Status:
RECRUITING
A Study to Investigate Efficacy and Safety of AZD1163 in Participants With Rheumatoid Arthritis
Lead Sponsor:
AstraZeneca
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Phase II study in participants with moderately-to-severely active rheumatoid Arthritis (RA) to evaluate efficacy and safety of AZD1163.
Detailed Description
AZD1163 is a novel bispecific antibody that inhibits the activity of extracellular peptidyl arginine deiminase 2 (PAD2) and peptidyl arginine deiminase 4 (PAD4) enzymes, which are responsible for prot...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 18 2028
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT07276581
Start Date
December 15 2025
End Date
August 18 2028
Last Update
February 10 2026
Active Locations (124)
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1
Research Site
Glendale, Arizona, United States, 85306
2
Research Site
Prescott Valley, Arizona, United States, 86314
3
Research Site
La Jolla, California, United States, 92093
4
Research Site
San Dimas, California, United States, 91773