Phase 2B Study to Evaluate ASN002 in Subjects With Moderate to Severe Atopic Dermatitis (RADIANT)
- Registration Number
- NCT03531957
- Lead Sponsor
- Asana BioSciences
- Brief Summary
This is a randomized double-blind/placebo study evaluate the efficacy of ASN002 in subjects with moderate to severe atopic dermatitis (AD).
- Detailed Description
This is a placebo controlled study where subjects with moderate to severe atopic dermatitis will be randomized (1:1:1:1) to receive ASN002 at 40 mg, 60 mg, or 80 mg, or placebo once daily for 12 weeks. Eligible subjects will get the opportunity to enroll in the 24 month open-label extension study (OLE). There will be a 4-week follow up period for subjects not participating in the OLE study. This study will also characterize the pharmacokinetics and pharmacodynamics of ASN002 through blood sampling and three or four biopsies from subjects who consent.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 244
-
Written informed consent obtained prior to any study-related procedure being performed;
- Male or female, 18≤ years and ≤75 years of age with chronic AD for at least 6 months.
- At least 10% body surface area (BSA) of AD involvement at the baseline visits
- Has a body mass index (BMI) ≤35 kg/m2
- History of inadequate response to topical corticosteroids or calcineurin inhibitors as treatment for AD within 1 year before the screening visit.
- Willing to apply only a basic bland emollient once or twice-daily for at least 7 days before the baseline visit.
- Willing to comply with discontinuation of certain treatments for AD, as directed by the Investigator.
- Willing to use medically effective methods of birth control
- Females of reproductive potential must have a negative serum pregnancy test at screening and negative urine pregnancy test at Day 1..
- Willing and able to comply with clinic visits and study-related procedures
-
Clinically infected atopic dermatitis.
- Presence of any of the following laboratory abnormalities at the screening visit: Hemoglobin < 11 g/dL, White blood cell (WBC) < 3.0 x 103 /μL, Platelet count < 125 x 103 /μL, Neutrophils < < 2.50 x 103 /μL, Lymphocytes ≤ 1.2 x 103 /μL, Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) > 1.5 x the upper limit of normal (ULN),Total bilirubin > ULN (except for elevated indirect bilirubin secondary to Gilbert's syndrome), Creatinine > ULN
- 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.
- Any condition requiring the use of anticoagulants.
- History of hypertrophic scarring or keloid formation in scars or suture sites.
- Any medical or psychiatric condition which, in the opinion of the investigator or the sponsor's medical monitor, would place the patient at risk, interfere with participation in the study, or interfere with the interpretation of study results
- Pregnant or breast-feeding women
- Known hypersensitivity to ASN002 or its excipients;
- Prior treatment with SYK or JAK inhibitors for which the subject received no clinical benefit, or the subject relapsed whilst on therapy.
- Has received any marketed or investigational biological agent within 12 weeks or 5 half-lives (whichever is longer) prior to Day 1.
- Planned major surgical procedure during the length of the patient's participation in this study
- There will be a waiting period of 4 weeks before receiving the first does for anyone who has used oral or intravenous treatments (other than biologics) that could affect atopic dermatitis, received a non-biological investigational product or device, excessive sun exposure, is planning a trip to a sunny climate, or has used tanning booths, or received or plans to receive a live attenuated vaccine one four weeks after the last day of taking the drug.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Oral Tablet Placebo Oral Tablet Matching placebo for ASN002 doses ASN002 80 mg ASN002 80 mg ASN002 ASN002 60 mg ASN002 60 mg ASN002 ASN002 40 mg ASN002 40 mg ASN002
- Primary Outcome Measures
Name Time Method Change From Baseline in Eczema Area and Severity Index (EASI) at Week 12 Week 12 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.
- Secondary Outcome Measures
Name Time Method Percent of Participant With at Least a 75% Reduction From Baseline in Eczema Area and Severity Index (EASI75) Week 12 Percent of participants with at least a 75% reduction from baseline in EASI (EASI75) at Week 12
Change From Baseline in Body Surface Area (BSA) Week 12 The overall body surface area (BSA) affected by atopic dermatitis is evaluated (from 0% to 100%).
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Week 12 In the SCORAD grading system, six items (erythema, edema/papulation, oozing/crusts, excoriation, lichenification, and dryness) evaluate the Atopic Dermatitis severity. The overall body surface area affected by atopic dermatitis was evaluated (from 0% to 100%) and included in the SCORAD scores. Loss of sleep and pruritus were evaluated by subjects on a visual analog scale (0-10) and were based on the average of the last three days/nights. The sum of these measures represented the SCORAD, which could range from 0 to 103. The higher the score the more severe the disease.
Change From Baseline in Patient-Oriented Eczema Measure (POEM) Week 12 The Patient-Oriented Eczema Measure (POEM) is a self-assessment of disease severity by the subject. The POEM has a maximum value of 28 based on the subject's response to seven questions scored from 0 to 4. The higher the value the more severe the disease is.
Change From Baseline in 5-D Pruritus (Itching) Scale Week 12 The 5-D Pruritus Scale is a 1-page, 5-question, validated questionnaire used in clinical trials to assess 5 dimensions of background itch: degree, duration, direction, disability, and distribution. Each question corresponds to 1 of the 5 dimensions of itch; subjects rated their symptoms over the preceding 2-week period as "present" or on a 1 to 5 scale, 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).
Percentage of Participants With a Response of Investigator's Global Assessment (IGA) 0 or 1 Week 12 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 0 is the least severe and 4 is the most severe.
Change From Baseline in Dermatology Life Quality Index (DLQI) Week 12 Dermatology Life Quality Index Questionnaire (DLQI) is a simple 10-question validated questionnaire that has been used in more than 40 different skin conditions. The DLQI total score is defined as the sum of the 10 item scales, ranging from 0 to 30. The higher the value, the more severe the disease is.
Trial Locations
- Locations (47)
Revival Research
🇺🇸Doral, Florida, United States
Innovaderm Research, Inc.
🇨🇦Montreal, Canada
Mt. Sinai Hospital
🇺🇸New York, New York, United States
Synexus
🇺🇸Greer, South Carolina, United States
Dawes Fretzin Clinical Research Group
🇺🇸Indianapolis, Indiana, United States
SkinWISE Dermatology
🇨🇦Winnipeg, Canada
Fachklinik Bad Bentheim
🇩🇪Bad Bentheim, Germany
AvantDerm
🇨🇦Toronto, Canada
NewLab Clinical Research, Inc.
🇨🇦Saint John's, Canada
MENSINGDERMA research GmbH
🇩🇪Hamburg, Germany
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Universitätsklinikum Dresden
🇩🇪Dresden, Germany
Charité - Universitätsmedizin Berlin
🇩🇪Berlin, Germany
Universitätshautklinik Münster
🇩🇪Münster, Germany
Universitätsklinikum Schleswig-Holstein
🇩🇪Lubeck, Germany
Universitätsklinikum Frankfurt
🇩🇪Frankfurt, Germany
SRH Wald-Klinikum Gera GmbH
🇩🇪Gera, Germany
Pinnacle Research Group, LLC
🇺🇸Anniston, Alabama, United States
Total Skin and Dermatology Center, PC.
🇺🇸Birmingham, Alabama, United States
Center for Dermatology Clinical Research, Inc.
🇺🇸Fremont, California, United States
Dermatology Research Associates
🇺🇸Los Angeles, California, United States
L.A. Universal Research Center, Inc.
🇺🇸Los Angeles, California, United States
Clinical Physiology Associates
🇺🇸Fort Myers, Florida, United States
Dermatology Center of Indiana, PC
🇺🇸Plainfield, Indiana, United States
The Indiana Clinical Trials Center
🇺🇸Plainfield, Indiana, United States
Leavitt Medical Associates of Florida
🇺🇸Ormond Beach, Florida, United States
ActivMed Practices and Research, Inc.
🇺🇸Portsmouth, New Hampshire, United States
Corning Center for Clinical Research
🇺🇸Corning, New York, United States
Wake Research Associates, LLC
🇺🇸Raleigh, North Carolina, United States
Dermatologists of Greater Colombus
🇺🇸Bexley, Ohio, United States
Wright State Physicians
🇺🇸Fairborn, Ohio, United States
Unity Clinical Research
🇺🇸Oklahoma City, Oklahoma, United States
Vital Prospects Clinical Research Institute
🇺🇸Tulsa, Oklahoma, United States
DermDox Centers for Dermatology
🇺🇸Hazleton, Pennsylvania, United States
Dermatology Treatment and Research Center
🇺🇸Dallas, Texas, United States
The Center for Skin Research
🇺🇸Houston, Texas, United States
Virginia Clinical Research, Inc.
🇺🇸Norfolk, Virginia, United States
Progressive Clinical Research
🇺🇸San Antonio, Texas, United States
Institute of Skin Advancement Medical, Surgical, Costmetic & Laser Dermatology
🇨🇦Calgary, Canada
Ontario Inc.
🇨🇦Ottawa, Canada
York Regional Dermatology
🇨🇦Richmond Hill, Canada
Universitätsklinikum Bonn AöR
🇩🇪Bonn, Germany
Innovate Research, LLC
🇺🇸Fort Worth, Texas, United States
Dermatology Specialists Research
🇺🇸Louisville, Kentucky, United States
Forward Clinical Trials
🇺🇸Tampa, Florida, United States
Central Kentucky Research Associates, LLC
🇺🇸Lexington, Kentucky, United States
Dermatology Consulting Services
🇺🇸Tampa, Florida, United States