Home › Trials › NCT07276581

AZD1163 treatment for adults with rheumatoid arthritis

A Multicentre, Parallel-group, Phase II, Randomised, Double-blind, 4 Arm Study to Evaluate Efficacy and Safety of AZD1163 in Participants With Moderately-to-Severely Active Rheumatoid Arthritis (LaunchPAD-RA)

PHASE2 · AstraZeneca · NCT07276581

This will test whether injections of AZD1163, given with standard rheumatoid arthritis medicines, help adults with moderately-to-severely active, ACPA-positive RA.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment320 (estimated)
Ages18 Years and up
SexAll
SponsorAstraZeneca (industry)
Locations144 sites (Glendale, Arizona and 143 other locations)
Trial IDNCT07276581 on ClinicalTrials.gov

What this trial studies

This Phase II, randomized, double-blind, placebo-controlled study will enroll about 320 ACPA-positive adults with moderately-to-severely active rheumatoid arthritis who remain on standard-of-care csDMARDs or TNFi ± csDMARD. Participants will be randomized 1:1:1:1 to receive one of three subcutaneous AZD1163 dosing regimens or placebo through Week 24, followed by a 28-week safety follow-up. AZD1163 is a bispecific antibody designed to inhibit extracellular PAD2 and PAD4 enzymes that drive protein citrullination and anti-citrullinated peptide antibody production in RA. The trial will monitor efficacy and safety outcomes while participants continue their background RA treatments.

Who should consider this trial

Good fit: Adults with adult-onset, moderately-to-severely active RA who are ACPA-positive and have had an inadequate response or intolerance to at least one csDMARD and/or one to two TNF inhibitors, and who have been stable on csDMARD or SC TNFi for the required lead-in period are the intended participants.

Not a fit: ACPA-negative patients, those with alternative autoimmune diagnoses that confound RA, or people who have recently received non-TNFi biologic or targeted synthetic DMARDs are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, AZD1163 could reduce autoantibody-driven inflammation and lower disease activity in ACPA-positive RA patients, improving symptoms and function.

How similar studies have performed: Targeting PAD enzymes with a bispecific antibody is a relatively novel approach and there is limited clinical evidence to date for PAD inhibition in RA.

Eligibility criteria

Show full inclusion / exclusion criteria 
* Inclusion

  * Diagnosed with adult-onset RA as defined by the 2010 ACR/EULAR classification criteria for at least 12 weeks prior to screening.
  * Moderately-to-severely active RA as defined by: a. \>= 6 swollen joints on 66SJC and \>= 6 tender joints on 68TJC; b. CRP \> upper limit of normal.
  * Have a positive ACPA at screening.
  * A history of inadequate response, or loss of response, or intolerance to: a. at least one csDMARD treatment, AND/OR b. At least one and at most 2 TNFi.
  * A history of at least 12 weeks treatment and \>= 4 weeks stable on a csDMARD and/or SC TNFi prior to the day of randomisation.
* Exclusion

  * History or evidence of an alternate autoimmune or other condition that could confound the diagnosis of RA. Participants with RA and secondary Sjogren's disease are eligible.
  * Have received or planning to receive any biologic DMARDs (except for TNFi) or targeted synthetic DMARDs.

Where this trial is running

Glendale, Arizona and 143 other locations

+94 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Rheumatoid Arthritis, Rheumatoid arthritis, AZD1163, placebo-controlled, double-blind, csDMARDs, TNFi, PAD2/4 inhibitor

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.