A Study to Assess the Safety, Tolerability and Efficacy of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis

Study Purpose

This is a study to evaluate the long-term safety and tolerability of bimekizumab in adult subjects with moderate to severe chronic plaque psoriasis (PSO).

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

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Subject is considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule, and medication intake according to the judgment of the Investigator - Subject completes the feeder study (PS0008 [NCT03412747], PS0009 [NCT03370133], PS0013 [NCT03410992]) without meeting any withdrawal criteria - Female subjects must be: 1.

Postmenopausal: Menopause is defined as 12 consecutive months of amenorrhea, for which there is no other obvious pathological or physiological cause 2. Permanently sterilized (eg, tubal occlusion, hysterectomy, bilateral salpingectomy) 3. Or, if of childbearing potential (and engaged in sexual activity that could result in procreation), must be willing to use a highly effective method of contraception throughout the duration of the study until 20 weeks after last administration of investigational medicinal product (IMP), and have a negative pregnancy test at the feeder study in final visit/Baseline visit in PS0014

Exclusion Criteria:

- Subject has previously participated in this study - Female subjects who plan to become pregnant during the study or within 20 weeks following last dose of study medication - Subject has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the subject's ability to participate in this study.

Note: For any subject with an ongoing Serious Adverse Event (SAE), or a history of serious infections in the feeder study, the Medical Monitor must be consulted prior to the subject's entry into PS0014, although the decision on whether to enroll the subject remains with the Investigator - Subject has a positive or indeterminate interferon gamma release assay (IGRA) in a feeder study, unless appropriately evaluated and treated - Subject may not participate in another study of a medicinal product or device under investigation other than the substudy - Subject has a history of chronic alcohol or drug abuse within 6 months prior to Baseline as assessed by medical history, site interview, and/or results of the specified urine drug screen

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.	NCT03598790
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 S.P.R.L.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	UCB Cares
Principal Investigator Affiliation	+1 844 599 2273 (UCB)
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Australia, Belgium, Canada, Germany, Hungary, Italy, Japan, Korea, Republic of, Poland, Russian Federation, Taiwan, United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Chronic Plaque Psoriasis, Moderate to Severe Chronic Plaque Psoriasis

Arms & Interventions

Arms

Experimental: Bimekizumab dose regimen 1

Subjects will receive bimekizumab dose regimen 1. Intervention Name: Bimekizumab

Experimental: Bimekizumab dose regimen 2

Subjects will receive bimekizumab dose regimen 2. Intervention Name: Bimekizumab

Interventions

Drug: - Bimekizumab

Subjects will receive bimekizumab 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.

Ps0014 957, Glendale, Arizona

Status

Active, not recruiting

Address

Ps0014 957

Glendale, Arizona, 85308

Site Contact

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