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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06624228




Registration number
NCT06624228
Ethics application status
Date submitted
30/09/2024
Date registered
2/10/2024

Titles & IDs
Public title
A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Study Participants With Active Psoriatic Arthritis
Scientific 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
Secondary ID [1] 0 0
PA0016
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psoriatic Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Bimekizumab
Treatment: Drugs - Risankizumab
Treatment: Drugs - Placebo

Experimental: Bimekizumab - Study participants will receive assigned bimekizumab dosage regimen and placebo to maintain the blinding during treatment period.

Active comparator: Risankizumab - Study participants will receive assigned risankizumab dosage regimen and placebo to maintain the blinding during treatment period.


Treatment: Drugs: Bimekizumab
Study participants will receive bimekizumab at pre-specified time points.

Treatment: Drugs: Risankizumab
Study participants will receive risankizumab at pre-specified time points.

Treatment: Drugs: Placebo
Study participants will receive placebo at pre-specified time points.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
American College of Rheumatology 50 (ACR50) at Week 16
Timepoint [1] 0 0
Week 16
Secondary outcome [1] 0 0
Minimal Disease Activity (MDA) at Week 16
Timepoint [1] 0 0
Week 16
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
Week 16
Secondary outcome [3] 0 0
Incidence of Participants With Treatment-emergent adverse events (TEAEs)
Timepoint [3] 0 0
From Baseline (Day 1) to End of Safety Follow-Up (up to 42 weeks)
Secondary outcome [4] 0 0
Incidence of Participants With Treatment-emergent serious AEs
Timepoint [4] 0 0
From Baseline (Day 1) to End of Safety Follow-Up (up to 42 weeks)
Secondary outcome [5] 0 0
Incidence of Participants With TEAEs leading to withdrawal from investigational medicinal product (IMP)
Timepoint [5] 0 0
From Baseline (Day 1) to End of Safety Follow-Up (up to 42 weeks)

Eligibility
Key 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 (TNFa) inhibitor. Study participants who have been on a TNFa inhibitor previously must not have discontinued the TNFa 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).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 TNFa 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/10/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/07/2026
Actual
Sample size
Target
550
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Pa0016 30003 - Maroochydore
Recruitment hospital [2] 0 0
Pa0016 30032 - Parramatta
Recruitment postcode(s) [1] 0 0
- Maroochydore
Recruitment postcode(s) [2] 0 0
- Parramatta
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
Ohio
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
United States of America
State/province [9] 0 0
Tennessee
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
United States of America
State/province [11] 0 0
Washington
Country [12] 0 0
United States of America
State/province [12] 0 0
Wisconsin
Country [13] 0 0
Bulgaria
State/province [13] 0 0
Plovdiv
Country [14] 0 0
Canada
State/province [14] 0 0
Quebec
Country [15] 0 0
Canada
State/province [15] 0 0
Trois-rivieres
Country [16] 0 0
Czechia
State/province [16] 0 0
Brno
Country [17] 0 0
Czechia
State/province [17] 0 0
Ostrava
Country [18] 0 0
Czechia
State/province [18] 0 0
Uherske Hradiste
Country [19] 0 0
Germany
State/province [19] 0 0
Ratingen
Country [20] 0 0
Hungary
State/province [20] 0 0
Budapest
Country [21] 0 0
Japan
State/province [21] 0 0
Osaka
Country [22] 0 0
Poland
State/province [22] 0 0
Bydgoszcz
Country [23] 0 0
Poland
State/province [23] 0 0
Krakow
Country [24] 0 0
Poland
State/province [24] 0 0
Lublin
Country [25] 0 0
Poland
State/province [25] 0 0
Poznan
Country [26] 0 0
Poland
State/province [26] 0 0
Sochaczew
Country [27] 0 0
Poland
State/province [27] 0 0
Warszawa
Country [28] 0 0
Spain
State/province [28] 0 0
A Coruna
Country [29] 0 0
Spain
State/province [29] 0 0
Santiago de Compostela

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
UCB Biopharma SRL
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
UCB Cares
Address 0 0
001 844 599 2273
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
UCB Cares
Address 0 0
Country 0 0
Phone 0 0
+18445992273
Fax 0 0
Email 0 0
ucbcares@ucb.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
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.
Available to whom?
Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, 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 pre-specified time, typically 12 months, on a password protected portal.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.Vivli.org


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06624228