A Study to Evaluate Rocatinlimab (AMG 451) in Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)
Phase 3
Active, not recruiting
- Conditions
- Atopic Dermatitis
- Interventions
- Drug: Placebo
- Registration Number
- NCT05704738
- Lead Sponsor
- Amgen
- Brief Summary
The purpose of this study is to evaluate the efficacy and safety of rocatinlimab in monotherapy and combination therapy treatment in adolescent participants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 500
Inclusion 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.
Exclusion 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
- Non-biologic, non-targeted systemic immunosuppressants
- Phototherapy
- Oral or Topical 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 4 inhibitors
- Other topical immunosuppressive agents
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Arm A: Dose 1 Rocatinlimab 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). Arm C: Placebo 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). Arm B: Dose 2 Rocatinlimab 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). Arm D: Open-Label Dose 1 Rocatinlimab 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.
- Primary Outcome Measures
Name Time Method Achievement of a Validated Investigator's Global Assessment for Atopic Dermatitis Score of 0 (Clear) or 1 (Almost Clear) with a ≥ 2 Point Reduction From Baseline (vIGA-AD 0/1) at Week 24 Baseline and Week 24 Achievement of ≥ 75% Reduction From Baseline in EASI Score (EASI 75) at Week 24 Baseline and Week 24
- Secondary Outcome Measures
Name Time Method Achievement of EASI 75 at Week 16 Baseline and Week 16 Achievement of a vIGA-AD 0/1 at Week 16 Baseline and Week 16 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 Baseline and Week 16 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 Baseline and Week 24 Achievement of ≥ 90% Reduction From Baseline in EASI Score (EASI 90) at Week 24 Baseline and Week 24 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 Baseline and Week 24 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 Baseline and Week 24 Initiation of rescue therapy for AD at or before Week 16 Baseline to Week 16 Initiation of rescue therapy for AD at or before Week 24 Baseline to Week 24 Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 16 Baseline to Week 16 Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 24 Baseline to Week 24 Change From Baseline in Scoring of Atopic Dermatitis (SCORAD) Itch Visual Analog Scale (VAS) Score at Week 16 Baseline to Week 16 Change From Baseline in SCORAD Itch VAS Score at Week 24 Baseline to Week 24 Achievement of a ≥ 4-point Reduction from Baseline in Dermatology Life Quality Index (DLQI) Score at Week 24 in Participants with Baseline DLQI ≥ 4 in Participants ≥ 16 Years of Age at Enrollment Baseline and Week 24 Change From Baseline in DLQI Score at Week 24 in Participants ≥ 16 Years of Age at Enrollment Baseline to Week 24 Change From Baseline in CDLQI Score at Week 24 in Participants < 16 Years of Age at Enrollment Baseline to Week 24 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 Baseline and Week 24 Change From Baseline in POEM Score at Week 24 Baseline to Week 24 Achievement of a ≥ 4-point Reduction From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 16 in Participants with Baseline Weekly Average of Daily AD Skin Pain NRS Score ≥ 4 Baseline and Week 16 Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 24 Baseline and Week 24 Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 16 Baseline and Week 16 Achievement of a ≥ 3-point Reduction From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 16 in Participants with Baseline Weekly Average of Daily AD Skin Pain NRS Score ≥ 3 Baseline and Week 16 Change From Baseline in Weekly Average of Sleep Disturbance NRS Score at Week 24 Baseline to Week 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 Baseline and Week 24 Change From Baseline in HADS-anxiety Subscale Score at Week 24 Baseline to Week 24 Achievement of a HADS-depression Subscale Score < 8 at Week 24 in Participants with Baseline HADS-depression Subscale Score ≥ 8 Baseline and Week 24 Change From Baseline in HADS-depression Subscale Score at Week 24 Baseline to Week 24 Achievement of a ≥ 8.7-point Reduction from Baseline in Severity SCORAD Score at Week 24 in Participants with Baseline SCORAD Score ≥ 8.7 Baseline and Week 24 Achievement of a ≥ 3-point Reduction From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 24 in Participants with Baseline Weekly Average of Daily AD Skin Pain NRS Score ≥ 3 Baseline and Week 24
Trial Locations
- Locations (246)
Cahaba Dermatology and Skin Health Center
🇺🇸Birmingham, Alabama, United States
AllerVie Clinical Research- Cullman
🇺🇸Cullman, Alabama, United States
Eclipse Clinical Research
🇺🇸Tucson, Arizona, United States
Arkansas Research Trials, LLC
🇺🇸North Little Rock, Arkansas, United States
Center for Dermatology Clinical Research Inc
🇺🇸Fremont, California, United States
Doc1 Healthcare Systems Incorporated
🇺🇸Fullerton, California, United States
Axon Clinical Research
🇺🇸Inglewood, California, United States
Avance Clinical Trials
🇺🇸Laguna Niguel, California, United States
Cura Clinical Research
🇺🇸Palmdale, California, United States
Integrative Skin Science and Research
🇺🇸Sacramento, California, United States
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