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

Chronic Hand Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03728504
• Other study ID #: ASN002AD-202
• Status: Completed
• Phase: Phase 2
• Start date: January 3, 2019
• Est. completion date: April 29, 2020

Study information

• Verified date: May 2023
• Source: Asana BioSciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: April 29, 2020
• Est. primary completion date: April 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Hand Dermatitis
• Dermatitis
• Eczema

Intervention

Drug:
• ASN002
Daily dose of ASN002 for 32 weeks
• Placebo Oral Tablet
Daily dose of Placebo Oral Tablet for 16 weeks

Locations

Country	Name	City	State
Canada	SimcoDerm Medical and Surgical Dermatology Centre	Barrie	Ontario
Canada	Wei Jing Loo Medicine Professional Corp.	London	Ontario
Canada	Lynderm Research Inc.	Markham	Ontario
Canada	Innovaderm Research, Inc.	Montreal
Canada	Centre de Recherche Dermatologique du Quebec metropolitain	Quebec
Canada	G. Daniel Schachter Medicine Professional	Toronto	Ontario
United States	Pinnacle Research Group, LLC	Anniston	Alabama
United States	Dermatologists of Greater Colombus	Bexley	Ohio
United States	Advanced Clinical Research	Boise	Idaho
United States	BTC Network	Fort Gratiot	Michigan
United States	Minnesota Clinical Research Center	Fridley	Minnesota
United States	Sweet Hope Research Specialty, Inc	Hialeah	Florida
United States	Maryland Laser Skin and Vein	Hunt Valley	Maryland
United States	Dawes Fretzin Clinical Research Group	Indianapolis	Indiana
United States	Dermatology Research Associates	Los Angeles	California
United States	Dermatology Specialists Research	Louisville	Kentucky
United States	RM Medical Research, Inc.	Miami	Florida
United States	DelRicht Research	New Orleans	Louisiana
United States	Virginia Clinical Research, Inc.	Norfolk	Virginia
United States	Lynn Health Science Institute	Oklahoma City	Oklahoma
United States	ActivMed Practices and Research, Inc.	Portsmouth	New Hampshire
United States	Progressive Clinical Research	San Antonio	Texas
United States	Dermatology Specialists of Spokane	Spokane	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Asana BioSciences

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change From Baseline in Hand Physician Global Assessment (PGA)	Proportion of participants with a response of Physicians Global Assessment achieving clear (0) or almost clear (1)	16 weeks
Secondary	Change From Baseline in Hand Patient Global Assessment (PaGA)	Reduction of PaGA compared to baseline where marked improvement was noted with at least 75% clear	16 weeks