A Study to Investigate Efficacy and Safety of AZD1163 in Participants With Rheumatoid Arthritis (NCT07276581) | Clinical Trial Compass
RecruitingPhase 2
A Study to Investigate Efficacy and Safety of AZD1163 in Participants With Rheumatoid Arthritis
United States320 participantsStarted 2025-12-15
Plain-language summary
Phase II study in participants with moderately-to-severely active rheumatoid Arthritis (RA) to evaluate efficacy and safety of AZD1163.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* 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.
What they're measuring
1
Change From Baseline in Disease Activity Score-C-Reactive Protein (DAS28-CRP) at Week 12