title: First-in-human randomized study of bimekizumab, a humanized monoclonal antibody and selective dual inhibitor of IL-17A and IL-17F, in mild psoriasis.
abstract: To assess safety, pharmacokinetics (PK) and clinical efficacy of bimekizumab (formerly UCB4940), a novel humanized monoclonal antibody and dual inhibitor of interleukin (IL)-17A and IL-17F, in subjects with mild plaque psoriasis.
  
  
  
  Randomized, double-blind, first-in-human study of bimekizumab in 39 subjects who received single-dose intravenous bimekizumab (8-640 mg) or placebo (NCT02529956).
  
  
  
  Bimekizumab demonstrated dose-proportional linear PK and was tolerated across the dose range assessed. No subject discontinued due to treatment-emergent adverse events and no severe adverse events were reported. Bimekizumab demonstrated fast onset of clinically-meaningful effects on skin of patients with mild psoriasis as early as Week 2. Maximal improvements (100% or near 100% reductions from baseline) in all measures of disease activity were observed between Weeks 8-12 in subjects receiving 160-640 mg bimekizumab. The duration of effect at doses ≥160 mg was evident up to Weeks 12-20 after a single intravenous dose, dependent on endpoint.
  
  
  
  This is the first study to demonstrate the safety, tolerability and clinical efficacy of a dual IL-17A and IL-17F inhibitor, in subjects with mild psoriasis. Bimekizumab showed fast onset of clinically-meaningful efficacy by Week 2, with a maximal or near-maximal magnitude of response that was maintained up to study Weeks 12-20. These findings support the continued clinical development of bimekizumab for diseases mediated by both IL-17A and IL-17F, including psoriasis.
authors.affiliation: UCB Pharma, Slough, UK.
authors.forename: Sophie
authors.initials: S
authors.lastname: Glatt
authors.affiliation: UCB Pharma, Slough, UK.
authors.forename: Eric
authors.initials: E
authors.lastname: Helmer
authors.affiliation: UCB Pharma, Monheim, Germany.
authors.forename: Birgit
authors.initials: B
authors.lastname: Haier
authors.affiliation: UCB Pharma, Slough, UK.
authors.forename: Foteini
authors.initials: F
authors.lastname: Strimenopoulou
authors.affiliation: UCB Pharma, Slough, UK.
authors.forename: Graham
authors.initials: G
authors.lastname: Price
authors.affiliation: UCB Pharma, Slough, UK.
authors.forename: Pavan
authors.initials: P
authors.lastname: Vajjah
authors.affiliation: UCB Pharma, Slough, UK.
authors.forename: Olivier A
authors.initials: OA
authors.lastname: Harari
authors.affiliation: PAREXEL International, Middlesex, UK.
authors.forename: John
authors.initials: J
authors.lastname: Lambert
authors.affiliation: UCB Pharma, Slough, UK.
authors.forename: Stevan
authors.initials: S
authors.lastname: Shaw
mesh_terms: D061605:Administration, Intravenous; D000328:Adult; D000368:Aged; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D020381:Interleukin-17 / Q000037:antagonists & inhibitors*; D008297:Male; D008875:Middle Aged; D011565:Psoriasis / Q000188:drug therapy*; D012720:Severity of Illness Index; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D061067:Antibodies, Monoclonal, Humanized; C508717:IL17A protein, human; C440021:IL17F protein, human; D020381:Interleukin-17; C000625981:bimekizumab
keywords: UCB4940; anti-IL17A; anti-IL17F; bimekizumab; interleukin-17; psoriasis