Recent Updates
Recently added Catalysts

AZD1163

Phase 2

Rheumatoid Arthritis | Small molecule | Immunology |AstraZeneca PLC|Trials Updated: Oct 9, 2026

AZD1163 development status

Highest phase Phase 2
Registered trials 2 across 1 sponsor since Oct 2023

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment320

FDA Designations

No designations recorded

AZD1163 clinical trials

AZD1163 · 1 trial · 1 indication

Phase 2 1
NCT07276581A Study to Investigate Efficacy and Safety of AZD1163 in Participants With Rheumatoid ArthritisRheumatoid Arthritis
RECRUITING320 Analytics
PHASE2RECRUITING
A Study to Investigate Efficacy and Safety of AZD1163 in Participants With Rheumatoid Arthritis
Rheumatoid ArthritisUnlock trial analytics

Study Endpoints

Primary Endpoints

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.

Secondary Endpoints

Percentage of Participants Achieving American College of Rheumatology Response Criteria 20 (ACR20) at Week 12
Week 12
Percentage of Participants Achieving ACR50 at Week 12
Week 12
Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 12
Week 12
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AZD1163 Dose 1EXPERIMENTALParticipants will receive subcutaneous (SC) injection of AZD1163 Dose 1 in combination with SoC (csDMARDs or TNFi +/- csDMARD) until Week 24.
AZD1163 Dose 2EXPERIMENTALParticipants will receive SC injection of AZD1163 Dose 2 in combination with SoC (csDMARDs or TNFi +/- csDMARD) until Week 24.
AZD1163 Dose 3EXPERIMENTALParticipants will receive SC injection of AZD1163 Dose 3 in combination with SoC (csDMARDs or TNFi +/- csDMARD) until Week 24.
PlaceboPLACEBO_COMPARATORParticipants will receive SC injection of placebo matched with AZD1163 dose in combination with SoC (csDMARDs or TNFi +/- csDMARD) until Week 24.

Interventions

NameTypeDescription
AZD1163DRUGParticipants will receive SC injection of one of three different doses of AZD1163 in combination with SoC (csDMARD or TNFi +/- csDMARDSoC) until Week 24.
PlaceboOTHERParticipants will receive SC injection of placebo matched to AZD1163 in combination with SoC (csDMARD or TNFi +/- csDMARDSoC) until Week 24.
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites147

* 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. ...

Countries:United StatesArgentinaBrazilBulgariaCanadaChileChinaGermanyHungaryJapanMexicoPolandPuerto RicoSouth AfricaSpainUkraineUnited Kingdom
Unlock Eligibility Criteria

Recent Changes (Last 90 Days)

LOWOct 9, 2026NCT07276581lastUpdatePostDate: changed
LOWOct 9, 2026NCT07276581lastUpdatePostDate: changed

Frequently asked questions about AZD1163

What is AZD1163?

AZD1163 is an investigational small molecule being developed by AstraZeneca PLC for the treatment of rheumatoid arthritis. It is currently in Phase 2 clinical development and has not been approved for any indication. AstraZeneca trades on the Nasdaq under the ticker AZN.

What is AZD1163 used for in rheumatoid arthritis?

AZD1163 is being studied as a treatment for rheumatoid arthritis, an inflammatory joint disease. It is an investigational therapy in Phase 2 testing and is not yet approved for use in rheumatoid arthritis or any other condition. Its safety and efficacy in patients are still being evaluated in clinical trials.

Who makes AZD1163?

AZD1163 is developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is running the clinical program for the drug in rheumatoid arthritis, including a Phase 2 study that is currently recruiting participants across multiple countries.

What phase is AZD1163 in?

AZD1163 is in Phase 2 clinical development. It is an investigational small molecule for rheumatoid arthritis and has not received FDA approval. The Phase 2 trial is currently recruiting, and no Phase 3 studies or completed trials for this drug have been reported.

What clinical trials is AZD1163 in?

AZD1163 is being evaluated in one clinical trial, NCT07276581, titled A Study to Investigate Efficacy and Safety of AZD1163 in Participants With Rheumatoid Arthritis. This Phase 2 study is currently recruiting and plans to enroll 320 participants aged 18 years and older across sites in the United States, Europe, Asia, Latin America, and other regions.

Is the AZD1163 trial placebo controlled?

Yes. The Phase 2 trial of AZD1163 in rheumatoid arthritis, NCT07276581, is a randomized, double-blind, placebo-controlled study. It plans to enroll 320 participants with rheumatoid arthritis and is currently recruiting. The trial does not select participants based on a biomarker.