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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 : January 10, 2018
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma S.P.R.L. )

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

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : December 2016
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: Treatment Arm 1
Subjects randomized in this arm will receive a combination of Bimekizumab and Placebo injections.
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.

Experimental: Treatment Arm 2
Subjects randomized in this arm will receive Bimekizumab injections.
Drug: Bimekizumab
Based on their randomization subjects will receive a combination of several injections of Bimekizumab.
Other Name: UCB4940




Primary Outcome Measures :
  1. Change from Baseline in Psoriasis Area and Severity Index (PASI) at Week 28 [ Time Frame: Week 28 ]
  2. Mean plasma concentration of bimekizumab at Week 16 [ Time Frame: Week 16 ]
  3. 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) ]
  4. Incidence of adverse events (AEs) [ Time Frame: From Baseline to Safety Follow Up Visit (Week 36) ]

Secondary Outcome Measures :
  1. 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 ]
  2. Number of subjects achieving a 90% or higher improvement in PASI (Psoriasis Area and Severity Index) score at Week 16 [ Time Frame: Week 16 ]
  3. Number of subjects achieving a 100% improvement from Baseline in PASI (Psoriasis Area and Severity Index) score at Week 16 [ Time Frame: Week 16 ]
  4. Percentage of subjects with IGA (Investigator´s Global Assessment) response at Week 16 [ Time Frame: Week 16 ]


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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:

  • 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

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): NCT03025542


Locations
United States, Ohio
Ps0016 704
Bexley, Ohio, United States
Australia
Ps0016 102
Kogarah, Australia
Ps0016 101
Melbourne, Australia
Ps0016 104
Woolloongabba, Australia
Canada
Ps0016 201
Ajax, Canada
Ps0016 203
London, Canada
Ps0016 202
Windsor, Canada
Moldova, Republic of
Ps0016 501
Chisinau, Moldova, Republic of
Sponsors and Collaborators
UCB Biopharma S.P.R.L.
Parexel
Investigators
Study Director: UCB Cares +1 844 599 2273(UCB)

Responsible Party: UCB Biopharma S.P.R.L.
ClinicalTrials.gov Identifier: NCT03025542     History of Changes
Other Study ID Numbers: PS0016
2016-002368-15 ( EudraCT Number )
First Posted: January 19, 2017    Key Record Dates
Last Update Posted: January 10, 2018
Last Verified: January 2018

Keywords provided by UCB Pharma ( UCB Biopharma S.P.R.L. ):
Psoriasis
Chronic Plaque Psoriasis
Bimekizumab

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases