Brief Summary
The co-primary objectives of the study are to:
* Evaluate the efficacy of rocatinlimab compared with placebo at Week 24, assessed using Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD).
* Evaluate the efficacy of rocatinlimab compared with placebo at Week 24, assessed using Eczema Area and Severity Index (EASI).
* Evaluate the efficacy of rocatinlimab compared with placebo at Week 24, assessed using Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD).
* Evaluate the efficacy of rocatinlimab compared with placebo at Week 24, assessed using Eczema Area and Severity Index (EASI).
Brief Title
A Study Assessing Rocatinlimab (AMG 451) Monotherapy in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Horizon)
Categories
Completion Date
Completion Date Type
Actual
Conditions
Atopic Dermatitis
Eligibility Criteria
Inclusion Criteria:
* Age ≥ 18 years (or ≥ legal adult age within the country if it is older than 18 years at signing of informed consent) 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 (with or without topical calcineurin inhibitors \[TCI\]) as appropriate or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks).
* EASI score ≥16
* vIGA-AD score ≥3
* ≥10% body surface area (BSA) of AD involvement
* Worst pruritus numerical rating scale ≥ 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
* 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 type 4 (PDE4) inhibitors
* Other topical immunosuppressive agents
* Combination agents including TCS of any potency or TCI, PDE4 inhibitors, or other immunosuppressive agents
* Age ≥ 18 years (or ≥ legal adult age within the country if it is older than 18 years at signing of informed consent) 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 (with or without topical calcineurin inhibitors \[TCI\]) as appropriate or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks).
* EASI score ≥16
* vIGA-AD score ≥3
* ≥10% body surface area (BSA) of AD involvement
* Worst pruritus numerical rating scale ≥ 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
* 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 type 4 (PDE4) inhibitors
* Other topical immunosuppressive agents
* Combination agents including TCS of any potency or TCI, PDE4 inhibitors, or other immunosuppressive agents
Inclusion Criteria
Inclusion Criteria:
* Age ≥ 18 years (or ≥ legal adult age within the country if it is older than 18 years at signing of informed consent) 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 (with or without topical calcineurin inhibitors \[TCI\]) as appropriate or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks).
* EASI score ≥16
* vIGA-AD score ≥3
* ≥10% body surface area (BSA) of AD involvement
* Worst pruritus numerical rating scale ≥ 4
* Age ≥ 18 years (or ≥ legal adult age within the country if it is older than 18 years at signing of informed consent) 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 (with or without topical calcineurin inhibitors \[TCI\]) as appropriate or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks).
* EASI score ≥16
* vIGA-AD score ≥3
* ≥10% body surface area (BSA) of AD involvement
* Worst pruritus numerical rating scale ≥ 4
Gender
All
Gender Based
false
Keywords
Atopic Dermatitis
AMG 451
KHK 4083
Eczema
Rocatinlimab
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
100 Years
Minimum Age
18 Years
NCT Id
NCT05651711
Org Class
Industry
Org Full Name
Amgen
Org Study Id
20210143
Overall Status
Completed
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Phase 3, Randomized, 24-week, Placebo-controlled, Double-blind Study to Assess the Efficacy, Safety and Tolerability of Rocatinlimab (AMG 451) Monotherapy in Adult Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Horizon)
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
2022-501538-44
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 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 to Week 24
Outcome Measure
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
Outcome Time Frame
Baseline and Week 24
Outcome Measure
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
Outcome Time Frame
Baseline and Week 24
Outcome Measure
Achievement of a Facial AD Severity Score of Clear at Week 24 for Participants with Facial AD at Baseline
Outcome Time Frame
Baseline and Week 24
Outcome Measure
Achievement of a Hand AD Severity Score of Clear at Week 24 for Participants with Hand AD at Baseline
Outcome Time Frame
Baseline and Week 16
Outcome Measure
Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 16
Outcome Time Frame
Baseline and Week 24
Outcome Measure
Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 24
Outcome Time Frame
Baseline and Week 16
Outcome Measure
Change from Baseline in SCORing Atopic Dermatitis (SCORAD) Itch Visual Analogue Scale (VAS) Score at Week 16
Outcome Time Frame
Baseline and 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
Outcome Time Frame
Baseline and Week 24
Outcome Measure
Change From Baseline in DLQI Score at Week 24
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 and Week 24
Outcome Measure
Change from Baseline in POEM Score at Week 24
Outcome Time Frame
Baseline to Week 16
Outcome Measure
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
Outcome Time Frame
Baseline to 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 to Week 24
Outcome Measure
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
Outcome Time Frame
Baseline to Week 16
Outcome Measure
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
Outcome Time Frame
Baseline to Week 24
Outcome Measure
Change From Baseline in Weekly Average of Daily Sleep Disturbance NRS Score at Week 24
Outcome Time Frame
Baseline and Week 24
Outcome Measure
Achievement of 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 and Week 24
Outcome Measure
Achievement of HADS-depression Subscale Score <8 at Week 24 in Participants with Baseline HADS-depression Subscale Score ≥ 8
Outcome Time Frame
Baseline and Week 24
Outcome Measure
Change From Baseline in HADS-anxiety Subscale Score at Week 24
Outcome Time Frame
Baseline and 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 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
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
100
Minimum Age Number (converted to Years and rounded down)
18
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