A Phase 3, Placebo-controlled, Double-blind Study Assessing Rocatinlimab (AMG 451) Monotherapy in Moderate-to-severe AD

JRCT ID: jRCT2031230004

Registered date:03/04/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Atopic Dermatitis
• Date of first enrollment: 22/03/2023
• Target sample size: 680
• Countries of recruitment: Australia,Japan,Belgium,Japan,Brazil,Japan,Canada,Japan,Czech Republic,Japan,Denmark,Japan,Estonia,Japan,Finland,Japan,Germany,Japan,Mexico,Japan,Poland,Japan,Portugal,Japan,Romania,Japan,South Africa,Japan,South Korea,Japan,Spain,Japan,Sweden,Japan,Turkey,Japan,United Kingdom,Japan,United States,Japan
• Study type: Interventional
• Intervention(s): Rocatinlimab Dose 1 every 4 weeks (Q4W) for 24 weeks with a loading dose at Week 2. Placebo Q4W for 24 weeks with a loading dose at Week 2.

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 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 Participants 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 >= 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 vIGA-AD 1 Response With Presence of Only Barely Perceptible Erythema or vIGA-AD 0 Response (Revised Investigator's Global Assessment [rIGA] 0/1) at Week 24
8.Achievement of a Facial AD Severity Score of Clear at Week 24 for Participants with Facial AD at Baseline
9.Achievement of a Hand AD Severity Score of Clear at Week 24 for Participants with Hand AD at Baseline
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 Atopic Dermatitis (SCORAD) Itch Visual Analogue 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
15.Change From Baseline in DLQI 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 >= 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 >= 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 >= 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 Daily Sleep Disturbance NRS Score at Week 24
24.Achievement of Hospital Anxiety and Depression Scale (HADS)-anxiety Subscale Score <8 at Week 24 in Participants with Baseline HADS-anxiety Subscale Score >= 8
25.Achievement of HADS-depression Subscale Score <8 at Week 24 in Participants with Baseline HADS-depression Subscale Score >= 8
26.Change From Baseline in HADS-anxiety Subscale Score at Week 24
27.Change From Baseline in HADS-depression Subscale Score at Week 24
28.Achievement of a >= 8.7-point Reduction From Baseline in SCORAD Score at Week 24 in Participants with Baseline SCORAD Score >= 8.7

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- Age >= 18 years with a diagnosis of AD according to the AAD Consensus Criteria (2014) present for at least 12 months
- 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, Anti-pruritic agents, Phototherapy and Janus kinase inhibitors
- Treatment with any of the following medications or therapies within 1 week, prior to Day 1:
TCS of any potency, TCI, Topical phosphodiesterase type 4 inhibitors and Other topical immunosuppressive agents

Related Information

• Primary Sponsor: Schwartz-Sagi Liat
• Secondary ID(s): NCT05651711,2022-501538-44-00