Long-Term Safety and Efficacy of Nemolizumab in Subjects with Moderate-to-Severe Atopic Dermatitis Description
Long-term study to assess the safety and efficacy of nemolizumab in subjects with moderate-to-severe AD
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1,700
Nemolizumab
Incidence and Severity of TEAEs
Time frame: Baseline to Week 200
Incidence of Serious TEAEs
Time frame: Baseline to Week 200
Incidence and Severity of Adverse Events of Special Interest (AESIs) Throughout the Study
Time frame: Baseline to Week 200
Proportion of Participants with IGA score = 0-1 at Each Visit
Time frame: Baseline to Week 200
Proportion of Participants with EASI-75 at Each Visit
Time frame: Baseline to Week 200
Change and Percent Change From Baseline in Overall Eczema Area and Severity Index (EASI) Score at Each Visit
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.
Time frame: Baseline to Week 200
Proportion of Participants with IGA ≤ 2 at Each Visit
Time frame: Baseline to Week 200
Change and Percent Change From Baseline in SCORAD Score at Each Visit
Time frame: Baseline to Week 200
Change and Percent Change From Baseline in Participant-Reported Pruritus Using 10-cm VAS (SCORAD Sub-Component)
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Galderma Investigational Site 8749
Birmingham, Alabama, United States
Galderma Investigational Site 8893
Birmingham, Alabama, United States
Galderma Investigational Site 8866
Guntersville, Alabama, United States
Galderma Investigational Site 8808
Scottsdale, Arizona, United States
Galderma Investigational Site 8873
Scottsdale, Arizona, United States
Galderma Investigational Site 8447
Fort Smith, Arkansas, United States
Galderma Investigational Site 8880
North Little Rock, Arkansas, United States
Galderma Investigational Site 8831
Anaheim, California, United States
Galderma Investigational Site 8906
Bell Gardens, California, United States
Galderma Investigational Site 8456
Beverly Hills, California, United States
...and 333 more locations
Time frame: Baseline to Week 200
Change and Percent Change From Baseline in Participant-Reported Sleep Loss Using 10-cm VAS (SCORAD Sub-Component)
Time frame: Baseline to Week 200
Proportion of Participants Reporting Low Disease Activity State Based on PGAD at Each Visit
Time frame: Baseline to Week 200
Proportion of Participants Satisfied with Study Treatment Based on PGAT at each visit
Time frame: Baseline to Week 200
Change from Baseline in Dermatology Life Quality Index (DLQI)
Time frame: Baseline to Week 200
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
Change From Baseline in Patient-Oriented Eczema Measure (POEM) Total Score at Each Visit Through Week 200
Time frame: Baseline to Week 200
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
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
Change From Baseline in EuroQoL 5-Dimension (EQ-5D) at Each Visit Through Week 200
Time frame: Baseline to Week 200
Proportion of Participants Receiving Any Rescue Therapy by Rescue Treatment Type at Any Visit During the Treatment Period
Time frame: Baseline to Week 200
Time to First Relapse
Time frame: Baseline to Week 200
Duration of Remission
Time frame: Baseline to Week 200
Time to Permanent Study Drug Discontinuation
Time frame: Baseline to Week 200