BG9924 in Combination With Methotrexate for Participants With Active Rheumatoid Arthritis

Study Overview
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Brief Summary
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This Phase 2b study is designed to evaluate the efficacy and safety of BG9924 given subcutaneously (SC) versus placebo in participants with active rheumatoid arthritis (RA) who have previously had an inadequate response to treatment with anti-tumor necrosis factor (anti-TNF) therapy.

Official Title
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A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, PK, and PD of BG9924 When Given in Combo With MTX to Subjects With Active RA Who Have Had an Inadequate Response to Anti-TNF

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Biological: BG9924
* Other: Placebo Comparator


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Diagnosis of rheumatoid arthritis (functional class I - III) at least 6 months prior to baseline Methotrexate (10 mg/week to 25 mg/week) > 3 months prior to Day 0 (stable dose > 4 weeks prior to Day 0) Must have had an inadequate response to anti-TNF therapy due to inadequate efficacy Key Exclusion Criteria: Medical History Serious local infection or systemic infection within 3 months of Day 0 History (Hx) of recurrent infections requiring oral or parental anti-infective treatment Hx of tuberculosis (TB) or positive purified protein derivative (PPD) test during the screening period Laboratory Tests Clinically significant lab tests at screening; or Positive for hepatitis C antibody or hepatitis B at screening NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BG9924<br>Subcutaneous administration of BG9924 given every other week for 12 weeks | Biological: BG9924<br>* Subcutaneous administration of BG9924 given every other week for 12 weeks<br>|
| Placebo Comparator: Placebo<br>Subcutaneous administration of placebo given every other week for 12 weeks | Other: Placebo Comparator<br>* Subcutaneous administration of placebo given every other week for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate efficacy of BG9924 in combination with methotrexate in RA participants who have had an inadequate response to anti-TNF therapy |  | 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the safety and tolerability of BG9924 in this participant population. |  | 26 weeks | 
| Assess the pharmacokinetic and pharmacodynamic profile of BG9924 in this participant population. |  | 26 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Active Rheumatoid Arthritis (RA)