Recruiting
Phase 2

AZD1163

Sponsor:

AstraZeneca

Code:

NCT07276581

Conditions

Rheumatoid Arthritis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

AZD1163

Placebo

Study Details

Brief summary:

Phase II study in participants with moderately-to-severely active rheumatoid Arthritis (RA) to evaluate efficacy and safety of AZD1163.

Conditions

Rheumatoid Arthritis

Study ID

NCT07276581

Start date

Dec 15, 2025

Status verified date

Jun, 2026

Completion date

Aug 18, 2028

Anticipated

Primary completion date

Nov 12, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

  • 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.

Study Design

Enrollment

320 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: AZD1163 Dose 1

Participants will receive subcutaneous (SC) injection of AZD1163 Dose 1 in combination with SoC (csDMARDs or TNFi +/- csDMARD) until Week 24.

experimental: AZD1163 Dose 2

Participants will receive SC injection of AZD1163 Dose 2 in combination with SoC (csDMARDs or TNFi +/- csDMARD) until Week 24.

experimental: AZD1163 Dose 3

Participants will receive SC injection of AZD1163 Dose 3 in combination with SoC (csDMARDs or TNFi +/- csDMARD) until Week 24.

placebo comparator: Placebo

Participants will receive SC injection of placebo matched with AZD1163 dose in combination with SoC (csDMARDs or TNFi +/- csDMARD) until Week 24.

Interventions

AZD1163

Participants will receive SC injection of one of three different doses of AZD1163 in combination with SoC (csDMARD or TNFi +/- csDMARDSoC) until Week 24.

Placebo

Participants will receive SC injection of placebo matched to AZD1163 in combination with SoC (csDMARD or TNFi +/- csDMARDSoC) until Week 24.

Primary outcome measure

  • Change From Baseline in Disease Activity Score-C-Reactive Protein (DAS28-CRP) at Week 12 [ Time Frame: Week 12 ]

Central Contacts and Locations

Central contacts

AstraZeneca Clinical Study Information Center

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

Locations

Research Site

Recruiting

Willowbrook, Illinois, United States, 60527

Research Site

Recruiting

Lake Charles, Louisiana, United States, 70605

Research Site

Recruiting

New Bedford, Massachusetts, United States, 02740

Research Site

Recruiting

St Louis, Missouri, United States, 63131

Research Site

Recruiting

Henderson, Nevada, United States, 89052

Research Site

Recruiting

Austin, Texas, United States, 78745

Research Site

Recruiting

Baytown, Texas, United States, 77521

Research Site

Recruiting

Houston, Texas, United States, 77027

Research Site

Recruiting

Houston, Texas, United States, 77089

Research Site

Recruiting

Tomball, Texas, United States, 77375

Research Site

Recruiting

Windsor, Ontario, Canada, N8X 5A7

Research Site

Recruiting

Trois-Rivières, Quebec, Canada, G9A 3Y2

More Information

Sponsor

AstraZeneca

Last update posted

Jun 24, 2026

Last verified

Jun, 2026

Keywords

  • Rheumatoid arthritis
  • AZD1163
  • placebo-controlled
  • double-blind
  • csDMARDs
  • TNFi
  • PAD2/4 inhibitor

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-06-24.