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出境医 / 临床实验 / Efficacy and Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis

Efficacy and Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis

Study Description
Brief Summary:
The main purpose of the study is to assess the efficacy and safety of nemolizumab after a 16-week treatment period in adult and adolescent subjects with moderate-to-severe atopic dermatitis (AD) not adequately controlled with topical treatments.

Condition or disease Intervention/treatment Phase
Moderate-to-Severe Atopic Dermatitis Drug: Placebo Drug: Nemolizumab Phase 3

Detailed Description:
This is a randomized, double-blind, placebo-controlled, multi-center, parallel-group study in adult and adolescent subjects of age 12 years and above with moderate-to-severe AD. Eligible subjects must have a documented history of inadequate response to topical AD medication(s). Approximately 750 subjects will be randomized in 2:1 to receive either nemolizumab or placebo, stratified by baseline disease severity (Investigator's Global Assessment (IGA) = 3, moderate; IGA = 4, severe) and peak pruritus numeric rating scale (PP NRS) severity (PP NRS = 7; PP NRS < 7).
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 750 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Treatment
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis
Actual Study Start Date : June 30, 2019
Estimated Primary Completion Date : May 30, 2022
Estimated Study Completion Date : May 30, 2022
Arms and Interventions
Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo
 Drug: Placebo
Placebo
Experimental: Nemolizumab
Nemolizumab Active
 Drug: Nemolizumab
Nemolizumab
Other Name: CD14152
Outcome Measures
Primary Outcome Measures :
  1. Proportion of subjects with an IGA success (IGA of 0 or 1) and a ≥ 2-point reduction [ Time Frame: Baseline to Week 16 ]
    IGA success rate defined as the proportion of subjects who achieve an IGA score of 1 (Almost Clear) or 0 (Clear) and at least a 2-grade improvement from Baseline to Week 16.

  2. Proportion of subjects with EASI-75 [ Time Frame: Baseline to Week 16 ]

Secondary Outcome Measures :
  1. Proportion of subjects with an improvement of PP NRS ≥ 4 [ Time Frame: Week 16 ]
  2. Proportion of subjects with PP NRS < 2 [ Time Frame: Week 16 ]
  3. Proportion of subjects with an improvement of sleep disturbance NRS (SD NRS) ≥ 4 [ Time Frame: Week 16 ]
  4. Proportion of subjects with an improvement of PP NRS ≥ 4 [ Time Frame: Week 4 ]
  5. Proportion of subjects with PP NRS < 2 [ Time Frame: Week 4 ]
  6. Proportion of subjects with an improvement of PP NRS ≥ 4 [ Time Frame: Week 2 ]
  7. Proportion of subjects with an improvement of PP NRS ≥ 4 [ Time Frame: Week 1 ]
  8. Proportion of subjects with EASI-75 and improvement of PP NRS ≥ 4 [ Time Frame: Week 16 ]
  9. Proportion of subjects with IGA success and improvement of PP NRS ≥ 4 [ Time Frame: Week 16 ]

Eligibility Criteria
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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Male or female subjects aged ≥ 12 years at the screening visit Note: Enrollment of subjects aged 12 to 17 years will begin after an IDMC has assessed interim safety data from the phase 2 study (Protocol 116912) and provided recommendations to the sponsor, who will then determine the eligibility of this age group for enrollment in the study
  • Chronic AD that has been documented for at least 2 years
  • EASI score ≥ 16
  • IGA score ≥ 3
  • AD involvement ≥ 10% of BSA
  • PPNRS score of at least 4.0 at the screening and baseline visit
  • Documented recent history of inadequate response to topical medications (TCS with or without TCI)
  • Female subjects of childbearing potential (that is, fertile, following menarche and until becoming postmenopausal unless permanently sterile) must agree either to be strictly abstinent throughout the study and for 12 weeks after the last study drug injection, or to use an adequate and approved method of contraception throughout the study and for 12 weeks after the last study drug injection

Key Exclusion Criteria:

  • Body weight < 30 kg
  • Pregnant women, breastfeeding women, or women planning a pregnancy during the clinical study
  • Cutaneous infection within 1 week before the baseline visit, any infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics or antifungals within 2 weeks before the baseline visit, or any confirmed or suspected coronavirus disease (COVID)-19 infection within 2 weeks before the screening or baseline visit
  • History of hypersensitivity (including anaphylaxis) to an immunoglobulin product (plasma-derived or recombinant, eg, monoclonal antibody)
  • Any clinically significant issue, based on investigator judgement
Contacts and Locations

Contacts
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Contact: Galderma Research & Development 817-961-5000 clinical.studies@galderma.com
Contact: Research & Development 817-961-5000 clinical.studies@galderma.com

Locations
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