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Trial record 12 of 80 for:    ASNS

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 : Active, not recruiting
First Posted : November 2, 2018
Last Update Posted : September 13, 2019
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)
Estimated Enrollment : 75 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
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : May 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



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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
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United States, Alabama
Pinnacle Research Group, LLC
Anniston, Alabama, United States, 36207
United States, California
Dermatology Research Associates
Los Angeles, California, United States, 90045
United States, Florida
RM Medical Research, Inc.
Miami, Florida, United States, 33174
United States, Idaho
Advanced Clinical Research
Boise, Idaho, United States, 83713
United States, Indiana
Dawes Fretzin Clinical Research Group
Indianapolis, Indiana, United States, 46256
United States, Minnesota
Minnesota Clinical Research Center
Fridley, Minnesota, United States, 55432
United States, New Hampshire
ActivMed Practices and Research, Inc.
Portsmouth, New Hampshire, United States, 03801
United States, Ohio
Dermatologists of Greater Colombus
Bexley, Ohio, United States, 43209
United States, Texas
Progressive Clinical Research
San Antonio, Texas, United States, 78213
United States, Virginia
Virginia Clinical Research, Inc.
Norfolk, Virginia, United States, 23502
Canada, Ontario
Wei Jing Loo Medicine Professional Corp.
London, Ontario, Canada, N6H5L5
Lynderm Research Inc.
Markham, Ontario, Canada, L3P1X2
G. Daniel Schachter Medicine Professional
Toronto, Ontario, Canada, M4W2N2
Canada
Innovaderm Research, Inc.
Montreal, Canada, H2K4L5
Centre de Recherche Dermatologique du Quebec metropolitain
Quebec, Canada, G1V4X7
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     History of Changes
Other Study ID Numbers: ASN002AD-202
First Posted: November 2, 2018    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: September 2019
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