A Phase 2 Master Protocol Assessing Inebilizumab and Blinatumomab in Autoimmune Diseases
Study Details
The main objective is to assess the safety and tolerability of inebilizumab in adult participants with active and refractory systemic lupus erythematosus (SLE) with nephritis (Subprotocol A) and to assess the safety and tolerability of subcutaneous (SC) blinatumomab in adult participants with active and refractory SLE with and without nephritis (Subprotocol B Part A) and in adult participants with active refractory rheumatoid arthritis (RA) (Subprotocol C Part A). The trial will also assess the efficacy of SC blinatumomab in adult participants with active and refractory SLE with and without nephritis (Subprotocol B Part B and Subprotocol C Part B).
Protocol Summary
Subprotocol A, B Part A, and C Part A: Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)
Timeframe: Day 1 to Week 52
Subprotocol A, B Part A, and C Part A: Number of Participants Who Experience a Serious TEAE
Timeframe: Day 1 to Week 52
Subprotocol B Part B Subgroup 1: Number of Participants With Complete Renal Response (CRR)
Timeframe: Week 52
Subprotocol B Part B Subgroup 2: Number of Participants With Remission in SLE as Defined by Definition of Remission in SLE (DORIS)
Timeframe: Week 26
Subprotocol C Part B: Percentage of Participants Achieving Disease Activity Score-28 Joint C-Reactive Protein (DAS28-CRP) Remission
Timeframe: Week 12
Subprotocol A, B Part A Subgroup 1 and Part B Subgroup 1: Number of Participants With CRR
Timeframe: Subprotocol A and B Part A: Week 12, Week 26, Week 38, and Week 52; Subprotocol B Part B: Week 12, Week 26, and Week 38
Subprotocol A, B Part A Subgroup 1 and Part B Subgroup 1: Number of Participants With Partial Renal Response (PRR)
Timeframe: Week 12, Week 26, Week 38, and Week 52
Subprotocol A and B: Number of Participants With Remission in SLE as Defined by DORIS
Timeframe: Subprotocol A, B Part A, and B Part B Subgroup 1: Week 12, Week 26, Week 38, and Week 52; Subprotocol B Part B Subgroup 2: Week 12, Week 38, and Week 52
Subprotocol A and B: Number of Participants With a Lupus Low Disease Activity State (LLDAS)
Timeframe: Week 12, Week 26, Week 38, and Week 52
Subprotocol A and B: Change From Baseline in SLE Activity Index-2000 (SLEDAI-2K) Score
Timeframe: Week 12, Week 26, Week 38, and Week 52
Subprotocol A, B Part A Subgroup 1 and Part B Subgroup 1: Change From Baseline in 24-hour UPCR
Timeframe: Week 12, Week 26, Week 38, and Week 52
Subprotocol A: Maximum Concentration (Cmax) of Inebilizumab
Timeframe: Day 1 to Week 52
Subprotocol A: Time to Cmax (tmax) of Inebilizumab
Timeframe: Day 1 to Week 52
Subprotocol A: Area Under the Concentration-time Curve (AUC) of Inebilizumab
Timeframe: Day 1 to Week 52
Subprotocol B and C: Cmax of Blinatumomab
Timeframe: up to Week 12
Subprotocol B and C: tmax of Blinatumomab
Timeframe: up to Week 12
Subprotocol B and C: AUC of Blinatumomab
Timeframe: up to Week 12
Subprotocol A: Number of Participants With Anti-inebilizumab Antibody Formation
Timeframe: Day 1 to Week 52
Subprotocol B and C: Number of Participants With Anti-blinatumomab Antibody Formation
Timeframe: Day 1 to Week 52
Subprotocol C Part A: Percentage of Participants Achieving DAS28-CRP < 2.6
Timeframe: Week 12 and Week 26
Subprotocol C Part A: Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) ≤ 2.8
Timeframe: Week 12 and Week 26
Subprotocol C Part A: Percentage of Participants Achieving Simplified Disease Activity Index (SDAI) ≤ 3.3
Timeframe: Week 12 and Week 26
Subprotocol C: Percentage of Participants Achieving American College of Rheumatology (ACR)20 response
Timeframe: Week 12 and Week 26
Subprotocol C: Percentage of Participants Achieving ACR50 Response
Timeframe: Week 12 and Week 26
Subprotocol C: Percentage of Participants Achieving ACR70 Response
Timeframe: Week 12 and Week 26
Subprotocol B Part B and C Part B: Number of Participants Who Experience a TEAE
Timeframe: Day 1 to Week 52
Subprotocol B Part B and C Part B: Number of Participants Who Experience a Serious TEAE
Timeframe: Day 1 to Week 52
Subprotocol B Part A Subgroup 1 and Part B Subgroup 1: Number of Participants With Primary Efficacy Renal Response (PERR)
Timeframe: Week 12, Week 26, Week 38, and Week 52
Subprotocol B Part B Subgroup 2: Number of Participants Who are Responders as Defined by SLE Responder Index 4 (SRI-4)
Timeframe: Week 12, Week 26, Week 38, and Week 52
Subprotocol B Part B Subgroup 2: Number of Participants Who are Responders as Defined by SRI-6
Timeframe: Week 12, Week 26, Week 38, and Week 52
Subprotocol B Part B Subgroup 2: Number of Participants Who are Responders as Defined by SRI-8
Timeframe: Week 12, Week 26, Week 38, and Week 52
Subprotocol B Part B Subgroup 2: Number of Participants Who are Responders as Defined by BILAG-based Combined Lupus Assessment (BICLA)
Timeframe: Week 12, Week 26, Week 38, and Week 52
Subprotocol C Part B: Percentage of Participants Achieving DAS28-CRP Remission at Week 26
Timeframe: Week 26
Subprotocol C Part B: Percentage of Participants Achieving CDAI Remission at Weeks 12 and 26
Timeframe: Week 12 and Week 26
Subprotocol C Part B: Percentage of Participants Achieving SDAI Remission at Weeks 12 and 26
Timeframe: Week 12 and Week 26
Subprotocol C Part B: Percentage of Participants Who Achieve DAS28-CRP Remission at Week 12 and Sustain Remission at Weeks 26, 38, and 52
Timeframe: Week 12, Week 26, Week 38, and Week 52