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

Conditions

• Atopic Dermatitis

Eligibility Criteria

Sex

ALL

Age

12 Years - 100 Years

Healthy Volunteers

Not accepted

Interventions

• Rocatinlimab — DRUG
  Subcutaneous (SC) injection
• Placebo — OTHER
  SC injection

Study Details

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

Key Dates

First listed

May 31, 2023

Start date

May 31, 2023

Status verified

Jul 2026

Primary completion

Jul 1, 2026

Completion

Jul 1, 2026

Study Design

Enrollment

2,621 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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 continue to receive OL Rocatinlimab Dose 1 Q4W.
• No Intervention: ARM F Group
  Participants in Arm E (OL Rocatinlimab Dose 1 Q4W) who meet defined criteria will have Rocatinlimab withdrawn, but will continue all subsequent study visits.
• Experimental: ARM G Group
  Participants from Arm F who meet defined criteria will resume OL Rocatinlimab Dose 1 Q4W.

Primary Outcome Measure

Number of Participants With Treatment-emergent Adverse Events [ Time Frame: Up to 116 weeks ]

Locations (136)

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