Phase 2, Rand, Placebo-Controlled, Double-Blind, Dose Ranging Study to Evaluating Safety/Efficacy of Gerilimzumab in Patients With Moderately to Severely Active Rheumatoid Arthritis Inadequately Treated With Methotrexate or TNFα Antagonist
Trial Snapshot
- Phase
- Phase 2
- Status
- Withdrawn
- Sponsor
- Bird Rock Bio, Inc.
- Primary Endpoint
- Change from baseline in mean DAS28-CRP (Disease Activity Score 28 using the C-Reactive Protein value)
Study Overview
Brief Summary
Phase 2 Study Evaluating Gerilimzumab's Safety/Efficacy for Patients with an Inadequate Response to MTX or a TNFα Antagonist in Rheumatoid Arthritis.
Detailed Description
The trial will include adult patients 18-80 years of age with active disease who have demonstrated an inadequate response to treatment with MTX. Eligible patients will enter a 6-week screening period receiving 15-25 mg MTX QWK (patients will remain on their current dose and route of administration of MTX through the screening period). Patients on a dose of MTX less than 15mg QWK will have their dose of MTX increased to 15mg QWK at the initial screening visit) followed by randomization in a 1:1:1:1 ratio to 1 of 3 doses of gerilimzumab (5, 10, or 20 mg loading dose followed by 2 mg, 5 mg or 10 mg of gerilimzumab Q8W) plus MTX, or placebo plus MTX for 12 weeks of treatment. Gerilimzumab and placebo will be administered as SC injections Q8W; MTX will continue to be administered as by same route of administration (tablets, SC, or IM injection) QWK.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Gerilimzumab 5/2 mg/Methotrexate/folate
• 5 mg gerilimzumab loading dose followed by 2 mg gerilimzumab every 8 weeks + 15-25 mg Methotrexate every week + 1 mg folic acid once daily
Intervention: Gerilimzumab (Drug)
Gerilimzumab 5/2 mg/Methotrexate/folate
• 5 mg gerilimzumab loading dose followed by 2 mg gerilimzumab every 8 weeks + 15-25 mg Methotrexate every week + 1 mg folic acid once daily
Intervention: Methotrexate (Drug)
Gerilimzumab 5/2 mg/Methotrexate/folate
• 5 mg gerilimzumab loading dose followed by 2 mg gerilimzumab every 8 weeks + 15-25 mg Methotrexate every week + 1 mg folic acid once daily
Intervention: Folic Acid (Drug)
Gerilimzumab 10/5mg/Methotrexate/folate
• 10 mg gerilimzumab loading dose followed by 5 mg gerilimzumab every 8 weeks + 15-25 mg Methotrexate every week + 1 mg folic acid once daily
Intervention: Gerilimzumab (Drug)
Gerilimzumab 10/5mg/Methotrexate/folate
• 10 mg gerilimzumab loading dose followed by 5 mg gerilimzumab every 8 weeks + 15-25 mg Methotrexate every week + 1 mg folic acid once daily
Intervention: Methotrexate (Drug)
Gerilimzumab 10/5mg/Methotrexate/folate
• 10 mg gerilimzumab loading dose followed by 5 mg gerilimzumab every 8 weeks + 15-25 mg Methotrexate every week + 1 mg folic acid once daily
Intervention: Folic Acid (Drug)
Gerilimzumab 20/10mg/Methotrexate/folate
• 20 mg gerilimzumab loading dose followed by 10 mg gerilimzumab every 8 weeks + 15-25 mg Methotrexate every week + 1 mg folic acid once daily
Intervention: Gerilimzumab (Drug)
Gerilimzumab 20/10mg/Methotrexate/folate
• 20 mg gerilimzumab loading dose followed by 10 mg gerilimzumab every 8 weeks + 15-25 mg Methotrexate every week + 1 mg folic acid once daily
Intervention: Methotrexate (Drug)
Gerilimzumab 20/10mg/Methotrexate/folate
• 20 mg gerilimzumab loading dose followed by 10 mg gerilimzumab every 8 weeks + 15-25 mg Methotrexate every week + 1 mg folic acid once daily
Intervention: Folic Acid (Drug)
Placebo/Methotrexate/folate
• Placebo every 8 weeks + 15-25 mg Methotrexate every week + 1 mg folic acid once daily
Intervention: Methotrexate (Drug)
Placebo/Methotrexate/folate
• Placebo every 8 weeks + 15-25 mg Methotrexate every week + 1 mg folic acid once daily
Intervention: Folic Acid (Drug)
Placebo/Methotrexate/folate
• Placebo every 8 weeks + 15-25 mg Methotrexate every week + 1 mg folic acid once daily
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Change from baseline in mean DAS28-CRP (Disease Activity Score 28 using the C-Reactive Protein value)
Time Frame: to be applied in weeks - 6, -2, -1, 0, 4, 8, 12 and 16
Secondary Outcomes
- The proportion of patients meeting the ACR20 (American College of Rheumatology 20%) response criteria at Week 12(to be applied in weeks -6, 0, 4, 8, 12 and 16)