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

Part of paid clinical trials in Glendale, Arizona.

Sponsor
AstraZeneca
Study ID
NCT07276581
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

Start date
Dec 15, 2025
Status verified
Apr 2026
Primary completion
Nov 12, 2027
Completion
Aug 18, 2028

Study Design

Enrollment
320 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (28)

FacilityCityStateZIPSite coordinators
Research SiteGlendaleArizona85306-
Research SitePrescott ValleyArizona86314-
Research SiteTucsonArizona85748-
Research SiteLa JollaCalifornia92037-
Research SiteSan DimasCalifornia91773-
Research SiteSan LeandroCalifornia94578-
Research SiteAuroraColorado80045-
Research SiteBoynton BeachFlorida33435-
Research SiteJacksonvilleFlorida32216-
Research SiteSouth MiamiFlorida33143-
Research SiteTampaFlorida33607-
Research SiteWinter HavenFlorida33880-
Research SiteMariettaGeorgia30060-
Research SiteSkokieIllinois60076-
Research SiteWillowbrookIllinois60527-
Research SiteLake CharlesLouisiana70605-
Research SiteBaltimoreMaryland21224-
Research SiteNew BedfordMassachusetts02740-
Research SiteKansas CityMissouri64151-
Research SiteSt LouisMissouri63131-
Research SiteHendersonNevada89052-
Research SiteMyrtle BeachSouth Carolina29572-
Research SiteAustinTexas78745-
Research SiteBaytownTexas77521-
Research SiteHoustonTexas77027-
Research SiteHoustonTexas77089-
Research SiteMesquiteTexas75150-
Research SiteTomballTexas77375-

Find similar trials in Glendale, AZ

By condition
Rheumatoid arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
Research Site· Glendale, AZResearch Site· Prescott Valley, AZResearch Site· Tucson, AZResearch Site· La Jolla, CAResearch Site· San Dimas, CAResearch Site· San Leandro, CA

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