Study to Evaluate Long-Term Safety of ASN002 in Subjects With Moderate to Severe Atopic Dermatitis
- Registration Number
- NCT03654755
- Lead Sponsor
- Asana BioSciences
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 162
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ASN002 40 mg ASN002 ASN002 40 mg ASN002 80 mg ASN002 ASN002 80 mg ASN002 60 mg ASN002 ASN002 60 mg
- Primary Outcome Measures
Name Time Method Change From Baseline in Eczema Area Severity Index (EASI) Score 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
- Secondary Outcome Measures
Name Time Method Number of Participants Achieving an Investigator Global Assessment (IGA) Scale of Clear (0) or Almost Clear (1) 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.Change From Baseline in Pruritus (Itch) Numeric Rating Scale (NRS) 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
Change From Baseline in 5-D Pruritus (Itch) Scale 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 natureChange From Baseline in Patient-Oriented Eczema Measure (POEM) 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
Trial Locations
- Locations (38)
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
L.A. Universal Research Center, Inc.
🇺🇸Los Angeles, California, United States
Dermatology Research Associates
🇺🇸Los Angeles, California, United States
Revival Research
🇺🇸Doral, Florida, United States
Clinical Physiology Associates
🇺🇸Fort Myers, Florida, United States
Leavitt Medical Associates of Florida
🇺🇸Ormond Beach, Florida, United States
Dermatology Consulting Services
🇺🇸Tampa, Florida, United States
Forward Clinical Trials
🇺🇸Tampa, Florida, United States
Scroll for more (28 remaining)Pinnacle Research Group, LLC🇺🇸Anniston, Alabama, United States