Chronic Plaque Psoriasis MedDRA version: 19.0 Level: LLT Classification code 10071117 Term: Plaque psoriasis System Organ Class: 100000004858
Conditions
Sponsors
UCB Biopharma SPRL
Eligibility
Sex/Gender
All
Inclusion 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) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
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 malignat 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the time-course of PASI over a 28-week period following the administration of bimekizumab given at Baseline and Week 4 to subjects with moderate to severe chronic plaque psoriasis.;Secondary Objective: - Evaluate the time-course of PASI over a 28-week period following the administration of bimekizumab given at Baseline and Weeks 4 and 16 in subjects with moderate to severe plaque psoriasis - Assess the pharmacokinetics (PK) and immunogenicity of bimekizumab - Assess the safety and tolerability of bimekizumab;Primary end point(s): - Change from Baseline in Psoriasis Area and Severity Index (PASI) at Week 28 - Mean plasma concentration of bimekizumab at Week 16 - Number of participants reporting positive Anti-Drug-Antibodies (ADA) titre prior to and following study treatment with bimekizumab - Incidence of adverse events (AEs);Timepoint(s) of evaluation of this end point: - Week 28 - Week 16 - From Baseline to the End of Treatment (Week 28) - From Baseline to Safety Follow Up Visit (Week 36) | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: - Week 16;Secondary end point(s): - Number of subjects achieving a 75% or higher improvement from Baseline in PASI (Psoriasis Area and Severity Index) score at Week 16 - Number of subjects achieving a 90% or higher improvement in PASI (Psoriasis Area and Severity Index) score at Week 16 - Number of subjects achieving a 100% improvement from Baseline in PASI (Psoriasis Area and Severity Index) score at Week 16 - Percentage of subjects with IGA (Investigator´s Global Assessment) response at Week 16 | — |
Countries
Australia, Canada, Georgia, Germany, Moldova, Republic of, Romania, United States
Contacts
Public ContactClin Trial Reg & Results Disclosure
UCB Biosciences GmbH
Outcome results
None listed