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



Status:Completed
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - 70
Updated:12/13/2018
Start Date:December 2016
End Date:December 2017

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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

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


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
We found this trial at
2
sites
Bexley, Ohio
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Bexley, OH
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Kogarah,
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Kogarah,
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