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A Phase 3, Multicenter, Double-blind Maintenance Study to Assess Long-term Safety, Tolerability, and Efficacy of Rocatinlimab in Adult and Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-ASCEND)
Overall Recruitment Status: Active, currently enrolling
 
Official Title
A Phase 3, Multicenter, Double-blind Maintenance Study to Assess Long-term Safety, Tolerability, and Efficacy of Rocatinlimab in Adult and Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-ASCEND)
 
Region Sponsors
California - Northern
Amgen
 
Acronym NCT No.
NCT05882877
 
Study Type Phase
Clinical Trial
Phase III
 
Purpose
The primary objective of this study is to describe the long-term safety and tolerability of rocatinlimab in participants with moderate-to-severe AD.
 
Detailed Description
 
 
 
Inclusion Criteria
  • • Completion of an end of treatment duration visit (Week 24 or Week 52 visit for adult or adolescent studies, respectively) in a rocatinlimab parent study (ROCKET-IGNITE, ROCKET-HORIZON, ROCKET-SHUTTLE, ROCKET-ASTRO, ROCKET-ORBIT, OR ROCKET-VOYAGER) within the past 28 days.
 
Exclusion Criteria
  • • Permanent investigational product discontinuation due to safety-related reasons, protocol-defined stopping rules or conditions/reasons unrelated to efficacy during the rocatinlimab parent study (ROCKET-IGNITE, ROCKET-HORIZON, ROCKET-SHUTTLE, ROCKET-ASTRO, ROCKET-ORBIT, OR ROCKET-VOYAGER), or at the time of Screening or Day 1.
 
Keywords and/or Specific Medical Conditions
  • Atopic Dermatitis, Rocatinlimab, AMG 451, Eczema,
  • Geriatric Medicine
  • Adolescent Medicine
  • Infectious Diseases
  • Dermatology
  • Pediatrics
 
KP Clinical Facility
  • Oakland Medical Center
  • Sacramento Medical Center
  • Sacramento Medical Center-Davis
  • San Francisco Medical Center
 
Clinical Area
  • Adolescent Medicine
  • Dermatology
  • Geriatric Medicine
  • Infectious Diseases
  • Pediatrics


Principal Investigator:
Paradi M Mirmirani
Contact Information:
- CTP Collaborate Team
-ctpcollaborate@kp.org
-All Kaiser Permanente Northern California Medical Centers


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