Study to Evaluate ASN002 in Subjects With Moderate To Severe Chronic Hand Eczema
A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of ASN002 in Subjects With Moderate To Severe Chronic Hand Eczema Refractory to Corticosteroid Therapy
1 other identifier
interventional
97
2 countries
23
Brief Summary
Randomized double-blind/placebo study to evaluate the efficacy of ASN002 in subjects with severe chronic hand eczema.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2019
Shorter than P25 for phase_2
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 31, 2018
CompletedFirst Posted
Study publicly available on registry
November 2, 2018
CompletedStudy Start
First participant enrolled
January 3, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 29, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 29, 2020
CompletedResults Posted
Study results publicly available
May 9, 2023
CompletedMay 9, 2023
May 1, 2023
1.3 years
October 31, 2018
April 13, 2023
May 5, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent Change From Baseline in Modified Total Lesion Symptom Score (mTLSS)
Percent change from baseline in hand mTLSS at Week 16. The mTLSS is an assessment of the severity of each of the following: erythema, scaling, lichenification/hyperkeratosis, vesicles, edema, fissures, and pruritus/pain. Each of these are rated using a 4-point severity scale. The ratings are added to create a total mTLSS calculated as the sum of assigned individual scores with a maximum value of 21 (most severe disease) and a minimum of 0 (no disease)
16 weeks
Secondary Outcomes (2)
Change From Baseline in Hand Physician Global Assessment (PGA)
16 weeks
Change From Baseline in Hand Patient Global Assessment (PaGA)
16 weeks
Study Arms (3)
ASN002 40 mg
EXPERIMENTAL40 mg ASN002
ASN002 80 mg
EXPERIMENTAL80 mg ASN002
Placebo oral tablet
PLACEBO COMPARATORMatching placebo for ASN002 doses
Interventions
Eligibility Criteria
You may qualify if:
- Written informed consent obtained prior to any study-related procedure being performed
- Male or female subject, aged 18 to 75 years, inclusive, at the time of consent.
- Subject has a history of severe CHE for at least 6 months prior to baseline
- Subject has hand eczema refractory to high potency or ultra-high potency topical corticosteroids
- Subject has moderate to severe CHE at Day 1, as defined by a hand PGA 3 or 4.
- Subject has been using an emollient on their hands and feet (except those containing urea or salicylic acid) every day at the same frequency for at least 1 week prior to Day 1
- Subject has a body mass index (BMI) ≤ 38 kg/m2.
- Female subject of childbearing potential has had a negative serum pregnancy test at screening and negative urine pregnancy test on Day 1.
- Willing and able to comply with clinical visits and study related procedures.
You may not qualify if:
- 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 \< 1.80 x 103 /μL, Lymphocytes \<0.9 x 103 /μL, Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \> 2x the upper limit of normal (ULN),Total bilirubin \> 1.2x ULN (except for elevated indirect bilirubin secondary to Gilbert's syndrome), Creatinine \> ULN
- A serious uncontrolled condition including hypertension, active 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.
- Active skin infections of the hands and/or feet
- 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.
- Subject has received any marketed or investigational biological agent within 12 weeks or 5 half-lives (whichever is longer) prior to Day 1.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Pinnacle Research Group, LLC
Anniston, Alabama, 36207, United States
Dermatology Research Associates
Los Angeles, California, 90045, United States
Sweet Hope Research Specialty, Inc
Hialeah, Florida, 33016, United States
RM Medical Research, Inc.
Miami, Florida, 33174, United States
Advanced Clinical Research
Boise, Idaho, 83713, United States
Dawes Fretzin Clinical Research Group
Indianapolis, Indiana, 46256, United States
Dermatology Specialists Research
Louisville, Kentucky, 40241, United States
DelRicht Research
New Orleans, Louisiana, 70115, United States
Maryland Laser Skin and Vein
Hunt Valley, Maryland, 21030, United States
BTC Network
Fort Gratiot, Michigan, 48059, United States
Minnesota Clinical Research Center
Fridley, Minnesota, 55432, United States
ActivMed Practices and Research, Inc.
Portsmouth, New Hampshire, 03801, United States
Dermatologists of Greater Colombus
Bexley, Ohio, 43209, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112, United States
Progressive Clinical Research
San Antonio, Texas, 78213, United States
Virginia Clinical Research, Inc.
Norfolk, Virginia, 23502, United States
Dermatology Specialists of Spokane
Spokane, Washington, 99202, United States
SimcoDerm Medical and Surgical Dermatology Centre
Barrie, Ontario, 73112, Canada
Wei Jing Loo Medicine Professional Corp.
London, Ontario, N6H5L5, Canada
Lynderm Research Inc.
Markham, Ontario, L3P1X2, Canada
G. Daniel Schachter Medicine Professional
Toronto, Ontario, M4W2N2, Canada
Innovaderm Research, Inc.
Montreal, H2K4L5, Canada
Centre de Recherche Dermatologique du Quebec metropolitain
Québec, G1V4X7, Canada
Related Publications (1)
Bar J, Del Duca E, David E, Bose S, Chefitz G, Brunner PM, Bissonnette R, Guttman-Yassky E. Skin Tape Stripping Reveals Distinct Biomarker Profiles in Chronic Hand Eczema of Patients With and Without Comorbid Atopic Dermatitis. Allergy. 2025 Aug;80(8):2271-2285. doi: 10.1111/all.16466. Epub 2025 Jan 6.
PMID: 39760239DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Niranjan Rao
- Organization
- Libertas BioSciences
Study Officials
- STUDY DIRECTOR
David Zammit, Ph.D.
Asana BioSciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 31, 2018
First Posted
November 2, 2018
Study Start
January 3, 2019
Primary Completion
April 29, 2020
Study Completion
April 29, 2020
Last Updated
May 9, 2023
Results First Posted
May 9, 2023
Record last verified: 2023-05