VIB4920 for Rheumatoid Arthritis

(CONTROL-RA Trial)

Recruiting at12 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Must be taking: TNFi therapy

Must not be taking: B cell depleting, JAK inhibitors

Disqualifiers: Autoimmune diseases, Infections, Cancer, others

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing if adding VIB4920 to existing Rheumatoid Arthritis treatments can help patients who haven't responded well to those treatments. It focuses on adults with moderate to high Rheumatoid Arthritis activity in the U.S. The goal is to see if VIB4920 can improve symptom control when used with current medications.

Do I need to stop my current medications for this trial?

The trial does not require you to stop your current medications, but you must be on a stable dose of certain medications like methotrexate, leflunomide, sulfasalazine, or hydroxychloroquine for at least 12 weeks. You may need to continue or discontinue your current TNFi treatment depending on your study group.

Research Team

Eugene William St. Clair

Principal Investigator

Duke University Medical Center: Division of Rheumatology and Immunology

Eligibility Criteria

Adults aged 18-70 with Rheumatoid Arthritis (RA) who haven't responded well to TNFi treatments can join. They must have been diagnosed at least 6 months ago, show certain levels of disease activity and joint tenderness/swelling, and be on stable doses of specific RA medications. Participants need to be vaccinated against COVID-19 as per CDC guidelines for immunocompromised individuals.

Inclusion Criteria

I have been on a stable TNFi treatment for at least 12 weeks and am open to adjusting it for the study.

I am between 18 and 75 years old.

I can understand and agree to the study's requirements.

Exclusion Criteria

Platelet count < 100 x 103/μl

Use of glucocorticoid and/or disease-modifying therapies as specified including prior treatment with any B cell depleting therapy, history of treatment with more than two different TNFi, treatment with other biologic therapy not targeting TNF-α, treatment with a JAK inhibitor, concurrent use of methotrexate and leflunomide in combination, prednisone > 10 mg a day or equivalent glucocorticoid use within the previous 4 weeks, intramuscular, intra-articular, or intravenous glucocorticoids within the previous 4 weeks, other immunomodulatory medications within the previous 12 weeks except for methotrexate, leflunomide, sulfasalazine, or hydroxychloroquine, lack of any subjective or objective clinical response to current TNFi use, use of an investigational agent including VIB4920 in the past 30 days or 5 half-lives, history of severe allergy, hypersensitivity reaction, or infusion reaction to any component of the VIB4920 formulation, history of Felty's syndrome, history of interstitial lung disease, deep venous thrombosis or thromboembolism in the prior two years

I have had infections or symptoms related to hepatitis, HIV, tuberculosis, COVID-19, herpes zoster, opportunistic infections, or recurrent lung infections in the past year.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive VIB4920 or placebo intravenously at weeks 0, 2, 4, 8, and 12, with continued background RA therapy

12 weeks

5 visits (in-person)

Post-administration observation

Participants are monitored for safety and efficacy after the treatment phase

28 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• VIB4920 (Monoclonal Antibodies)

Trial Overview The trial is testing VIB4920, a new potential treatment for RA. Some patients will add VIB4920 to their current TNFi therapy for 12 weeks, while others will take it without TNFi or receive a placebo. The goal is to see if VIB4920 improves symptoms in those not helped by TNFi alone.

Participant Groups

Group I: VIB4920 without TNFi Experimental Treatment 1 Intervention

Participants will stop TNFi after randomization to this arm, and receive VIB4920 in an evaluator-blinded fashion intravenously at a dose of 1500 mg at weeks 0, 2, 4, 8, and 12 while maintaining all other background disease-modifying RA therapy (e.g., methotrexate, hydroxychloroquine, etc.) through the study period. This arm is evaluator blinded (not aware of treatment status), with the participant aware of treatment status but evaluator is not, due to not using a TNFi placebo for this study

Group II: VIB4920 with TNFi Experimental Treatment 1 Intervention

Participants will receive VIB4920 in a blinded fashion intravenously at a dose of 1500 mg at weeks 0, 2, 4, 8, and 12 and continue all background disease-modifying RA therapy, including the TNFi, through the study period

Group III: VIB4920 Placebo with TNFi Placebo Group 1 Intervention

Participants will receive VIB4920 placebo in a blinded fashion intravenously at weeks 0, 2, 4, 8, and 12 and continue all background disease-modifying RA therapy, including the TNFi, through the study period VIB4920 placebo consists of 0.9% normal saline in 250mL bags.

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials

3,361

Recruited

5,516,000+

Dr. Jeanne Marrazzo

National Institute of Allergy and Infectious Diseases (NIAID)

Chief Executive Officer since 2023

MD, MPH

Dr. H. Clifford Lane

National Institute of Allergy and Infectious Diseases (NIAID)

Chief Medical Officer

MD

Immune Tolerance Network (ITN)

Collaborator

Trials

68

Recruited

7,900+

Dr. Mark Anderson

Immune Tolerance Network (ITN)

Chief Executive Officer since 2000

MD, PhD from University of California, San Francisco

Dr. Dawn Smilek

Immune Tolerance Network (ITN)

Chief Medical Officer since 2021

MD, PhD