A Study to Test the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis
Study Purpose
This is a study to demonstrate the clinical efficacy, safety and tolerability of bimekizumab administered subcutaneously (sc) compared with placebo in the treatment of subjects with active Psoriatic Arthritis (PsA).
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 18 Years and Over |
Gender | All |
Inclusion Criteria:
- - An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent form is signed and dated by the subject.
- - Subject is male or female at least 18 years of age.
- - Female subject 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 must be a suitable candidate for treatment with adalimumab and has no contraindications to receive adalimumab as per the local label as assessed by the Investigator.
- - 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 for the treatment of Psoriatic Arthritis (PsA) or Psoriasis (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.
- - 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.
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT03895203 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 3 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
UCB Biopharma SRL |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
UCB Cares |
Principal Investigator Affiliation | 001 844 599 2273 (UCB) |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Recruiting |
Countries | Australia, Belgium, Canada, Czechia, France, Germany, Hungary, Italy, Japan, Poland, Russian Federation, Spain, United Kingdom, United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Psoriatic Arthritis |
Arms
Experimental: Bimekzumab dosage regimen
Subjects randomized to this arm will receive assigned bimekizumab dosage regimen and placebo to maintain the blinding with adalimumab and placebo arms during the Treatment Period.
Active Comparator: Adalimumab dosage regimen
Subjects randomized to this arm will receive the assigned adalimumab dosage regimen during the Treatment Period.
Placebo Comparator: Placebo
Subjects randomized to this arm will receive placebo during the Double-Blind Treatment Period and will be reallocated to receive bimekizumab dosage regimen during the Maintenance Period.
Interventions
Drug: - Bimekizumab
Subjects will receive bimekizumab at pre-specified time-points.
Drug: - Adalimumab
Adalimumab will be administered according to the labeling recommendations.
Other: - Placebo
Subjects will receive placebo at pre-specified time-points.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Recruiting
Address
Pa0010 50017
Phoenix, Arizona, 85037
Status
Recruiting
Address
Pa0010 50035
San Diego, California, 92025
Status
Suspended
Address
Pa0010 50004
Tustin, California, 92780
Status
Suspended
Address
Pa0010 50033
Palm Harbor, Florida, 34684
Status
Suspended
Address
Pa0010 50039
Atlanta, Georgia, 30342
Status
Recruiting
Address
Pa0010 50028
Lexington, Kentucky, 40504
Status
Suspended
Address
Pa0010 50023
Baton Rouge, Louisiana, 70836
Status
Recruiting
Address
Pa0010 50015
Hagerstown, Maryland, 21742
Status
Recruiting
Address
Pa0010 50016
Saint Louis, Missouri, 63141
Status
Suspended
Address
Pa0010 50029
Albuquerque, New Mexico, 87102
Status
Recruiting
Address
Pa0010 50010
Brooklyn, New York, 11201
Status
Recruiting
Address
Pa0010 50125
Charlotte, North Carolina, 28210
Status
Suspended
Address
Pa0010 50013
Wilmington, North Carolina, 28401
Status
Recruiting
Address
Pa0010 50020
Duncansville, Pennsylvania, 16635
Status
Suspended
Address
Pa0010 50006
Wyomissing, Pennsylvania, 19610
Status
Recruiting
Address
Pa0010 50008
Johnston, Rhode Island, 02919
Status
Recruiting
Address
Pa0010 50007
Orangeburg, South Carolina, 29118
Status
Suspended
Address
Pa0010 50021
Summerville, South Carolina, 29486
Status
Recruiting
Address
Pa0010 50001
Jackson, Tennessee, 38305
Status
Suspended
Address
Pa0010 50012
Memphis, Tennessee, 38119
Status
Suspended
Address
Pa0010 50049
Corpus Christi, Texas, 78404
Status
Recruiting
Address
Pa0010 50036
Mesquite, Texas, 75150
Status
Withdrawn
Address
Pa0010 50022
Chesapeake, Virginia, 23320
Status
Suspended
Address
Pa0010 50027
Seattle, Washington, 98122
Status
Recruiting
Address
Pa0010 50050
Beckley, West Virginia, 25801
International Sites
Status
Suspended
Address
Pa0010 40104
Santiago De Compostela, ,