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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03025542




Registration number
NCT03025542
Ethics application status
Date submitted
17/01/2017
Date registered
19/01/2017
Date last updated
28/10/2022

Titles & IDs
Public title
A Study to Evaluate the Pharmacokinetics (PK), Pharmacodynamics (PD), and Safety of Bimekizumab in Patients With Chronic Plaque Psoriasis
Scientific 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
Secondary ID [1] 0 0
2016-002368-15
Secondary ID [2] 0 0
PS0016
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Plaque Psoriasis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Bimekizumab
Other interventions - Placebo

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

Experimental: Treatment Arm 2 - Subjects randomized in this arm will receive Bimekizumab injections.


Treatment: Drugs: Bimekizumab
Based on their randomization subjects will receive a combination of several injections of Bimekizumab.

Other interventions: Placebo
Subjects will receive injections of Placebo.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Psoriasis Area and Severity Index (PASI) at Week 28
Timepoint [1] 0 0
From Baseline to Week 28
Primary outcome [2] 0 0
Plasma Concentration of Bimekizumab at Baseline
Timepoint [2] 0 0
at Baseline
Primary outcome [3] 0 0
Plasma Concentration of Bimekizumab at Week 2
Timepoint [3] 0 0
at Week 2
Primary outcome [4] 0 0
Plasma Concentration of Bimekizumab at Week 4
Timepoint [4] 0 0
at Week 4
Primary outcome [5] 0 0
Plasma Concentration of Bimekizumab at Week 8
Timepoint [5] 0 0
at Week 8
Primary outcome [6] 0 0
Plasma Concentration of Bimekizumab at Week 12
Timepoint [6] 0 0
at Week 12
Primary outcome [7] 0 0
Plasma Concentration of Bimekizumab at Week 16
Timepoint [7] 0 0
at Week 16
Primary outcome [8] 0 0
Plasma Concentration of Bimekizumab at Week 20
Timepoint [8] 0 0
at Week 20
Primary outcome [9] 0 0
Plasma Concentration of Bimekizumab at Week 24
Timepoint [9] 0 0
at Week 24
Primary outcome [10] 0 0
Plasma Concentration of Bimekizumab at Week 28
Timepoint [10] 0 0
at Week 28
Primary outcome [11] 0 0
Plasma Concentration of Bimekizumab at Week 36
Timepoint [11] 0 0
at Week 36
Primary outcome [12] 0 0
Percentage of Participants Reporting Positive Anti-Drug-Antibodies (ADA) Titre Prior to Study Treatment With Bimekizumab at Baseline
Timepoint [12] 0 0
at Baseline
Primary outcome [13] 0 0
Percentage of Participants Reporting an Overall Positive Anti-Drug-Antibodies (ADA) Titre Following Study Treatment With Bimekizumab
Timepoint [13] 0 0
From Baseline to Safety Follow-Up Visit (Week 36)
Primary outcome [14] 0 0
Percentage of Participants Who Experienced at Least One Adverse Events (AEs)
Timepoint [14] 0 0
From Screening to Safety Follow-Up Visit (Week 36)
Secondary outcome [1] 0 0
Percentage of Participants Achieving a 75% or Higher Improvement From Baseline in PASI (Psoriasis Area and Severity Index) Score at Week 16
Timepoint [1] 0 0
From Baseline to Week 16
Secondary outcome [2] 0 0
Percentage of Participants Achieving a 90% or Higher Improvement From Baseline in PASI (Psoriasis Area and Severity Index) Score at Week 16
Timepoint [2] 0 0
From Baseline to Week 16
Secondary outcome [3] 0 0
Percentage of Participants Achieving a 100% Improvement From Baseline in PASI (Psoriasis Area and Severity Index) Score at Week 16
Timepoint [3] 0 0
From Baseline to Week 16
Secondary outcome [4] 0 0
Percentage of Participants With IGA (Investigator´s Global Assessment) Response at Week 16
Timepoint [4] 0 0
at Week 16

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/12/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
11/12/2017
Sample size
Target
Accrual to date
Final
49
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Ps0016 102 - Kogarah
Recruitment hospital [2] 0 0
Ps0016 101 - Melbourne
Recruitment hospital [3] 0 0
Ps0016 104 - Woolloongabba
Recruitment postcode(s) [1] 0 0
- Kogarah
Recruitment postcode(s) [2] 0 0
- Melbourne
Recruitment postcode(s) [3] 0 0
- Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Ohio
Country [2] 0 0
Canada
State/province [2] 0 0
Ajax
Country [3] 0 0
Canada
State/province [3] 0 0
London
Country [4] 0 0
Canada
State/province [4] 0 0
Windsor
Country [5] 0 0
Moldova, Republic of
State/province [5] 0 0
Chisinau

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
UCB Biopharma SRL
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Parexel
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/study/NCT03025542
Trial related presentations / publications
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
UCB Cares
Address 0 0
001 844 599 2273(UCB)
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03025542