A Study to Evaluate the Pharmacokinetics (PK), Pharmacodynamics (PD), and Safety of Bimekizumab in Patients With Chronic Plaque Psoriasis
Condition: Chronic Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Bimekizumab; Placebo
Intervention description: Based on their randomization subjects will receive a combination of several injections of Bimekizumab.; Subjects will receive injections of Placebo.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking description: This is an Investigator- and Subject-blind study.
Enrollment: 49.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Psoriasis; Chronic Plaque Psoriasis; Bimekizumab

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
    

Eligibility 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