Ireland
--:--IST
Recruiting Phase 2

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

NCT07276581 · tracked via the Priya Life Science Spain tracker
Phase
Phase 2
Started
2025-12-15
Last updated
2026-10-09

Condition(s) studied

Rheumatoid Arthritis

Investigational drug(s) / intervention(s)

AZD1163Placebo

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.

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
* 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.

Primary outcome measure(s)

  • Change From Baseline in Disease Activity Score-C-Reactive Protein (DAS28-CRP) at Week 12 — Week 12
    Change from baseline in DAS28-CRP at Week 12.

Trial sites (147)

FacilityCityRegionStatus
Research Site Glendale Arizona Recruiting
Research Site Prescott Valley Arizona Withdrawn
Research Site Tucson Arizona Recruiting
Research Site La Jolla California Recruiting
Research Site San Dimas California Withdrawn
Research Site San Leandro California Recruiting
Research Site Aurora Colorado Recruiting
Research Site Boynton Beach Florida Withdrawn
Research Site Jacksonville Florida Withdrawn
Research Site South Miami Florida Suspended
Research Site Tampa Florida Withdrawn
Research Site Winter Haven Florida Recruiting
Research Site Marietta Georgia Recruiting
Research Site Skokie Illinois Recruiting
Research Site Willowbrook Illinois Recruiting
Research Site Lake Charles Louisiana Recruiting
Research Site Baltimore Maryland Recruiting
Research Site Rockville Maryland Not Yet Recruiting
Research Site New Bedford Massachusetts Recruiting
Research Site Kansas City Missouri Recruiting
Research Site St Louis Missouri Recruiting
Research Site Henderson Nevada Recruiting
Research Site Myrtle Beach South Carolina Recruiting
Research Site Austin Texas Recruiting
Research Site Baytown Texas Recruiting
Research Site Houston Texas Recruiting
Research Site Houston Texas Recruiting
Research Site Mesquite Texas Recruiting
Research Site Tomball Texas Recruiting
Research Site Caba Argentina Recruiting
Research Site Ciudad de Buenos Aires Argentina Recruiting
Research Site Ciudad de Buenos Aires Argentina Recruiting
Research Site Córdoba Argentina Recruiting
Research Site San Isidro Argentina Recruiting
Research Site San Miguel de Tucumán Argentina Recruiting
Research Site Juiz de Fora Brazil Not Yet Recruiting
Research Site Pelotas Brazil Recruiting
Research Site Porto Alegre Brazil Recruiting
Research Site Porto Alegre Brazil Recruiting
Research Site Salvador Brazil Recruiting

+ 107 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07276581 on ClinicalTrials.gov ↗ ← All trials in Spain