Atopic Dermatitis
Conditions
Keywords
Atopic Dermatitis, Rocatinlimab, AMG 451, KHK4083
Brief summary
The primary objective of this study is to describe the safety and tolerability of rocatinlimab in adolescents with moderate-to-severe AD.
Interventions
DRUGRocatinlimab
Subcutaneous (SC) injection
Sponsors
Amgen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥ 12 to \< 18 years at day 1. * Participant has a diagnosis of AD (according to American Academy of Dermatology Consensus Criteria \[Eichenfield, 2014\]) that has been present for at least 12 months before signing of informed consent * Prior to informed consent, history of inadequate response to topical corticosteroids (TCS) of medium to 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) * Eczema Area and Severity Index (EASI) score ≥ 12 * vIGA-AD score ≥ 3 * ≥ 10% BSA of AD involvement at day 1 pre-enrollment
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 agents within 1 week before day 1 pre-enrollment: * Topical PDE4 inhibitors * Other topical immunosuppressive agents (not including TCS/TCI) * Combination topical agents containing a high- or super-high potency corticosteroid
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Experienced Treatment-emergent Serious Adverse Events (TESAEs) | From first dose of trial intervention to end of trial; median (min, max) duration was 52.1 (2.0, 70.1) weeks | An adverse event (AE) was any untoward medical occurrence in a clinical trial participant irrespective of a causal relationship with the study treatment. A SAE was defined as any untoward medical occurrence that meets at least 1 of the following serious criteria: resulted in death (fatal), was immediately life-threatening, required in-patient hospitalization or prolonged existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or other medically important serious event. A TESAE was defined as an SAE that occurred on or after the first dose of trial intervention. |
Countries
Argentina, Australia, Brazil, Canada, Hong Kong, South Korea, Turkey (Türkiye), United Kingdom, United States
Contacts
STUDY_DIRECTORMD
Amgen
Participant flow
Recruitment details
A total of 187 participants were enrolled at 59 trial centers located in Argentina, Australia, Brazil, Canada, Hong Kong, South Korea, Turkey, the United Kingdom and the United States between January 2023 and July 2025.
Pre-assignment details
A total of 235 participants were screened, of which 187 were enrolled and received treatment with rocatinlimab.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 14.8 Years STANDARD_DEVIATION 1.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 77 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 110 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 2 Participants |
| Race/Ethnicity, Customized Asian | 51 Participants |
| Race/Ethnicity, Customized Black or African American | 15 Participants |
| Race/Ethnicity, Customized Multiple or More than one race | 8 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 2 Participants |
| Race/Ethnicity, Customized Other | 5 Participants |
| Race/Ethnicity, Customized White | 104 Participants |
| Sex: Female, Male Female | 91 Participants |
| Sex: Female, Male Male | 96 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 187 |
| other Total, other adverse events | 110 / 187 |
| serious Total, serious adverse events | 4 / 187 |
Outcome results
None listed