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

• Status: Completed
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UCB Biopharma S.P.R.L.
• Collaborators: Parexel; PAREXEL International (IRL) Limited

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