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Clinical Trial Details for Study to Evaluate ASN002 in Subjects With Severe Chronic Hand Eczema


Asana BioSciences
NCT ID: NCT03728504
Last Updated: May 16, 2019

The Study at a Glance

  • Status: Recruiting
  • Phase: Phase 2
  • Gender: All
  • Age: 18 Years - 75 Years
  • Condition: Chronic Hand Dermatitis
  • Study Type: Interventional
  • Intervention:
  • Lead Sponsor: Asana BioSciences
  • Location: Not Provided

Official Title

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of ASN002 in Subjects With Severe Chronic Hand Eczema Refractory to Topical Corticosteroid Therapy

Purpose

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

Eligibility

Ages Eligible for Study

18 Years to 75 Years

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.

Additional Information, Locations & Contacts

Sponsors & Collaborators

Asana BioSciences

Investigators

Study Director: David Zammit, Ph.D.

Asana BioSciences

Please refer to this study by its ClinicalTrials.gov identifier: NCT03728504

Location

Contacts

Pinnacle Research Group, LLC

Anniston, Alabama 36207

United States

Dermatology Research Associates

Los Angeles, California 90045

United States

Wendy Hulsopple

whulsopple@drsofen.com

RM Medical Research, Inc.

Miami, Florida 33174

United States

Marta Delgado

Advanced Clinical Research

Boise, Idaho 83713

United States

Ryan Harris, MD

Dawes Fretzin Clinical Research Group

Indianapolis, Indiana 46256

United States

Minnesota Clinical Research Center

Fridley, Minnesota 55432

United States

Steven Kempers, MD

ActivMed Practices and Research, Inc.

Portsmouth, New Hampshire 03801

United States

Abigail Brown

Dermatologists of Greater Colombus

Bexley, Ohio 43209

United States

Sarah Clark

sclark@dermgc.com

Progressive Clinical Research

San Antonio, Texas 78213

United States

Ryann Bizick-Magee

rmagee@progclin.com

Virginia Clinical Research, Inc.

Norfolk, Virginia 23502

United States

Celina Davis

cdavis@vcrinc.org

Wei Jing Loo Medicine Professional Corp.

London, Ontario N6H5L5

Canada

Wei J Loo

Lynderm Research Inc.

Markham, Ontario L3P1X2

Canada

Charles Lynde, MD

G. Daniel Schachter Medicine Professional

Toronto, Ontario M4W2N2

Canada

Sameh D Hanna, MD

Innovaderm Research, Inc.

Montreal, H2K4L5

Canada

Centre de Recherche Dermatologique du Quebec metropolitain

Quebec, G1V4X7

Canada

Yves Poulin, MD