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A Study to Investigate Efficacy and Safety of AZD1163 in Participants With Rheumatoid Arthritis

ConditionRheumatoid Arthritis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAstraZeneca

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • AZD1163

    Drug

    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

    Other intervention

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

Treatment groups

320 Participants
are divided into 4 treatment groups
Group A: AZD1163 Dose 1Experimental treatment 1 intervention
Group B: AZD1163 Dose 2Experimental treatment 1 intervention
Group C: AZD1163 Dose 3Experimental treatment 1 intervention
Group D: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change From Baseline in Disease Activity Score-C-Reactive Protein (DAS28-CRP) at Week 12

Change from baseline in DAS28-CRP at Week 12.

Time frame
Week 12

Secondary outcomes

1

Percentage of Participants Achieving American College of Rheumatology Response Criteria 20 (ACR20) at Week 12

Proportion of participants achieving a 20% improvement in ACR response criteria at Week 12.

Time frame
Week 12
2

Percentage of Participants Achieving ACR50 at Week 12

Proportion of participants achieving a 50% improvement in ACR response criteria at Week 12.

Time frame
Week 12
3

Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 12

Change from baseline in CDAI at Week 12.

Time frame
Week 12
4

Change From Baseline in Simplified Disease Activity Index (SDAI) at Week 12

Change from baseline in SDAI at Week 12.

Time frame
Week 12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AstraZeneca

Lead sponsor

Source ClinicalTrials.gov
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