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.
Brief Title
A Study to Evaluate Rocatinlimab (AMG 451) in Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)
Completion Date
Completion Date Type
Estimated
Conditions
Atopic Dermatitis
Eligibility Criteria
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:
1. Systemic corticosteroids
2. Non-biologic, non-targeted systemic immunosuppressants
3. Phototherapy
4. Oral or Topical Janus kinase inhibitors
* Treatment with any of the following medications or therapies within 1 week, prior to Day 1:
1. TCS of any potency
2. TCI
3. Topical phosphodiesterase 4 inhibitors
4. Other topical immunosuppressive agents
* 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:
1. Systemic corticosteroids
2. Non-biologic, non-targeted systemic immunosuppressants
3. Phototherapy
4. Oral or Topical Janus kinase inhibitors
* Treatment with any of the following medications or therapies within 1 week, prior to Day 1:
1. TCS of any potency
2. TCI
3. Topical phosphodiesterase 4 inhibitors
4. Other topical immunosuppressive agents
Inclusion Criteria
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.
* 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.
Gender
All
Gender Based
false
Keywords
Atopic Dermatitis
AMG 451
KHK4083
Rocatinlimab
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
17 Years
Minimum Age
12 Years
NCT Id
NCT05704738
Org Class
Industry
Org Full Name
Amgen
Org Study Id
20210145
Overall Status
Active, not recruiting
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
A Phase 3, Randomized, 52-week, Placebo-controlled, Double-blind Study With Re-randomization to Assess the Efficacy, Safety, and Tolerability of Rocatinlimab (AMG 451) in Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-ASTRO)
Primary Outcomes
Outcome Measure
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
Outcome Time Frame
Baseline and Week 24
Outcome Measure
Achievement of ≥ 75% Reduction From Baseline in EASI Score (EASI 75) at Week 24
Outcome Time Frame
Baseline and Week 24
Secondary Ids
Secondary Id
2022-501586-50
Secondary Outcomes
Outcome Time Frame
Baseline and Week 16
Outcome Measure
Achievement of EASI 75 at Week 16
Outcome Time Frame
Baseline and Week 16
Outcome Measure
Achievement of a vIGA-AD 0/1 at Week 16
Outcome Time Frame
Baseline and Week 16
Outcome Measure
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
Outcome Time Frame
Baseline and Week 24
Outcome Measure
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
Outcome Time Frame
Baseline and Week 24
Outcome Measure
Achievement of ≥ 90% Reduction From Baseline in EASI Score (EASI 90) at Week 24
Outcome Time Frame
Baseline and Week 24
Outcome Measure
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
Outcome Time Frame
Baseline and Week 24
Outcome Measure
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
Outcome Time Frame
Baseline to Week 16
Outcome Measure
Initiation of rescue therapy for AD at or before Week 16
Outcome Time Frame
Baseline to Week 24
Outcome Measure
Initiation of rescue therapy for AD at or before Week 24
Outcome Time Frame
Baseline to Week 16
Outcome Measure
Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 16
Outcome Time Frame
Baseline to Week 24
Outcome Measure
Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 24
Outcome Time Frame
Baseline to Week 16
Outcome Measure
Change From Baseline in Scoring of Atopic Dermatitis (SCORAD) Itch Visual Analog Scale (VAS) Score at Week 16
Outcome Time Frame
Baseline to Week 24
Outcome Measure
Change From Baseline in SCORAD Itch VAS Score at Week 24
Outcome Time Frame
Baseline and Week 24
Outcome Measure
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
Outcome Time Frame
Baseline to Week 24
Outcome Measure
Change From Baseline in DLQI Score at Week 24 in Participants ≥ 16 Years of Age at Enrollment
Outcome Time Frame
Baseline to Week 24
Outcome Measure
Change From Baseline in CDLQI Score at Week 24 in Participants < 16 Years of Age at Enrollment
Outcome Time Frame
Baseline and Week 24
Outcome Measure
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
Outcome Time Frame
Baseline to Week 24
Outcome Measure
Change From Baseline in POEM Score at Week 24
Outcome Time Frame
Baseline and Week 16
Outcome Measure
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
Outcome Time Frame
Baseline and Week 24
Outcome Measure
Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 24
Outcome Time Frame
Baseline and Week 16
Outcome Measure
Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 16
Outcome Time Frame
Baseline and Week 24
Outcome Measure
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
Outcome Time Frame
Baseline and Week 16
Outcome Measure
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
Outcome Time Frame
Baseline to Week 24
Outcome Measure
Change From Baseline in Weekly Average of Sleep Disturbance NRS Score at Week 24
Outcome Time Frame
Baseline and Week 24
Outcome Measure
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
Outcome Time Frame
Baseline to Week 24
Outcome Measure
Change From Baseline in HADS-anxiety Subscale Score at Week 24
Outcome Time Frame
Baseline and Week 24
Outcome Measure
Achievement of a HADS-depression Subscale Score < 8 at Week 24 in Participants with Baseline HADS-depression Subscale Score ≥ 8
Outcome Time Frame
Baseline to Week 24
Outcome Measure
Change From Baseline in HADS-depression Subscale Score at Week 24
Outcome Time Frame
Baseline and Week 24
Outcome Measure
Achievement of a ≥ 8.7-point Reduction from Baseline in Severity SCORAD Score at Week 24 in Participants with Baseline SCORAD Score ≥ 8.7
See Also Links
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Child
Maximum Age Number (converted to Years and rounded down)
17
Minimum Age Number (converted to Years and rounded down)
12
Investigators
Investigator Type
Principal Investigator
Investigator Name
Holly Kanavy
Investigator Email
HKanavy@montefiore.org
Investigator Phone
866-633-8255 / 718-230-2997 / 510-996-0741