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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
Trial website
Trial related presentations / publications
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents


Results are available at https://clinicaltrials.gov/study/NCT03025542