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.

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NCT07276581

A Study to Investigate Efficacy and Safety of AZD1163 in Participants With Rheumatoid Arthritis

Recruiting
PHASE2Ages 18+InterventionalTreatment
AstraZeneca
~320 participants
Updated 2026-06-24 on ClinicalTrials.gov
What's tested:AZD1163Placebo

At a glance

Recruiting sites
45 of 144 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change From Baseline in Disease Activity Score-C-Reactive Protein (DAS28-CRP) at Week 12
Measured over Week 12
Rheumatoid Arthritis
144 sites across 30 states
Japan17
China15
Mexico11
Ukraine9
Hungary8
Brazil7
Chile7
South Africa7
AstraZeneca Clinical Study Information Center
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  • 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.