Dupilumab in Japanese Patients With Atopic Dermatitis
- Registration Number
- NCT04678882
- Lead Sponsor
- Sanofi
- Brief Summary
Primary Objective:
To evaluate the efficacy of dupilumab administered concomitantly with topical corticosteroids (TCS)
Secondary Objective:
To evaluate the efficacy of dupilumab administered concomitantly with TCS. To assess the safety of dupilumab over 16 weeks of treatment when administered concomitantly with TCS in participants.
To assess immunogenicity as determined by the incidence, titer, and clinical impact of treatment-emergent anti-drug antibodies (ADA) to dupilumab over time in pediatric patients with atopic dermatitis (AD) (aged ≥6 months to \<18 years old) To assess the concentration of dupilumab in serum following administration concomitantly with TCS.
- Detailed Description
For participant who declines to enter open-lebal extension (OLE), the duration of the study for each participant is approximately 33 weeks (including screening and follow-up) For participant choosing enter OLE, the duration is approximately 21 weeks (including screening) plus 3 years OLE period or until approval of the indication in Japan whichever is sooner.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 62
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dupilumab Dupilumab SAR231893 Double dose on day1 and followed by single dose every 2 weeks or single dose every 4 weeks Placebo Placebo Double dose on day1 and followed by single dose every 2 weeks or single dose every 4 weeks
- Primary Outcome Measures
Name Time Method Proportion of participants with Eczema Area and Severity Index (EASI)-75 (≥75% improvement from baseline EASI) At Week 16 The EASI is a composite index with scores ranging from 0 to 72.Higher scores indicates worse condition
- Secondary Outcome Measures
Name Time Method Percent change in weekly average of daily worst itch numerical rating scale (NRS) for participants aged ≥6 years to <12 years old From baseline to week 16 The worst itch NRS is a simple assessment tool those participants ≥6 years old to \<12 years old will use to report the intensity of their pruritus (itch). This is an 11-point scale (0 to 10) in which 0 indicates no itching while 10 indicate worst itching possible.
Percent change in EASI score From baseline to week 16 The EASI is a composite index with scores ranging from 0 to 72.Higher scores indicates worse condition
Percent change in weekly average of daily worst scratch/itch NRS for participants aged ≥6 months to <6 years old From baseline to week 16 The worst scratch/itch NRS is a simple assessment tool those participants ≥6 years old to \<6 years old range from 1 to 10 in which 0 indicates no itching while 10 indicate worst itching possible
Percent change for intensity of pruritus From baseline to week 16 The intensity is assessed by numerical rating scale ranging from 0 to 10 which higher scale indicate worse itch condition
Change in percent body surface area (BSA) affected by atopic dermatitis (AD) From baseline to week 16 BSA affected by atopic dermatitis will be assessed for each major section of the body (head, trunk, arms, and legs).
Change in Children's Dermatology Life Quality Index (CDLQI) (≥4 years) From baseline to week 16 The CDLQI is a validated questionnaire designed to measure the impact of skin disease on the Quality of Life. The higher the score, the greater the impact is on the quality of life
Change in weekly average of daily worst scratch/itch NRS for participants aged ≥6 months to <6 years old From baseline to week 16 The worst scratch/itch NRS is a simple assessment tool those participants ≥6 years old to \<12 years old range from 1 to 10 in which 1 indicates no itching while 10 indicate worst itching possible
Number of Participants With TEAEs, SAEs, and AESI From Baseline of open-label extension (OLE) Through the Last Study Visit Week 16 to Week 116 Proportion of participants with Investigator's Global Assessment (IGA) 0 or 1 At Week 16 The IGA is an assessment instrument used in clinical studies to rate the severity of AD globally, based on a 5-point scale ranging from 0 (clear) to 4 (severe)
Proportion of participants with EASI-90 (≥90% improvement from baseline) At Week 16 The EASI is a composite index with scores ranging from 0 to 72.Higher scores is worse condition
Change in weekly average of daily worst peak pruritus NRS for participants aged ≥12 years to <18 years old From baseline to week 16 The peak pruritus NRS is a simple assessment tool that participants ≥ 12 to \<18 years old will use to report the intensity of their pruritus (itch) ranges from 0 to 10 with 1 being 'no itch' and 10 being the' worst itch imaginable'
Number of Participants With Skin-Infection TEAEs (Excluding Herpetic Infections) From Baseline to 16 Weeks of Treatment Baseline (Day 1) to Week 16 Percent change in weekly average of daily worst peak pruritus NRS for participants aged ≥12 years to <18 years old From baseline to week 16 The peak pruritus NRS is a simple assessment tool that participants ≥ 12 to \<18 years old will use to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being 'no itch' and 10 being the' worst itch imaginable'
Proportion of participants with EASI-50 (≥50% improvement from baseline) At Week 16 The EASI is a composite index with scores ranging from 0 to 72.Higher scores is worse condition
Change in Infants' Dermatitis Quality of Life Index (IDQOL) (<4 years) From baseline to week 16 The IDQOL is a validated questionnaire developed to measure the impact of skin disease on the QOL of infants and preschool children \<4 years of age wil completed by the child's parent or caregiver. The higher the score, the greater the impact is on the quality of life. -
Change in Patient Oriented Eczema Measure (POEM) From baseline to week 16 The POEM is a 7-item (dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping) questionnaire used to assess disease symptoms with a scoring system of 1 to 28. The higher score, the higher morbidity
Change in weekly average of daily worst itch NRS for participants aged ≥6 years to <12 years old From baseline to week 16 The worst itch NRS is a simple assessment tool those participants ≥6 years old to \<12 years old range from 1 to 10 in which 1 indicates no itching while 10 indicate worst itching possible -
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), Serious Adverse Events (SAEs), and Adverse Event of Special Interest (AESI) From Baseline to 16 Weeks of Treatment Baseline (Day 1) to Week 16 Number of Participants With Treatment-emergent Anti-drug Antibody (ADA) to Dupilumab Over Time in Pediatric Participants with AD (Aged ≥6 Months to <18 Years old) Baseline (Day 1) to Week 116 Serum Concentration of Dupilumab up to Week 116 Pre-dose at Baseline (Day 1), and Weeks 4, 12, 16, 24, 32, 52, 68, 92, and 116
Trial Locations
- Locations (19)
Investigational Site Number : 3920011
🇯🇵Nagoya-shi, Aichi, Japan
Investigational Site Number : 3920014
🇯🇵Toyoake-shi, Aichi, Japan
Investigational Site Number : 3920015
🇯🇵Fukutsu-shi, Fukuoka, Japan
Investigational Site Number : 3920013
🇯🇵Sapporo-shi, Hokkaido, Japan
Investigational Site Number : 3920007
🇯🇵Kobe-shi, Hyogo, Japan
Investigational Site Number : 3920009
🇯🇵Sapporo-shi, Hokkaido, Japan
Investigational Site Number : 3920008
🇯🇵Kobe-shi, Hyogo, Japan
Investigational Site Number : 3920003
🇯🇵Sagamihara-shi, Kanagawa, Japan
Investigational Site Number : 3920017
🇯🇵Yokohama-Shi, Kanagawa, Japan
Investigational Site Number : 3920006
🇯🇵Tsu-shi, Mie, Japan
Investigational Site Number : 3920019
🇯🇵Toyonaka-shi, Osaka, Japan
Investigational Site Number : 3920016
🇯🇵Kumagaya-shi, Saitama, Japan
Investigational Site Number : 3920023
🇯🇵Chuo-ku, Tokyo, Japan
Investigational Site Number : 3920012
🇯🇵Koto-ku, Tokyo, Japan
Investigational Site Number : 3920001
🇯🇵Hiroshima-shi, Hiroshima, Japan
Investigational Site Number : 3920010
🇯🇵Yokohama-shi, Kanagawa, Japan
Investigational Site Number : 3920020
🇯🇵Sakai-shi, Osaka, Japan
Investigational Site Number : 3920022
🇯🇵Toshima-ku, Tokyo, Japan
Investigational Site Number : 3920021
🇯🇵Habikino-shi, Japan