A Study to Evaluate the Pharmacokinetics (PK), Pharmacodynamics (PD), and Safety of Bimekizumab in Patients With Chronic Plaque Psoriasis

UCB

Status and phase: Completed; Phase 2

Conditions: Chronic Plaque Psoriasis

Treatments: Drug: Bimekizumab; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03025542

PS0016

2016-002368-15 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 49 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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49 participants in 2 patient groups

Treatment Arm 1

Experimental group

Description:

Subjects randomized in this arm will receive a combination of Bimekizumab and Placebo injections.

Treatment:

Drug: Bimekizumab

Other: Placebo

Treatment Arm 2

Experimental group

Description:

Subjects randomized in this arm will receive Bimekizumab injections.

Treatment:

Drug: Bimekizumab