Back to resultsStudy to Evaluate Long-Term Safety of ASN002 in Subjects With Moderate to Severe Atopic Dermatitis
Primary Purpose
Atopic Dermatitis
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ASN002
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis focused on measuring eczema
Eligibility Criteria
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 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 must be a candidate for prolonged open label ASN002 treatment according to the investigator's judgment.
- Subject has a body mass index (BMI) ≤ 35 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.
Sites / Locations
- Pinnacle Research Group, LLC
- Total Skin and Dermatology Center, PC.
- Center for Dermatology Clinical Research, Inc.
- L.A. Universal Research Center, Inc.
- Dermatology Research Associates
- Revival Research
- Clinical Physiology Associates
- Leavitt Medical Associates of Florida
- Dermatology Consulting Services
- Forward Clinical Trials
- Dawes Fretzin Clinical Research Group
- Dermatology Center of Indiana, PC
- The Indiana Clinical Trials Center
- Central Kentucky Research Associates, LLC
- Dermatology Specialists Research
- Tufts Medical Center
- ActivMed Practices and Research, Inc.
- Corning Center for Clinical Research
- Mt. Sinai Hospital
- Wake Research Associates, LLC
- Dermatologists of Greater Colombus
- Wright State Physicians
- Unity Clinical Research
- Vital Prospects Clinical Research Institute
- DermDox Centers for Dermatology
- Synexus
- Dermatology Treatment and Research Center
- Innovate Research, LLC
- The Center for Skin Research
- Progressive Clinical Research
- Virginia Clinical Research, Inc.
- Institute of Skin Advancement Medical, Surgical, Costmetic & Laser Dermatology
- Innovaderm Research, Inc.
- Ontario Inc.
- York Regional Dermatology
- NewLab Clinical Research, Inc.
- AvantDerm
- SkinWISE Dermatology
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
ASN002 40 mg
ASN002 60 mg
ASN002 80 mg
Arm Description
ASN002 40 mg
ASN002 60 mg
ASN002 80 mg
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03654755
Brief Title
Study to Evaluate Long-Term Safety of ASN002 in Subjects With Moderate to Severe Atopic Dermatitis
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Terminated
Why Stopped
Phase 2 study results
Study Start Date
September 29, 2018 (Actual)
Primary Completion Date
October 29, 2019 (Actual)
Study Completion Date
October 29, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Asana BioSciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
eczema
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
162 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ASN002 40 mg
Arm Type
Experimental
Arm Description
ASN002 40 mg
Arm Title
ASN002 60 mg
Arm Type
Experimental
Arm Description
ASN002 60 mg
Arm Title
ASN002 80 mg
Arm Type
Experimental
Arm Description
ASN002 80 mg
Intervention Type
Drug
Intervention Name(s)
ASN002
Intervention Description
Daily dose of ASN002 for up to 110 weeks
Primary Outcome Measure Information:
Title
Change From Baseline in Eczema Area Severity Index (EASI) Score
Description
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
Time Frame
3 Months
Secondary Outcome Measure Information:
Title
Number of Participants Achieving an Investigator Global Assessment (IGA) Scale of Clear (0) or Almost Clear (1)
Description
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.
Time Frame
3 months
Title
Change From Baseline in 5-D Pruritus (Itch) Scale
Description
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
Time Frame
3 months
Title
Change From Baseline in Pruritus (Itch) Numeric Rating Scale (NRS)
Description
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
Time Frame
3 months
Title
Change From Baseline in Patient-Oriented Eczema Measure (POEM)
Description
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
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Zammit, Ph.D.
Organizational Affiliation
Asana BioSciences
Official's Role
Study Director
Facility Information:
Facility Name
Pinnacle Research Group, LLC
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Facility Name
Total Skin and Dermatology Center, PC.
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Center for Dermatology Clinical Research, Inc.
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
L.A. Universal Research Center, Inc.
City
Los Angeles
State/Province
California
ZIP/Postal Code
89148
Country
United States
Facility Name
Dermatology Research Associates
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
Revival Research
City
Doral
State/Province
Florida
ZIP/Postal Code
33122
Country
United States
Facility Name
Clinical Physiology Associates
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Leavitt Medical Associates of Florida
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Dermatology Consulting Services
City
Tampa
State/Province
Florida
ZIP/Postal Code
33625
Country
United States
Facility Name
Forward Clinical Trials
City
Tampa
State/Province
Florida
ZIP/Postal Code
33625
Country
United States
Facility Name
Dawes Fretzin Clinical Research Group
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Facility Name
Dermatology Center of Indiana, PC
City
Plainfield
State/Province
Indiana
ZIP/Postal Code
46168
Country
United States
Facility Name
The Indiana Clinical Trials Center
City
Plainfield
State/Province
Indiana
ZIP/Postal Code
46168
Country
United States
Facility Name
Central Kentucky Research Associates, LLC
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
Dermatology Specialists Research
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40241
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
ActivMed Practices and Research, Inc.
City
Portsmouth
State/Province
New Hampshire
ZIP/Postal Code
03801
Country
United States
Facility Name
Corning Center for Clinical Research
City
Corning
State/Province
New York
ZIP/Postal Code
14830
Country
United States
Facility Name
Mt. Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Wake Research Associates, LLC
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Dermatologists of Greater Colombus
City
Bexley
State/Province
Ohio
ZIP/Postal Code
43209
Country
United States
Facility Name
Wright State Physicians
City
Fairborn
State/Province
Ohio
ZIP/Postal Code
45324
Country
United States
Facility Name
Unity Clinical Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73118
Country
United States
Facility Name
Vital Prospects Clinical Research Institute
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
DermDox Centers for Dermatology
City
Hazleton
State/Province
Pennsylvania
ZIP/Postal Code
18201
Country
United States
Facility Name
Synexus
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
Dermatology Treatment and Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75320
Country
United States
Facility Name
Innovate Research, LLC
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76244
Country
United States
Facility Name
The Center for Skin Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77056
Country
United States
Facility Name
Progressive Clinical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78213
Country
United States
Facility Name
Virginia Clinical Research, Inc.
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Institute of Skin Advancement Medical, Surgical, Costmetic & Laser Dermatology
City
Calgary
ZIP/Postal Code
T3A2N1
Country
Canada
Facility Name
Innovaderm Research, Inc.
City
Montreal
ZIP/Postal Code
H2K4L5
Country
Canada
Facility Name
Ontario Inc.
City
Ottawa
ZIP/Postal Code
K2C3N2
Country
Canada
Facility Name
York Regional Dermatology
City
Richmond Hill
ZIP/Postal Code
L4C9M7
Country
Canada
Facility Name
NewLab Clinical Research, Inc.
City
Saint John's
ZIP/Postal Code
A1C2H5
Country
Canada
Facility Name
AvantDerm
City
Toronto
ZIP/Postal Code
M5A3R6
Country
Canada
Facility Name
SkinWISE Dermatology
City
Winnipeg
ZIP/Postal Code
ABR3M3Z4
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Study to Evaluate Long-Term Safety of ASN002 in Subjects With Moderate to Severe Atopic Dermatitis
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