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RecruitingPhase 2

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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Injections

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This phase 2 study tests how well AZD1163 works and how safe it is. It is for people with rheumatoid arthritis (RA) that started in adulthood and is moderately to severely active. RA is a disease in which the immune system attacks the joints.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have RA that started in adulthood, meets standard diagnosis rules, and was diagnosed at least 12 weeks before screening.
  • Have at least 6 swollen joints and at least 6 tender joints.
  • Have a CRP blood test result above normal. CRP is a sign of inflammation.
  • Test positive for ACPA at screening. ACPA is an immune protein linked to RA.
  • Have tried at least one standard disease-modifying arthritis drug (csDMARD), one or two TNF blocker drugs (TNFi), or both. Treatment did not work well enough, stopped working, or caused side effects you could not tolerate.
  • Have used a csDMARD, a TNF blocker injected under the skin, or both for at least 12 weeks before study group assignment, with treatment stable for at least 4 weeks.

Who can't join

  • Have another immune system disease or condition that could make the RA diagnosis unclear. People with RA and secondary Sjogren’s disease, which can cause dry eyes and mouth, may still join.
  • Have received or plan to receive biologic disease-modifying arthritis drugs other than TNF blockers, or targeted synthetic disease-modifying arthritis drugs. These are types of medicines that act on the immune system.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (29)

AZ

CA

CO

FL

GA

IL

LA

MA

MD

MO

NV

SC

TX