A Study to Evaluate the Pharmacokinetics (PK), Pharmacodynamics (PD), and Safety of Bimekizumab in Patients With Chronic Plaque Psoriasis
Completed · Phase 2 · Has a placebo group
Conditions studied: Chronic Plaque Psoriasis
In brief
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
Key facts
- Study ID
- NCT03025542
- Run by
- UCB Biopharma SRL
- People needed
- 49
- Starts
- 2016-12-27
- Expected to finish
- 2017-12-11
- Last updated by the study team
- 2026-03-24
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- Ps0016 704 — Bexley, Ohio, United States
- Ps0016 102 — Kogarah, Australia
- Ps0016 101 — Melbourne, Australia
- Ps0016 104 — Woolloongabba, Australia
- Ps0016 201 — Ajax, Canada
- Ps0016 203 — London, Canada
- Ps0016 202 — Windsor, Canada
- Ps0016 501 — Chisinau, Moldova
Full record on ClinicalTrials.gov
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