Testing AZD1163 against a placebo for rheumatoid arthritis
Official title: 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)
Interventions
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.
Placebo
Participants will receive SC injection of placebo matched to AZD1163 in combination with SoC (csDMARD or TNFi +/- csDMARDSoC) until Week 24.
Canadian Sites (2)
Research Site
Windsor, Ontario, Canada
Research Site
Trois-Rivières, Quebec, Canada
Eligibility Criteria
See who this study is looking for7 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Diagnosed with adult-onset RA as defined by the 2010 ACR/EULAR classification criteria for at least 12 weeks prior to screeningScreeningThe checks done before joining, to see whether a study fits.Read more →.
- +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 randomisationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →.
- +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.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more → — a middle-stage study in a few hundred people at most, looking at what the treatment does and watching for side effectsSide effectAn unwanted effect thought to be caused by the treatment itself.Read more →.
What is being given or done in this study: AZD1163, PlaceboPlaceboA dummy treatment with no active medicine, used for comparison.Read more →.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
There are 4 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 320 people.
The study is currently expected to finish around August 2028.
The main measurement is taken over: Week 12.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Change From BaselineBaselineYour starting measurements, taken before treatment begins.Read more → in Disease Activity Score-C-Reactive Protein (DAS28-CRP) at Week 12 — measured over Week 12.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07276581 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About AZD1163Drug
Participants will receive SC injection of one of three different doses of AZD1163 in combination with SoC (csDMARD or TNFi +/- csDMARDSoC) until Week 24.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About PlaceboOther
Participants will receive SC injection of placebo matched to AZD1163 in combination with SoC (csDMARD or TNFi +/- csDMARDSoC) until Week 24.
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Week 12.
The study as a whole is currently expected to finish around 2028-08-18.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 320 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 2 locations, including: Windsor, Ontario, Canada; Trois-Rivières, Quebec, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
Phase II study in participants with moderately-to-severely active rheumatoid Arthritis (RA) to evaluate efficacy and safety of AZD1163.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.