Inebilizumab and Blinatumomab for Autoimmune Diseases

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

Recruiting Phase 2 Interventional Study
Systemic Lupus Erythematosus Active Refractory Rheumatoid Arthritis
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
220 (estimated)
Sponsor
Amgen · Industry
Who this trial is looking for

This trial is looking for adults with systemic lupus erythematosus or rheumatoid arthritis. Participating involves receiving treatment with inebilizumab or blinatumomab and attending follow-up visits to monitor your health.

Are You a Good Fit for This Trial?
Must be taking PrednisoneHydroxychloroquineMMFAZAMethotrexateLeflunomide
Rules you out End-stage renal disease

You may be able to join if

  • I have been diagnosed with systemic lupus erythematosus or rheumatoid arthritis.
  • I have specific autoantibodies in my blood related to my disease.
  • I have active disease and have not responded to other treatments.
  • I have moderate to severe disease activity with joint swelling.
  • I have been taking certain medications at stable doses before starting the trial.

You may not be able to join if

  • I have received a live vaccine within 4 weeks before starting the trial.
  • I have severe kidney disease.
  • I have significant organ damage due to lupus.
  • I have had a recent severe lupus flare needing immediate treatment.
  • I have had a kidney transplant or plan to have one during the trial.
  • I have active central nervous system lupus.
  • I have a history of serious brain conditions or events.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
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…
Trial Locations
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Eligibility Criteria
\*Subprotocol A and B are no longer recruiting participants\* Inclusion Criteria: * Subprotocol A and B: Diagnosis of SLE according to 2019 European League Against Rheumatism and the American College of Rheumatology (ACR) classification criteria. * Subprotocol A and B: Participant must be positive…
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