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Clinical Trials List

Protocol NumberI1F-MC-RHBP

NCT Number(ClinicalTrials.gov Identfier)NCT02513550

2015-08-01 - 2017-12-31

Phase III

Terminated4

ICD-10L40.0

Psoriasis vulgaris

A Multicenter, Randomized, Double-Blind Study Comparing the Efficacy and Safety of Ixekizumab Dosing Regimens in Patients with Moderate-to-Severe Plaque Psoriasis

Trial Applicant

ELI LILLY AND COMPANY(TAIWAN), INC.
Sponsor

Eli Lilly and Company
Trial scale

Multi-Regional Multi-Center
Update

2025/08/20

Investigators and Locations

Principal Investigator 何宜承 Division of Dermatology

Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

林尚宏 Division of Dermatology

The Actual Total Number of Participants Enrolled

0 Completed

Principal Investigator 許漢銘 Division of Dermatology

National Taiwan University Hospital

Co-Principal Investigator

林子凱 Division of Dermatology

The Actual Total Number of Participants Enrolled

0 Completed

Principal Investigator Yu-Huei Huang Division of Dermatology

Linkou Chang Gung Medical Foundation

Co-Principal Investigator

Ya-Ching Chang Division of Dermatology
Chung-Yao Hsu Division of Dermatology

The Actual Total Number of Participants Enrolled

0 Completed

Audit

None

Principal Investigator TSEN-FANG TSAI Division of Dermatology

National Taiwan University Hospital

Co-Principal Investigator

Chih-Chieh Chan Division of Dermatology

The Actual Total Number of Participants Enrolled

0 Completed

Audit

None

Condition/Disease

Moderate-to-Severe Plaque Psoriasis

Objectives

The coprimary objectives of the study are to compare the efficacy of continuous Q2W dosing versus continuous Q4W dosing of ixekizumab in the treatment of patients with moderate-to-severe plaque Ps, as measured by static Physician Global Assessment (sPGA) (0,1) and PASI 75 (at least a 75% improvement from baseline in Psoriasis Area and Severity Index [PASI] score).

Test Drug

Ixekizumab

Active Ingredient

Ixekizumab

Dosage Form

injection

Dosage

Endpoints

 The proportion of patients achieving sPGA (0,1) at Week 52 (nonresponder imputation [NRI])
 Proportion of patients achieving PASI 75 at Week 52 (NRI)

Inclution Criteria

Inclusion Criteria:
• Present with chronic plaque psoriasis for at least 6 months prior to enrollment
• At least 10% BSA of psoriasis at screening and at enrollment
• sPGA score of at least 3 and PASI score of at least 12 at screening and at enrollment
• Candidates for phototherapy and/or systemic therapy
• Participant must agree to use reliable method of birth control during the study; women must continue using birth control for at least 12 weeks after stopping treatment

Exclusion Criteria

Exclusion Criteria:
• Predominant pattern of pustular, erythrodermic, or guttate forms of psoriasis
• History of drug-induced psoriasis
• Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks prior to enrollment and during the study
• Received systemic non-biologic psoriasis therapy or phototherapy within the previous 4 weeks; or had topical psoriasis treatment within the previous 2 weeks prior to enrollment
• Concurrent or recent use of any biologic agent
• Have participated in any study with ixekizumab
• Received a live vaccination within 12 weeks prior to enrollment
• Serious disorder or illness other than psoriasis
• Ongoing or serious infection within the last 12 weeks or evidence of tuberculosis
• Major surgery within 8 weeks of baseline, or will require surgery during the study
• Breastfeeding or nursing (lactating) women

The Estimated Number of Participants

Taiwan

60 participants
Global

1440 participants