Psoriasis Clinical Trial

Study to Evaluate Safety and Efficacy of Different Doses of Bimekizumab in Patients With Chronic Plaque Psoriasis

Summary

This is a Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose ranging study to investigate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of Bimekizumab compared with placebo in adult subjects with moderate to severe chronic plaque psoriasis in order to guide the selection of doses and clinical indices in the Phase 3 development program.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Subject has provided informed consent
Chronic plaque psoriasis for at least 6 months prior to Screening
PASI (Psoriasis Area and Severity Index) >=12 and BSA (body surface area) >=10% and IGA (Investigator's Global Assessment) score 3 or greater on a 5-point scale
Candidates for systemic psoriasis therapy and/or phototherapy and/or chemophototherapy
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
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

Exclusion Criteria:

Subjects with erythrodermic, guttate, pustular form of psoriasis, or drug-induced psoriasis
Subject has any severe, progressive and/or uncontrolled renal, hepatic, hematological, endocrine, pulmonary, cardiac, gastrointestinal or neurological disease
Subject has any significant concurrent medical condition or laboratory abnormalities, as defined in the study protocol
Subject taking prohibited psoriatic medications
Subject receiving any live vaccines within 8 weeks prior to the Baseline and subjects receiving Bacillus Calmette-Guerin (BCG) vaccination within 1 year prior to study drug administration
Subject has previously received treatment with any anti-interleukin-17 (anti-IL-17) therapy or has been exposed to more than 1 biological response modifier (limited to anti-tumor necrosis factor (TNF) or IL-12/23) for psoriatic arthritis or psoriasis prior to the Baseline
Subject has any current sign or symptom that may indicate an active infection (except for common cold)

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

250

Study ID:

NCT02905006

Recruitment Status:

Completed

Sponsor:

UCB Biopharma S.P.R.L.

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There is 1 Location for this study

See Locations Near You

Ps0010 711
Fremont California, , United States
Ps0010 708
Los Angeles California, , United States
Ps0010 706
Washington District of Columbia, , United States
Ps0010 704
West Des Moines Iowa, , United States
Ps0010 718
Rochester New York, , United States
Ps0010 738
Wilmington North Carolina, , United States
Ps0010 736
Cleveland Ohio, , United States
Ps0010 712
Portland Oregon, , United States
Ps0010 733
Dallas Texas, , United States
Ps0010 702
Houston Texas, , United States
Ps0010 709
Houston Texas, , United States
Ps0010 203
Surrey British Columbia, , Canada
Ps0010 204
Hamilton Ontario, , Canada
Ps0010 201
North Bay Ontario, , Canada
Ps0010 206
Peterborough Ontario, , Canada
Ps0010 205
Waterloo Ontario, , Canada
Ps0010 214
Quebec City Quebec, , Canada
Ps0010 209
Edmonton , , Canada
Ps0010 214
Quebec City , , Canada
Ps0010 300
Ostrava Poruba , , Czechia
Ps0010 303
Pardubice , , Czechia
Ps0010 301
Praha , , Czechia
Ps0010 304
Praha , , Czechia
Ps0010 404
Kecskemet , , Hungary
Ps0010 400
Oroshaza , , Hungary
Ps0010 405
Szekszard , , Hungary
Ps0010 502
Nagoya , , Japan
Ps0010 501
Shinaga Wa-ku , , Japan
Ps0010 503
Tokio , , Japan
Ps0010 504
Tokyo , , Japan
Ps0010 600
Bialystok , , Poland
Ps0010 611
Bialystok , , Poland
Ps0010 605
Gdansk , , Poland
Ps0010 610
Gdynia , , Poland
Ps0010 604
Kielce , , Poland
Ps0010 608
Krakow , , Poland
Ps0010 606
Lublin , , Poland
Ps0010 603
Podlaski , , Poland
Ps0010 607
Warszawa , , Poland
Ps0010 601
Wroclaw , , Poland
Ps0010 609
Wroclaw , , Poland

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

250

Study ID:

NCT02905006

Recruitment Status:

Completed

Sponsor:


UCB Biopharma S.P.R.L.

How clear is this clinincal trial information?

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