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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05882877




Registration number
NCT05882877
Ethics application status
Date submitted
22/05/2023
Date registered
31/05/2023
Date last updated
21/11/2024

Titles & IDs
Public 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)
Scientific 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)
Secondary ID [1] 0 0
2022-501587-17
Secondary ID [2] 0 0
20210146
Universal Trial Number (UTN)
Trial acronym
ROCKET-ASCEND
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Rocatinlimab
Other interventions - Placebo

Experimental: ARM A: Dose 1 to Dose 1 - Participants from parent Rocatinlimab studies ROCKET-Ignite, ROCKET-Horizon, ROCKET-SHUTTLE, or ROCKET-ASTRO who received Dose 1 will be randomized or assigned to receive Dose 1 Every 4 Weeks (Q4W) or Every 8 Weeks (Q8W). Participants from parent Rocatinlimab study ROCKET-VOYAGER who received Dose 1 will be assigned to receive Dose 1 Q4W.

Experimental: ARM B: Dose 2 to Dose 2 - Participants from parent Rocatinlimab studies ROCKET-Ignite, ROCKET-SHUTTLE, or ROCKET-ASTRO who received Dose 2 will be randomized or assigned to receive Dose 2 Q4W or Q8W.

Placebo comparator: ARM C: Dose 1 or Dose 2 to Placebo - Participants from parent Rocatinlimab studies ROCKET-Ignite or ROCKET-Horizon who received Dose 1 will be randomized to receive placebo Q4W. Participants from parent Rocatinlimab study ROCKET-Ignite who received Dose 2 will be randomized to receive placebo Q4W.

Placebo comparator: ARM D: Placebo to Placebo - Participants from parent Rocatinlimab studies ROCKET- Ignite, ROCKET-Horizon, ROCKET-SHUTTLE, ROCKET-ASTRO, or ROCKET-VOYAGER who received placebo will be randomized or assigned to receive placebo Q4W.

Experimental: ARM E: Dose 1, Dose 2, Placebo, or Open-label (OL) to OL Dose 1 - Participants from parent Rocatinlimab studies ROCKET- Ignite, ROCKET-Horizon, ROCKET- SHUTTLE, ROCKET-ASTRO, or ROCKET-VOYAGER who received Dose 1, Dose 2, or placebo will be assigned to receive OL Rocatinlimab Dose 1 Q4W.

Participants who received OL in parent Rocatinlimab study ROCKET- ASTRO will continue to receive OL Rocatinlimab Dose 1 Q4W.

All participants from parent Rocatinlimab study ROCKET-Orbit will be assigned to receive OL Rocatinlimab Dose 1 Q4W.


Treatment: Drugs: Rocatinlimab
Subcutaneous (SC) injection

Other interventions: Placebo
SC injection
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Treatment-emergent Adverse Events
Timepoint [1] 0 0
Up to 116 weeks
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
Week 32
Secondary outcome [2] 0 0
Maintaining a Revised IGA (rIGA™) 0/1 Response at Week 32 Among Participants Achieving rIGA 0/1 Response at Day 1
Timepoint [2] 0 0
Week 32
Secondary outcome [3] 0 0
Maintaining Eczema Area and Severity Index (EASI) 75 Response at Week 32 Among Participants Achieving EASI 75 Response at Day 1
Timepoint [3] 0 0
Week 32
Secondary outcome [4] 0 0
Maintaining EASI 90 Response at Week 32 Among Participants Achieving EASI 90 Response at Day 1
Timepoint [4] 0 0
Week 32
Secondary outcome [5] 0 0
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
Timepoint [5] 0 0
Week 32
Secondary outcome [6] 0 0
Maintaining >= 4-point reduction from parent study baseline in worst pruritus NRS score at week 32
Timepoint [6] 0 0
Week 32

Eligibility
Key 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.
* 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).
Minimum age
12 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/05/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
14/05/2027
Actual
Sample size
Target
2200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Premier Specialists - Kogarah
Recruitment hospital [2] 0 0
St George Dermatology and Skin Cancer Centre - Kogarah
Recruitment hospital [3] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [4] 0 0
The Skin Centre - Benowa
Recruitment hospital [5] 0 0
Princess Alexandra Hospital - South Brisbane
Recruitment hospital [6] 0 0
Veracity Clinical Research - Woolloongabba
Recruitment hospital [7] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [8] 0 0
Emeritus Research Melbourne - Camberwell
Recruitment hospital [9] 0 0
Skin Health Institute - Carlton
Recruitment hospital [10] 0 0
Monash Childrens Hospital - Clayton
Recruitment hospital [11] 0 0
The Alfred Hospital - Melbourne
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The Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
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2065 - St Leonards
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4217 - Benowa
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4101 - South Brisbane
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4102 - Woolloongabba
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3128 - Box Hill
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3124 - Camberwell
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3053 - Carlton
Recruitment postcode(s) [9] 0 0
3168 - Clayton
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3004 - Melbourne
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3050 - Parkville
Recruitment outside Australia
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Shipley

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Amgen
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT05882877
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Amgen Call Center
Address 0 0
Country 0 0
Phone 0 0
866-572-6436
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05882877