At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- AZD1163 (drug), Placebo (other)
- How long the study runs
- Study runs about 32 months (dates as stated)
- About the drug or intervention
- 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.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 320
- Started
- 2025-12-15
- Last checked
- 2026-10
Plain English Summary
What is this study?
- • Testing a new treatment for rheumatoid arthritis
- • Phase2 - 320 participants
- • Phase II study in participants with moderately-to-severely active rheumatoid Arthritis (RA) to evaluate efficacy and safety of AZD1163
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with rheumatoid arthritis
Where?
- • Glasgow - Research Site
- • Leeds - Research Site
- • Luton - Research Site
- • Staffordshire - Research Site
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
Phase II study in participants with moderately-to-severely active rheumatoid Arthritis (RA) to evaluate efficacy and safety of AZD1163.
More detail
AZD1163 is a novel bispecific antibody that inhibits the activity of extracellular peptidyl arginine deiminase 2 (PAD2) and peptidyl arginine deiminase 4 (PAD4) enzymes, which are responsible for protein citrullination. In RA, citrullinated proteins lead to the production of pathogenic anti-citrullinated peptide antibodies (ACPA). This is a Phase II, randomised, double-blind, multicentre, 4 arm placebo-controlled study designed to evaluate the efficacy and safety of AZD1163 in ACPA + adults with moderate-to-severely active RA on standard of care (SoC) (conventional synthetic disease-modifying antirheumatic drugs \[csDMARDs\] or tumour necrosis factor inhibitor \[TNFi\] +/- csDMARD). The study will have a screening period followed by a randomisation period wherein approximately 320 participants will be randomised in a 1:1:1:1 ratio to receive study intervention. Participants will receive subcutaneous (SC) injection of one of three different doses of AZD1163 or placebo, along with SoC until Week 24 followed by a safety follow-up (FU) period of 28 weeks.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Inclusion
- ✓Diagnosed with adult-onset RA as defined by the 2010 ACR/EULAR classification criteria for at least 12 weeks prior...
- ✓Moderately-to-severely active RA as defined by: a. \>= 6 swollen joints on 66SJC and \>= 6 tender joints on 68TJC;...
- ✓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...
See the full criteria
Where Is This Study? (4 UK sites)
Research Site
Glasgow G31 2ER, United Kingdom
Research Site
Leeds LS7 4SA, United Kingdom
Research Site
Luton LU4 0DZ, United Kingdom
Research Site
Staffordshire WS11 5XY, United Kingdom
How to Get in Touch
AstraZeneca Clinical Study Information Center
Sponsor contactCONTACT