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

Primary Purpose

Chronic Hand Dermatitis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ASN002
Placebo Oral Tablet
Sponsored by
Asana BioSciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hand Dermatitis focused on measuring eczema, hand eczema, hand dermatitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 severe CHE at Day 1, as defined by a hand PGA ≥ 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) ≤ 35 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 1.2 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.

Sites / Locations

  • Pinnacle Research Group, LLC
  • Dermatology Research Associates
  • Sweet Hope Research Specialty, Inc
  • RM Medical Research, Inc.
  • Advanced Clinical Research
  • Dawes Fretzin Clinical Research Group
  • Dermatology Specialists Research
  • DelRicht Research
  • Maryland Laser Skin and Vein
  • BTC Network
  • Minnesota Clinical Research Center
  • ActivMed Practices and Research, Inc.
  • Dermatologists of Greater Colombus
  • Lynn Health Science Institute
  • Progressive Clinical Research
  • Virginia Clinical Research, Inc.
  • Dermatology Specialists of Spokane
  • SimcoDerm Medical and Surgical Dermatology Centre
  • Wei Jing Loo Medicine Professional Corp.
  • Lynderm Research Inc.
  • G. Daniel Schachter Medicine Professional
  • Innovaderm Research, Inc.
  • Centre de Recherche Dermatologique du Quebec metropolitain

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

ASN002 40 mg

ASN002 80 mg

Placebo oral tablet

Arm Description

40 mg ASN002

80 mg ASN002

Matching placebo for ASN002 doses

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)
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

Full Information

First Posted
October 31, 2018
Last Updated
May 5, 2023
Sponsor
Asana BioSciences
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1. Study Identification

Unique Protocol Identification Number
NCT03728504
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 3, 2019 (Actual)
Primary Completion Date
April 29, 2020 (Actual)
Study Completion Date
April 29, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Asana BioSciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hand Dermatitis
Keywords
eczema, hand eczema, hand dermatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
97 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ASN002 40 mg
Arm Type
Experimental
Arm Description
40 mg ASN002
Arm Title
ASN002 80 mg
Arm Type
Experimental
Arm Description
80 mg ASN002
Arm Title
Placebo oral tablet
Arm Type
Placebo Comparator
Arm Description
Matching placebo for ASN002 doses
Intervention Type
Drug
Intervention Name(s)
ASN002
Intervention Description
Daily dose of ASN002 for 32 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Intervention Description
Daily dose of Placebo Oral Tablet for 16 weeks
Primary Outcome Measure Information:
Title
Percent Change From Baseline in Modified Total Lesion Symptom Score (mTLSS)
Description
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)
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Change From Baseline in Hand Physician Global Assessment (PGA)
Description
Proportion of participants with a response of Physicians Global Assessment achieving clear (0) or almost clear (1)
Time Frame
16 weeks
Title
Change From Baseline in Hand Patient Global Assessment (PaGA)
Description
Reduction of PaGA compared to baseline where marked improvement was noted with at least 75% clear
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Zammit, Ph.D.
Organizational Affiliation
Asana BioSciences
Official's Role
Study Director
Facility Information:
Facility Name
Pinnacle Research Group, LLC
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Facility Name
Dermatology Research Associates
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
Sweet Hope Research Specialty, Inc
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
RM Medical Research, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33174
Country
United States
Facility Name
Advanced Clinical Research
City
Boise
State/Province
Idaho
ZIP/Postal Code
83713
Country
United States
Facility Name
Dawes Fretzin Clinical Research Group
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Facility Name
Dermatology Specialists Research
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40241
Country
United States
Facility Name
DelRicht Research
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Maryland Laser Skin and Vein
City
Hunt Valley
State/Province
Maryland
ZIP/Postal Code
21030
Country
United States
Facility Name
BTC Network
City
Fort Gratiot
State/Province
Michigan
ZIP/Postal Code
48059
Country
United States
Facility Name
Minnesota Clinical Research Center
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
ActivMed Practices and Research, Inc.
City
Portsmouth
State/Province
New Hampshire
ZIP/Postal Code
03801
Country
United States
Facility Name
Dermatologists of Greater Colombus
City
Bexley
State/Province
Ohio
ZIP/Postal Code
43209
Country
United States
Facility Name
Lynn Health Science Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Progressive Clinical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78213
Country
United States
Facility Name
Virginia Clinical Research, Inc.
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Dermatology Specialists of Spokane
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
SimcoDerm Medical and Surgical Dermatology Centre
City
Barrie
State/Province
Ontario
ZIP/Postal Code
73112
Country
Canada
Facility Name
Wei Jing Loo Medicine Professional Corp.
City
London
State/Province
Ontario
ZIP/Postal Code
N6H5L5
Country
Canada
Facility Name
Lynderm Research Inc.
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P1X2
Country
Canada
Facility Name
G. Daniel Schachter Medicine Professional
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4W2N2
Country
Canada
Facility Name
Innovaderm Research, Inc.
City
Montreal
ZIP/Postal Code
H2K4L5
Country
Canada
Facility Name
Centre de Recherche Dermatologique du Quebec metropolitain
City
Quebec
ZIP/Postal Code
G1V4X7
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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