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

September 14, 2023 updated by: Asana BioSciences

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

162

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Calgary, Canada, T3A2N1
        • Institute of Skin Advancement Medical, Surgical, Costmetic & Laser Dermatology
      • Montreal, Canada, H2K4L5
        • Innovaderm Research, Inc.
      • Ottawa, Canada, K2C3N2
        • Ontario Inc.
      • Richmond Hill, Canada, L4C9M7
        • York Regional Dermatology
      • Saint John's, Canada, A1C2H5
        • NewLab Clinical Research, Inc.
      • Toronto, Canada, M5A3R6
        • AvantDerm
      • Winnipeg, Canada, ABR3M3Z4
        • SkinWise Dermatology
  • United States
    • Alabama
      • Anniston, Alabama, United States, 36207
        • Pinnacle Research Group, LLC
      • Birmingham, Alabama, United States, 35205
        • Total Skin and Dermatology Center, PC.
    • California
      • Fremont, California, United States, 94538
        • Center for Dermatology Clinical Research, Inc.
      • Los Angeles, California, United States, 90045
        • Dermatology Research Associates
      • Los Angeles, California, United States, 89148
        • L.A. Universal Research Center, INC.
    • Florida
      • Doral, Florida, United States, 33122
        • Revival Research
      • Fort Myers, Florida, United States, 33912
        • Clinical Physiology Associates
      • Ormond Beach, Florida, United States, 32174
        • Leavitt Medical Associates of Florida
      • Tampa, Florida, United States, 33625
        • Dermatology Consulting Services
      • Tampa, Florida, United States, 33625
        • Forward Clinical Trials
    • Indiana
      • Indianapolis, Indiana, United States, 46256
        • Dawes Fretzin Clinical Research Group
      • Plainfield, Indiana, United States, 46168
        • The Indiana Clinical Trials Center
      • Plainfield, Indiana, United States, 46168
        • Dermatology Center of Indiana, PC
    • Kentucky
      • Lexington, Kentucky, United States, 40509
        • Central Kentucky Research Associates, LLC
      • Louisville, Kentucky, United States, 40241
        • Dermatology Specialists Research
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center
    • New Hampshire
      • Portsmouth, New Hampshire, United States, 03801
        • ActivMed Practices and Research, Inc.
    • New York
      • Corning, New York, United States, 14830
        • Corning Center for Clinical Research
      • New York, New York, United States, 10029
        • Mt. Sinai Hospital
    • North Carolina
      • Raleigh, North Carolina, United States, 27612
        • Wake Research Associates, LLC
    • Ohio
      • Bexley, Ohio, United States, 43209
        • Dermatologists of Greater Colombus
      • Fairborn, Ohio, United States, 45324
        • Wright State Physicians
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73118
        • Unity Clinical Research
      • Tulsa, Oklahoma, United States, 74136
        • Vital Prospects Clinical Research Institute
    • Pennsylvania
      • Hazleton, Pennsylvania, United States, 18201
        • DermDox Centers for Dermatology
    • South Carolina
      • Greer, South Carolina, United States, 29651
        • SYNEXUS
    • Texas
      • Dallas, Texas, United States, 75320
        • Dermatology Treatment and Research Center
      • Fort Worth, Texas, United States, 76244
        • Innovate Research, LLC
      • Houston, Texas, United States, 77056
        • The Center for Skin Research
      • San Antonio, Texas, United States, 78213
        • Progressive Clinical Research
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Virginia Clinical Research, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ASN002 40 mg
Drug: ASN002
Daily dose of ASN002 for up to 110 weeks
Experimental: ASN002 60 mg
Drug: ASN002
Daily dose of ASN002 for up to 110 weeks
Experimental: ASN002 80 mg
Drug: ASN002
Daily dose of ASN002 for up to 110 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Eczema Area Severity Index (EASI) Score
Time Frame: 3 Months

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Achieving an Investigator Global Assessment (IGA) Scale of Clear (0) or Almost Clear (1)
Time Frame: 3 months

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
Change From Baseline in 5-D Pruritus (Itch) Scale
Time Frame: 3 months

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
Change From Baseline in Pruritus (Itch) Numeric Rating Scale (NRS)
Time Frame: 3 months
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
Change From Baseline in Patient-Oriented Eczema Measure (POEM)
Time Frame: 3 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asana BioSciences

Investigators

  • Study Director: David Zammit, Ph.D., Asana BioSciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 29, 2018

Primary Completion (Actual)

October 29, 2019

Study Completion (Actual)

October 29, 2019

Study Registration Dates

First Submitted

August 16, 2018

First Submitted That Met QC Criteria

August 29, 2018

First Posted (Actual)

August 31, 2018

Study Record Updates

Last Update Posted (Actual)

September 18, 2023

Last Update Submitted That Met QC Criteria

September 14, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASN002AD-201-EXT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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