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)
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)
Phase II study in participants with moderately-to-severely active rheumatoid Arthritis (RA) to evaluate efficacy and safety of AZD1163.
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.
Inclusion
Exclusion
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Caba, C1128AAF, Argentina
Ciudad de Buenos Aires, C1015ABO, Argentina
Ciudad de Buenos Aires, C1428DUQ, Argentina
Iizuka-shi, 820-8505, Japan
Kawachinagano-shi, 586-8521, Japan
Meguro-ku, 152-8902, Japan
Sagamihara-shi, 252-0315, Japan
Sasebo-shi, 857-1195, Japan
Sayama-shi, 350-1305, Japan
Staffordshire, WS11 5XY, United Kingdom