A Phase 3, Double-blind Maintenance Study Assessing Rocatinlimab in Moderate-to-severe AD

JRCT ID: jRCT2031230198

Registered date:01/07/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Atopic Dermatitis
• Date of first enrollment: 05/09/2023
• Target sample size: 2200
• Countries of recruitment: Argentina,Japan,Australia,Japan,Belgium,Japan,Brazil,Japan,Canada,Japan,China,Japan,Croatia,Japan,Czech Republic,Japan,France,Japan,Germany,Japan,Greece,Japan,Hungary,Japan,Italy,Japan,Mexico,Japan,Netherlands,Japan,Poland,Japan,Portugal,Japan,Romania,Japan,Slovakia,Japan,South Korea,Japan,Spain,Japan,Taiwan,Japan,Turkey,Japan,United Kingdom,Japan,United States,Japan,Austria,Japan,Denmark,Japan,Latvia,Japan,Malaysia,Japan,Switzerland,Japan
• Study type: Interventional

Intervention(s)

- 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).
- 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, or ROCKET-SHUTTLE who received placebo will be randomized 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, or ROCKET-ASTRO 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 studies ROCKET-VOYAGER or ROCKET-Orbit will be assigned to receive OL Rocatinlimab Dose 1 Q4W.

Outcome(s)

• Primary Outcome: 1. Treatment-emergent adverse events (including clinically significant changes in laboratory values and vital signs) and serious adverse events

Secondary Outcome

1. Maintaining vIGA-AD 0/1 response among subjects achieving vIGA-AD 0/1 response at day 1
2. Maintaining vIGA-AD 1 response with presence of only barely perceptible erythema or vIGA-AD 0 response among subjects achieving vIGA-AD 1 response with presence of only barely perceptible erythema or vIGA-AD 0 response at day 1
3. Maintaining EASI 75 response among subjects achieving EASI 75 response at day 1
4. Maintaining vIGA-AD 0/1 response and EASI 75 response among subjects achieving vIGA-AD 0/1 response and EASI 75 response at day 1
5. Percent change from parent study baseline in EASI score among subjects achieving EASI 75 response at day 1
6. Maintaining >= 4-point reduction from parent study baseline in weekly average of daily worst pruritus NRS score among subjects achieving >= 4-point reduction from parent study baseline in weekly average of daily worst pruritus NRS score at day 1

Key inclusion & exclusion criteria

• Age minimum: >= 12age old
• Age maximum: Not applicable
• Gender: Both
• Include 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.
• Exclude 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.

Related Information

• Primary Sponsor: Jain Neal
• Secondary ID(s): NCT05882877,2022-501587-17