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Trial record 1 of 1 for:    NCT03025542
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Study to Evaluate the Pharmacokinetics (PK), Pharmacodynamics (PD), and Safety of Bimekizumab in Patients With Chronic Plaque Psoriasis

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ClinicalTrials.gov Identifier: NCT03025542
Recruitment Status : Completed
First Posted : January 19, 2017
Last Update Posted : December 11, 2018
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma S.P.R.L. )

Tracking Information
First Submitted Date  ICMJE January 17, 2017
First Posted Date  ICMJE January 19, 2017
Last Update Posted Date December 11, 2018
Actual Study Start Date  ICMJE December 2016
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 18, 2017)
  • Change from Baseline in Psoriasis Area and Severity Index (PASI) at Week 28 [ Time Frame: Week 28 ]
  • Mean plasma concentration of bimekizumab at Week 16 [ Time Frame: Week 16 ]
  • Number of participants reporting positive Anti-Drug-Antibodies (ADA) titre prior to and following study treatment with bimekizumab [ Time Frame: From Baseline to the End of Treatment (Week 28) ]
  • Incidence of adverse events (AEs) [ Time Frame: From Baseline to Safety Follow Up Visit (Week 36) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 18, 2017)
  • Number of subjects achieving a 75% or higher improvement from Baseline in PASI (Psoriasis Area and Severity Index) score at Week 16 [ Time Frame: Week 16 ]
  • Number of subjects achieving a 90% or higher improvement in PASI (Psoriasis Area and Severity Index) score at Week 16 [ Time Frame: Week 16 ]
  • Number of subjects achieving a 100% improvement from Baseline in PASI (Psoriasis Area and Severity Index) score at Week 16 [ Time Frame: Week 16 ]
  • Percentage of subjects with IGA (Investigator´s Global Assessment) response at Week 16 [ Time Frame: Week 16 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Pharmacokinetics (PK), Pharmacodynamics (PD), and Safety of Bimekizumab in Patients With Chronic Plaque Psoriasis
Official Title  ICMJE A Multicenter, Randomized, Subject-Blind, Investigator-Blind Study to Evaluate the Time Course of Pharmacodynamic Response, Safety and Pharmacokinetics of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
Brief Summary This is a Phase 2a, multicenter, randomized, subject-blind, investigator-blind, study to investigate the pharmacokinetics (PK), pharmacodynamics (PD), and safety of bimekizumab in adult subjects with moderate to severe chronic plaque psoriasis
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Plaque Psoriasis
Intervention  ICMJE
  • Drug: Bimekizumab
    Based on their randomization subjects will receive a combination of several injections of Bimekizumab.
    Other Name: UCB4940
  • Other: Placebo
    Subjects will receive injections of Placebo.
Study Arms  ICMJE
  • Experimental: Treatment Arm 1
    Subjects randomized in this arm will receive a combination of Bimekizumab and Placebo injections.
    Interventions:
    • Drug: Bimekizumab
    • Other: Placebo
  • Experimental: Treatment Arm 2
    Subjects randomized in this arm will receive Bimekizumab injections.
    Intervention: Drug: Bimekizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 5, 2017)
49
Original Estimated Enrollment  ICMJE
 (submitted: January 18, 2017)
45
Actual Study Completion Date  ICMJE December 2017
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female at least 18 years of age and less than or equal to 70
  • Chronic plaque psoriasis for at least 6 months prior to Screening
  • Psoriasis Area and Severity Index (PASI) >=12 and body surface area (BSA) >=10% and Investigator's Global Assessment (IGA) score >=3 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, 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 a bimekizumab study
  • Subjects with erythrodermic, guttate, pustular form of psoriasis, or drug-induced psoriasis
  • History of chronic or recurrent infections, or a serious or life-threatening infection within the 6 months prior to the Baseline Visit (including herpes zoster)
  • High risk of infection in the Investigator's opinion
  • Current sign or symptom that may indicate an active infection
  • Concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection
  • Live (includes attenuated) vaccination within the 8 weeks prior to Baseline
  • Subjects with concurrent malignancy or history of malignancy during the past 5 years (except for specific malignant condition as defined in the protocol)
  • Primary immunosuppressive conditions
  • TB infection, high risk of acquiring TB infection, latent TB infection (LTBI), or current or history of NTMB infection
  • Laboratory abnormalities, as defined in the study protocol
  • Any condition which, in the Investigator's judgement, would make the subject unsuitable for inclusion in the study
  • Exposure to more than 1 biological response modifier (limited to anti-TNF or IL-12/-23) or any biologic response modifier during the three months prior to the Baseline Visit
  • Subjects have received previous treatment with any anti-IL-17 therapy for the treatment of psoriasis or psoriatic arthritis
  • Subjects with a diagnosis of inflammatory conditions other than psoriasis or psoriatic arthritis, including but not limited to rheumatoid arthritis, sarcoidosis, or systemic lupus erythematosus. Subjects with a diagnosis of Crohn's disease or ulcerative colitis are allowed as long as they have no active symptomatic disease at Screening or Baseline
  • Subjects taking psoriatic arthritis medications other than nonsteroidal anti-inflammatory drugs (NSAIDs) or analgesics
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   Moldova, Republic of,   United States
Removed Location Countries Germany
 
Administrative Information
NCT Number  ICMJE NCT03025542
Other Study ID Numbers  ICMJE PS0016
2016-002368-15 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party UCB Pharma ( UCB Biopharma S.P.R.L. )
Study Sponsor  ICMJE UCB Biopharma S.P.R.L.
Collaborators  ICMJE Parexel
Investigators  ICMJE
Study Director: UCB Cares +1 844 599 2273(UCB)
PRS Account UCB Pharma
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP