A Study Evaluating Rocatinlimab in Moderate-to-severe Atopic Dermatitis (ROCKET-IGNITE)

Phase 3

Completed

• Conditions: Atopic Dermatitis
• Interventions: Drug: Rocatinlimab; Drug: Placebo

• Registration Number: NCT05398445
• Lead Sponsor: Amgen

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of rocatinlimab in monotherapy treatment.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-24
• Study Start: 2022-05-31
• Study First Submitted QC: 2022-05-31
• Study First Posted: 2022-06-01
• Primary Completion: 2024-11-28
• Study Completion: 2025-01-13
• Disposition First Posted: 2025-01-22
• Disposition First Submitted: 2025-03-12
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-01
• Last Update Posted: 2025-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 769

Inclusion Criteria

• Age ≥ 18 years with a diagnosis of AD according to the AAD Consensus Criteria (2014) present for at least 12 months
• History of inadequate response to TCS (Topical Corticosteroid) of medium to higher potency (with or without topical calcineurin inhibitors [TCI]).
• EASI score ≥16
• vIGA-AD score ≥3
• ≥10% body surface area (BSA) of AD involvement
• Worst pruritus numerical rating scale ≥ 4

Exclusion Criteria

• Treatment with a biological product within 12 weeks or 5 half-lives, whichever is longer, prior to Day 1

• Treatment with any of the following medications or therapies within 4 weeks or 5 half-lives, whichever is longer, prior to Day 1:

  • Systemic corticosteroids
  • Systemic immunosuppressants
  • Phototherapy
  • Janus kinase inhibitors

• Treatment with any of the following medications or therapies within 1 week, prior to Day 1:

  • TCS of any potency
  • TCI
  • Topical phosphodiesterase type 4 inhibitors
  • Other topical immunosuppressive agents
  • Combination topical agents including TCS of any potency, TCI, PDE4 inhibitors, or other topical immunosuppressive agents

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	Rocatinlimab	Rocatinlimab Dose 1 every 4 weeks (Q4W) + loading dose at Week 2
Arm C	Placebo	Placebo Q4W+ loading dose at Week 2
Arm B	Rocatinlimab	Rocatinlimab Dose 2 Q4W + loading dose at Week 2

Primary Outcome Measures

Name	Time	Method
Achievement of a Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0 or 1 with ≥2 point reduction from baseline at Week 24	Baseline, Week 24
Achievement of ≥75% reduction from baseline in Eczema Area and Severity Index (EASI) score at Week 24	Baseline, Week 24

Secondary Outcome Measures

Name	Time	Method
Change from baseline in HADS-depression subscale score at Week 24	Baseline, Week 24
Achievement of ≥75% reduction from baseline in EASI score at Week 16	Baseline, Week 16
Achievement of a vIGA-AD score of 0 or 1 from baseline at Week 16	Baseline, Week 16
Achievement of a ≥ 4-point reduction from baseline in weekly average of daily worst pruritus numerical rating scale (NRS) score at Week 16 in subjects with baseline weekly average of daily worst pruritus NRS score ≥ 4	Baseline, Week 16
Achievement of a ≥ 4-point reduction from baseline in weekly average of daily worst pruritus NRS score at Week 24 in subjects with baseline weekly average of daily worst pruritus NRS score ≥ 4	Baseline, Week 24
Achievement of ≥90% reduction from baseline in EASI score at Week 24	Baseline, Week 24
Achievement of a ≥ 4-point reduction from baseline in weekly average of daily AD skin pain NRS score at Week 24 in subjects with baseline weekly average of AD skin pain NRS score ≥ 4	Baseline, Week 24
Achievement of a vIGA-AD 1 response with presence of only barely perceptible erythema or vIGA-AD 0 response (revised Investigator's Global Assessment [rIGA™] 0/1) at Week 24	Baseline, Week 24
Achievement of Facial AD Severity Score (FASS) of clear at Week 24 for subjects with facial AD at baseline	Baseline, Week 24
Change from baseline in weekly average of daily worst pruritus NRS score at week 16	Baseline, Week 16
Change from baseline in weekly average of daily worst pruritus NRS score at Week 24	Baseline, Week 24
Achievement of Hand AD Severity Score (HASS) of clear at Week 24 for subjects with hand AD at baseline	Baseline, Week 24
Change from baseline in SCORing Atopic Dermatitis (SCORAD) itch visual analogue scale (VAS) score at Week 16	Baseline, Week 16
Change from baseline in SCORAD itch VAS score at Week 24	Baseline, Week 24
Achievement of ≥ 4-point reduction from baseline in DLQI score at Week 24 in subjects with baseline DLQI score ≥ 4	Baseline, Week 24
Change from baseline in DLQI score at Week 24	Baseline, Week 24
Achievement of ≥ 4-point reduction from baseline in POEM score at Week 24 in subjects with baseline POEM score ≥ 4	Baseline, Week 24
Change from baseline in POEM score at Week 24	Baseline, Week 24
Change from baseline in HADS-anxiety subscale score at Week 24	Baseline, Week 24
Achievement of HADS-depression subscale score < 8 at week 24 in subjects with baseline HADS-depression subscale score ≥ 8	Baseline, Week 24
Achievement of a ≥ 4-point reduction from baseline in weekly average of daily AD skin pain NRS score at Week 16 in subjects with baseline weekly average of AD skin pain NRS score ≥ 4	Baseline, Week 16
Change from baseline in weekly average of daily AD skin pain NRS score at Week 24	Baseline, Week 24
Change from baseline in weekly average of daily AD skin pain NRS score at Week 16	Baseline, Week 16
Achievement of a ≥ 3-point reduction from baseline in weekly average of daily AD skin pain NRS score at Week 24 in subjects with baseline weekly average of AD skin pain NRS score ≥ 3	Baseline, Week 24
Achievement of a ≥ 3-point reduction from baseline in weekly average of daily AD skin pain NRS score at Week 16 in subjects with baseline weekly average of AD skin pain NRS score ≥ 3	Baseline, Week 16
Change from baseline in weekly average of daily sleep disturbance NRS score at Week 24	Baseline, Week 24
Achievement of Hospital Anxiety and Depression Scale (HADS)-anxiety subscale score < 8 at Week 24 in subjects with baseline HADS-anxiety subscale score ≥ 8	Baseline, Week 24
Achievement of a ≥ 8.7-point reduction from baseline in SCORAD score at Week 24 in participants with baseline SCORAD score ≥ 8.7	Baseline, Week 24

Trial Locations

Locations (201)

Cahaba Dermatology and Skin Health Center; 🇺🇸 Birmingham, Alabama, United States

Alliance Dermatology and Mohs Center; 🇺🇸 Phoenix, Arizona, United States

Anaheim Clinical Trials; 🇺🇸 Anaheim, California, United States

First OC Dermatology; 🇺🇸 Fountain Valley, California, United States

Kaiser Permanente - Glendale Medical Center; 🇺🇸 Glendale, California, United States

Long Beach Research Institute; 🇺🇸 Long Beach, California, United States

Kaiser Permanente Los Angeles Medical Center; 🇺🇸 Los Angeles, California, United States

Dermatology Research Associates; 🇺🇸 Los Angeles, California, United States

Cura Clinical Research; 🇺🇸 Sherman Oaks, California, United States

IMMUNOe Research Centers; 🇺🇸 Centennial, Colorado, United States

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