Clinical Trials List
Protocol Number20210142
NCT Number(ClinicalTrials.gov Identfier)NCT05651711
2023-01-27 - 2025-09-30
Phase III
Not yet recruiting3
Recruiting2
Terminated1
A Phase 3, Randomized, 24-week, Placebo-controlled, Double-blind Study to Assess the Efficacy, Safety and Tolerability of Rocatinlimab (AMG 451) Monotherapy in Adult Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Horizon)
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Trial Applicant
IQVIA RDS Taiwan Ltd.
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Chih-Chieh Chan Division of Dermatology
- WEI-HSIN WU Division of Dermatology
- 卓雍哲 Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 林尚宏 Division of Dermatology
- 曾涵琪 Division of Dermatology
- 鄭裕文 Division of Dermatology
- Lai San Wong Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- Yu-Huei Huang Division of Dermatology
- Chun-Wei Lu Division of Dermatology
- Chung-Yao Hsu Division of Dermatology
- 紀景琪 Division of Dermatology
- Ya-Ching Chang Division of Dermatology
- I-Hsin Shih Division of Dermatology
- 陳偉廸 Division of Dermatology
- Chin-Yi Yang Division of Dermatology
- Chun-Bing Chen Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- DINGDAR LEE Division of Dermatology
- Cheng-Yuan Li Division of Dermatology
- 吳貞宜 Division of Dermatology
- Chih-Chiang Chen Division of Dermatology
- 何翊芯 Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- Wei-Ting Tu Division of Dermatology
- 廖怡貞 Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 蕭百芬 Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Atopic Dermatitis
Objectives
This is a Phase 3, 24-week, randomized, placebo-controlled, double-blind trial evaluating rocatinlimab monotherapy in adults with moderate-to-severe atopic dermatitis (AD) who are unresponsive to topical medications. efficacy, safety and tolerability of the subjects. Prior late-stage therapy, including prior use of biologics or small molecule targeted drugs (e.g., Janus agonist [JAK] inhibitors), may be allowed after an adequate washout period.
Test Drug
Rocatinlimab (AMG 451)
Active Ingredient
AMG 451
Dosage Form
Preservative-free solution for subcutaneous injection
Dosage
150 mg/mL
Endpoints
Main evaluation indicators
• Achieved a vIGA-AD score of 0 (clear) or 1 (almost clear) at Week 24 and decreased by ≥ 2 points from baseline (vIGA-AD 0/1)
• Achieve EASI score at Week 24 with a ≥ 75% reduction from baseline (EASI 75)
• Reached EASI 75 at Week 16
• Achieved vIGA-AD 0/1 at Week 16
• Weekly mean weekly mean of worst daily numeric rating scale (NRS) score at baseline≥ 4 points for subjects who achieved NRS weekly mean reduction from baseline at week 16• 8805; 4 points
Subjects who achieved a weekly mean of ≥ 4 points in worst daily itching NRS score at baseline achieved an NRS mean weekly decrease of ≥ 4 points from baseline at week 24
• Achieve EASI score at Week 24 ≥ 90% reduction from baseline (EASI 90)
• To assess the efficacy of rocatinlimab 300 mg and 150 mg compared with placebo at Week 24 as measured by the Dermatology Life Quality Index (DLQI) PRO
• Change in DLQI scores from baseline to week 24
• Weekly mean change from baseline in daily AD skin pain NRS scores at Week 24
• • A vIGA-AD 1 response with only barely noticeable erythema or a vIGA-AD 0 response at week 24
• Subjects with facial AD at baseline reached a facial AD severity score of clear at week 24
• Subjects with hand AD at baseline reached a hand AD severity score of clear at Week 24
• Subjects with genital AD at baseline reached a genital AD severity score of clear at week 24
Secondary evaluation metrics
• Weekly mean change from baseline in worst daily itching NRS score at week 16
• Weekly mean change from baseline in worst daily itching NRS score at week 24
• Change from Baseline in Scoring for Atopic Dermatitis (SCORAD) Visual Analog Scale (VAS) Score at Week 16
• Change in SCORAD Tickle VAS Score from Baseline at Week 24
Subjects with a baseline DLQI score of ≥ 4 who achieved a DLQI score reduction of ≥ 4 points from baseline at Week 24
Subjects with a baseline POEM score of ≥ 4 who achieved a POEM score reduction of ≥ 4 points from baseline at Week 24
• Change in POEM Score from Baseline to Week 24
• Weekly mean change from baseline in daily AD skin pain NRS scores at Week 16
• Weekly mean change from baseline in daily sleep disturbance NRS scores at Week 24
Subjects with a baseline HADS Anxiety subscale score of ≥ 8 achieved a HADS Anxiety subscale score < 8 at Week 24
Subjects with a baseline HADS Depression subscale score of ≥ 8 achieved a HADS Depression subscale score < 8 at Week 24
• Change in HADS Anxiety Subscale Scores from Baseline to Week 24
• Change in HADS Depression subscale scores from baseline to week 24
Subjects with a baseline SCORAD score of ≥ 8.7 achieved a SCORAD score reduction of ≥ 8.7 points from baseline at Week 24
Safety and immunogenicity
• Treatment adverse events (including clinically significant laboratory test values and vital sign changes) and serious adverse events
• Anti-rocatinlimab antibody formation
• Achieved a vIGA-AD score of 0 (clear) or 1 (almost clear) at Week 24 and decreased by ≥ 2 points from baseline (vIGA-AD 0/1)
• Achieve EASI score at Week 24 with a ≥ 75% reduction from baseline (EASI 75)
• Reached EASI 75 at Week 16
• Achieved vIGA-AD 0/1 at Week 16
• Weekly mean weekly mean of worst daily numeric rating scale (NRS) score at baseline≥ 4 points for subjects who achieved NRS weekly mean reduction from baseline at week 16• 8805; 4 points
Subjects who achieved a weekly mean of ≥ 4 points in worst daily itching NRS score at baseline achieved an NRS mean weekly decrease of ≥ 4 points from baseline at week 24
• Achieve EASI score at Week 24 ≥ 90% reduction from baseline (EASI 90)
• To assess the efficacy of rocatinlimab 300 mg and 150 mg compared with placebo at Week 24 as measured by the Dermatology Life Quality Index (DLQI) PRO
• Change in DLQI scores from baseline to week 24
• Weekly mean change from baseline in daily AD skin pain NRS scores at Week 24
• • A vIGA-AD 1 response with only barely noticeable erythema or a vIGA-AD 0 response at week 24
• Subjects with facial AD at baseline reached a facial AD severity score of clear at week 24
• Subjects with hand AD at baseline reached a hand AD severity score of clear at Week 24
• Subjects with genital AD at baseline reached a genital AD severity score of clear at week 24
Secondary evaluation metrics
• Weekly mean change from baseline in worst daily itching NRS score at week 16
• Weekly mean change from baseline in worst daily itching NRS score at week 24
• Change from Baseline in Scoring for Atopic Dermatitis (SCORAD) Visual Analog Scale (VAS) Score at Week 16
• Change in SCORAD Tickle VAS Score from Baseline at Week 24
Subjects with a baseline DLQI score of ≥ 4 who achieved a DLQI score reduction of ≥ 4 points from baseline at Week 24
Subjects with a baseline POEM score of ≥ 4 who achieved a POEM score reduction of ≥ 4 points from baseline at Week 24
• Change in POEM Score from Baseline to Week 24
• Weekly mean change from baseline in daily AD skin pain NRS scores at Week 16
• Weekly mean change from baseline in daily sleep disturbance NRS scores at Week 24
Subjects with a baseline HADS Anxiety subscale score of ≥ 8 achieved a HADS Anxiety subscale score < 8 at Week 24
Subjects with a baseline HADS Depression subscale score of ≥ 8 achieved a HADS Depression subscale score < 8 at Week 24
• Change in HADS Anxiety Subscale Scores from Baseline to Week 24
• Change in HADS Depression subscale scores from baseline to week 24
Subjects with a baseline SCORAD score of ≥ 8.7 achieved a SCORAD score reduction of ≥ 8.7 points from baseline at Week 24
Safety and immunogenicity
• Treatment adverse events (including clinically significant laboratory test values and vital sign changes) and serious adverse events
• Anti-rocatinlimab antibody formation
Inclution Criteria
Inclusion Criteria:
Age ≥ 18 years (or ≥ legal adult age within the country if it is older than 18 years at signing of informed consent) 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 or higher potency (with or without topical calcineurin inhibitors [TCI]) as appropriate or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks).
EASI score ≥16
vIGA-AD score ≥3
≥10% body surface area (BSA) of AD involvement
Worst pruritus numerical rating scale ≥ 4
Age ≥ 18 years (or ≥ legal adult age within the country if it is older than 18 years at signing of informed consent) 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 or higher potency (with or without topical calcineurin inhibitors [TCI]) as appropriate or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks).
EASI score ≥16
vIGA-AD score ≥3
≥10% body surface area (BSA) of AD involvement
Worst pruritus numerical rating scale ≥ 4
Exclusion Criteria
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
Oral or topical 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 (PDE4) inhibitors
Other topical immunosuppressive agents
Combination agents including TCS of any potency or TCI, PDE4 inhibitors, or other immunosuppressive agents
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
Oral or topical 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 (PDE4) inhibitors
Other topical immunosuppressive agents
Combination agents including TCS of any potency or TCI, PDE4 inhibitors, or other immunosuppressive agents
The Estimated Number of Participants
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Taiwan
40 participants
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Global
770 participants
