Phase II Randomized Study to Evaluate the Efficacy and Safety of AZD1163 in Participants with Moderately-to-Severely Active Rheumatoid Arthritis

The primary objective of this study is to evaluate the clinical efficacy of AZD1163 compared to placebo in patients with moderately-to-severely active rheumatoid arthritis. 5

The secondary objectives include:

• Further assessment of the clinical efficacy of AZD1163. 5
• Evaluation of the pharmacokinetics of the study drug. 6
• Assessment of the immunogenicity of AZD1163. 4

The study involves a total of 198 patients diagnosed with rheumatoid arthritis. The participant population includes both males and females within the age ranges corresponding to codes 3 and 4. Eligible subjects must have a diagnosis of adult-onset rheumatoid arthritis based on the 2010 ACR/EULAR classification criteria for a minimum of 12 weeks. Inclusion requires moderately-to-severely active disease, characterized by specific counts of swollen joints and tender joints, along with elevated C-reactive protein levels. Furthermore, participants must demonstrate anti-citrullinated protein antibody positivity at screening. The population is comprised of individuals with a history of inadequate response or intolerance to conventional synthetic disease-modifying antirheumatic drugs and a limited number of tumor necrosis factor inhibitors. A stable treatment regimen of these therapies for at least 12 weeks prior to randomization is required.

This Phase II, multicentre, parallel-group, randomised, double-blind, 4-arm study is designed to evaluate the efficacy and safety of AZD1163 compared to a placebo in adults with moderately-to-severely active rheumatoid arthritis. The investigation utilizes subcutaneous use of a solution for injection. The primary endpoint is the change from baseline in the disease activity score-C-reactive protein (DAS28-CRP) at week 12. Secondary endpoints include the achievement of American College of Rheumatology Response Criteria 20 (ACR20) and ACR50, changes in the clinical disease activity index (CDAI) and simplified disease activity index (SDAI), serum concentrations of AZD1163, and the incidence of anti-drug antibodies (ADA).

The experimental medication is AZD1163, provided as a solution for injection. This substance is administered via subcutaneous route.

The control group receives AZD1163 Placebo as a placebo.

The efficacy of AZD1163 in participants with rheumatoid arthritis will be evaluated using several parameters. The primary endpoint is the change from baseline in the Disease Activity Score-C-Reactive Protein (DAS28-CRP) at week 12.

Secondary efficacy assessments at week 12 include:

• The percentage of participants achieving the American College of Rheumatology Response Criteria 20 (ACR20).
• The percentage of participants achieving ACR50.
• The change from baseline in the Clinical Disease Activity Index (CDAI).
• The change from baseline in the Simplified Disease Activity Index (SDAI).
• Serum concentrations of AZD1163.
• The incidence, prevalence, and titres of anti-drug antibodies (ADA).