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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03728504
Recruitment Status : Completed
First Posted : November 2, 2018
Last Update Posted : June 17, 2020
Sponsor:
Information provided by (Responsible Party):
Asana BioSciences

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

Condition or disease Intervention/treatment Phase
Chronic Hand Dermatitis Drug: ASN002 Drug: Placebo Oral Tablet Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 97 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Topical Corticosteroid Therapy
Actual Study Start Date : January 3, 2019
Actual Primary Completion Date : April 28, 2020
Actual Study Completion Date : April 28, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema
Drug Information available for: Asparagine

Arm Intervention/treatment
Experimental: ASN002 40 mg
40 mg ASN002
Drug: ASN002
Daily dose of ASN002 for 32 weeks

Experimental: ASN002 80 mg
80 mg ASN002
Drug: ASN002
Daily dose of ASN002 for 32 weeks

Placebo Comparator: Placebo oral tablet
Matching placebo for ASN002 doses
Drug: Placebo Oral Tablet
Daily dose of Placebo Oral Tablet for 16 weeks




Primary Outcome Measures :
  1. Change from baseline in modified Total Lesion Symptom Score (mTLSS) [ Time Frame: 16 weeks ]
    Change from baseline in hand mTLSS at week 16


Secondary Outcome Measures :
  1. Change from baseline in hand modified Total Lesion Symptom Score (mTLSS) [ Time Frame: 4, 8, 12, 16, and 32 weeks ]
    Reduction of mTLSS compared to baseline

  2. Change from baseline in hand Physician Global Assessment (PGA) [ Time Frame: 4, 8, 12, 16, and 32 weeks ]
    Proportion of participants with a response of PGA 0 or 1

  3. Change from baseline in hand Patient Global Assessment (PaGA) [ Time Frame: 4, 8, 12, 16, and 32 weeks ]
    Reduction of PaGA compared to baseline



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03728504


Locations
Show Show 23 study locations
Sponsors and Collaborators
Asana BioSciences
Investigators
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Study Director: David Zammit, Ph.D. Asana BioSciences
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Responsible Party: Asana BioSciences
ClinicalTrials.gov Identifier: NCT03728504    
Other Study ID Numbers: ASN002AD-202
First Posted: November 2, 2018    Key Record Dates
Last Update Posted: June 17, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Asana BioSciences:
eczema
hand eczema
hand dermatitis
Additional relevant MeSH terms:
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Dermatitis
Eczema
Skin Diseases
Skin Diseases, Eczematous