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).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
220
IV Infusion
SC Injection
HonorHealth Research and Innovation Institute
Scottsdale, Arizona, United States
RECRUITINGUniversity of Colorado
Aurora, Colorado, United States
RECRUITINGVida Research Center
Hialeah, Florida, United States
TERMINATEDHomestead Associates In Research Inc
Homestead, Florida, United States
Subprotocol A, B Part A, and C Part A: Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)
Time frame: Day 1 to Week 52
Subprotocol A, B Part A, and C Part A: Number of Participants Who Experience a Serious TEAE
Time frame: Day 1 to Week 52
Subprotocol B Part B Subgroup 1: Number of Participants With Complete Renal Response (CRR)
Time frame: Week 52
Subprotocol B Part B Subgroup 2: Number of Participants With Remission in SLE as Defined by Definition of Remission in SLE (DORIS)
Time frame: Week 26
Subprotocol C Part B: Percentage of Participants Achieving Disease Activity Score-28 Joint C-Reactive Protein (DAS28-CRP) Remission
Time frame: Week 12
Subprotocol A, B Part A Subgroup 1 and Part B Subgroup 1: Number of Participants With CRR
Time frame: 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)
Time frame: Week 12, Week 26, Week 38, and Week 52
Subprotocol A and B: Number of Participants With Remission in SLE as Defined by DORIS
Time frame: 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)
Time frame: Week 12, Week 26, Week 38, and Week 52
Subprotocol A and B: Change From Baseline in SLE Activity Index-2000 (SLEDAI-2K) Score
Time frame: 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
Time frame: Week 12, Week 26, Week 38, and Week 52
Subprotocol A: Maximum Concentration (Cmax) of Inebilizumab
Time frame: Day 1 to Week 52
Subprotocol A: Time to Cmax (tmax) of Inebilizumab
Time frame: Day 1 to Week 52
Subprotocol A: Area Under the Concentration-time Curve (AUC) of Inebilizumab
Time frame: Day 1 to Week 52
Subprotocol B and C: Cmax of Blinatumomab
Time frame: up to Week 12
Subprotocol B and C: tmax of Blinatumomab
Time frame: up to Week 12
Subprotocol B and C: AUC of Blinatumomab
Time frame: up to Week 12
Subprotocol A: Number of Participants With Anti-inebilizumab Antibody Formation
Time frame: Day 1 to Week 52
Subprotocol B and C: Number of Participants With Anti-blinatumomab Antibody Formation
Time frame: Day 1 to Week 52
Subprotocol C Part A: Percentage of Participants Achieving DAS28-CRP < 2.6
Time frame: Week 12 and Week 26
Subprotocol C Part A: Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) ≤ 2.8
Time frame: Week 12 and Week 26
Subprotocol C Part A: Percentage of Participants Achieving Simplified Disease Activity Index (SDAI) ≤ 3.3
Time frame: Week 12 and Week 26
Subprotocol C: Percentage of Participants Achieving American College of Rheumatology (ACR)20 response
Time frame: Week 12 and Week 26
Subprotocol C: Percentage of Participants Achieving ACR50 Response
Time frame: Week 12 and Week 26
Subprotocol C: Percentage of Participants Achieving ACR70 Response
Time frame: Week 12 and Week 26
Subprotocol B Part B and C Part B: Number of Participants Who Experience a TEAE
Time frame: Day 1 to Week 52
Subprotocol B Part B and C Part B: Number of Participants Who Experience a Serious TEAE
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: Week 12, Week 26, Week 38, and Week 52
Subprotocol C Part B: Percentage of Participants Achieving DAS28-CRP Remission at Week 26
Time frame: Week 26
Subprotocol C Part B: Percentage of Participants Achieving CDAI Remission at Weeks 12 and 26
Time frame: Week 12 and Week 26
Subprotocol C Part B: Percentage of Participants Achieving SDAI Remission at Weeks 12 and 26
Time frame: 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
Time frame: Week 12, Week 26, Week 38, and Week 52
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Vitaly Clinical Research
Miami, Florida, United States
TERMINATEDBioresearch Partner Coral Terrace
South Miami, Florida, United States
RECRUITINGUniversity Medical Center New Orleans
New Orleans, Louisiana, United States
RECRUITINGMassachusetts General Hospital
Boston, Massachusetts, United States
RECRUITINGMayo Clinic
Rochester, Minnesota, United States
RECRUITINGNorthwell Health
Great Neck, New York, United States
RECRUITING...and 48 more locations