AzTrials
AzTrials

Psoriatic ArthritisPhase 3NCT06624228

A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Study Participants With Active Psoriatic Arthritis

A Phase 3 study testing Bimekizumab and Risankizumab in people with Psoriatic Arthritis, run by UCB Biopharma SRL at 127 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of the study is to compare the efficacy of bimekizumab versus risankizumab after 16 weeks of treatment in study participants with active psoriatic arthritis (PsA). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Psoriatic Arthritis
What is being tested?
Bimekizumab and Risankizumab
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
553 participants
Where
127 sitesin 11 countries
Study dates
21 Oct 2024to 3 Jun 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.
Show all 14Show fewer
  • 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 or is taking or has taken weight management medications without meeting the mandatory dose stability period/washout 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.

Trial locations and contacts

127 sites in 11 countries.

127 sites in 11 countries

United States34 sites

  • Pa0016 50653

    Albuquerque, New Mexico, 87102

  • Pa0016 50666

    Brooklyn, New York, 11201

  • Pa0016 50630

    Clearwater, Florida, 33765

  • Pa0016 50654

    Covina, California, 91722

  • Pa0016 50679

    Cutler Bay, Florida, 33189

  • Pa0016 50652

    Duncansville, Pennsylvania, 16635

  • Pa0016 50689

    Eagan, Minnesota, 55123

  • Pa0016 50685

    Fort Lauderdale, Florida, 33309

  • Pa0016 50673

    Fort Worth, Texas, 76109

  • Pa0016 50662

    Gilbert, Arizona, 85297

  • Pa0016 50062

    Glendale, Arizona, 85306

  • Pa0016 50674

    Glendale, Wisconsin, 53217

  • Pa0016 50686

    Hagerstown, Maryland, 21740

  • Pa0016 50001

    Jackson, Tennessee, 38305

  • Pa0016 50682

    Kansas City, Missouri, 64111

  • Pa0016 50048

    Katy, Texas, 77449

  • Pa0016 50665

    Lansing, Michigan, 48910

  • Pa0016 50657

    Lubbock, Texas, 79424

  • Pa0016 50664

    Middletown, Ohio, 45044

  • Pa0016 50059

    Ormond Beach, Florida, 32174

  • Pa0016 50058

    Phoenix, Arizona, 85032

  • Pa0016 50324

    Plantation, Florida, 33324

  • Pa0016 50551

    Saint Clair Shores, Michigan, 48081

  • Pa0016 50663

    San Diego, California, 92128

  • Pa0016 50672

    Santa Monica, California, 90404

  • Pa0016 50651

    Skokie, Illinois, 60076

  • Pa0016 50061

    Spokane Valley, Washington, 99216

  • Pa0016 50016

    St Louis, Missouri, 63141

  • Pa0016 50131

    Sun City, Arizona, 85351

  • Pa0016 50655

    Tomball, Texas, 77375

  • Pa0016 50680

    Vandalia, Ohio, 45377

  • Pa0016 50650

    Willowbrook, Illinois, 60527

  • Pa0016 50006

    Wyomissing, Pennsylvania, 19610

  • Pa0016 50678

    Zephyrhills, Florida, 33542

Other trials in United States

Poland30 sites

  • Pa0016 40789

    Bialystok

  • Pa0016 40791

    Bialystok

  • Pa0016 40824

    Bialystok

  • Pa0016 40119

    Bydgoszcz

  • Pa0016 40798

    Bydgoszcz

  • Pa0016 40038

    Elblag

  • Pa0016 40795

    Katowice

  • Pa0016 40092

    Krakow

  • Pa0016 40490

    Krakow

  • Pa0016 40502

    Krakow

  • Pa0016 40792

    Krakow

  • Pa0016 40037

    Lublin

  • Pa0016 40483

    Nadarzyn

  • Pa0016 40091

    Nowa Sól

  • Pa0016 40796

    Olsztyn

  • Pa0016 40794

    Opole

  • Pa0016 40044

    Poznan

  • Pa0016 40090

    Poznan

  • Pa0016 40807

    Poznan

  • Pa0016 40790

    Sochaczew

  • Pa0016 40788

    Torun

  • Pa0016 40094

    Warsaw

  • Pa0016 40394

    Warsaw

  • Pa0016 40539

    Warsaw

  • Pa0016 40604

    Warsaw

  • Pa0016 40793

    Warsaw

  • Pa0016 40797

    Warsaw

  • Pa0016 40043

    Wroclaw

  • Pa0016 40095

    Wroclaw

  • Pa0016 40805

    Wroclaw

Other trials in Poland

Bulgaria11 sites

  • Pa0016 40313

    Pleven

  • Pa0016 40006

    Plovdiv

  • Pa0016 40813

    Plovdiv

  • Pa0016 40818

    Plovdiv

  • Pa0016 40820

    Plovdiv

  • Pa0016 40656

    Rousse

  • Pa0016 40823

    Rousse

  • Pa0016 40314

    Sofia

  • Pa0016 40380

    Sofia

  • Pa0016 40811

    Sofia

  • Pa0016 40819

    Sofia

Other trials in Bulgaria

Germany9 sites

  • Pa0016 40073

    Bad Nauheim

  • Pa0016 40025

    Berlin

  • Pa0016 40138

    Bonn

  • Pa0016 40808

    Cologne

  • Pa0016 40072

    Freiburg im Breisgau

  • Pa0016 40029

    Hamburg

  • Pa0016 40810

    Herne

  • Pa0016 40724

    München

  • Pa0016 40800

    Ratingen

Other trials in Germany

Japan9 sites

  • Pa0016 20035

    Bunkyō City

  • Pa0016 20045

    Kita-gun

  • Pa0016 20049

    Kitakyushu

  • Pa0016 20069

    Meguro-ku

  • Pa0016 20336

    Mitaka-shi

  • Pa0016 20041

    Osaka

  • Pa0016 20046

    Osaka

  • Pa0016 20031

    Sapporo

  • Pa0016 20043

    tabashi City

Other trials in Japan

Spain8 sites

  • Pa0016 40806

    A Coruña

  • Pa0016 40269

    Bilbao

  • Pa0016 40231

    Madrid

  • Pa0016 40102

    Málaga

  • Pa0016 40803

    Sabadell

  • Pa0016 40753

    Santiago de Compostela

  • Pa0016 40049

    Seville

  • Pa0016 40799

    Seville

Other trials in Spain

Czechia7 sites

  • Pa0016 40065

    Brno

  • Pa0016 40062

    Moravska Ostrava A Privoz

  • Pa0016 40802

    Ostrava

  • Pa0016 40066

    Prague

  • Pa0016 40801

    Prague

  • Pa0016 40010

    Uherské Hradiště

  • Pa0016 40012

    Zlín

Other trials in Czechia

United Kingdom7 sites

  • Pa0016 40833

    Barnet

  • Pa0016 40281

    Leeds

  • Pa0016 40827

    Luton

  • Pa0016 40237

    Manchester

  • Pa0016 40306

    Newcastle upon Tyne

  • Pa0016 40828

    Reading

  • Pa0016 40108

    Salford

Other trials in United Kingdom

Australia6 sites

  • Pa0016 30002

    Clayton

  • Pa0016 30034

    Footscray

  • Pa0016 30033

    Heidelberg

  • Pa0016 30003

    Maroochydore

  • Pa0016 30032

    Parramatta

  • Pa0016 30009

    Westmead

Other trials in Australia

Hungary4 sites

  • Pa0016 40081

    Budapest

  • Pa0016 40804

    Budapest

  • Pa0016 40809

    Hódmezővásárhely

  • Pa0016 40031

    Szeged

Other trials in Hungary

Canada2 sites

  • Pa0016 50041

    Québec

  • Pa0016 50044

    Trois-Rivières

Other trials in Canada

About this study

Official title: 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

The purpose of the study is to compare the efficacy of bimekizumab versus risankizumab after 16 weeks of treatment in study participants with active psoriatic arthritis (PsA).

Being tested
Bimekizumab, Risankizumab, Placebo
Keywords
bimekizumab, risankizumab, arthritis
Medical subject headings
Arthritis, Psoriatic, Arthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BimekizumabDrug

    Study participants will receive bimekizumab at pre-specified time points.

  • RisankizumabDrug

    Study participants will receive risankizumab at pre-specified time points.

  • PlaceboDrug

    Study participants will receive placebo at pre-specified time points.

Study groups in NCT06624228
Study groupRoleWhat they receive
BimekizumabExperimentalStudy participants will receive assigned bimekizumab dosage regimen and placebo to maintain the blinding during treatment period.
Receives: Drug: Bimekizumab; Drug: Placebo
RisankizumabActive comparatorStudy participants will receive assigned risankizumab dosage regimen and placebo to maintain the blinding during treatment period.
Receives: Drug: Risankizumab; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. American College of Rheumatology 50 (ACR50) at Week 16

    The ACR50 response rate is based on a 50% or greater improvement of arthritis relative to Baseline.

    • TJC and SJC: 2-point scale (0=absent;1=present) • Patient's Global Assessment of Psoriatic Arthritis (PGA-PsA): 100 VAS (0=very good, no symptoms;100=very poor, severe symptoms)
    • Physician's Global Assessment of Psoriatic Arthritis (PhGA-PsA): 100 VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • Patient's Assessment of Arthritis Pain (PtAAP): 100 VAS (0=no pain;100=most severe pain).
    • Health Assessment Questionnaire Disability Index score (HAQ-DI) assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, with lower scores meaning less disability.
    • High sensitivity C-reactive protein (hs-CRP) in mg/L

    Measured: Week 16

Secondary outcomes (6)

  1. Minimal Disease Activity (MDA) at Week 16

    A study participant is considered as having MDA if 5 or more of the following 7 criteria are fulfilled:

    • Tender joint count ≤1
    • Swollen joint count ≤1
    • PASI ≤1 or BSA ≤3
    • PtAAP VAS ≤15
    • PGA-PsA VAS ≤20
    • HAQ-DI ≤0.5
    • Tender enthesial points ≤1

    Measured: Week 16

  2. Percentage of participants reaching the composite endpoint composed of ACR50 and Psoriasis Area and Severity Index 100% (PASI100) response at Week 16 in the subgroup of study participants with PSO involving at least 3% body surface area (BSA) at Baseline

    The ACR50 response rate is based on a 50% or greater improvement of arthritis relative to Baseline.

    The PASI100 response is based on at least 100% improvement in the PASI score. Body divided into 4 areas: head, upper extremities, trunk and lower extremities. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.

    Measured: Week 16

  3. American College of Rheumatology 50 (ACR50) at Week 4

    The ACR50 response rate is based on a 50% or greater improvement of arthritis relative to Baseline.

    • TJC and SJC: 2-point scale (0=absent;1=present) • Patient's Global Assessment of Psoriatic Arthritis (PGA-PsA): 100 VAS (0=very good, no symptoms;100=very poor, severe symptoms)
    • Physician's Global Assessment of Psoriatic Arthritis (PhGA-PsA): 100 VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • Patient's Assessment of Arthritis Pain (PtAAP): 100 VAS (0=no pain;100=most severe pain).
    • Health Assessment Questionnaire Disability Index score (HAQ-DI) assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, with lower scores meaning less disability.
    • High sensitivity C-reactive protein (hs-CRP) in mg/L

    Measured: Week 4

  4. Incidence of Participants With Treatment-emergent adverse events (TEAEs)

    An Adverse Event (AE) is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP.

    Measured: From Baseline (Day 1) to End of Safety Follow-Up (up to 37 weeks)

  5. Incidence of Participants With Treatment-emergent serious AEs

    A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose:

    • Results in death
    • Is life-threatening
    • Requires in patient hospitalization or prolongation of existing hospitalization Is a congenital anomaly or birth defect
    • Results in permanent or significant disability/incapacity
    • Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above

    Measured: From Baseline (Day 1) to End of Safety Follow-Up (up to 37 weeks)

  6. Incidence of Participants With TEAEs leading to withdrawal from investigational medicinal product (IMP)

    An AE is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP.

    Measured: From Baseline (Day 1) to End of Safety Follow-Up (up to 37 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2024
  2. Study start21 Oct 2024
  3. Primary completion6 Feb 2026
  4. Study completion3 Jun 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
553 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06624228
Sponsor's protocol ID
PA0016
Other IDs
2024-511738-11, U1111-1306-6697
Status last verified
Aug 2026
First submitted
30 Sep 2024
Last updated
2 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bimekizumab and Risankizumab in people with Psoriatic Arthritis, run by UCB Biopharma SRL at 127 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 127 sites in United States, Poland, Bulgaria, Germany, Japan and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

American College of Rheumatology 50 (ACR50) at Week 16 (time frame: Week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06624228.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in