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Clinical Trials List

Protocol Number20210142
NCT Number(ClinicalTrials.gov Identfier)NCT05398445
Completed

2023-01-27 - 2025-09-30

Phase III

Terminated7

ICD-10L22

Diaper dermatitis

ICD-9691.0

Diaper or napkin rash

A Phase 3, 24-week, Randomized, 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)

  • Trial Applicant

    IQVIA RDS Taiwan Ltd.

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Yun-Ting Chang Division of Dermatology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Chia-Yu Chu Division of Dermatology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 吳南霖 Division of Dermatology
MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Yu-Huei Huang Division of Dermatology
Taipei Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Chih-Hung Lee Division of Dermatology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Wen-Hung Chung Division of Dermatology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Chao-Chun Yang
National Taiwan University Hospital

Co-Principal Investigator

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 the efficacy, safety, and tolerability of rocatinlimab monotherapy in adult subjects with moderate to severe atopic dermatitis (AD) who have had an inadequate response to topical medications. Prior advanced therapy, including use of biologics or small molecule targeted therapies (e.g., Janus kinase [JAK] inhibitors), is permitted to participate in the trial after a sufficient washout period.

Test Drug

皮下注射劑

Active Ingredient

AMG 451

Dosage Form

220

Dosage

150 mg/mL

Endpoints

Key Performance Indicators

• Achieve a vIGA-AD score of 0 (cleared) or 1 (almost cleared) at week 24, with a reduction of ≥ 2 points from baseline (vIGA-AD 0/1)

• Achieve an EASI score of ≥ 75% reduction from baseline at week 24 (EASI 75)

• Achieve EASI 75 at week 16

• Achieve vIGA-AD 0/1 at week 16

• Participants with a weekly average of ≥ 4 points on the Numerical Rating Scale (NRS) at baseline, achieving a weekly average reduction of ≥ 4 points from baseline on the NRS at week 16

• Participants with a weekly average of ≥ 4 points on the NRS at baseline, achieving a weekly average reduction of ≥ 4 points from baseline on the NRS at week 24

• Achieve an EASI score of ≥ 2% reduction from baseline at week 24 90% (EASI 90)

• Subjects with a baseline AD skin pain NRS score of ≥ 4 per week achieved a weekly NRS score reduction of ≥ 4 per week from the baseline at week 24.

• Achieve vIGA-AD 1 response at week 24 with only barely perceptible erythema or vIGA-AD 0 response (revised trial administrator overall assessment [rIGA™] 0/1)

• Subjects with facial AD at baseline achieve FASS (cleared) at week 24

• Subjects with hand AD at baseline achieve HASS (cleared) at week 24

Secondary assessment measures

• Weekly mean change from baseline in daily most severe pruritus NRS score at week 16

• Weekly mean change from baseline in daily most severe pruritus NRS score at week 24

• Weekly mean change from baseline in Atopic Dermatitis Rating (SCORAD) Itching Visual Analogue Scale (VAS) score at week 16

• Weekly mean change from baseline in SCORAD Itching VAS score at week 24

• Baseline DLQI score ≥ 4 Subjects with a baseline POEM score ≥ 4 points achieved a DLQI score reduction of ≥ 4 points from the baseline by week 24.

• Change in DLQI score from baseline to week 24

• Subjects with a baseline POEM score ≥ 4 points achieved a POEM score reduction of ≥ 4 points from the baseline by week 24.

• Change in POEM score from baseline to week 24

• Subjects with a baseline AD skin pain NRS score of ≥ 4 points per week achieved a weekly average NRS score reduction of ≥ 4 points from the baseline by week 16.

• Weekly average change in daily AD skin pain NRS score from the baseline by week 24.

• Weekly average change in daily AD skin pain NRS score from the baseline by week 16.

• Subjects with a baseline AD skin pain NRS score of ≥ 3 points per week achieved a weekly average NRS score reduction of ≥ 3 points from the baseline by week 24.

• Baseline AD • Subjects with a weekly mean NRS score ≥ 3 for skin pain achieved a weekly mean NRS score ≥ 3 points lower than baseline by week 16.

• Weekly mean change from baseline in daily sleep disturbance NRS score by week 24.

• Subjects with a baseline HADS anxiety subscale score ≥ 8 achieved a HADS anxiety subscale score < 8 by week 24.

• Subjects with a baseline HADS depression subscale score ≥ 8 achieved a HADS depression subscale score < 8 by week 24.

• Change in HADS anxiety subscale score from baseline to week 24.

• Change in HADS depression subscale score from baseline to week 24.

• Subjects with a baseline SCORAD score ≥ 8.7 achieved a SCORAD score ≥ 8.7 points lower than baseline by week 24. Safety and Immunogenicity

• Adverse events during treatment (including clinically significant changes in laboratory values ​​and vital signs) and serious adverse events

• Anti-rocatinlimab antibody formation

Inclution Criteria

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

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

The Estimated Number of Participants

  • Taiwan

    40 participants

  • Global

    770 participants

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