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

NCT05882877
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Phase
Phase 3
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Recruitment status
Terminated
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Participants
2,621
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Lead sponsor
Amgen
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Start date
2023-05-31
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Number of sites
547
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Summary
The primary objective of this study is to describe the long-term safety and tolerability of rocatinlimab in participants with moderate-to-severe AD.
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Acronym
ROCKET-ASCEND
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Short title
A Study to Assess Long-term Safety, Tolerability, and Efficacy of Rocatinlimab in Adult and Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)
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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)
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Terminated
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Phase
Phase 3
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Study type
Interventional
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Reason stopped
Sponsor Decision
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Completion date
2026-07-01
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First posted
2023-05-31
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Registry last updated
2026-07-16
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Primary completion date
2026-07-01
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Start date
2023-05-31
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Actual participants
2,621
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Participants
2,621
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Participant count basis
Actual
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Protocol amendments
6
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Number of sites
547
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Amgen
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05882877
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ClinicalTrials.gov ID
NCT05882877
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Double masking
Masked roles
Participants, Investigators
Sources for study design
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  1. Number of Participants With Treatment-emergent Adverse Events

    Timeframe: Up to 116 weeks

  1. Maintaining Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD™) 0/1 Response at Week 32 Among Participants Achieving vIGA-AD™ 0/1 Response at Day 1

    Timeframe: Week 32

    This outcome measure applies only to participants from parent rocatinlimab studies ROCKET-Ignite and ROCKET-Horizon who entered into the randomized treatment withdrawal cohort.

  2. Maintaining a Revised IGA (rIGA™) 0/1 Response at Week 32 Among Participants Achieving rIGA™ 0/1 Response at Day 1

    Timeframe: Week 32

    This outcome measure applies only to participants from parent rocatinlimab studies ROCKET-Ignite and ROCKET-Horizon who entered into the randomized treatment withdrawal cohort.

  3. Maintaining Eczema Area and Severity Index (EASI) 75 Response at Week 32 Among Participants Achieving EASI 75 Response at Day 1

    Timeframe: Week 32

    This outcome measure applies only to participants from parent rocatinlimab studies ROCKET-Ignite and ROCKET-Horizon who entered into the randomized treatment withdrawal cohort.

  4. Maintaining EASI 90 Response at Week 32 Among Participants Achieving EASI 90 Response at Day 1

    Timeframe: Week 32

    This outcome measure applies only to participants from parent rocatinlimab studies ROCKET-Ignite and ROCKET-Horizon who entered into the randomized treatment withdrawal cohort.

  5. Maintaining vIGA-AD™ 0/1 Response and EASI 75 Response at Week 32 Among Participants Achieving vIGA-AD™ 0/1 Response and EASI 75 Response at Day 1

    Timeframe: Week 32

    This outcome measure applies only to participants from parent rocatinlimab studies ROCKET-Ignite and ROCKET-Horizon who entered into the randomized treatment withdrawal cohort.

  6. Maintaining ≥ 4-point Reduction from Parent Study Baseline in Worst Pruritus NRS Score at Week 32 Among Participants Achieving ≥ 4 Point Reduction from Parent Study Baseline in Worst Pruritus NRS Score at Day 1

    Timeframe: Week 32

    This outcome measure applies only to participants from parent rocatinlimab studies ROCKET-Ignite and ROCKET-Horizon who entered into the randomized treatment withdrawal cohort.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Children, Adults, Older adults
Minimum age
12 Years
Maximum age
100 Years
Healthy volunteers
No

  • 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.
  • Participants from the parent study ROCKET-ORBIT must achieve an improvement in EASI score at week 52 of at least 60% compared to parent study baseline (EASI 60).

  • 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.
Sources for eligibility
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  • Cahaba Dermatology and Skin Health CenterBirmingham, United States
  • Medical Dermatology SpecialistsPhoenix, United States
  • Alliance Dermatology and Mohs CenterPhoenix, United States
  • Affiliated DermatologyScottsdale, United States
  • Scottsdale Clinical TrialsScottsdale, United States
  • Dermatology Trial AssociatesBryant, United States
  • Burke Pharmaceutical ResearchHot Springs, United States
  • Arkansas Research Trials, LLCNorth Little Rock, United States
  • Kern Research IncBakersfield, United States
  • Hope Clinical Research LLCCanoga Park, United States
  • West Coast Research LLCDublin, United States
  • California Dermatology and Clinical Research InstituteEncinitas, United States
  • First OC DermatologyFountain Valley, United States
  • Antelope Valley Clinical TrialsLancaster, United States
  • Chemidox Clinical Trials IncorporatedLancaster, United States
  • Long Beach Research InstituteLong Beach, United States
  • University of California Los AngelesLos Angeles, United States
  • Dermatology Research AssociatesLos Angeles, United States
  • Wallace Medical Group IncLos Angeles, United States
  • Northridge Clinical TrialsNorthridge, United States
  • University of California IrvineOrange, United States
  • Havana Research Institute IncPasadena, United States
  • Integrative Skin Science and ResearchSacramento, United States
  • University of California at Davis Medical CenterSacramento, United States
  • Kaiser Permanente South Sacramento Medical CenterSacramento, United States

And 522 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Other registry identifiers

  • 2022-501587-17
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)

Targets (1)