Atopic Dermatitis (Nemolizumab Study)

Study Description

Brief Summary

Long-Term Safety and Efficacy of Nemolizumab in Subjects with Moderate-to-Severe Atopic Dermatitis Description.

Condition or Disease

Moderate-to-Severe Atopic Dermatitis

Detailed Description

Long-term study to assess the safety and efficacy of nemolizumab in subjects with moderate-to-severe AD

Study Design

Study Type: Interventional  (Clinical Trial)
Actual Enrollment: 1700 participants
Allocation: N/A
Intervention Model: 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 (CD14152) in Subjects With Moderate-to-Severe Atopic Dermatitis
Actual Study Start Date: December 30, 2019
Actual Primary Completion Date: August 31, 2026
Actual Study Completion Date: August 31, 2026

Outcome Measures

Primary Outcome Measures

  1. Incidence and Severity of TEAEs [ Time Frame: Baseline to Week 200 ]
  2. Incidence of Serious TEAEs [ Time Frame: Baseline to Week 200 ]
  3. Incidence and Severity of Adverse Events of Special Interest (AESIs) Throughout the Study [ Time Frame: Baseline to Week 200 ]

Secondary Outcome Measures

  1. Proportion of Participants with IGA score = 0-1 at Each Visit [ Time Frame: Baseline to Week 200 ]
  2. Proportion of Participants with EASI-75 at Each Visit [ Time Frame: Baseline to Week 200 ]
  3. Change and Percent Change From Baseline in Overall Eczema Area and Severity Index (EASI) Score at Each Visit [ Time Frame: Baseline to Week 200 ]
    EASI assesses severity and extent of AD signs through a composite score of erythema, induration/population, excoriation, and lichenification. The severity will be assessed on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, trunk, upper limbs, and lower limbs, with half points allowed. The EASI score can range from 0 to 72 with higher scores representing greater severity of atopic dermatitis.
  4. Proportion of Participants with IGA ‚ȧ 2 at Each Visit [¬†Time¬†Frame:¬†Baseline to Week 200¬†]
  5. Change and Percent Change From Baseline in SCORAD Score at Each Visit [ Time Frame: Baseline to Week 200 ]
  6. Change and Percent Change From Baseline in Participant-Reported Pruritus Using 10-cm VAS (SCORAD Sub-Component) [ Time Frame: Baseline to Week 200 ]
  7. Change and Percent Change From Baseline in Participant-Reported Sleep Loss Using 10-cm VAS (SCORAD Sub-Component) [ Time Frame: Baseline to Week 200 ]
  8. Proportion of Participants Reporting Low Disease Activity State Based on PGAD at Each Visit [ Time Frame: Baseline to Week 200 ]
  9. Proportion of Participants Satisfied with Study Treatment Based on PGAT at each visit [ Time Frame: Baseline to Week 200 ]
  10. Change from Baseline in Dermatology Life Quality Index (DLQI) [ Time Frame: Baseline to Week 200 ]
  11. Change From Baseline in Children’s Dermatology Life Quality Index (cDLQI) Total Score at Each Visit Through Week 200 [¬†Time¬†Frame:¬†Baseline to Week 200¬†]
  12. Change From Baseline in Patient-Oriented Eczema Measure (POEM) Total Score at Each Visit Through Week 200 [ Time Frame: Baseline to Week 200 ]
  13. Change From Baseline in Hospital Anxiety and Depression Scale (HADS) for Each Subscale at Each Visit Through Week 200 [ Time Frame: Baseline to Week 200 ]
  14. Change From Baseline in Work Productivity and Activity Impairment: Atopic Dermatitis (WPAI:AD) for Each Subscale at Each Visit Through Week 200 [ Time Frame: Baseline to Week 200 ]
  15. Change From Baseline in EuroQoL 5-Dimension (EQ-5D) at Each Visit Through Week 200 [ Time Frame: Baseline to Week 200 ]
  16. Proportion of Participants Receiving Any Rescue Therapy by Rescue Treatment Type at Any Visit During the Treatment Period [ Time Frame: Baseline to Week 200 ]
  17. Time to First Relapse [ Time Frame: Baseline to Week 200 ]
  18. Duration of Remission [ Time Frame: Baseline to Week 200 ]
  19. Time to Permanent Study Drug Discontinuation [ Time Frame: Baseline to Week 200 ]

Eligibility Criteria

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

Inclusion Criteria

  • Subjects who may benefit from study participation in the opinion of the investigator and had participated in a prior nemolizumab study for AD
  • 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.

Exclusion Criteria

  • 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.
  • Pregnant women, breastfeeding women, or women planning a pregnancy during the clinical study.
  • Body weight < 30 kg
  • 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.
  • History of hypersensitivity (including anaphylaxis) to an immunoglobulin product (plasma-derived or recombinant, eg, monoclonal antibody)
  • Any clinically significant issue, based investigator judgement
ADDITIONAL DETAILS