Bimekizumab for Psoriatic Arthritis

Phase 3

Waitlist Available

Research Sponsored by UCB Biopharma SRL

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

* Study participants must have a documented diagnosis of adult-onset PsA classified by and that meets the CASPAR classification criteria for at least 6 months prior to Screening with active PsA (despite previous csDMARD or apremilast therapy) and must have at Baseline tender joint count (TJC) ≥3 out of 68 joints and swollen joint count (SJC) ≥3 out of 66 joints (dactylitis of a digit counts as 1 joint each).

* Study participant must have at least 1 active psoriatic lesion(s) and/or a documented history of chronic plaque-type psoriasis (PSO).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline (day 1) to end of safety follow-up (up to 42 weeks)

Awards & highlights

Pivotal Trial

Summary

This trial aims to see if bimekizumab works better than risankizumab in treating active psoriatic arthritis after 16 weeks of treatment.

Who is the study for?

This trial is for adults with active Psoriatic Arthritis diagnosed at least 6 months ago, who have not responded well to or tolerated previous treatments. Participants must have at least 3 tender and swollen joints and one psoriatic skin lesion or a history of plaque-type psoriasis.

What is being tested?

The study aims to compare the effectiveness of two drugs, Bimekizumab and Risankizumab, over a period of 16 weeks in treating Psoriatic Arthritis. Some participants will receive a placebo instead as part of the control group.

What are the potential side effects?

Potential side effects may include reactions at the injection site, increased risk of infections due to immune system suppression, headaches, fatigue, and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with PsA for at least 6 months and still have active symptoms despite treatment.

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I have at least one active psoriasis lesion or a history of chronic plaque psoriasis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline (day 1) to end of safety follow-up (up to 42 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline (day 1) to end of safety follow-up (up to 42 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (day 1) to end of safety follow-up (up to 42 weeks) for reporting.