Recruiting
Sponsor ID
20240033

A Phase 2 Master Protocol Assessing Inebilizumab and Blinatumomab in Autoimmune Diseases

Sponsor ID
20240033
Clinicaltrials.gov ID
NCT06570798
EUCTIS ID
N/A
EudraCT ID
2024-514382-19

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).

Additional Study Details

Phase
Phase 2
Product
AMG 335
Type
Interventional
Masking
None (Open Label)
Enrollment
220
Additional Study Details

Protocol Summary

Primary Outcome Measures

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

Secondary Outcome Measures

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

Locations

Location
Status
Contact Us
Location
Vitaly Clinical Research
Miami, FL, United States, 33125
Status
Terminated
Location
Vida Research Center
Hialeah, FL, United States, 33010
Status
Terminated
Location
Homestead Associates In Research Inc
Homestead, FL, United States, 33033
Status
Terminated
Location
Centre Hospitalier Universitaire de Liege - Sart Tilman
Liege, Belgium, 4000
Status
Recruiting
Location
Northwell Health
Great Neck, NY, United States, 11021
Status
Recruiting
Location
Prolato Clinical Research Center
Houston, TX, United States, 77054
Status
Completed
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