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

Conditions

• Active Refractory Rheumatoid Arthritis
• Systemic Lupus Erythematosus

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Inebilizumab — DRUG
  IV Infusion
• Blinatumomab — DRUG
  SC Injection

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).

Key Dates

Start date

Jul 16, 2025

Status verified

Apr 2026

Primary completion

Jul 21, 2028

Completion

Jul 21, 2028

Study Design

Enrollment

220 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Subprotocol A: Inebilizumab 3 Doses
  Participants will receive 3 doses of inebilizumab administered via an intravenous (IV) infusion.
• Experimental: Subprotocol A: Inebilizumab 4 Doses
  Participants will receive 4 doses of inebilizumab administered via an IV infusion.
• Experimental: Subprotocol B Part A: Blinatumomab Low-dose
  Participants will receive blinatumomab low-dose administered via SC injection.
• Experimental: Subprotocol B Part A: Blinatumomab Medium-dose
  Participants will receive blinatumomab medium-dose administered via SC injection.
• Experimental: Subprotocol B Part A: Blinatumomab High-dose
  Participants will receive blinatumomab high-dose administered via SC injection.
• Experimental: Subprotocol B Part B: Dose Expansion
  Participants will receive blinatumomab at a dose which will be determined during Subprotocol B Part A.
• Experimental: Subprotocol C Part A: Blinatumomab Low-dose
  Participants will receive blinatumomab low-dose administered via SC injection during Subprotocol C Part A.
• Experimental: Subprotocol C Part A: Blinatumomab Medium-dose
  Participants will receive blinatumomab medium-dose administered via SC injection during Subprotocol C Part A.
• Experimental: Subprotocol C Part A: Blinatumomab High-dose
  Participants will receive blinatumomab high-dose administered via SC injection during Subprotocol C Part A.
• Experimental: Subprotocol C Part B: Dose Expansion
  Participants will receive blinatumomab at a dose which will be determined during Subprotocol C Part A.

Primary Outcome Measure

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 ]

Central Contacts

• Amgen Call Center
  866-572-6436
  [email protected]

Locations (17)

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