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Study to Evaluate Safety and Efficacy of Different Doses of Bimekizumab in Patients With Chronic Plaque Psoriasis (BE ABLE 1)

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: NCT02905006
Recruitment Status : Completed
First Posted : September 19, 2016
Last Update Posted : October 9, 2019
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma S.P.R.L. )

Brief 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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose Ranging Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
Study Start Date : August 2016
Actual Primary Completion Date : June 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Placebo Comparator: Placebo Other: Placebo
Subjects randomized to the placebo group, will receive a combination of several injections of Placebo to maintain the blinding.

Experimental: Bimekizumab dosing regimen 1 Drug: Bimekizumab
Subjects will be randomized to receive a combination of injections of Bimekizumab.
Other Name: UCB4940

Other: Placebo
Subjects randomized to the placebo group, will receive a combination of several injections of Placebo to maintain the blinding.

Experimental: Bimekizumab dosing regimen 2 Drug: Bimekizumab
Subjects will be randomized to receive a combination of injections of Bimekizumab.
Other Name: UCB4940

Other: Placebo
Subjects randomized to the placebo group, will receive a combination of several injections of Placebo to maintain the blinding.

Experimental: Bimekizumab dosing regimen 3 Drug: Bimekizumab
Subjects will be randomized to receive a combination of injections of Bimekizumab.
Other Name: UCB4940

Other: Placebo
Subjects randomized to the placebo group, will receive a combination of several injections of Placebo to maintain the blinding.

Experimental: Bimekizumab dosing regimen 4 Drug: Bimekizumab
Subjects will be randomized to receive a combination of injections of Bimekizumab.
Other Name: UCB4940

Other: Placebo
Subjects randomized to the placebo group, will receive a combination of several injections of Placebo to maintain the blinding.

Experimental: Bimekizumab dosing regimen 5 Drug: Bimekizumab
Subjects will be randomized to receive a combination of injections of Bimekizumab.
Other Name: UCB4940




Primary Outcome Measures :
  1. Percentage of subjects achieving a 90% or higher improvement from Baseline in Psoriasis Area and Severity Index (PASI) score at Week 12 [ Time Frame: Week 12 ]

Secondary Outcome Measures :
  1. Percentage of subjects with Investigator's Global Assessment (IGA) response at Week 12 [ Time Frame: Week 12 ]
  2. Percentage of subjects with Investigator's Global Assessment (IGA) response at Week 8 [ Time Frame: Week 8 ]
  3. Percentage of subjects achieving a 90% or higher improvement from Baseline in Psoriasis Area and Severity Index (PASI) score at Week 8 [ Time Frame: Week 8 ]
  4. Percentage of subjects achieving a 75% or higher improvement in Psoriasis Area and Severity Index (PASI) score at Week 12 [ Time Frame: Week 12 ]
  5. Percentage of subjects achieving a 100% improvement from Baseline in Psoriasis Area and Severity Index (PASI) score at Week 12 [ Time Frame: Week 12 ]


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 and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

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): NCT02905006


Locations
Show Show 41 study locations
Sponsors and Collaborators
UCB Biopharma S.P.R.L.
Parexel
Investigators
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Study Director: UCB Cares +1 844 599 2273 (UCB)
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Responsible Party: UCB Biopharma S.P.R.L.
ClinicalTrials.gov Identifier: NCT02905006    
Other Study ID Numbers: PS0010
2016-001891-31 ( EudraCT Number )
First Posted: September 19, 2016    Key Record Dates
Last Update Posted: October 9, 2019
Last Verified: September 2019
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