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Trial record 1 of 1 for:    NCT03230292
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This is a Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Bimekizumab in Adult Patients With Chronic Plaque Psoriasis.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03230292
Recruitment Status : Completed
First Posted : July 26, 2017
Last Update Posted : March 6, 2020
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma S.P.R.L. )

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

Condition or disease Intervention/treatment Phase
Chronic Plaque Psoriasis Drug: Bimekizumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, 48-week, Open-label Extension Study to Assess the Long-term Safety, Tolerability, and Efficacy of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis.
Actual Study Start Date : July 3, 2017
Actual Primary Completion Date : March 6, 2019
Actual Study Completion Date : March 6, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: Cohort 1
Subjects in this cohort will receive dose 1 every four weeks (Q4W) subcutaneously (sc) during the 48-week open-label Treatment Period. There will be an option to increase the dose to dose 2 Q4W at the discretion of the Investigator if the subject's Psoriasis Area and Severity Index (PASI) response is >=50% to <75% reduction from the Baseline of PS0016 at Week 12 or later. If the subject's disease is adequately controlled on dose 2 Q4W, they may return to dose 1 Q4W at the discretion of the Investigator.
Drug: Bimekizumab
Bimekizumab will be administered subcutaneously in 2 different doses.
Other Name: UCB4940




Primary Outcome Measures :
  1. Incidence of Treatment Emergent Adverse Events (TEAEs) adjusted by duration of subject exposure to treatment [ Time Frame: From Baseline (Week 0) until Safety Follow Up Visit (up to Week 64) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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, Paracoccidiodes, 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03230292


Locations
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United States, North Carolina
Ps0018 701
High Point, North Carolina, United States, 27265
United States, Ohio
Ps0018 704
Bexley, Ohio, United States, 43209
Australia
Ps0018 101
Carlton, Australia
Ps0018 103
East Melbourne, Australia
Ps0018 102
Kogarah, Australia
Ps0018 104
Woolloongabba, Australia
Canada
Ps0018 201
Ajax, Canada
Ps0018 203
London, Canada
Ps0018 202
Windsor, Canada
Moldova, Republic of
Ps0018 501
Chisinau, Moldova, Republic of
Sponsors and Collaborators
UCB Biopharma S.P.R.L.
Investigators
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Study Director: UCB Cares UCB (+1 844 599 2273)

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Responsible Party: UCB Biopharma S.P.R.L.
ClinicalTrials.gov Identifier: NCT03230292    
Other Study ID Numbers: PS0018
2016-002934-57 ( EudraCT Number )
First Posted: July 26, 2017    Key Record Dates
Last Update Posted: March 6, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by UCB Pharma ( UCB Biopharma S.P.R.L. ):
Psoriasis
Chronic Plaque Psoriasis
Bimekizumab
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases