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出境医 / 临床实验 / Long-term Safety and Efficacy of Nemolizumab With Moderate-to-severe Atopic Dermatitis

Long-term Safety and Efficacy of Nemolizumab With Moderate-to-severe Atopic Dermatitis

Study Description
Brief Summary:
Long-Term Safety and Efficacy of Nemolizumab in Subjects with Moderate-to-Severe Atopic Dermatitis Description

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

Detailed Description:
Long-term study to assess the safety and efficacy of nemolizumab in subjects with moderate-to-severe AD
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1300 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter, Long-Term Study to Assess the Safety and Efficacy of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis
Actual Study Start Date : December 30, 2019
Estimated Primary Completion Date : September 30, 2023
Estimated Study Completion Date : September 30, 2023
Arms and Interventions
Arm Intervention/treatment
Experimental: Nemolizumab
Nemolizumab administered via subcutaneous injection
 Drug: Nemolizumab
Nemolizumab
Other Name: CD14152
Outcome Measures
Primary Outcome Measures :
  1. Incidence and severity of TEAEs [ Time Frame: Baseline to Week 112 ]
  2. Incidence of serious TEAEs [ Time Frame: Baseline to Week 112 ]

Secondary Outcome Measures :
  1. Proportion of subjects with IGA score = 0-1 at each visit [ Time Frame: Baseline to Week 112 ]
  2. Proportion of subjects with EASI-75 at each visit [ Time Frame: Baseline to Week 112 ]
  3. Change and percent change from baseline in the overall Eczema Area and Severity Index (EASI) score at each visit [ Time Frame: Baseline to Week 112 ]
    EASI assesses severity and extent of AD signs through a composite score of erythema, induration/population, excoriation, and lichenification. The EASI score can range from 0 to 72. The higher the score

  4. Change and percent change from baseline in the overall Investigator's Global Assessment (IGA) score at each visit [ Time Frame: Baseline to Week 112 ]
    IGA assesses the severity of AD on a 5-point scale from 0 (clear) to 4 (severe)

  5. Proportion of subjects with IGA ≤ 2 at each visit [ Time Frame: Baseline to Week 112 ]
  6. Change and percent change from baseline in SCORAD score at each visit [ Time Frame: Baseline to Week 112 ]
  7. Change and percent change from baseline in subject-reported pruritus using 10-cm VAS (SCORAD sub-component) [ Time Frame: Baseline to Week 112 ]
  8. Change and percent change from baseline in subject-reported sleep loss using 10-cm VAS (SCORAD sub-component) [ Time Frame: Baseline to Week 112 ]
  9. Proportion of subjects reporting low disease activity state based on PGAD at each visit [ Time Frame: Baseline to Week 112 ]
  10. Proportion of subjects satisfied with study treatment based on PGAT at each visit [ Time Frame: Baseline to Week 112 ]
  11. Proportion of subjects receiving any concomitant AD treatment [ Time Frame: Baseline to Week 104 ]
  12. Proportion of subjects receiving any rescue therapy [ Time Frame: Baseline to Week 104 ]

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:

  1. Subjects who may benefit from study participation in the opinion of the investigator and had participated in a prior nemolizumab study for AD
  2. Female subjects of childbearing potential (ie, fertile, following menarche and until becoming post-menopausal 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 effective and approved method of contraception throughout the study and for 12 weeks after the last study drug injection.

Key Exclusion Criteria:

  1. Subjects who, during their participation in a prior nemolizumab study, experienced an AE which in the opinion of the investigator could indicate that continued treatment with nemolizumab may present an unreasonable risk for the subject.
  2. Pregnant women, breastfeeding women, or women planning a pregnancy during the clinical study.
  3. Body weight < 30 kg
  4. 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. Subjects may be rescreened once the infection has resolved. Resolution of COVID-19 infection can be confirmed by recovery assessment methods.
  5. History of hypersensitivity (including anaphylaxis) to an immunoglobulin product (plasma-derived or recombinant, eg, monoclonal antibody)
  6. Any clinically significant issue, based 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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