A study to evaluate the safety, tolerability and efficacy of bimekizumab in adult subjects with moderate to severe chronic plaque psoriasis

Phase 1

• Conditions: Moderate to Severe Chronic Plaque Psoriasis; MedDRA version: 20.0Level: LLTClassification code 10071117Term: Plaque psoriasisSystem Organ Class: 100000004858; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2016-003427-30-HU
• Lead Sponsor: CB Biopharma SR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-31
• Last Update Posted: 15 January 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1120

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:
a) Postmenopausal: Menopause is defined as 12 consecutive months of amenorrhea, for which there is no other obvious pathological or physiological cause
b) Permanently sterilized (eg, tubal occlusion, hysterectomy, bilateral
salpingectomy)
c) 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1020
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

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 must have a negative interferon gamma release assay (IGRA) as measured at the final dosing visit of the feeder study
- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified