A Study to Investigate Efficacy and Safety of AZD1163 in Participants With Rheumatoid Arthritis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AZD1163, Placebo.
- Who it may be relevant to
- Registry conditions: Rheumatoid Arthritis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Argentina, Brazil, Bulgaria, Canada +12
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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)
Overview
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 weeks.
Interventions
- 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.
Primary outcome measures
- Change From Baseline in Disease Activity Score-C-Reactive Protein (DAS28-CRP) at Week 12 [Time frame: Week 12]
Secondary outcome measures (6)
- Percentage of Participants Achieving American College of Rheumatology Response Criteria 20 (ACR20) at Week 12 [Time frame: Week 12]
- Percentage of Participants Achieving ACR50 at Week 12 [Time frame: Week 12]
- Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 12 [Time frame: Week 12]
- Change From Baseline in Simplified Disease Activity Index (SDAI) at Week 12 [Time frame: Week 12]
- Summary statistics to evaluate the PK of AZD1163 [Time frame: Week 0 to Week 24 and Follow-Up]
- Summary statistics to evaluate the immunogenicity of AZD1163 [Time frame: Week 0 to Week 24 and Follow-Up]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 28 centers
- Research Site — Glendale
- Research Site — Prescott Valley
- Research Site — Tucson
- Research Site — La Jolla
- Research Site — San Dimas
- Research Site — San Leandro
- Research Site — Aurora
- Research Site — Boynton Beach
- … and 20 more centers
Japan · 17 centers
Center list to be confirmed — check the primary protocol.
China · 15 centers
- Research Site — Beijing
- Research Site — Beijing
- Research Site — Changchun
- Research Site — Changsha
- Research Site — Guangzhou
- Research Site — Jiujiang
- Research Site — Kunming
- Research Site — Linyi
- … and 7 more centers
Mexico · 11 centers
Center list to be confirmed — check the primary protocol.
Ukraine · 9 centers
Center list to be confirmed — check the primary protocol.
Hungary · 8 centers
- Research Site — Budapest
- Research Site — Budapest
- Research Site — Budapest
- Research Site — Debrecen
- Research Site — Gyula
- … and 3 more centers
Brazil · 7 centers
- Research Site — Juiz de Fora
- Research Site — Pelotas
- Research Site — Porto Alegre
- Research Site — Porto Alegre
- Research Site — Salvador
- Research Site — São Paulo
- Research Site — São Paulo
Chile · 7 centers
- Research Site — Providencia
- Research Site — Santiago
- Research Site — Santiago
- Research Site — Temuco
- Research Site — Valdivia
- Research Site — Victoria
- Research Site — Viña del Mar
South Africa · 7 centers
Center list to be confirmed — check the primary protocol.
Spain · 7 centers
Center list to be confirmed — check the primary protocol.
Argentina · 6 centers
- Research Site — Caba
- Research Site — Ciudad de Buenos Aires
- Research Site — Ciudad de Buenos Aires
- Research Site — Córdoba
- Research Site — San Isidro
- Research Site — San Miguel de Tucumán
Bulgaria · 6 centers
- Research Site — Haskovo
- Research Site — Pleven
- Research Site — Sofia
- Research Site — Sofia
- Research Site — Sofia
- Research Site — Sofia
Poland · 5 centers
Center list to be confirmed — check the primary protocol.
Germany · 4 centers
- Research Site — Bad Doberan
- Research Site — Berlin
- Research Site — Hamburg
- Research Site — Sendenhorst
United Kingdom · 4 centers
Center list to be confirmed — check the primary protocol.
Canada · 2 centers
- Research Site — Windsor
- Research Site — Trois-Rivières
Puerto Rico · 1 center
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07276581 · D9640C00003 · 2025-522076-85 · 167070