Phase 2 Study of AZD1163 for Rheumatoid Arthritis
This study is testing a new medication called AZD1163 for people with moderately-to-severely active rheumatoid arthritis (RA). AZD1163 is a bispecific antibody that works by targeting specific enzymes (PAD2 and PAD4) involved in RA. To join, you must be an adult (18+) diagnosed with RA for at least 12 weeks, have moderately-to-severely active RA with specific joint counts and inflammation, and have a positive ACPA (anti-citrullinated protein antibody) test. The study will compare AZD1163 at three different doses to a placebo (an inactive substance) over 24 weeks. All participants will also continue their usual RA medications. The main goal is to see how much AZD1163 improves your disease activity (measured by DAS28-CRP) after 12 weeks, and to check its safety. About 320 people are expected to join.
- Study design
- This is a Phase 2, randomized, double-blind, multicenter study with 320 participants. Participants will be assigned by chance to one of four groups: three different doses of AZD1163 or a placebo.
- What's involved
- Participants will receive injections of AZD1163 or placebo along with their standard RA medication for 24 weeks. This will be followed by a safety follow-up period of 28 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will have a safety follow-up period of 28 weeks after the 24-week treatment period.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study to Investigate Efficacy and Safety of AZD1163 in Participants With Rheumatoid Arthritis
At a glance
Conditions
Where it's being run
144 sites across 30 statesWho to contact
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What this trial measures
- Change From Baseline in Disease Activity Score-C-Reactive Protein (DAS28-CRP) at Week 12Week 12
Change from baseline in DAS28-CRP at Week 12.