Loading clinical trials...

A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

A Multicenter, Open-Label Study to Assess the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis

NCT03598790•UCB Biopharma SRL

View on ClinicalTrials.gov

Summary

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).

Detailed Description

The study consists of a 144-week Treatment Period (open-label) and an optional 48-week Open-Label Extension Period 2 (OLE2) for eligible subjects in the USA and Canada.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Treatment Period (open-label)
•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
•OLE2 Period (USA and Canada)
•Completed the OLE Period without meeting any withdrawal criteria
•Compliant with ongoing clinical study requirements
+3 more criteria

Exclusion Criteria

•Treatment Period (open-label)
•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
•OLE2 Period (USA and Canada)
•Subject has developed any medical or psychiatric condition, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in OLE2 Period
•Subject had a positive or indeterminate interferon-gamma release assay (IGRA) in the OLE study to Week 144, unless appropriately evaluated and treated
+2 more criteria

Locations (189)

Ps0014 957

Glendale, Arizona, United States

Ps0014 946

Phoenix, Arizona, United States

Ps0014 910

Bakersfield, California, United States

Ps0014 927

Los Angeles, California, United States

Ps0014 919

San Diego, California, United States

Ps0014 955

San Diego, California, United States

Ps0014 943

San Luis Obispo, California, United States

Ps0014 967

Santa Monica, California, United States

Ps0014 934

Washington D.C., District of Columbia, United States

Ps0014 909

Boynton Beach, Florida, United States

Key Dates

Start Date

September 5, 2018

Primary Completion Date

November 14, 2023

Completion Date

November 14, 2023

Last Updated

January 28, 2026

Enrollment

1,353

ACTUAL participants

Conditions

Chronic Plaque PsoriasisModerate to Severe Chronic Plaque Psoriasis

Interventions

Bimekizumab

DRUG

A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to Placebo and an Active Comparator in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis

NCT03370133

Chronic Plaque PsoriasisModerate to Severe Chronic Plaque Psoriasis+1 more

View study

NOT_YET_RECRUITINGPHASE3

Open Label Study to Investigate the Safety and Efficacy of Ponesimod in Moderate-to-Severe Chronic Plaque Psoriasis

NCT07362017

Moderate-to-severe Chronic Plaque Psoriasis

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 28, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to Placebo and an Active Comparator in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis

Open Label Study to Investigate the Safety and Efficacy of Ponesimod in Moderate-to-Severe Chronic Plaque Psoriasis

Open-Label Extension Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis

Safety and Tolerability of Repeat Courses of IM Alefacept

A Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Bimekizumab in Adult Patients With Chronic Plaque Psoriasis

Study to Evaluate the Safety and Antipsoriatic Efficacy of BOS-475 in a Psoriasis Plaque Test