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Taking people in BulgariaPhase 2

Tests AZD1163 in adults with moderately to severely active rheumatoid arthritis

Tests the drug AZD1163 against a placebo in adults with active rheumatoid arthritis.

Key facts

Who runs it
AstraZeneca
Where
Haskovo, Pleven, and Sofia, BulgariaSee the 3 sitesAlso in 16 other countries, 122 sites
Registry title
A Study to Investigate Efficacy and Safety of AZD1163 in Participants With Rheumatoid Arthritis
Status
Recruiting
Phase
Phase 2
People taking part
320 people, planned
Started
15 Dec 2025
Expected to end
18 Aug 2028
Type of study
Interventional, 4 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • AZD1163
  • Placebo
Record updated
9 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with moderately-to-severely active rheumatoid arthritis (RA) to test the drug AZD1163 against placebo.

Age
18 years and older
Sex
All sexes can join.
Disease stage
RA diagnosed in adulthood (2010 ACR/EULAR criteria) for at least 12 weeks, with moderately-to-severely active disease: at least 6 swollen joints, at least 6 tender joints, and CRP above the upper limit of normal.
Earlier treatment
Must have had an inadequate response, loss of response or intolerance to at least one csDMARD and/or at least one and at most 2 TNFi. Must have had at least 12 weeks of treatment, stable for at least 4 weeks, on a csDMARD and/or SC TNFi before randomisation. Must not have had biologic DMARDs (except TNFi) or targeted synthetic DMARDs.
Biomarker or test result
Positive ACPA at screening.

Main reasons for not taking part

  • Another autoimmune or other condition that could confuse the RA diagnosis (RA with secondary Sjogren's disease can join)
  • Has received or plans to receive biologic DMARDs other than TNFi
  • Has received or plans to receive targeted synthetic DMARDs

The registry criteria, word for word

Show all 2 criteriaShow less

Other 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

Where in Bulgaria

Also in 16 other countries, 122 sites

  • HaskovoHospital not named in the registryTaking people
  • PlevenHospital not named in the registryTaking people
  • SofiaHospital not named in the registryTaking people

About the trial

What the trial wants to find out

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

The 4 groups in the trial

  • AZD1163 Dose 1Treatment being tested

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

    Treatment: AZD1163

  • AZD1163 Dose 2Treatment being tested

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

    Treatment: AZD1163

  • AZD1163 Dose 3Treatment being tested

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

    Treatment: AZD1163

  • PlaceboPlacebo, for comparison

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

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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)
Plain-language title
Tests AZD1163 in adults with moderately to severely active rheumatoid arthritisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
9 October 2026