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 |
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
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
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