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A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-Center Study to Evaluate the Efficacy and Safety of nemolizumab in Japanese Atopic Dermatitis Patients with moderate to severe pruritus

Trial Profile

A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-Center Study to Evaluate the Efficacy and Safety of nemolizumab in Japanese Atopic Dermatitis Patients with moderate to severe pruritus

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 25 May 2023

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At a glance

  • Drugs Nemolizumab (Primary)
  • Indications Atopic dermatitis; Pruritus
  • Focus Registrational; Therapeutic Use
  • Acronyms Study-JP01
  • Sponsors Maruho
  • Most Recent Events

    • 25 May 2023 Results of post hoc subgroup analysis assessing Clinically meaningful improvements in cutaneous lesions and quality of life measures in patients with atopic dermatitis published in the Journal of Dermatological Treatment
    • 11 Mar 2023 Results of post hoc analysis assessing the impact of nemolizumab 60 mg on QOL in Japanese patients aged greater than equal to 13 years with AD and inadequately controlled moderate-to-severe pruritus, using data derived from patient-reported outcome (PRO) measures, published in the Dermatology and Therapy.
    • 28 Mar 2022 According to a Maruho media release, the company has received manufacturing and marketing approval from the Ministry of Health, Labour and Welfare for "Mitchga Subcutaneous Injection 60mg Syringes" for the treatment of itching associated with atopic dermatitis (only when existing treatment is insufficiently effective) in Japan.
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