What is this study trying to find out about autoimmune diseases like SLE and RA?

This study is evaluating the safety, tolerability, and effectiveness of two drugs, inebilizumab and blinatumomab, in adults with active and hard-to-treat systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA). The research aims to understand how these treatments affect disease activity and safety in different patient groups. It is sponsored by Amgen to help improve treatment options for these conditions.

Who may be eligible for this autoimmune disease clinical trial?

Adults aged 18 to 75 years with a diagnosis of active and refractory systemic lupus erythematosus (SLE) or rheumatoid arthritis (RA) may be eligible. Participants should have had an inadequate response or intolerance to certain therapies and be on stable doses of some medications. This trial is open to all genders. Please review eligibility criteria for more details.

Is there any cost to participate in this autoimmune disease clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. However, personal expenses such as travel or accommodations may not be covered and can vary by participant. Participants should consider these potential costs when deciding about joining the trial.

Actively Recruiting

Phase 2

Age: 18Years - 75Years

All Genders

ID06570798

A Phase 2, Open Label, Multicenter Trial Assessing Safety, Tolerability, and Efficacy of Inebilizumab and Blinatumomab in Autoimmune Diseases

Led by Amgen · Updated on 2026-05-07

220

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety, tolerability, and effectiveness of two drugs, inebilizumab and blinatumomab, in adults with active and hard-to-treat autoimmune diseases. These diseases include systemic lupus erythematosus SLE with nephritis and rheumatoid arthritis RA. The trial aims to understand how these treatments work in different groups of participants with these conditions through multiple subprotocols. Participants will receive either inebilizumab through intravenous infusions or blinatumomab through subcutaneous injections. Different dosing schedules are used for each drug, including three or four doses for inebilizumab and various low, medium, or high doses for blinatumomab. The study is divided into subprotocols focusing on different patient groups and dosing parts. During the study, participants will be monitored for treatment-emergent adverse events and serious side effects over up to 52 weeks. Researchers will assess kidney response, disease remission, and disease activity scores at various time points. Blood tests, antibody measurements, and disease activity indices will be used to evaluate the participants responses and safety. The study lasts from the first day of treatment through week 52 with ongoing evaluations.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 75Years

All Genders

Eligibility Criteria

You may qualify if you...

Adults aged 18 to 75 years
Diagnosis of systemic lupus erythematosus (SLE) according to 2019 EULAR and ACR criteria or rheumatoid arthritis (RA) according to 2010 ACR/EULAR criteria
Positive for at least one specific autoantibody for SLE participants
Active, biopsy-proven lupus nephritis for relevant subgroups
Moderate to severe disease activity with specified disease scores
Inadequate response, loss of response, or intolerance to prior therapies as defined in the protocol
Stable doses of specified corticosteroids and immunosuppressive medications prior to Day 1
For RA participants, refractory disease despite prior conventional and biologic treatments
High sensitivity C-Reactive Protein (hsCRP) level above normal for certain RA subgroups

You will not qualify if you...

Receipt of live or live attenuated vaccines within 4 weeks before first dose or during treatment
Estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m² for lupus nephritis participants
Significant irreversible organ damage related to SLE
Acute severe lupus flare needing immediate treatment during screening
Previous or planned kidney transplant during trial period
Other renal diseases that interfere with lupus nephritis assessment
Certain CNS pathologies or events such as seizures, stroke, or dementia
History of inflammatory joint diseases other than RA or severe systemic involvement in RA
Functional Class IV status in RA
Prior treatments including B-cell directed CAR T-cell therapies, total lymphoid irradiation, bone marrow transplant, T-cell vaccination, or natalizumab

Research Team

Amgen Call Center

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