Study to Evaluate ASN002 in Subjects With Moderate To Severe Chronic Hand Eczema

NCT ID: NCT03728504

Last Updated: 2023-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 97 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-03
• Study Completion Date: 2020-04-29

Brief Summary

Randomized double-blind/placebo study to evaluate the efficacy of ASN002 in subjects with severe chronic hand eczema.

Detailed Description

This is a placebo controlled study where subjects with severe chronic hand eczema will be randomized (1:1:1) to receive ASN002 at 40 mg, 80 mg, or placebo once daily for 16 weeks (Part A). Then, in Part B, subjects who were assigned to placebo in the first part of the study will receive the highest dose of ASN002 (80 mg) for the rest of the treatment period (up to Week 32). The subjects who were assigned ASN002 in the first part of the study will continue on the same assigned treatment dose during the second part of the study (Week 16 to Week 32). The total treatment period of 32 weeks will be followed by a 4 week follow-up period.This study will also characterize the pharmacokinetics and pharmacodynamics of ASN002 through blood sampling and three or four biopsies from subjects who consent.

Conditions

Chronic Hand Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

ASN002 40 mg

40 mg ASN002

Group Type: EXPERIMENTAL

ASN002

Intervention Type: DRUG

Daily dose of ASN002 for 32 weeks

ASN002 80 mg

80 mg ASN002

Group Type: EXPERIMENTAL

ASN002

Intervention Type: DRUG

Daily dose of ASN002 for 32 weeks

Placebo oral tablet

Matching placebo for ASN002 doses

Group Type: PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type: DRUG

Daily dose of Placebo Oral Tablet for 16 weeks

Interventions

ASN002

Daily dose of ASN002 for 32 weeks

Intervention Type: DRUG

Placebo Oral Tablet

Daily dose of Placebo Oral Tablet for 16 weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asana BioSciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Zammit, Ph.D.

Role: STUDY_DIRECTOR

Asana BioSciences

Locations

Pinnacle Research Group, LLC

Anniston, Alabama, United States

Dermatology Research Associates

Los Angeles, California, United States

Sweet Hope Research Specialty, Inc

Hialeah, Florida, United States

RM Medical Research, Inc.

Miami, Florida, United States

Advanced Clinical Research

Boise, Idaho, United States

Dawes Fretzin Clinical Research Group

Indianapolis, Indiana, United States

Dermatology Specialists Research

Louisville, Kentucky, United States

DelRicht Research

New Orleans, Louisiana, United States

Maryland Laser Skin and Vein

Hunt Valley, Maryland, United States

BTC Network

Fort Gratiot, Michigan, United States

Minnesota Clinical Research Center

Fridley, Minnesota, United States

ActivMed Practices and Research, Inc.

Portsmouth, New Hampshire, United States

Dermatologists of Greater Colombus

Bexley, Ohio, United States

Lynn Health Science Institute

Oklahoma City, Oklahoma, United States

Progressive Clinical Research

San Antonio, Texas, United States

Virginia Clinical Research, Inc.

Norfolk, Virginia, United States

Dermatology Specialists of Spokane

Spokane, Washington, United States

SimcoDerm Medical and Surgical Dermatology Centre

Barrie, Ontario, Canada

Wei Jing Loo Medicine Professional Corp.

London, Ontario, Canada

Lynderm Research Inc.

Markham, Ontario, Canada

G. Daniel Schachter Medicine Professional

Toronto, Ontario, Canada

Innovaderm Research, Inc.

Montreal, , Canada

Centre de Recherche Dermatologique du Quebec metropolitain

Québec, , Canada

Countries

United States; Canada

References

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.

Reference Type: DERIVED

PMID: 39760239 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

ASN002AD-202

Identifier Type: -

Identifier Source: org_study_id