🏛️ Verified NIH Record • Updated 2026-08-20

A Phase 2 Master Protocol Assessing Inebilizumab and Blinatumomab in Autoimmune Diseases (NCT06570798)

A Phase 2, Open Label, Multicenter, Platform Trial to Assess the Safety, Tolerability, and Efficacy of Inebilizumab and Blinatumomab in Subjects With Autoimmune Diseases

🟢 Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Amgen

🩺 Plain-English Summary (8th-Grade Level)

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).

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (29 items) and avoid the listed exclusions (18 items).

Location: HonorHealth Research and Innovation Institute — Scottsdale, Arizona

Age range: 18 Years to 75 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • Subprotocol A, B and C: Receipt of a live and/or live attenuated vaccine within 4 weeks prior to first dose of trial drug, during the treatment period, or until B-cell repletion after the end of the treatment period. Administration of inactivated (killed) vaccines is acceptable.
  • Subprotocol A and B: Estimated glomerular filtration rate (eGFR) of \< 30 mL per minute per 1.73 m\^2 of body surface area (calculated using the Modification of Diet in Renal Disease \[MDRD\] formula, with screening laboratory results for serum creatinine value).
  • Subprotocol A and B: Significant likely irreversible organ damage related to SLE (eg, end-stage renal disease \[ESRD\]).
  • Subprotocol A and B: Any acute, severe lupus related flare during screening that needs immediate treatment.
  • Subprotocol A and B: A previous kidney transplant or planned transplant within trial treatment period.
  • Subprotocol A and B: History of or current renal diseases (Parts A and B, Subgroup 1) that in the opinion of the investigator could interfere with the LN assessment and confound the disease activity assessment (eg, diabetic nephropathy).
  • Subprotocol A: Renal biopsy showing pure class V.
  • Subprotocol B: Active CNS Lupus within one year prior to screening.
  • Subprotocol B and C: History or presence of clinically relevant central nervous system (CNS) pathology or event such as seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, or organic brain syndrome.
  • Subprotocol C: Prior history of current inflammatory joint disease other than RA including but not limited to SLE, mixed connective tissue disorder, scleroderma, polymyositis, or significant systemic involvement secondary to RA (eg, vasculitis, pulmonary fibrosis, or Felty's syndrome).
  • Subprotocol C: Functional Class IV as defined by the ACR classification of functional status in RA.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (58 Sites)

Showing the first 25 of 58 sites.

  • HonorHealth Research and Innovation Institute — Scottsdale, Arizona
  • University of Colorado — Aurora, Colorado
  • Vida Research Center — Hialeah, Florida
  • Homestead Associates In Research Inc — Homestead, Florida
  • Vitaly Clinical Research — Miami, Florida
  • Bioresearch Partner Coral Terrace — South Miami, Florida
  • University Medical Center New Orleans — New Orleans, Louisiana
  • Massachusetts General Hospital — Boston, Massachusetts
  • Mayo Clinic — Rochester, Minnesota
  • Northwell Health — Great Neck, New York
  • Westchester Medical Center — Hawthorne, New York
  • Columbia University Medical Center — New York, New York
  • University of Rochester Medical Center — Rochester, New York
  • MetroHealth Medical Center — Cleveland, Ohio
  • The Metro Health System Main Campus — Cleveland, Ohio
  • Cleveland Clinic Foundation — Cleveland, Ohio
  • Prolato Clinical Research Center — Houston, Texas
  • Seattle Rheumatology Associates — Seattle, Washington
  • Linear Clinical Research Limited — Perth, Western Australia
  • Cliniques Universtaire Saint Luc Universite Catholique de Louvain — Brussels,
  • Universitair Ziekenhuis Gent — Ghent,
  • Universitair Ziekenhuis Leuven - Campus Gasthuisberg — Leuven,
  • Centre Hospitalier Universitaire de Liege - Sart Tilman — Liège,
  • Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre — Le Kremlin-Bicêtre,
  • Centre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez — Lille,

📞 Contact the Study Coordinator

Phone: (866) 572-6436

Email: medinfo@amgen.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗