RecruitingPhase 2

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

United States, Argentina, Brazil320 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 range

18 Years

Sex

ALL

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change From Baseline in Disease Activity Score-C-Reactive Protein (DAS28-CRP) at Week 12

Timeframe: Week 12

Trial details

NCT IDNCT07276581

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-11-12

Contact for this trial

AstraZeneca Clinical Study Information Center

1-877-240-9479 information.center@astrazeneca.com

View on ClinicalTrials.gov More Rheumatoid Arthritis trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.