NCT04110873

A Phase II, Placebo-controlled Trial Evaluating the Efficacy of Antroquinonol in Patients With Atopic Dermatitis

A Phase II, Three-arms, Double-blind, Dosing-ranging, Placebo-controlled Trial Evaluating the Efficacy of Antroquinonol in Patients With Atopic Dermatitis

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Chung Shan Medical University · Academic / Other
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Primary Objective: To evaluate the activity of Antroquinonol in patients with atopic dermatitis. Secondary Objective: To assess the mechanism and cytokines change of Antroquinonol in patients with atopic dermatitis. Exploratory Objective: To explore potential relationships between Antroquinonol exposure and safety and efficacy endpoints.

Detailed description

This is a Phase II, three-arms, double-blind, dosing-ranging, placebo-controlled trial evaluating the efficacy of Antroquinonol in patients with atopic dermatitis. The study is conducted in compliance with the guidelines for Good Clinical Practice and the Declaration of Helsinki. Approval is obtained from the local ethics committee or institutional review board at each study center. All the patients provided written informed consent. 60 patients totally (20 patients per arm) with atopic dermatitis will receive Antroquinonol or placebo. A patient will have received at one dose of Antroquinonol or placebo with tropical urea ointment and have three baseline scores assessment (see Statistical Methods). Enrollment will continue until the target number of evaluable patients has been enrolled. Written informed consent must be obtained from all patients before initiating Screening. The Screening period will be up to 14 days in duration (Days -14 to -1). Following completion of all Screening assessments and confirmation of eligibility criteria, patients will receive Antroquinonol 50mg, 100mg or placebo per day (QD) on Day 0 for 12 weeks or until documented evidence of unacceptable toxicity, non-compliance or withdrawal of consent by the patient, or the investigator decides to discontinue treatment, whichever comes first. The time of study drug administration should be recorded in the patient diary. Patients will attend study visits on Days 0, 28, 56 and 84. The following procedures will be performed according to the schedule of assessments: physical examination, vital signs, performance status, clinical laboratory tests, adverse events (AEs), concomitant medication and patient compliance. Scores assessments will be performed at Screening, Day 28, Day 56 and Day 84 including EASI score, SCORAD, sIGA score, BSA affected by atopic dermatitis and pruritus verbal rating scale. The primary endpoint is the percentage improvement between baseline and week 12 in Eczema Area and Severity Index (EASI).

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	Antroquinonol Capsule 50mg	patients will receive Antroquinonol 50mg per day (QD) on Day 1 for 12 weeks
DRUG	Antroquinonol Capsule 100mg	patients will receive Antroquinonol 100mg per day (QD) on Day 1 for 12 weeks
DRUG	Placebo oral capsule	patients will receive placebo per day (QD) on Day 1 for 12 weeks

Timeline

• Start date: 2018-07-27
• Primary completion: 2019-06-25
• Completion: 2019-06-25
• First posted: 2019-10-01
• Last updated: 2019-10-01

Locations

1 site across 1 country: Taiwan