NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

A Study to Assess the Safety, Tolerability, and Efficacy of Rocatinlimab in Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)

NCT05633355

CompletedPhase 3

Sponsor: Amgen

Conditions: Atopic Dermatitis

Interventions: Rocatinlimab

Countries: United States, Argentina, Australia, Brazil, Canada, Hong Kong, South Korea, Turkey (Türkiye)

The primary objective of this study is to describe the safety and tolerability of rocatinlimab in adolescents with moderate-to-severe AD.

Eligibility overview

Sex: ALL

Age: 12 Years to 17 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (77)

Phoenix, Arizona, United States
Tempe, Arizona, United States
Bryant, Arkansas, United States
Little Rock, Arkansas, United States
Irvine, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Kissimmee, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami Lakes, Florida, United States
Lexington, Kentucky, United States
East Windsor, New Jersey, United States
Jackson Heights, New York, United States
New York, New York, United States
Findlay, Ohio, United States
Portland, Oregon, United States
Sugarloaf, Pennsylvania, United States
Corpus Christi, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
Murray, Utah, United States
CABA, Buenos Aires, Argentina
Buenos Aires, Distrito Federal, Argentina
Buenos Aires, Distrito Federal, Argentina
Rosario, Santa Fe Province, Argentina
Rosario, Santa Fe Province, Argentina
Rosario, Santa Fe Province, Argentina
Phillip, Australian Capital Territory, Australia
Darlinghurst, New South Wales, Australia
+ 47 more on CT.gov