A Study to Evaluate the Safety and Efficacy of VIB4920 in Participants With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: VIB4920; Placebo
Intervention description: liquid for IV infusion following dilution in normal saline; 0.9% saline for IV infusion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 78.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Rheumatoid Arthritis; RA; VIB4920; MEDI4920

Summary:

      The purpose of the study is to evaluate the efficacy, safety, and pharmacokinetics (PK) of
      VIB4920 (formerly MEDI4920) in adult participants with rheumatoid arthritis (RA).
    

Eligibility criteria:

        Principal Inclusion Criteria:

          1. Male or female adults, >= 18 years of age at time of informed consent.

          2. Diagnosed with RA according to the European League Against Rheumatism/American College
             of Rheumatology (EULAR/ACR) 2010 criteria >= 6 months prior to screening.

          3. Disease Activity Score in 28 Joints (DAS 28) using C-reactive Protein (DAS28-CRP) >
             3.2 at screening with >= 4 tender joint count (TJC) and >= 4 swollen joint count (SJC)
             out of the 28 joints assessed for DAS28 present at screening and confirmed present at
             visit 2 prior to randomization.

          4. Positive for rheumatoid factor (RF) and/or anti-citrullinated protein antibodies
             (ACPA) at screening, in accordance with criteria at the central laboratory.

          5. Treated with methotrexate (MTX), with or without a concomitant conventional
             disease-modifying anti-rheumatic drug (cDMARD).

          6. Agreeing to use of protocol defined contraception methods.

        Principal Exclusion Criteria:

          1. Prior or current inflammatory joint disease other than RA.

          2. Severe interstitial lung disease.

          3. Prior receipt of any biologic B-cell-depleting therapy.

          4. Receipt of any anti - tumor necrosis factor alpha (TNF-α) biologic agent < 8 weeks
             prior to screening.

          5. Receipt of any biologic disease-modifying anti-rheumatic drug (bDMARD) with a
             mechanism of action other than direct TNF-α blockade, < 12 weeks or < 5 half-lives of
             the drug prior to screening.

          6. Injectable corticosteroids or treatment with > 10 mg/day dose of oral prednisolone or
             equivalent within 4 weeks prior to screening.

          7. Previous treatment with anti-cluster of differentiation 40 ligand (CD40L) compounds at
             any time before randomization.

          8. Hepatitis B, hepatitis C, or human immunodeficiency virus infection.

          9. Pregnant or lactating or planning to get pregnant during the duration of the study.

         10. Evidence of active tuberculosis (TB) or being at high risk for TB.

         11. History of more than one episode of herpes zoster in the 12 months prior to screening
             or any opportunistic infection in the 12 months prior to screening, excluding
             localized mucocutaneous candidiasis.

         12. Receipt of live vaccine or live therapeutic infectious agent within the 4 weeks prior
             to screening.