The trial is taking place at:
J

Jubilee Clinical Research Inc | Las Vegas, NV

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

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Amgen

Status and phase

Enrolling
Phase 3

Conditions

Atopic Dermatitis

Treatments

Drug: Rocatinlimab
Other: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT05882877
2022-501587-17 (EudraCT Number)
20210146

Details and patient eligibility

About

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

Enrollment

2,200 estimated patients

Sex

All

Ages

12 to 100 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

2,200 participants in 5 patient groups, including a placebo group

ARM A: Dose 1 to Dose 1
Experimental group
Description:
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.
Treatment:
Drug: Rocatinlimab
ARM B: Dose 2 to Dose 2
Experimental group
Description:
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.
Treatment:
Drug: Rocatinlimab
ARM C: Dose 1 or Dose 2 to Placebo
Placebo Comparator group
Description:
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.
Treatment:
Other: Placebo
ARM D: Placebo to Placebo
Placebo Comparator group
Description:
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.
Treatment:
Other: Placebo
ARM E: Dose 1, Dose 2, Placebo, or Open-label (OL) to OL Dose 1
Experimental group
Description:
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:
Drug: Rocatinlimab

Trial contacts and locations

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Central trial contact

Amgen Call Center

Data sourced from clinicaltrials.gov

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