Clinical trial NCT03025542: A Study to Evaluate the Pharmacokinetics (PK), Pharmacodynamics (PD), and Safety of Bimekizumab in Patients With Chronic Plaque Psoriasis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Plaque Psoriasis
Keywords: Psoriasis
Chronic Plaque Psoriasis
Bimekizumab
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
Collaborators: name: Parexel
First posted: 2017-01-19
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Change From Baseline in Psoriasis Area and Severity Index (PASI) at Week 28
timeFrame: From Baseline to Week 28
measure: Plasma Concentration of Bimekizumab at Baseline
timeFrame: at Baseline
measure: Plasma Concentration of Bimekizumab at Week 2
timeFrame: at Week 2
measure: Plasma Concentration of Bimekizumab at Week 4
timeFrame: at Week 4
measure: Plasma Concentration of Bimekizumab at Week 8
timeFrame: at Week 8
measure: Plasma Concentration of Bimekizumab at Week 12
timeFrame: at Week 12
measure: Plasma Concentration of Bimekizumab at Week 16
timeFrame: at Week 16
measure: Plasma Concentration of Bimekizumab at Week 20
timeFrame: at Week 20
measure: Plasma Concentration of Bimekizumab at Week 24
timeFrame: at Week 24
measure: Plasma Concentration of Bimekizumab at Week 28
timeFrame: at Week 28
measure: Plasma Concentration of Bimekizumab at Week 36
timeFrame: at Week 36
measure: Percentage of Participants Reporting Positive Anti-Drug-Antibodies (ADA) Titre Prior to Study Treatment With Bimekizumab at Baseline
timeFrame: at Baseline
measure: Percentage of Participants Reporting an Overall Positive Anti-Drug-Antibodies (ADA) Titre Following Study Treatment With Bimekizumab
timeFrame: From Baseline to Safety Follow-Up Visit (Week 36)
measure: Percentage of Participants Who Experienced at Least One Adverse Events (AEs)
timeFrame: From Screening to Safety Follow-Up Visit (Week 36)
Secondary outcomes:
measure: Percentage of Participants Achieving a 75% or Higher Improvement From Baseline in PASI (Psoriasis Area and Severity Index) Score at Week 16
timeFrame: From Baseline to Week 16
measure: Percentage of Participants Achieving a 90% or Higher Improvement From Baseline in PASI (Psoriasis Area and Severity Index) Score at Week 16
timeFrame: From Baseline to Week 16
measure: Percentage of Participants Achieving a 100% Improvement From Baseline in PASI (Psoriasis Area and Severity Index) Score at Week 16
timeFrame: From Baseline to Week 16
measure: Percentage of Participants With IGA (Investigator´s Global Assessment) Response at Week 16
timeFrame: at Week 16
Other outcomes:
Locations:
city: Bexley
country: United States
facility: Ps0016 704
state: Ohio
city: Kogarah
country: Australia
facility: Ps0016 102
city: Melbourne
country: Australia
facility: Ps0016 101
city: Woolloongabba
country: Australia
facility: Ps0016 104
city: Ajax
country: Canada
facility: Ps0016 201
city: London
country: Canada
facility: Ps0016 203
city: Windsor
country: Canada
facility: Ps0016 202
city: Chisinau
country: Moldova, Republic of
facility: Ps0016 501
Study officials:
affiliation: 001 844 599 2273(UCB)
name: UCB Cares
role: STUDY_DIRECTOR
References:
citation: Oliver R, Krueger JG, Glatt S, Vajjah P, Mistry C, Page M, Edwards H, Garcet S, Li X, Dizier B, Maroof A, Watling M, El Baghdady A, Baeten D, Ionescu L, Shaw S. Bimekizumab for the treatment of moderate-to-severe plaque psoriasis: efficacy, safety, pharmacokinetics, pharmacodynamics and transcriptomics from a phase IIa, randomized, double-blind multicentre study. Br J Dermatol. 2022 Apr;186(4):652-663. doi: 10.1111/bjd.20827. Epub 2021 Dec 27.
citation: Gordon KB, Langley RG, Warren RB, Okubo Y, Stein Gold L, Merola JF, Peterson L, Wixted K, Cross N, Deherder D, Thaci D. Bimekizumab Safety in Patients With Moderate to Severe Plaque Psoriasis: Pooled Results From Phase 2 and Phase 3 Randomized Clinical Trials. JAMA Dermatol. 2022 Jul 1;158(7):735-744. doi: 10.1001/jamadermatol.2022.1185.