Moderate-to-Severe Atopic Dermatitis
Conditions
Brief summary
Long-Term Safety and Efficacy of Nemolizumab in Subjects with Moderate-to-Severe Atopic Dermatitis Description
Detailed description
Long-term study to assess the safety and efficacy of nemolizumab in subjects with moderate-to-severe AD
Interventions
DRUGNemolizumab
Nemolizumab
Sponsors
Galderma R&D
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and Severity of TEAEs | Baseline to Week 200 |
| Incidence of Serious TEAEs | Baseline to Week 200 |
| Incidence and Severity of Adverse Events of Special Interest (AESIs) Throughout the Study | Baseline to Week 200 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants with IGA ≤ 2 at Each Visit | Baseline to Week 200 | — |
| Change and Percent Change From Baseline in SCORAD Score at Each Visit | Baseline to Week 200 | — |
| Change and Percent Change From Baseline in Participant-Reported Pruritus Using 10-cm VAS (SCORAD Sub-Component) | Baseline to Week 200 | — |
| Change and Percent Change From Baseline in Participant-Reported Sleep Loss Using 10-cm VAS (SCORAD Sub-Component) | Baseline to Week 200 | — |
| Proportion of Participants Reporting Low Disease Activity State Based on PGAD at Each Visit | Baseline to Week 200 | — |
| Proportion of Participants Satisfied with Study Treatment Based on PGAT at each visit | Baseline to Week 200 | — |
| Change from Baseline in Dermatology Life Quality Index (DLQI) | Baseline to Week 200 | — |
| Change From Baseline in Children's Dermatology Life Quality Index (cDLQI) Total Score at Each Visit Through Week 200 | Baseline to Week 200 | — |
| Proportion of Participants with IGA score = 0-1 at Each Visit | Baseline to Week 200 | — |
| Change From Baseline in Hospital Anxiety and Depression Scale (HADS) for Each Subscale at Each Visit Through Week 200 | 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 | Baseline to Week 200 | — |
| Change From Baseline in EuroQoL 5-Dimension (EQ-5D) at Each Visit Through Week 200 | Baseline to Week 200 | — |
| Proportion of Participants Receiving Any Rescue Therapy by Rescue Treatment Type at Any Visit During the Treatment Period | Baseline to Week 200 | — |
| Time to First Relapse | Baseline to Week 200 | — |
| Duration of Remission | Baseline to Week 200 | — |
| Time to Permanent Study Drug Discontinuation | Baseline to Week 200 | — |
| Change From Baseline in Patient-Oriented Eczema Measure (POEM) Total Score at Each Visit Through Week 200 | Baseline to Week 200 | — |
| Proportion of Participants with EASI-75 at Each Visit | Baseline to Week 200 | — |
| Change and Percent Change From Baseline in Overall Eczema Area and Severity Index (EASI) Score at Each Visit | 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. |
Countries
Australia, Austria, Belgium, Bulgaria, Canada, Czechia, Estonia, France, Georgia, Germany, Hungary, Italy, Latvia, Lithuania, Netherlands, New Zealand, Poland, Singapore, South Korea, Spain, United Kingdom, United States
Outcome results
None listed