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

NCT04110873 | Terminated Phase 2 DMC

• 1 other identifier: CS17155
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atopic Dermatitis

Keywords

antroquinonol, Atopic dermatitis

Outcome Measures

Primary Outcomes (1)

• Eczema Area and Severity Index (EASI)

  The percentage improvement between week 0(baseline) and week 12 in Eczema Area and Severity Index (EASI)

  week 0(baseline) and week12

Secondary Outcomes (11)

• Eczema Area and Severity Index (EASI) at each time point

  week 0(baseline), week 4, week8 and week12

• Scoring Atopic Dermatitis (SCORAD)

  week 0(baseline), week 4, week8 and week12

• static Investigator's Global Assessment (sIGA)

  week 0(baseline), week 4, week8 and week12

• Body-surface area affected by atopic dermatitis

  week 0(baseline), week 4, week8 and week12

• Pruritus verbal rating scale

  week 0(baseline), week 4, week8 and week12

Other Outcomes (1)

• The percentage change between baseline and week 12 in serum cytokines

  week 0(baseline) and week12

Study Arms (3)

Antroquinonol capsule 50mg

EXPERIMENTAL

patients will receive Antroquinonol 50mg per day (QD) on Day 1 for 12 weeks

Drug: Antroquinonol Capsule 50mg

Antroquinonol capsule 100mg

EXPERIMENTAL

patients will receive Antroquinonol 100mg per day (QD) on Day 1 for 12 weeks

Drug: Antroquinonol Capsule 100mg

Placebo oral capsule

PLACEBO COMPARATOR

patients will receive placebo per day (QD) on Day 1 for 12 weeks

Drug: Placebo oral capsule

Interventions

Antroquinonol Capsule 50mg DRUG

patients will receive Antroquinonol 50mg per day (QD) on Day 1 for 12 weeks

Also known as: Antroquinonol 50mg

Antroquinonol capsule 50mg

Antroquinonol Capsule 100mg DRUG

patients will receive Antroquinonol 100mg per day (QD) on Day 1 for 12 weeks

Also known as: Antroquinonol 100mg

Antroquinonol capsule 100mg

Placebo oral capsule DRUG

patients will receive placebo per day (QD) on Day 1 for 12 weeks

Also known as: Placebo

Placebo oral capsule

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients between the ages of 20 and 65 years who had moderate-to-severe atopic dermatitis (using the Hanifin and Rajka Diagnostic Criteria)
• Patients with body weight ≥ 25 kg and ≤ 120 kg, signing informed consent
• To be eligible to participate, patients were required to have
• a score of at least 5 on the Eczema Area and Severity Index (EASI), which ranges from 0 to 72, with higher scores indicating worse disease severity;
• a score for pruritus of at least 30 mm on a visual-analogue scale, which ranges from 0 (no itch) to 100 mm (worst itch imaginable);
• a score of at least 2 on the static Investigator's Global Assessment (sIGA), which ranges from 0 (clear) to 4 ( severe disease).
• BSA affected or PSAI ≥ 5%

You may not qualify if:

• Patients meeting any of the following criteria must not be enrolled in the study:
• Patients with active dermatologic diseases concomitant with atopic dermatitis.
• Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study
• Subjects with defective epidermal barrier(e.g Netherton's syndrome)
• Any subject who is immunocompromised or has a history of malignant disease. This information will be gathered verbally from the patient while taking a medical history from the patient, and will not involve further testing such as an HIV test.
• Subjects with a history of psychiatric disease or history of alcohol or drug abuse that would interfere with the ability to comply with the study protocol
• Any noticeable breaks or cracks in the skin on either arm, including severely excoriated skin or skin with open or weeping wounds suggestive of an active infection or increased susceptibility to infection.
• Ongoing participation in another investigational trial
• Use of any oral or topical antibiotic for up to four weeks prior to the Treatment visit or active infection that in the opinion of the investigator would compromise the patient's ability to tolerate therapy
• Use of any systemic immunosuppressive therapy (e.g. CsA, MTX, etc.) within four weeks of the Treatment visit.
• Participant who has a condition or is in a situation that, in the investigator's opinion, may put the patient at significant risk, or may significantly interfere with the patient's participation in the study.
• Subjects with prosthetic heart valves, pacemakers, intravascular catheters, or other foreign or prosthetic devices.
• History of food or drug-related severe anaphylactoid or anaphylactic reaction(s)
• Pregnancy or breastfeeding
• History or presence of epilepsy, significant neurological disorders, cerebrovascular attack or ischemia

Sponsors & Collaborators

• Chung Shan Medical University: lead
• Golden Biotechnology Corporation: collaborator

Study Sites (1)

Chung Shan Medical University Hospital

Taichung, 402, Taiwan

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

antroquinonol

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Wei C- C, M.D.

  Chung Shan Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chung Shan Medical University Hospital

Study Record Dates

• First Submitted: September 30, 2019
• First Posted: October 1, 2019
• Study Start: July 27, 2018
• Primary Completion: June 25, 2019
• Study Completion: June 25, 2019
• Last Updated: October 1, 2019

Record last verified: 2019-09

Locations

TW (1)