A study to investigate how well and safe a trial drug called AZD1163, administered as an injection, works in improving symptoms and inflammation in adult participants with moderately to severely active rheumatoid arthritis.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

AstraZeneca AB

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Decision date (initial)

2026-04-24

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

AstraZeneca AB

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Dose response, Safety, Pharmacokinetic

To evaluate the clinical efficacy of AZD1163 as compared to placebo.

Secondary objectives 3

1. To evaluate the clinical efficacy of AZD1163
2. To evaluate the pharmacokinetics (PK) of AZD1163
3. To evaluate the immunogenicity of AZD1163

Conditions and MedDRA coding

Rheumatoid arthritis

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration, European Medicines Agency

Plan to share IPD

Yes

IPD plan description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared. AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment https://vivli.org/. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Diagnosed with adult-onset RA as defined by the 2010 ACR/EULAR classification criteria for at least 12 weeks prior to screening.
2. 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.
3. Have a positive ACPA at screening.
4. 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.
5. 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 criteria 2

1. 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.
2. Have received or planning to receive any biologic DMARDs (except for TNFi) or targeted synthetic DMARDs.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

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

Secondary endpoints 3

1. Percentage of Participants Achieving American College of Rheumatology Response Criteria 20 (ACR20) at Week 12 - Percentage of Participants Achieving ACR50 at Week 12 - Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 12 - Change From Baseline in Simplified Disease Activity Index (SDAI) at Week 12
2. AZD1163 concentrations in serum.
3. ADA (incidence, prevalence, and titres)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

AstraZeneca AB

Sponsor organisation

AstraZeneca AB

Address

-

City

Sodertalje

Postcode

151 85

Country

Sweden

Scientific contact point

Organisation

AstraZeneca AB

Contact name

AstraZeneca Clinical Study Information Center

Public contact point

Organisation

AstraZeneca AB

Contact name

AstraZeneca Clinical Study Information Center

Locations

5 EU/EEA countries · 30 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 25 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications