A Study to Investigate Efficacy and Safety of AZD1163 in Participants With Rheumatoid Arthritis (LaunchPAD-RA)

AstraZeneca

Status and phase: Enrolling; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Drug: AZD1163; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07276581

167070 (Registry Identifier)

D9640C00003

2025-522076-85 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 320 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• 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.
  • 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 b. At least one and at most 2 TNFi.
  • 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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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320 participants in 4 patient groups, including a placebo group

AZD1163 Dose 1

Experimental group

Description:

Participants will receive subcutaneous (SC) injection of AZD1163 Dose 1 in combination with SoC (csDMARDs or TNFi +/- csDMARD) until Week 24.

Treatment:

Drug: AZD1163

AZD1163 Dose 2

Experimental group

Description:

Participants will receive SC injection of AZD1163 Dose 2 in combination with SoC (csDMARDs or TNFi +/- csDMARD) until Week 24.

Treatment:

Drug: AZD1163

AZD1163 Dose 3

Experimental group

Description:

Participants will receive SC injection of AZD1163 Dose 3 in combination with SoC (csDMARDs or TNFi +/- csDMARD) until Week 24.

Treatment:

Drug: AZD1163

Placebo

Placebo Comparator group

Description:

Participants will receive SC injection of placebo matched with AZD1163 dose in combination with SoC (csDMARDs or TNFi +/- csDMARD) until Week 24.

Treatment:

Other: Placebo