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

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: 20/04/2023
• Target sample size: 500
• Countries of recruitment: Belgium,Japan,Brazil,Japan,Canada,Japan,Chile,Japan,China,Japan,Croatia,Japan,France,Japan,Germany,Japan,Greece,Japan,Hungary,Japan,Israel,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)

Experimental: Arm A: Dose 1
Part 1 (Initial Period); Week 0 to Week 24: Rocatinlimab Dose 1 every 4 weeks (Q4W) for 24 weeks with loading dose at Week 2 (+ topical corticosteroids (TCS)/ topical calcineurin inhibitor (TCI) if within combination therapy cohort).
Part 2 (Maintenance Period); Week 24 to Week 52: Part 1 Responders will be rerandomised at Week 24 to Rocatinlimab Dose 1 Q4W or every 8 weeks (Q8W) for 28 weeks (+ TCS/TCI if within combination therapy cohort).

Experimental: Arm B: Dose 2
Part 1 (Initial Period); Week 0 to Week 24: Rocatinlimab Dose 2 Q4W for 24 weeks with loading dose at Week 2 (+TCS/TCI if within combination therapy cohort).
Part 2 (Maintenance Period); Week 24 to Week 52: Part 1 Responders will be rerandomised at Week 24 to Rocatinlimab Dose 2 Q4W or Q8W for 28 weeks (with TCS/TCI if within combination therapy cohort).

Experimental: Arm C: Placebo
Part 1 (Initial Period); Week 0 to Week 24: Placebo Q4W for 24 weeks with loading dose at Week 2 (+TCS/TCI if within combination therapy cohort).
Part 2 (Maintenance Period); Week 24 to Week 52: Part 1 Responders will be reassigned at Week 24 with Placebo Q4W for 28 weeks (with TCS/TCI if within combination therapy cohort).

Experimental: Arm D: Open-Label Dose 1
Part 2; Week 24 to Week 52: Part 1 Non-Responders will be reassigned at Week 24 with Rocatinlimab Open-label Dose 1 Q4W for 28 weeks (with TCS/TCI if within combination therapy cohort). Participants in Arms A, B or C Maintenance Period will be reassigned with Rocatinlimab Open-label Dose 1 Q4W (with TCS/TCI if within combination therapy cohort) upon relapse after Week 24.

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
2.Achievement of a vIGA-AD 0/1 at 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
4.Achievement of a >= 4-point Reduction From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 24 in Partiipants with Baseline Weekly Average of Daily Worst Pruritus NRS Score >= 4
5.Achievement of >= 90% Reduction From Baseline in EASI Score (EASI 90) at Week 24
6.Achievement of a >= 4-point Reduction From Baseline in Weekly Average of AD Skin Pain NRS Score at Week 24 in Participants with Baseline Weekly Average of AD Skin Pain NRS Score >= 4
7.Achievement of a vIGA-AD Score of 1 with Presence of Only Barely Perceptible Erythema or vIGA-AD Score of 0 (revised Investigator's Global Assessment [rIGA] 0/1) at Week 24
8.Initiation of rescue therapy for AD at or before Week 16
9.Initiation of rescue therapy for AD at or before Week 24
10.Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 16
11.Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 24
12.Change From Baseline in Scoring of Atopic Dermatitis (SCORAD) Itch Visual Analog Scale (VAS) Score at Week 16
13.Change From Baseline in SCORAD Itch VAS Score at Week 24
14.Achievement of a >= 4-point Reduction from Baseline in Dermatology Life Quality Index (DLQI) Score at Week 24 in Participants with Baseline DLQI >= 4 (Children's Dermatology Life Quality Index [CDLQI] in Participants < 16 Years of Age at Screening)
15.Change From Baseline in DLQI or CDLQI Score at Week 24
16.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
17.Change From Baseline in POEM Score at Week 24
18.Achievement of a >= 4-point Reduction From Baseline in Weekly Average of AD Skin Pain NRS Score at Week 16 in Participants with Baseline Weekly Average of AD Skin Pain NRS Score >= 4
19.Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 24
20.Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 16
21.Achievement of a >= 3-point Reduction From Baseline in Weekly Average of AD Skin Pain NRS Score at Week 24 in Participants with Baseline Weekly Average of AD Skin Pain NRS Score >= 3
22.Achievement of a >= 3-point Reduction From Baseline in Weekly Average of AD Skin Pain NRS Score at Week 16 in Participants with Baseline Weekly Average of AD Skin Pain NRS Score >= 3
23.Change From Baseline in Weekly Average of Sleep Disturbance NRS Score at Week 24
24.Achievement of a Hospital Anxiety and Depression Scale (HADS)-anxiety Subscale Score < 8 at Week 24 in Participants with Baseline HADS-anxiety Subscale Score >= 8
25.Change From Baseline in HADS-anxiety Subscale Score at Week 24
26.Achievement of a HADS-depression Subscale Score < 8 at Week 24 in Participants with Baseline HADS-depression Subscale Score >= 8
27.Change From Baseline in HADS-depression Subscale Score at Week 24
28.Achievement of a >= 8.7-point Reduction from Baseline in Severity SCORAD Score at Week 24 in Participants with Baseline SCORAD Score >= 8.7

Key inclusion & exclusion criteria

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

Include criteria

- Age >= 12 to < 18 years at Day 1.
- Diagnosis of AD (according to American Academy of Dermatology Consensus Criteria [Eichenfield et al, 2014]) that has been present for at least 12 months before signing of informed consent.
- Body weight >= 40 kg at screening.
- History of inadequate response to TCS of medium to higher potency (with or without TCI).
- EASI score >= 12 at initial screening.
- EASI score >= 16 at Day 1.
- vIGA-AD score >= 3.
- >= 10% body surface area of AD involvement.
- Worst pruritus NRS >= 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): NCT05704738,2022-501586-50