a study to evaluate the pharmacokinetics (pk), pharmacodynamics (pd), and safety of bimekizumab in patients with chronic plaque psoriasis

Conditions: Chronic Plaque Psoriasis

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

Keywords: psoriasis chronic plaque psoriasis bimekizumab