RECRUITING

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

Talk to us

Conditions

Systemic Lupus ErythematosusActive Refractory Rheumatoid ArthritisInebilizumabBlinatumomabRheumatoid arthritis

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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) and in adult participants with active refractory rheumatoid arthritis (RA) (Subprotocol C).

Official Title

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

Quick Facts

Study Start:2025-07-16
Study Completion:2029-06-23
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06570798

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subprotocol A and B: Diagnosis of SLE according to 2019 European League Against Rheumatism and the American College of Rheumatology (ACR) classification criteria.
  2. * Subprotocol A and B: Participant must be positive for at least one of the following autoantibodies at screening (performed by central laboratory) or through documented history:
  3. 1. Antinuclear antibodies (ANA) ≥ 1:80
  4. 2. Anti-double stranded deoxyribonucleic acid (anti-dsDNA) antibodies elevated to above normal range (ie, positive results)
  5. 3. Anti-Smith antibodies elevated to above normal (ie, positive results).
  6. * Subprotocol A and B (with LN): Active, biopsy-proven, proliferative LN demonstrating class III or class IV with or without co-existing features of Class V LN (or pure Class V LN for Subprotocol B only) according to 2018 International Society of Nephrology/Renal Pathology Society (ISN/RPS) criteria. The local biopsy report will be used.
  7. * Subprotocol A and B (with LN): Inadequate response, loss of response or intolerance to at least 1 therapy (Subprotocol A) or 2 immunosuppressive therapies (Subprotocol B with LN) at the maximally tolerated doses as recommended by the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines (KDIGO, 2024). Inadequate response is defined as: UPCR ≥ 1.0 mg/mg.
  8. * Subprotocol B (SLE without nephritis): Systemic Lupus Erythematosus Disease Activity Index 2K ≥ 6.
  9. * Subprotocol B (SLE without nephritis): Refractory SLE participants with inadequate response to multiple therapies (excluding hydroxychloroquine or corticosteroids) and have failed either a biologic agent or cyclophosphamide.
  10. * Subprotocol A and B: If receiving any of the following medications, participants must be on these doses prior to day 1:
  11. 1. Prednisone dose ≤ 20 mg/day (or its equivalent in other corticosteroid forms) and at a stable dose for 5 days
  12. 2. Hydroxychloroquine dose ≤ 400 mg/day and at a stable dose for 4 weeks. Other equivalent antimalarials (chloroquine, quinacrine) are also accepted at a stable dose for 4 weeks.
  13. 3. MMF dose ≤ 3 g/day or MPA dose ≤ 2160 mg/day and at a stable dose for 2 weeks.
  14. 4. AZA dose ≤ 2 mg/kg/day and at a stable dose for 2 weeks.
  15. * Subprotocol C: Diagnosis of RA according to the 2010 ACR/ European Alliance of Associations for Rheumatology (EULAR) classification criteria.
  16. * Subprotocol C: Active disease defined as DAS28-CRP \> 3.2 with at least 1 swollen joint at screening.
  17. * Subprotocol C: Refractory disease defined as:
  18. * Moderate to severe active disease despite having received treatment with:
  19. 1. at least 1 conventional synthetic disease-modifying antirheumatic drug (csDMARD), AND
  20. 2. at least 2 biologic disease-modifying antirheumatic drugs (bDMARDs) of different mechanisms of action OR 1 bDMARD and at least 1 targeted synthetic disease-modifying antirheumatic drugs (tsDMARD).
  21. * Inadequate response or intolerance to csDMARDs, bDMARDs, and tsDMARDs should be defined as:
  22. 1. Participant having active disease despite a minimum of 12 weeks of treatment with a csDMARD, bDMARD, or tsDMARD.
  23. 2. Intolerance to treatment as defined by participant having experienced an adverse effect from treatment with a csDMARD, bDMARD, or tsDMARD.
  1. * 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).
  2. * Subprotocol A and B: Significant likely irreversible organ damage related to SLE (eg, end-stage renal disease \[ESRD\]).
  3. * Subprotocol A and B: Any acute, severe lupus related flare during screening that needs immediate treatment.
  4. * Subprotocol A and B: A previous kidney transplant or planned transplant within study treatment period.
  5. * Subprotocol A and B: History of or current renal diseases (other than LN) that in the opinion of the investigator could interfere with the LN assessment and confound the disease activity assessment (eg, diabetic nephropathy).
  6. * Subprotocol A: Renal biopsy showing pure class V.
  7. * Subprotocol C: Prior history of current inflammatory joint disease other than RA including but not limited to systemic lupus erythematosus, mixed connective tissue disorder, scleroderma, polymyositis, or significant systemic involvement secondary to RA (eg, vasculitis, pulmonary fibrosis, or Felty's syndrome).
  8. * Subprotocol C: Functional Class IV as defined by the ACR classification of functional status in RA.

Contacts and Locations

Study Contact

Amgen Call Center
CONTACT
866-572-6436
medinfo@amgen.com

Principal Investigator

MD
STUDY_DIRECTOR
Amgen

Study Locations (Sites)

HonorHealth Research and Innovation Institute
Scottsdale, Arizona, 85258
United States
University of Colorado
Aurora, Colorado, 80045
United States
Vida Research Center
Hialeah, Florida, 33010
United States
Homestead Associates In Research Inc
Homestead, Florida, 33033
United States
Vitaly Clinical Research
Miami, Florida, 33125
United States
Northwell Health
Great Neck, New York, 11021
United States
MetroHealth Medical Center
Cleveland, Ohio, 44109
United States
Prolato Clinical Research Center
Houston, Texas, 77054
United States

Collaborators and Investigators

Sponsor: Amgen

  • MD, STUDY_DIRECTOR, Amgen

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-16
Study Completion Date2029-06-23

Study Record Updates

Study Start Date2025-07-16
Study Completion Date2029-06-23

Terms related to this study

Keywords Provided by Researchers

  • Systemic lupus erythematosus
  • Inebilizumab
  • Blinatumomab
  • Active refractory rheumatoid arthritis
  • Rheumatoid arthritis

Additional Relevant MeSH Terms

  • Systemic Lupus Erythematosus
  • Active Refractory Rheumatoid Arthritis