A Study to Evaluate the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis (BE COMPLETE)

April 2, 2024 updated by: UCB Biopharma SRL

A Multicenter, Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis

This is a study to demonstrate the clinical efficacy, safety and tolerability of bimekizumab administered subcutaneously (sc) compared with placebo in the treatment of tumor necrosis factor alpha-inadequate responders (TNFα-IR) subjects with active Psoriatic Arthritis (PsA).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

400

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Camberwell, Australia
        • Pa0011 30005
      • Victoria Park, Australia
        • Pa0011 30007
      • Woodville South, Australia
        • Pa0011 30006
  • Canada
      • Rimouski, Canada
        • Pa0011 50042
      • Sydney, Canada
        • Pa0011 50043
      • Trois-rivieres, Canada
        • Pa0011 50044
  • Czechia
      • Pardubice, Czechia
        • Pa0011 40009
      • Praha 2, Czechia
        • Pa0011 40066
      • Praha 5, Czechia
        • Pa0011 40063
      • Zlin, Czechia
        • Pa0011 40012
  • Germany
      • Cottbus, Germany
        • Pa0011 40076
      • Erlangen, Germany
        • Pa0011 40023
      • Frankfurt, Germany
        • Pa0011 40117
      • Hamburg, Germany
        • Pa0011 40029
      • Hamburg, Germany
        • Pa0011 40071
      • Leipzig, Germany
        • Pa0011 40078
      • Ratingen, Germany
        • Pa0011 40026
  • Hungary
      • Budapest, Hungary
        • Pa0011 40083
      • Szentes, Hungary
        • Pa0011 40079
  • Italy
      • Catania, Italy
        • Pa0011 40084
      • Milano, Italy
        • Pa0011 40087
      • Reggio Emilia, Italy
        • Pa0011 40086
  • Japan
      • Chuo-ku, Japan
        • Pa0011 20030
      • Itabashi-ku, Japan
        • Pa0011 20043
      • Kawachinagano, Japan
        • Pa0011 20036
      • Kita-gun, Japan
        • Pa0011 20045
      • Kitakyushu, Japan
        • Pa0011 20049
      • Minato-ku, Japan
        • Pa0011 20044
      • Osaka, Japan
        • Pa0011 20041
      • Osaka, Japan
        • Pa0011 20046
      • Sapporo, Japan
        • Pa0011 20031
      • Sasebo, Japan
        • Pa0011 20042
      • Suita, Japan
        • Pa0011 20032
  • Poland
      • Bydgoszcz, Poland
        • Pa0011 40119
      • Elblag, Poland
        • Pa0011 40038
      • Lublin, Poland
        • Pa0011 40037
      • Nowa Sol, Poland
        • Pa0011 40091
      • Poznan, Poland
        • Pa0011 40044
      • Poznan, Poland
        • Pa0011 40090
      • Torun, Poland
        • Pa0011 40118
      • Warszawa, Poland
        • Pa0011 40041
      • Warszawa, Poland
        • Pa0011 40097
      • Warszawa, Poland
        • Pa0011 40098
      • Wroclaw, Poland
        • Pa0011 40039
      • Wroclaw, Poland
        • Pa0011 40043
  • Russian Federation
      • Korolev, Russian Federation
        • Pa0011 20005
      • Moscow, Russian Federation
        • Pa0011 20010
      • Petrozavodsk, Russian Federation
        • Pa0011 20013
      • Saint Petersburg, Russian Federation
        • Pa0011 20004
      • Saint-petersburg, Russian Federation
        • Pa0011 20001
      • Saint-petersburg, Russian Federation
        • Pa0011 20009
      • Saratov, Russian Federation
        • Pa0011 20007
      • Ulyanovsk, Russian Federation
        • Pa0011 20014
      • Vladimir, Russian Federation
        • Pa0011 20006
      • Yaroslavl, Russian Federation
        • Pa0011 20008
      • Yaroslavl, Russian Federation
        • Pa0011 20015
  • United Kingdom
      • Bradford, United Kingdom
        • Pa0011 40111
      • Oxford, United Kingdom
        • Pa0011 40109
      • Stamford, United Kingdom
        • Pa0011 40116
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85037
        • Pa0011 50017
    • California
      • San Diego, California, United States, 92128
        • Pa0011 50035
      • Tustin, California, United States, 92780
        • Pa0011 50004
    • Florida
      • Palm Harbor, Florida, United States, 34684
        • Pa0011 50033
      • Tampa, Florida, United States, 33613
        • Pa0011 50037
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Pa0011 50039
    • Idaho
      • Boise, Idaho, United States, 83702
        • Pa0011 50024
    • Kentucky
      • Lexington, Kentucky, United States, 40504
        • Pa0011 50028
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70836
        • Pa0011 50023
    • Maryland
      • Hagerstown, Maryland, United States, 21740
        • Pa0011 50015
      • Wheaton, Maryland, United States, 20902
        • Pa0011 50026
    • Massachusetts
      • Boston, Massachusetts, United States, 02115-5817
        • Pa0011 50047
    • Michigan
      • Lansing, Michigan, United States, 48911
        • Pa0011 50019
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • Pa0011 50016
    • New Jersey
      • Freehold, New Jersey, United States, 07728
        • Pa0011 50005
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Pa0011 50029
    • New York
      • Brooklyn, New York, United States, 11201
        • Pa0011 50010
      • New York, New York, United States, 10003
        • Pa0011 50011
      • Rochester, New York, United States, 14642
        • Pa0011 50034
    • North Carolina
      • Charlotte, North Carolina, United States, 28210
        • Pa0011 50125
      • Salisbury, North Carolina, United States, 28144
        • Pa0011 50031
    • Ohio
      • Vandalia, Ohio, United States, 45377
        • Pa0011 50040
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Pa0011 50020
      • Philadelphia, Pennsylvania, United States, 19104
        • Pa0011 50064
      • Wyomissing, Pennsylvania, United States, 19610
        • Pa0011 50006
    • Rhode Island
      • Johnston, Rhode Island, United States, 02919
        • Pa0011 50008
    • South Carolina
      • Summerville, South Carolina, United States, 29486
        • Pa0011 50021
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • Pa0011 50001
      • Memphis, Tennessee, United States, 38119-5214
        • Pa0011 50012
    • Texas
      • Austin, Texas, United States, 78731
        • Pa0011 50002
      • Mesquite, Texas, United States, 75150
        • Pa0011 50036
      • Waco, Texas, United States, 76710
        • Pa0011 50009
    • West Virginia
      • Beckley, West Virginia, United States, 25801
        • Pa0011 50050

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Subject is male or female at least 18 years of age
  • Female subjects must be postmenopausal, permanently sterilized or willing to use a highly effective method of contraception
  • Documented diagnosis of adult-onset Psoriatic Arthritis (PsA) meeting the Classification Criteria for Psoriatic Arthritis (CASPAR) for at least 6 months prior to Screening with active PsA and must have at Baseline tender joint count (TJC) >=3 out of 68 and swollen joint count (SJC) >=3 out of 66
  • Subject must be negative for rheumatoid factor and anti-cyclic citrullinated peptide (CCP) antibodies
  • Subject must have at least 1 active psoriatic lesion(s) and/or a documented history of psoriasis (PSO)
  • Subject has a history of inadequate response (lack of efficacy after at least 3 months of therapy at an approved dose) or intolerance to treatment with 1 or 2 tumor necrosis factor alpha (TNF(α)) inhibitors for either PsA or PSO
  • Subjects currently taking NSAIDs, cyclooxygenase 2 (COX-2) inhibitors, analgesics (including mild opioids), corticosteroids, methotrexate (MTX), leflunomide (LEF), sulfasalazine (SSZ), hydroxychloroquine (HCQ) AND/OR apremilast can be allowed if they fulfill specific requirements prior to study entry

Exclusion Criteria:

  • Female subjects who are breastfeeding, pregnant, or plan to become pregnant during the study
  • Subjects with current or prior exposure to any biologics except tumor necrosis factor (TNF) inhibitors for the treatment of PsA or PSO
  • Subject has an active infection or a history of recent serious infections
  • Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection
  • Subject has a diagnosis of inflammatory conditions other than PSO or PsA. Subjects with a diagnosis of Crohn's disease, ulcerative colitis, or other inflammatory bowel disease (IBD) are allowed as long as they have no active symptomatic disease at Screening or Baseline
  • Subject had acute anterior uveitis within 6 weeks of Baseline
  • Subject 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
  • Subject has a form of PSO other than chronic plaque-type (eg, pustular, erythrodermic and guttate PSO, or drug-induced PSO)
  • Presence of active suicidal ideation, or moderately severe major depression or severe major depression
  • Subject has a history of chronic alcohol or drug abuse within 6 months prior to Screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Subjects randomized to this arm will receive placebo.
Other: Placebo
Subjects will receive placebo at pre-specified time-points.
Other Names:
  • PBO
Experimental: Bimekizumab dosage regimen
Subjects randomized to this arm will receive assigned bimekizumab dosage regimen.
Drug: Bimekizumab
Subjects will receive bimekizumab at pre-specified time-points.
Other Names:
  • UCB4940
  • BKZ

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
American College of Rheumatology (ACR) 50 response at Week 16
Time Frame: Week 16
The ACR50 response rate is based on a 50% or greater improvement of arthritis relative to Baseline.
Week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 16
Time Frame: Baseline, Week 16
HAQ-DI is derived based on the mean of individual scores in 8 categories of daily living actives (using 20 questions). Each question is scored 0-3 (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do). Thus, the mean also has a range from 0-3. Change from baseline is computed as the value at Week 16 minus the baseline value. A negative value in change from baseline indicates an improvement.
Baseline, Week 16
Psoriasis Area Severity Index 90 (PASI90) response at Week 4 in the subgroup of subjects with psoriasis (PSO) involving at least 3% body surface area (BSA) at Baseline
Time Frame: Baseline, Week 4

The Psoriasis Area Severity Index 90 (PASI90) response is based on at least 90% improvement in the PASI score compared to Baseline.

The PASI is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. 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 the 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.
Baseline, Week 4
Psoriasis Area Severity Index 90 (PASI90) response at Week 16 in the subgroup of subjects with psoriasis (PSO) involving at least 3% body surface area (BSA) at Baseline
Time Frame: Baseline, Week 16

The Psoriasis Area Severity Index 90 (PASI90) response is based on at least 90% improvement in the PASI score compared to Baseline.

The PASI is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. 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 the 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.
Baseline, Week 16
Change from Baseline in the Short Form 36-item Health Survey (SF-36) Physical Component Summary (PCS) score at Week 16
Time Frame: Baseline, Week 16
There are 8 SF-36 domain scores. In addition to domain scores, the PCS scores are calculated from the 8 domains. Each of the 8 domain scores and the component summary scores ranging from 0 to 100, with higher scores indicating better health status. A larger positive value in change from Baseline indicates an improvement.
Baseline, Week 16
Minimal Disease Activity (MDA) at Week 16
Time Frame: Week 16

Minimal Disease Activity (MDA) is a state of disease activity deemed a useful target of treatment by both the patient and physician, given current treatment possibilities and limitations. Criteria covering all domains of the disease have been developed to determine whether or not a patient has reached MDA based on key outcome measures in Psoriatic Arthritis (PsA).

A subject is considered as having MDA if 5 or more of the following 7 criteria are fulfilled: 1) Tender joint count <=1, 2) Swollen joint count <=1, 3) PASI <=1 or BSA <=3; 4) Patient pain Visual Analog Scale (VAS) <=15, 5) Patient global activity VAS <=20, 6) Health Assessment Questionnaire - Disability Index (HAQ-DI) <=0.5 and 7) Tender enthesial points <=1.
Week 16
American College of Rheumatology (ACR) 20 response at Week 16
Time Frame: Week 16
The ACR20 response rate is based on a 20% or greater improvement of arthritis relative to Baseline.
Week 16
American College of Rheumatology (ACR) 70 response at Week 16
Time Frame: Week 16
The ACR70 response rate is based on a 70% or greater improvement of arthritis relative to Baseline.
Week 16
Investigator Global Assessment (IGA) response defined as score of 0 (clear) or 1 (almost clear) AND at least a 2-grade reduction from Baseline at Week 4 in the subset of subjects with psoriatic skin lesions at Baseline
Time Frame: Baseline, Week 4
Investigator Global Assessment (IGA) response is defined as Clear or Almost Clear with at least a 2-category improvement relative to Baseline.
Baseline, Week 4
Investigator Global Assessment (IGA) response defined as score of 0 (clear) or 1 (almost clear) AND at least a 2-grade reduction from Baseline at Week 16 in the subset of subjects with psoriatic skin lesions at Baseline
Time Frame: Baseline, Week 16
Investigator Global Assessment (IGA) response is defined as Clear or Almost Clear with at least a 2-category improvement relative to Baseline.
Baseline, Week 16
Change from Baseline in the Patient's Assessment of Arthritis Pain (PtAAP) at Week 16
Time Frame: Baseline, Week 16
The PtAAP Visual Analog Scale (VAS) or 'Pain VAS' is part of the American College of Rheumatology (ACR) core set of measures in arthritis. Subjects will assess their arthritis pain using a VAS where 0 is "no pain" and 100 is "most severe pain."
Baseline, Week 16
Change from Baseline in Psoriatic Arthritis Impact of Disease-12 (PsAID-12) total score at Week 16
Time Frame: Baseline, Week 16
The PsAID-12 total score is a patient-reported outcome measure for assessing the impact of Psoriatic Arthritis (PsA) in 12 physical and psychological domains, including pain, fatigue, skin problems, work and/or leisure activities, functional capacity, discomfort, sleep disturbance, coping, anxiety/fear/uncertainty, embarrassment and/or shame, social participation, and depression. Each domain is assessed with a single question using a 0 to 10 numerical rating scale. Each domain score is multiplied by a weighting factor and the results are then summed to provide the total score. The total score ranges from 0 to 10, with higher scores indicating a worse status. A score below 4 out of 10 is considered a patient-acceptable status. A change of 3 or more points is considered relevant absolute change.
Baseline, Week 16
Incidence of treatment-emergent adverse events (TEAEs) during the study
Time Frame: From Baseline until Safety Follow-Up (up to Week 36)
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
From Baseline until Safety Follow-Up (up to Week 36)
Incidence of treatment-emergent serious adverse events (SAEs) during the study
Time Frame: From Baseline until Safety Follow-Up (up to Week 36)

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
  • Is an infection that requires treatment parenteral antibiotics
  • 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
From Baseline until Safety Follow-Up (up to Week 36)
Treatment-emergent adverse events (TEAEs) leading to withdrawal from investigational medicinal product (IMP) during the study
Time Frame: From Baseline until Safety Follow-Up (up to Week 36)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
From Baseline until Safety Follow-Up (up to Week 36)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCB Biopharma SRL

Investigators

  • Study Director: UCB Cares, 001 844 599 2273 (UCB)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 28, 2019

Primary Completion (Actual)

December 8, 2021

Study Completion (Actual)

February 14, 2022

Study Registration Dates

First Submitted

March 21, 2019

First Submitted That Met QC Criteria

March 27, 2019

First Posted (Actual)

April 1, 2019

Study Record Updates

Last Update Posted (Actual)

April 4, 2024

Last Update Submitted That Met QC Criteria

April 2, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PA0011
  • 2017-002804-29 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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 pre-specified 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.

IPD Sharing Time Frame

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.

IPD Sharing Access Criteria

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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Psoriatic Arthritis

Clinical Trials on Bimekizumab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burkina Faso

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe