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Evaluating bimekizumab for treating active psoriatic arthritis in adults

A Multicenter, Randomized, Double-Blind, Risankizumab-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Study Participants With Active Psoriatic Arthritis

Phase 3 Interventional UCB Pharma · NCT06624228

This study is testing whether a new drug called bimekizumab can help adults with active psoriatic arthritis feel better compared to another drug, risankizumab, after 16 weeks of treatment.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment550 (estimated)
Ages18 Years and up
SexAll
SponsorUCB Pharma Industry-sponsored
Drugs / interventionsbimekizumab, risankizumab, methotrexate
Locations123 sites (Gilbert, Arizona and 122 other locations)
Trial IDNCT06624228 on ClinicalTrials.gov

What this trial studies

This study aims to compare the effectiveness and safety of bimekizumab against risankizumab in adults with active psoriatic arthritis after 16 weeks of treatment. Participants must have a documented diagnosis of adult-onset psoriatic arthritis and have shown inadequate response to previous therapies. The study will involve administering either bimekizumab, risankizumab, or a placebo to assess improvements in joint symptoms and skin lesions. The results will help determine the best treatment option for managing this condition.

Who should consider this trial

Good fit: Ideal candidates are adults diagnosed with active psoriatic arthritis who have not responded adequately to previous treatments.

Not a fit: Patients who have not been diagnosed with psoriatic arthritis or those who have not previously tried csDMARD therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for patients suffering from active psoriatic arthritis.

How similar studies have performed: Other studies have shown promising results with similar biologic treatments for psoriatic arthritis, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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).
* Study participants may currently be on conventional synthetic disease-modifying antirheumatic drug (csDMARD) therapy and must have previously been treated with at least 1 csDMARD (methotrexate (MTX), leflunomide (LEF), sulfasalazine (SSZ)). Study participants must have had an inadequate response to therapy or discontinued due to intolerance. (Inadequate response is determined by the Investigator and is defined as not achieving the minimal response after 12 weeks of therapy.)
* Study participants can either be biological disease-modifying antirheumatic drug (bDMARD)-naïve or have received not more than 1 prior tumor necrosis factor alpha (TNFα) inhibitor. Study participants who have been on a TNFα inhibitor previously must not have discontinued the TNFα inhibitor due to financial or health insurance reasons and must have either:
* experienced an inadequate response to previous treatment given at an approved dose for at least 3 months, or
* been intolerant to administration (eg, had a side-effect/adverse event (AE) that led to discontinuation).

Exclusion Criteria:

* Study participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study.
* Female participants who are breastfeeding, pregnant, or plan to become pregnant during the study.
* Participant has an active infection or a history of recent serious infections.
* Participant has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection.
* Study participant has a diagnosis of inflammatory conditions other than PSO or PsA including, but not limited to, rheumatoid arthritis, sarcoidosis, systemic lupus erythematosus, reactive arthritis, and axial spondyloarthritis.
* Study participants with a history of anterior uveitis are allowed if they have no active symptoms at Screening or Baseline. Study participants with a diagnosis of Crohn's disease or ulcerative colitis are allowed if they have no active symptomatic disease at Screening or Baseline.
* Study participants with fibromyalgia or osteoarthritis symptoms that in the Investigator's opinion would have potential to interfere with efficacy assessments.
* Participant has any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer.
* Participant has a history of chronic alcohol or drug abuse within 6 months prior to Screening.
* Study participants taking psoriatic arthritis (PsA) medications other than MTX, SSZ, apremilast, hydroxychloroquine (HCQ), LEF, nonsteroidal anti-inflammatory drug (NSAIDs)/ cyclooxygenase-2 (COX-2) inhibitors, oral corticosteroids, and analgesics as outlined in the Inclusion criteria.
* Study participant is taking or has taken prohibited PsA or PSO medications without meeting the mandatory wash-out period relative to the Baseline Visit.
* Study participant is taking or has taken janus kinase (JAK) inhibitor.
* Study participant is taking or has taken bDMARDs, including bimekizumab or risankizumab, with the exception of having received 1 prior TNFα inhibitor.
* Study participant previously participated in another study of a medical device under investigation within the 4 weeks prior to the Screening Visit or is currently participating in another study of a medical device under investigation.

Where this trial is running

Gilbert, Arizona and 122 other locations

+73 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Psoriatic Arthritisbimekizumabrisankizumabarthritis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.