Phase 3, 52-week Study Evaluating Rocatinlimab (AMG 451) in Adolescent Subjects With Moderate-to-severe AD (ROCKET-ASTRO)

JRCT ID: jRCT2031230022

Registered date:16/04/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Atopic Dermatitis
• Date of first enrollment: 14/04/2023
• Target sample size: 30
• Countries of recruitment: Belgium,Japan,Brazil,Japan,Canada,Japan,Chile,Japan,China,Japan,Croatia,Japan,France,Japan,Germany,Japan,Greece,Japan,Hungary,Japan,Italy,Japan,Mexico,Japan,Poland,Japan,Romania,Japan,South Korea,Japan,Spain,Japan,Taiwan,Japan,Thailand,Japan,United States,Japan
• Study type: Interventional

Intervention(s)

Part 1: Rocatinlimab or Placebo every 4 weeks (Q4W) for 24 weeks with a loading dose at Week 2 (+TCS/TCI if within combination therapy cohort).
Part 2: Rocatinlimab Q4W or Q8W for 28 weeks (+TCS/TCI if within combination therapy cohort).

Outcome(s)

Primary Outcome

1. Achievement of a Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0 or 1 with >= 2 point reduction from baseline at Week 24 [ Time Frame: Baseline, Week 24 ]
2. Achievement of >= 75% reduction from baseline in Eczema Area and Severity Index (EASI) score at Week 24 [ Time Frame: Baseline, Week 24 ]

Secondary Outcome

1. Achievement of EASI 75 at Week 16 [ Time Frame: Baseline and Week 16 ]
2.Achievement of vIGA 0/1 with a >= 2-point Reduction From Baseline at week 16 [ Time Frame: Baseline, Week 16 ]
3. Achievement of a >= 4-point Reduction From Baseline in Weekly Average of Daily Worst Pruritus Numeric Rating Scale (NRS) Score at Week 16 in Participants with Baseline Weekly Average of Daily Worst Pruritus NRS Score >= 4 [ Time Frame: Baseline and Week 16 ]
4. Achievement of a >= 4-point Reduction From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 24 in Participants with Baseline Weekly Average of Daily Worst Pruritus NRS Score >= 4 [ Time Frame: Baseline and Week 24 ]
5. Achievement of >= 90% Reduction From Baseline in EASI Score (EASI 90) at Week 24 [ Time Frame: Baseline and Week 24 ]
6. Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 24 [ Time Frame: Baseline to Week 24 ]
7. Achievement of vIGA-AD 0 or 1 with a >= 2-point Reduction and presence of barely perceptible erythema or no erythema at Week 24 [ Time Frame: Baseline and Week 24 ]
8. Change from Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 16 [ Time Frame: Baseline and Week 16 ]
9. Change from Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 24 [ Time Frame: Baseline and Week 24 ]
10. Change from Baseline in SCORing Atopic Dermatitis (SCORAD) Itch Visual Analogue Scale (VAS) Score at Week 16 [ Time Frame: Baseline and Week 16 ]
11. Change from Baseline in SCORAD Itch VAS Score at Week 24 [ Time Frame: Baseline and Week 24 ]
12. Achievement of a >= 4-point Reduction from Baseline in Dermatology Life Quality Index (DLQI) Score at Week 24 in Subjects with Baseline DLQI >= 4 (Children's Dermatology Life Quality Index [CDLQI] in Subjects < 16 Years of Age) [ Time Frame: Baseline and Week 24 ]
13. Change from Baseline in DLQI or CDLQI Score at Week 24 [ Time Frame: Baseline and Week 24 ]
14. Achievement of a >= 4-point Reduction From Baseline in Patient Oriented Eczema Measure (POEM) Score at Week 24 in Participants with Baseline POEM Score >= 4 [ Time Frame: Baseline and Week 24 ]
15. Change from Baseline in POEM Score at Week 24 [ Time Frame: Baseline and Week 24 ]
16. Change From Baseline in Weekly Average of Sleep Disturbance NRS Score at Week 24 [ Time Frame: Baseline to Week 24 ]
17. Achievement of Hospital Anxiety and Depression Scale (HADS)-anxiety Subscale Score <8 at Week 24 in Participants with Baseline HADS-anxiety Subscale Score >=8 [ Time Frame: Baseline and Week 24 ]
18. Change from Baseline in HADS-anxiety Subscale Score at Week 24 [ Time Frame: Baseline and Week 24 ]
19. Achievement of HADS-depression Subscale Score <8 at Week 24 in Participants with Baseline HADS-depression Subscale Score >=8 [ Time Frame: Baseline and Week 24 ]
20. Change from Baseline in HADS-depression Subscale Score at Week 24 [ Time Frame: Baseline and Week 24 ]
21. Achievement of >= 8.7-point Reduction from Baseline in SCORAD Score at Week 24 in Participants with Baseline SCORAD Score >= 8.7 [ Time Frame: Baseline and Week 24 ]

Key inclusion & exclusion criteria

• Age minimum: >= 12age old
• Age maximum: < 18age old
• Gender: Both

Include criteria

- Age >= 12 to < 18 years at Day 1
- Body weight >= 40 kg at screening
- History of inadequate response to TCS (Topical Corticosteroid) of medium or higher potency within 6 months (with or without topical calcineurin inhibitors [TCI])
- EASI score >= 16
- vIGA-AD score >= 3
- >= 10% body surface area (BSA) of AD involvement
- Worst pruritus numerical rating scale >= 4

Exclude criteria

- Treatment with a biological product within 12 weeks or 5 half-lives, whichever is longer, prior to Day 1
- Treatment with any of the following medications or therapies within 4 weeks or 5 half-lives, whichever is longer, prior to Day 1:
Systemic corticosteroids, Systemic immunosuppressants, Phototherapy, and Janus kinase inhibitors
- Treatment with any of the following medications or therapies within 1 week, prior to Day 1:
TCS, TCI, Topical phosphodiesterase type 4 inhibitors, and Other topical immunosuppressive agents

Related Information

• Primary Sponsor: Bouloc Anne
• Secondary ID(s): NCT05704738,2022-000940-31,2022-501586-50-00