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. 2021 Apr 19;2021(4):CD011535. doi: 10.1002/14651858.CD011535.pub4

NCT03025542.

Methods RCT, placebo‐controlled, double‐blind study
Date of study: December 2016
Location: USA, Australia, Canada
Phase 2
Participants Randomised: 49 participants
Inclusion criteria
  • Men or women at least 18 years of age and ≤ 70

  • Chronic plaque psoriasis for at least 6 months prior to screening

  • PASI ≥ 12 and 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

  • Women must be postmenopausal, permanently sterilised or, if of childbearing potential, must be willing to use a highly effective method of contraception up until 20 weeks after last administration of study drug, and have a negative pregnancy test at Visit 1 (screening) and immediately prior to first dose

  • Men with a partner of childbearing potential must be willing to use a condom when sexually active, up until 20 weeks after the last administration of study medication (anticipated 5 half‐lives)


Exclusion criteria
  • Previously participating in a bimekizumab study

  • 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 HIV infection

  • Live (includes attenuated) vaccination within the 8 weeks prior to baseline

  • 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 person 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 3 months prior to the baseline visit

  • Have received previous treatment with any anti‐IL‐17 therapy for the treatment of psoriasis or psoriatic arthritis

  • With a diagnosis of inflammatory conditions other than psoriasis or psoriatic arthritis, including but not limited to rheumatoid arthritis, sarcoidosis, or systemic lupus erythematosus. People 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

  • Taking psoriatic arthritis medications other than nonsteroidal anti‐inflammatory drugs (NSAIDs) or analgesics

Interventions Intervention
A. Bimekizumab
Control interventions
B. Placebo
Outcomes At week 16
Primary composite outcome
Change from baseline in PASI at week 28 (Time frame: week 28)
Notes Ongoing study
Last checked in September 2020