Clinical trial NCT03728504: Study to Evaluate ASN002 in Subjects With Moderate To Severe Chronic Hand Eczema
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Hand Dermatitis
Keywords: eczema
hand eczema
hand dermatitis
Lead sponsor: Asana BioSciences
Sponsor class: INDUSTRY
First posted: 2018-11-02
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Percent Change From Baseline in Modified Total Lesion Symptom Score (mTLSS)
timeFrame: 16 weeks
Secondary outcomes:
measure: Change From Baseline in Hand Physician Global Assessment (PGA)
timeFrame: 16 weeks
measure: Change From Baseline in Hand Patient Global Assessment (PaGA)
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Pinnacle Research Group, LLC
state: Alabama
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: Hialeah
country: United States
facility: Sweet Hope Research Specialty, Inc
state: Florida
city: Miami
country: United States
facility: RM Medical Research, Inc.
state: Florida
city: Boise
country: United States
facility: Advanced Clinical Research
state: Idaho
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group
state: Indiana
city: Louisville
country: United States
facility: Dermatology Specialists Research
state: Kentucky
city: New Orleans
country: United States
facility: DelRicht Research
state: Louisiana
city: Hunt Valley
country: United States
facility: Maryland Laser Skin and Vein
state: Maryland
city: Fort Gratiot
country: United States
facility: BTC Network
state: Michigan
city: Fridley
country: United States
facility: Minnesota Clinical Research Center
state: Minnesota
city: Portsmouth
country: United States
facility: ActivMed Practices and Research, Inc.
state: New Hampshire
city: Bexley
country: United States
facility: Dermatologists of Greater Colombus
state: Ohio
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: San Antonio
country: United States
facility: Progressive Clinical Research
state: Texas
city: Norfolk
country: United States
facility: Virginia Clinical Research, Inc.
state: Virginia
city: Spokane
country: United States
facility: Dermatology Specialists of Spokane
state: Washington
city: Barrie
country: Canada
facility: SimcoDerm Medical and Surgical Dermatology Centre
state: Ontario
city: London
country: Canada
facility: Wei Jing Loo Medicine Professional Corp.
state: Ontario
city: Markham
country: Canada
facility: Lynderm Research Inc.
state: Ontario
city: Toronto
country: Canada
facility: G. Daniel Schachter Medicine Professional
state: Ontario
city: Montreal
country: Canada
facility: Innovaderm Research, Inc.
city: Quebec
country: Canada
facility: Centre de Recherche Dermatologique du Quebec metropolitain
Study officials:
affiliation: Asana BioSciences
name: David Zammit, Ph.D.
role: STUDY_DIRECTOR
References: