Study to Evaluate Long-Term Safety of ASN002 in Subjects With Moderate to Severe Atopic Dermatitis

Atopic Dermatitis Clinical Trial

Official title:

A Phase 2, Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of ASN002 in Subjects With Moderate to Severe Atopic Dermatitis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03654755
• Other study ID #: ASN002AD-201-EXT
• Status: Terminated
• Phase: Phase 2
• Start date: September 29, 2018
• Est. completion date: October 29, 2019

Study information

• Verified date: September 2023
• Source: Asana BioSciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized open label study to evaluate the long term safety of ASN002 in subjects with moderate to severe atopic dermatitis (AD).

Description:

This is a randomized open label study where subjects with moderate to severe atopic dermatitis will roll over from the Phase 1 ASN002AD-101 (NCT03139981) and ASN002AD-201 (NCT03531957) Ph2b study and be randomized to receive ASN002 at 40mg, 60mg, or 80mg once daily for up to 24 months. This study will also characterize the pharmacokinetics of ASN002 through blood sampling from subjects who consent.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 162
• Est. completion date: October 29, 2019
• Est. primary completion date: October 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria

• Subject with a history of moderate to severe atopic dermatitis who participated in the preceding ASN002AD-201 and ASN002AD-101 study
• Subject must be a candidate for prolonged open label ASN002/gusacitinib treatment according to the investigator's judgment.
• Subject has been using an emollient daily for at least 1 week prior to Day 1 and agrees to continue using that same emollient daily throughout the study.
• Men and women participating in the study must use medically acceptable birth control or total abstinence from sexual intercourse
• Subject is willing to participate and is capable of giving informed consent. Note:

Consent must be obtained prior to any study-related procedures.

• Subjects must be willing to comply with all study procedures and must be available for the duration of the study.
• Subject has a body mass index (BMI) = 38 kg/m2. Exclusion Criteria
• Subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study.
• Subject has clinically infected atopic dermatitis.
• A serious uncontrolled condition including hypertension, history of tuberculosis, hepatitis B or C infection, immune deficiency, heart disease, heart conduction disorder, diverticulitis, diabetes, reflux disease requiring protocol pump inhibitor therapy, malabsorption syndrome, or cancer
• Subject has a history of skin disease or presence of skin condition that, in the opinion of the investigator, would interfere with the study assessments.
• Subject has a history of eczema herpeticum within 12 months, and/or a history of 2 or more episodes of eczema herpeticum in the past.
• Willing to comply with discontinuation of certain treatments for AD, as directed by the Investigator.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• ASN002
Daily dose of ASN002 for up to 110 weeks

Locations

Country	Name	City	State
Canada	Institute of Skin Advancement Medical, Surgical, Costmetic & Laser Dermatology	Calgary
Canada	Innovaderm Research, Inc.	Montreal
Canada	Ontario Inc.	Ottawa
Canada	York Regional Dermatology	Richmond Hill
Canada	NewLab Clinical Research, Inc.	Saint John's
Canada	AvantDerm	Toronto
Canada	SkinWISE Dermatology	Winnipeg
United States	Pinnacle Research Group, LLC	Anniston	Alabama
United States	Dermatologists of Greater Colombus	Bexley	Ohio
United States	Total Skin and Dermatology Center, PC.	Birmingham	Alabama
United States	Tufts Medical Center	Boston	Massachusetts
United States	Corning Center for Clinical Research	Corning	New York
United States	Dermatology Treatment and Research Center	Dallas	Texas
United States	Revival Research	Doral	Florida
United States	Wright State Physicians	Fairborn	Ohio
United States	Clinical Physiology Associates	Fort Myers	Florida
United States	Innovate Research, LLC	Fort Worth	Texas
United States	Center for Dermatology Clinical Research, Inc.	Fremont	California
United States	Synexus	Greer	South Carolina
United States	DermDox Centers for Dermatology	Hazleton	Pennsylvania
United States	The Center for Skin Research	Houston	Texas
United States	Dawes Fretzin Clinical Research Group	Indianapolis	Indiana
United States	Central Kentucky Research Associates, LLC	Lexington	Kentucky
United States	Dermatology Research Associates	Los Angeles	California
United States	L.A. Universal Research Center, Inc.	Los Angeles	California
United States	Dermatology Specialists Research	Louisville	Kentucky
United States	Mt. Sinai Hospital	New York	New York
United States	Virginia Clinical Research, Inc.	Norfolk	Virginia
United States	Unity Clinical Research	Oklahoma City	Oklahoma
United States	Leavitt Medical Associates of Florida	Ormond Beach	Florida
United States	Dermatology Center of Indiana, PC	Plainfield	Indiana
United States	The Indiana Clinical Trials Center	Plainfield	Indiana
United States	ActivMed Practices and Research, Inc.	Portsmouth	New Hampshire
United States	Wake Research Associates, LLC	Raleigh	North Carolina
United States	Progressive Clinical Research	San Antonio	Texas
United States	Dermatology Consulting Services	Tampa	Florida
United States	Forward Clinical Trials	Tampa	Florida
United States	Vital Prospects Clinical Research Institute	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Asana BioSciences

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Eczema Area Severity Index (EASI) Score	The Eczema Area and Severity Index (EASI) is a composite score ranging from 0 to 72, the higher the value the worse the disease, that takes into account the degree of erythema, induration/infiltration (papules), excoriation, and lichenification (each scored from 0 to 3 separately) for each of four body regions, with adjustment for the percentage of BSA involved for each body region and for the proportion of the body region to the whole body.; Due to early termination of the study, all efficacy analyses were descriptive in nature	3 Months
Secondary	Number of Participants Achieving an Investigator Global Assessment (IGA) Scale of Clear (0) or Almost Clear (1)	The IGA is a global assessment of the current state of the disease. It is a 5-point (0-4) morphological assessment of overall disease severity. The IGA is selected using descriptors that best describe the overall appearance of the lesions at any given point. Signs like inflammation, redness, oozing, and crusting are evaluated. The 0 is the least severe and 4 is the most severe.; Due to early termination of the study, all efficacy analyses were descriptive in nature.	3 months
Secondary	Change From Baseline in 5-D Pruritus (Itch) Scale	The 5-D Pruritus Scale is a validated questionnaire used in clinical trials to assess the degree, duration, direction, disability, and distribution of the itch to rate the their symptoms over the preceding 2-week period. Each symptoms is scored on a scale of 1 to 5, with 5 being the most affected. The total score of 5-D pruritus is a sum of the 5 scores to provide a total score range from 5 (best) to 25 (worst).; Due to early termination of the study, all efficacy analyses were descriptive in nature	3 months
Secondary	Change From Baseline in Pruritus (Itch) Numeric Rating Scale (NRS)	Intensity of itch will be measured using an NRS to indicate the intensity of the worst itching over the past 24 hours using a 0 to 10 numeric rating scale, where "0" represents "no itching" and "10" represents "worst itching imaginable" Due to early termination of the study, all efficacy analyses were descriptive in nature	3 months
Secondary	Change From Baseline in Patient-Oriented Eczema Measure (POEM)	POEM developed by Charman et al. is a self-assessment of disease severity by the participant. The POEM includes 7 questions to evaluate the number of days the signs and symptoms of eczema over the last week. The answer to each question is categorized by the frequency of the sign or symptom from no days to 7 days. Each question is scored from 0 to 4 and the sum of the questions if the POEM score. The score ranges from 0 to 28 with 0 being the least frequency and 28 showing that all the signs and symptoms occur every day. Therefore, the higher the score, the more severe the eczema. Due to early termination of the study, all efficacy analyses were descriptive in nature	3 months