NCT07276581

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

A Multicentre, Parallel-group, Phase II, Randomised, Double-blind, 4 Arm Study to Evaluate Efficacy and Safety of AZD1163 in Participants With Moderately-to-Severely Active Rheumatoid Arthritis (LaunchPAD-RA)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 320 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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 days.

Conditions

• Rheumatoid Arthritis

Interventions

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

Timeline

• Start date: 2025-12-15
• Primary completion: 2027-11-12
• Completion: 2028-08-18
• First posted: 2025-12-11
• Last updated: 2026-03-24

Locations

139 sites across 17 countries: United States, Argentina, Brazil, Bulgaria, Canada, Chile, China, Germany, Hungary, Japan, Mexico, Poland, Puerto Rico, South Africa, Spain, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study