AZD1163 treatment for adults with rheumatoid arthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

* 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 it's running

• Research Site
  Glendale, Arizona, United States Recruiting
• Research Site
  Tucson, Arizona, United States Recruiting
• Research Site
  La Jolla, California, United States Recruiting
• Research Site
  San Leandro, California, United States Recruiting
• Research Site
  Aurora, Colorado, United States Recruiting
• Research Site
  Winter Haven, Florida, United States Recruiting

+97 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• GenAI-assisted RA bone erosion risk and DMARD choice

  This study tests whether GenAI-based decision support can help doctors assess rheumatoid arthritis bone erosion risk and pick DMARDs for newly diagnosed inpatients.

  Recruiting Guang'anmen Hospital of China Academy of Chinese Medical Sciences · Beijing, Beijing Municipality · NCT07914907

• Pain patterns in rheumatic diseases: see if pain works differently in patients and healthy people

  This observational study tests how pain is experienced and measured in people with rheumatic diseases compared with healthy volunteers.

  Recruiting National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT07829497

• Telitacicept for difficult-to-treat rheumatoid arthritis

  This study tests whether adding telitacicept to standard therapy helps adults with hard-to-treat rheumatoid arthritis see better control of their symptoms.

  Recruiting Phase 2 Peking University People's Hospital · Hefei, Anhui and 46 other locations · NCT07796516

• PTC844 in people with active rheumatoid arthritis

  This study tests whether PTC844 is safe and how it behaves in the body compared with placebo for people with active rheumatoid arthritis.

  Recruiting at 6 sites Phase 2 PTC Therapeutics · Chandler, Arizona and 25 other locations · NCT07779616

• First-in-human test of CND319 in healthy people and people with rheumatic diseases

  This early study tests whether CND319 is safe and tolerable and whether it shows any signs of activity in healthy adults and in people with rheumatoid arthritis or Sjogren's syndrome.

  Recruiting Phase 1 Candid Therapeutics · Melbourne, Victoria · NCT07712939

• IV sarilumab for adults with rheumatoid arthritis

  This study tests IV sarilumab to see how it works and how safe it is for adults with moderately to severely active rheumatoid arthritis, with or without certain standard arthritis medicines.

  Recruiting at 12 sites Phase 1/2 Sanofi · Centennial, Colorado and 11 other locations · NCT07704580

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.