oncology Cardiovascular Asthma (2/3) Rare Diseases Rare Blood Disorders MS, Neuro, Gene therapy Vaccines Study Description Patients Design Endpoints Status CHILDREN Phase 3 408 • In children 6 to <12 years of age with • Primary: Annualized rate of • SSD: Jun. 2017 ASTHMA uncontrolled persistent asthma severe exacerbation events • DE: 2020 VOYAGE Evaluation of dupilumab in • Randomized, Double-blind, Placebo- during Tx period children (6 to <12 years) with controlled, parallel group 52 weeks Tx, • Secondary: Safety and uncontrolled asthma 12 weeks post Tx tolerability, PROs, Systemic EFC14153 exposure and incidence of anti- NCT02948959 drug antibodies, Association between dupilumab Tx and pediatric immune responses to vaccines 4 Immuno-inflammation Diabetes Dupilumab (anti-IL4Rα mAb) Oncology Cardiovascular Asthma (3/3) Rare Diseases Rare Blood Disorders MS, Neuro, Gene therapy Vaccines Study Description Patients Design Endpoints Status Persistent Phase 3 486 • In adults and adolescents with a • Primary: change in pre- • SSD: Jan. 2019 Asthma - China diagnosis of asthma for ≥ 12 months bronchodilator FEV1 at week • DE: 2021 Efficacy and Safety of • Randomized, Double-blind, Placebo- 12 for patients without OCS EFC13995 dupilumab in patients with controlled, parallel group, • Secondary: change in FEV1 in Persistent Asthma • 2 arms: dupilumab and placebo, with in overall population, annualized NCT03782532 each arm patients with and without oral rate of exacerbation events, of corticosteroids (OCS) maintenance LOAC event, of severe therapy exacerbation resulting in • Study duration: 40 weeks study hospitalization, time to first including 3 to 5 weeks of screening exacerbation event, time to first period, 24 weeks Tx and 12 weeks post LOAC, change in Asthma Tx Control Questionnaire, asthma symptoms score, nocturnal awakenings, use of daily puffs of rescue medication, Asthma QoL 5 Immuno-inflammation Diabetes Dupilumab (anti-IL4Rα mAb) Oncology Cardiovascular Atopic Dermatitis (AD) (1/4) Rare Diseases Rare Blood Disorders MS, Neuro, Gene therapy Vaccines Study Description Patients Design Endpoints Status OLE Phase 3 765 • For patients having participated in a prior • Primary: Incidence and rate of • SSD: Oct. 2015 Pediatrics expected dupilumab study in pediatrics with AD TEAEs • DE: 2023 AD A study to assess the long-term • Open label extension study • Secondary: SAEs and TEAEs safety of dupilumab of special interest, % of patients who achieve and maintain R668-AD-Reg administered in patients 6 to <18 years of age with AD remission, EASI-75: % of 1434 patients achieving and NCT02612454 maintaining at least 75% reduction in EASI score over time, EASI-50: % of patients achieving and maintaining at least 50% reduction in EASI scores over time 6 Immuno-inflammation Diabetes Dupilumab (anti-IL4Rα mAb) Oncology Cardiovascular Atopic Dermatitis (AD) (2/4) Rare Diseases Rare Blood Disorders MS, Neuro, Gene therapy Vaccines Study Description Patients Design Endpoints Status LIBERTY AD Phase 2/3 280 • Part A: Open-label, single-ascending • Part A: PK • SSD: Dec. 2017 PRESCHOOL dose, sequential cohort phase 2 study • Part B: Proportion of patients • DE: 2022 Safety, Pharmacokinetics and • Part B: Randomized, double-blind, with Investigator's Global R668-AD-1539 Efficacy of Dupilumab in parallel-group, placebo-controlled phase Assessment "0" or "1" (on a 5- 3 study point scale) at week 16 NTC03346434 Patients ≥6 Months to <6 Years With Severe Atopic Dermatitis 7 Immuno-inflammation Diabetes Dupilumab (anti-IL4Rα mAb) Oncology Cardiovascular Atopic Dermatitis (AD) (3/4) Rare Diseases Rare Blood Disorders MS, Neuro, Gene therapy Vaccines Study Description Patients Design Endpoints Status Open-Label Phase 3 2678 • Open label extension study for patients • Primary: TEAEs, • SSD: Oct. 2013 who participated in placebo-controlled • Secondary: SAEs and AEs of • DE: 2022 R668-AD-1225 Open-Label study of Dupilumab dupilumab AD trials. The study primarily special interest, % of patients NCT01949311 in patients with Atopic evaluates long term safety (adverse who achieve and maintain Dermatitis events) and immunogenicity. Efficacy remission, EASI-75: % of parameters are based on IGA, EASI) patients achieving and and the NRS. maintaining at least 75% reduction in EASI score over time, EASI-50: % of patients achieving and maintaining at least 50% reduction in EASI scores over time 8 Immuno-inflammation Diabetes Dupilumab (anti-IL4Rα mAb) Oncology Cardiovascular Atopic Dermatitis (AD) (4/4) Rare Diseases Rare Blood Disorders MS, Neuro, Gene therapy Vaccines Study Description Patients Design Endpoints Status AD in Chinese Phase 3 163 • Chinese patients with chronic AD • Primary: Investigator’s Global • SSD: Dec 2018 Patients present for at elast 3 years before the Assessment (IGA), • DE: 2020 Efficacy and Safety of screening visit, • Secondary:, % of patients with EFC15116 Dupilumab in Chinese Patients • Randomized, Double-Blind, Placebo- EASI-75 response, % of controlled patients with reduction of peak NCT03912259 with Moderate-to-severe Atopic Dermatitis • 2 Arms: dupilumab vs Placebo daily pruritus NRS ≥ 4, % of patients with reduction of peak daily pruritus NRS ≥ 3, change in NRS, change in EASI score, change in BSA affected by AD, Dermatology QoL and EQ-5D, change in patients oriented eczema measure (POEM), sick- leave/missed school days proportion, AEs, dupimumab immunogenicity 9 Immuno-inflammation Diabetes Dupilumab (anti-IL4Rα mAb) Oncology Cardiovascular Eosinophilic Esophagitis (EoE) Rare Diseases Rare Blood Disorders MS, Neuro, Gene therapy Vaccines Study Description Patients Design Endpoints Status EoE Phase 3 425 • Patients with documented diagnosis of • Primary: Proportion of patients • SSD: Nov. 2018 EoE by endoscopic biopsy, achieving peak esophageal • DE: primary Efficacy and Safety of • Randomized, double-blind, parallel intraepithelial eosinophil count completion: 2022, R668 – EE - Dupilumab in Adult and assignment, placebo-controlled study, of ≤6 eosinophils per high- full completion: 2023 1774 Adolescent patients with • Part A: dupilumab or placebo (double- power field (eos/hpf), Absolute blind) for 24 weeks, change in Dysphagia Symptom NCT03633617 Eosinophilic Esophagitis • Part B: dupilumab dose regimen 1, Questionnaire (DSQ) score dupilumab dose regimen 2 or placebo • Secondary: Absolute change in (double-blind) for 24 weeks EoE endoscopic reference • Part C: for patients eligible at the end of score (EREFS), Percent Part A and Part B, dupilumab dose change in peak esophageal regimen 1, dupilumab dose regimen 2 intraepithelial eosinophil count (double-blind) for 28 weeks (eos/hpf), Absolute change in • 12-week follow-up for all patients EoE grade score from EoE (eligible and non eligible) Histology Scoring System (EoEHSS), Proportion of patients achieving peak esophageal intraepithelial eosinophil count of ≤15, Proportion of patients achieving
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