Psoriasis Clinical Trial

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

Summary

This is a study to assess the long-term safety, tolerability, and efficacy of bimekizumab.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Subject must have completed all dosing requirements in PS0016 without meeting any withdrawal criteria
Female subjects must be postmenopausal, permanently sterilized or, if of childbearing potential, must be willing to use a highly effective method of contraception up till 20 weeks after last administration of study drug, and have a negative pregnancy test at Visit 1 (Screening) and immediately prior to first dose
Male subjects with a partner of childbearing potential must be willing to use a condom when sexually active, up till 20 weeks after the last administration of study medication (anticipated 5 half-lives)

Exclusion Criteria:

Subjects previously participating in this study
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 (including herpes zoster or hospitalizations) in PS0016, the Medical Monitor must be consulted prior to the subject's entry into PS0018
Subject has any current sign or symptom that may indicate a medically significant infection
Subject has current clinically active infection with Histoplasma, Coccidiodes, Paracoccidioides, Pneumocystis, tuberculosis (TB), nontuberculous mycobacteria (NTMB),Blastomyces, Aspergillus, or Candidiasis (systemic). Any subject diagnosed with Histoplasmosis, Coccidiodes, Paracoccidioides, Pneumocystis, TB, NTMB, Blastomyces, Aspergillus, or Candidiasis (systemic) during PS0016 is excluded from PS0018 even if treatment has been completed.
Any subject who meets any withdrawal criteria in the feeder study (PS0016) is excluded from participating in the open-label extension study (PS0018)

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

43

Study ID:

NCT03230292

Recruitment Status:

Completed

Sponsor:

UCB Biopharma SRL

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There are 2 Locations for this study

See Locations Near You

Ps0018 701
High Point North Carolina, 27265, United States
Ps0018 704
Bexley Ohio, 43209, United States
Ps0018 101
Carlton , , Australia
Ps0018 103
East Melbourne , , Australia
Ps0018 102
Kogarah , , Australia
Ps0018 104
Woolloongabba , , Australia
Ps0018 201
Ajax , , Canada
Ps0018 203
London , , Canada
Ps0018 202
Windsor , , Canada
Ps0018 501
Chisinau , , Moldova, Republic of

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

43

Study ID:

NCT03230292

Recruitment Status:

Completed

Sponsor:


UCB Biopharma SRL

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