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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

Tracking Information
First Submitted Date  ICMJE October 31, 2018
First Posted Date  ICMJE November 2, 2018
Last Update Posted Date June 17, 2020
Actual Study Start Date  ICMJE January 3, 2019
Actual Primary Completion Date April 28, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 31, 2018)
Change from baseline in modified Total Lesion Symptom Score (mTLSS) [ Time Frame: 16 weeks ]
Change from baseline in hand mTLSS at week 16
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 31, 2018)
  • 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
  • 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
  • Change from baseline in hand Patient Global Assessment (PaGA) [ Time Frame: 4, 8, 12, 16, and 32 weeks ]
    Reduction of PaGA compared to baseline
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate ASN002 in Subjects With Moderate To Severe Chronic Hand Eczema
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Hand Dermatitis
Intervention  ICMJE
  • Drug: ASN002
    Daily dose of ASN002 for 32 weeks
  • Drug: Placebo Oral Tablet
    Daily dose of Placebo Oral Tablet for 16 weeks
Study Arms  ICMJE
  • Experimental: ASN002 40 mg
    40 mg ASN002
    Intervention: Drug: ASN002
  • Experimental: ASN002 80 mg
    80 mg ASN002
    Intervention: Drug: ASN002
  • Placebo Comparator: Placebo oral tablet
    Matching placebo for ASN002 doses
    Intervention: Drug: Placebo Oral Tablet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 15, 2020)
97
Original Estimated Enrollment  ICMJE
 (submitted: October 31, 2018)
75
Actual Study Completion Date  ICMJE April 28, 2020
Actual Primary Completion Date April 28, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03728504
Other Study ID Numbers  ICMJE ASN002AD-202
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Asana BioSciences
Study Sponsor  ICMJE Asana BioSciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: David Zammit, Ph.D. Asana BioSciences
PRS Account Asana BioSciences
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP