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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03654755
Other study ID # ASN002AD-201-EXT
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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