Clinical Trials Logo
  1. Home
  2. Atopic Dermatitis
  3. NCT06224192
  4. Details
NCT06224192 Clinical Trial

A Study With Self-administered Rocatinlimab in Adolescent and Adult Participants With Moderate-to-severe AD

Atopic Dermatitis Clinical Trial

— ROCKET-Outpost  

Official title:
A Phase 3, Multicenter, Randomized, Open-label, Performance Study With Self-administered Subcutaneous Rocatinlimab (AMG 451) in Adolescent and Adult Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Outpost)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06224192
Other study ID # 20230180
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date April 2, 2024
Est. completion date April 22, 2026

Study information
Verified date April 2024
Source Amgen
Contact Amgen Call Center
Phone 866-572-6436
Email medinfo@amgen.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary objective of this study is to assess successful self-administration of rocatinlimab subcutaneous using devices for injection at home.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date April 22, 2026
Est. primary completion date May 22, 2025
Accepts healthy volunteers No
Gender All
Age group 12 Years to 100 Years
Eligibility Inclusion Criteria: - Age = 12 at Day 1. - Diagnosis of AD according to American Academy of Dermatology (AAD) Consensus Criteria (2014) that has been present for at least 12 months. - History of inadequate response to Topical Corticosteroids (TCS) of medium to higher potency (with or without topical calcineurin inhibitors [TCI]). - Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™) score = 3. Exclusion Criteria: - Treatment with a biological product within 12 weeks or 5 half-lives, whichever is longer, prior to day 1 pre-randomization. - Treatment with any of the following medications or therapies within 5 half-lives prior to day 1 pre-randomization: 1. Systemic corticosteroids 2. Non-biologic, non-targeted systemic immunosuppressants 3. Oral or Topical Janus kinase inhibitors - Treatment with any of the following medications or therapies within 1 week before day 1 pre-randomization: 1. Topical phosphodiesterase 4 (PDE4) inhibitors 2. Other topical immunosuppressive agents (not including TCS/TCI) 3. Combination topical agents containing any of the above components

Study Design

Related Conditions & MeSH terms

Intervention

Combination Product:
• Rocatinlimab Prefilled Syringe
Prefilled Syringe (PFS) for subcutaneous (SC) injection self-administration of rocatinlimab.

Locations
Country Name City State
United States Hamilton Research, LLC Alpharetta Georgia
United States Treasure Valley Medical Research Boise Idaho
United States Excel Clinical Research Las Vegas Nevada
United States Dermatology and Skin Cancer Center Leawood Leawood Kansas
United States Long Beach Research Institute Long Beach California
United States Dermatology Research Associates Los Angeles California
United States Apex Clinical Research Center LLC Mayfield Heights Ohio
United States Anchor Medical Research Miami Florida
United States Virginia Dermatology and Skin Cancer Center Norfolk Virginia
United States Las Vegas Clinical Trials North Las Vegas Nevada
United States Health Concepts Rapid City South Dakota
United States Skin Cancer and Dermatology Institute Reno Nevada
United States Integrative Skin Science and Research Sacramento California
United States Essential Medical Research LLC Tulsa Oklahoma

Sponsors (1)
Lead Sponsor Collaborator
Amgen

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Proportion of full-dose self-administered rocatinlimab injections as reported by participants or caregivers among attempted home-use injections at weeks 4 and 12 combined Up to Week 12
Secondary Proportion of devices that have been reported with Product Complaints by participants, caregivers, or investigators among dispensed home-use devices at weeks 4 and 12 combined Up to Week 12
See also
  Status Clinical Trial Phase
Completed NCT05018806 - Proof of Concept Study of Rilzabrutinib in Adult Patients With Moderate-to-severe Atopic Dermatitis Phase 2
Completed NCT04090229 - A Multi-center, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of Subcutaneously Delivered ASLAN004 in Adults With Moderate-Severe Atopic Dermatitis Phase 1
Terminated NCT03847389 - Clobetasol Topical Oil for Children With Moderate to Severe Atopic Dermatitis Phase 1/Phase 2
Active, not recruiting NCT05388760 - Tralokinumab Monotherapy for Children With Moderate-to-severe Atopic Dermatitis - TRAPEDS 1 (TRAlokinumab PEDiatric Trial no. 1) Phase 2
Completed NCT05530707 - Evaluation of Acceptability, Skin Barrier Restoration and Balance of Atopic Skin Using Moisturizer N/A
Completed NCT02595073 - Clinical Study to Evaluate the Efficacy and Safety of Desoximetasone (DSXS) With Atopic Dermatitis Phase 3
Recruiting NCT05509023 - Evaluating Safety and Efficacy of ADX-914 in Patients With Moderate to Severe Atopic Dermatitis (SIGNAL-AD) Phase 2
Recruiting NCT05048056 - Phase 2 Study of Efficacy and Safety of AK120, in Subjects With Moderate-to-Severe Atopic Dermatitis Phase 2
Completed NCT04598269 - Study of ATI-1777 in Adult Patients With Moderate or Severe Atopic Dermatitis Phase 2
Recruiting NCT03936335 - An Observational Retrospective Cohort Study Being Conducted in Women With Atopic Dermatitis (AD)
Withdrawn NCT03089476 - Evaluating Skin Barrier Dysfunction in Infants at High Risk of Atopy N/A
Recruiting NCT05029895 - A Study to Evaluate Adverse Events and Change in Disease State of Oral Upadacitinib in Adolescent Participants Ages 12 to <18 Years Old Diagnosed With Atopic Dermatitis (AD)
Terminated NCT03654755 - Study to Evaluate Long-Term Safety of ASN002 in Subjects With Moderate to Severe Atopic Dermatitis Phase 2
Completed NCT04556461 - Effects of Tralokinumab Treatment of Atopic Dermatitis on Skin Barrier Function Phase 2
Recruiting NCT04818138 - BROadband vs Narrowband photoTherapy for Eczema Trial Nested in the CACTI Cohort N/A
Completed NCT03719742 - A Clinical Study to Evaluate the Safety and Efficacy of a Baby Cleanser and a Moisturizer N/A
Completed NCT05375955 - A Study to Learn About The Study Medicine (PF-07038124) In Patients With Mild To Moderate Atopic Dermatitis Or Mild To Severe Plaque Psoriasis. Phase 2
Completed NCT03441568 - In-home Use Test of the New Modified Diprobase Formulation to Assess the Safety and Tolerability in Infants and Children Under Physician's Control N/A
Recruiting NCT06366932 - Optimization of Atopic Dermatitis Treatment That Requires Second-line Systemic Therapy Through Predictive Models Phase 4
Completed NCT03304470 - A Study to Evaluate the Safety and Efficacy of ATx201 in Subjects With Moderate Atopic Dermatitis Phase 2

External Links