Combining a CD40L-Binding Protein (VIB4920) With a TNF-alpha Inhibitor for the Treatment of Inadequately Controlled Rheumatoid Arthritis (ITN092AI)

Status: Withdrawn
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The primary objective is to determine if the addition of a 12-week course of treatment with VIB4920 to TNFi treatment will result in improved clinical disease control in patients with RA who have had an inadequate response to a TNFi.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• Participant or legally authorized representative must be able to understand and provide informed consent

• Adults ≥ 18 years of age

• Diagnosed with RA by fulfilling the ACR/EULAR 2010 Classification Criteria for RA ≥ 6 months prior to screening (Appendix 9)

• Documented positive test for rheumatoid factor (RF) and/or anti-cyclic citrullinated peptide antibody (ACPA)

• SDAI ≥ 17

• At least 4 tender and 4 swollen joints by a 44 joint count (Appendix 5)

• Receiving treatment with an FDA-approved TNFi (including biosimilars) that is dosed subcutaneously at an FDA-approved dosing regimen for at least 12 weeks.

• Willing to continue or discontinue treatment with their current TNFi at the same dose depending upon study arm assignment

• If treated with leflunomide, sulfasalazine, or hydroxychloroquine, must be taking a stable dose for at least 12 weeks

⁃ If treated with methotrexate, must be taking a stable dose for at least 12 weeks. The following exceptions are permitted within the 12 weeks prior to screening:

∙ Holding methotrexate after COVID-19 vaccination as per American College of Rheumatology guidance (https://rheumatology.org/)

‣ Holding methotrexate for 1 or 2 weeks after influenza vaccination

⁃ All participants who engage in sexual activity that could lead to pregnancy must agree to use abstinence or an FDA-approved contraception for the duration of the study to prevent pregnancy

Locations
United States
California
University of California San Francisco School of Medicine: Lupus Clinic and Rheumatology Clinical Research Center
San Francisco
Colorado
University of Colorado School of Medicine: Division of Rheumatology
Aurora
Massachusetts
Brigham & Women's Hospital: Department of Medicine, Rheumatology, Immunology
Boston
Michigan
University of Michigan Health System: Department of Internal Medicine, Division of Rheumatology
Ann Arbor
North Carolina
Duke University Medical Center: Division of Rheumatology and Immunology
Durham
Time Frame
Start Date: 2023-07-25
Completion Date: 2029-04-06
Treatments
Placebo_comparator: VIB4920 Placebo with TNFi
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.
Experimental: VIB4920 with TNFi
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
Experimental: VIB4920 without TNFi
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
Sponsors
Leads: National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators: Immune Tolerance Network (ITN)

This content was sourced from clinicaltrials.gov

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