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Trial record 8 of 80 for:    ASNS

A Study To Evaluate ASN002 In Subjects With Atopic Dermatitis

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: NCT03139981
Recruitment Status : Completed
First Posted : May 4, 2017
Last Update Posted : January 2, 2018
Sponsor:
Information provided by (Responsible Party):
Asana BioSciences

Brief Summary:
This is a dose escalation study to test the safety, tolerability and preliminary efficacy of ASN002 in people with moderate to severe atopic dermatitis (AD).

Condition or disease Intervention/treatment Phase
Dermatitis, Atopic Dermatitis Eczema Dermatitis, Eczematous Drug: ASN002 Drug: Placebo Oral Tablet Phase 1

Detailed Description:
This study is a dose escalation study to determine a safe and tolerable dose of ASN002 for people with moderate to severe atopic dermatitis. This study will also characterize the pharmacokinetics and pharmacodynamics of ASN002 through blood sampling and skin biopsies. Subjects will also be assessed for improvement in their atopic dermatitis. There will be a screening period (up to 30 days) and a treatment period for 4 weeks with a 14 day follow up with an end-of-study visit.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double blind study
Primary Purpose: Treatment
Official Title: A Randomized, Double -Blind, Placebo-Controlled, Sequential, Multiple-Dose Escalation Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Preliminary Efficacy Of ASN002 In Subjects With Moderate-To-Severe Atopic Dermatitis
Actual Study Start Date : April 12, 2017
Actual Primary Completion Date : November 5, 2017
Actual Study Completion Date : December 5, 2017

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 28 days

Drug: Placebo Oral Tablet
Placebo for ASN002 for 28 days

Experimental: ASN002 80 mg
80 mg ASN002
Drug: ASN002
Daily dose of ASN002 for 28 days

Drug: Placebo Oral Tablet
Placebo for ASN002 for 28 days

Experimental: ASN002 20 mg
20 mg ASN002
Drug: ASN002
Daily dose of ASN002 for 28 days

Drug: Placebo Oral Tablet
Placebo for ASN002 for 28 days

Experimental: ASN002 120 mg
120 mg ASN002
Drug: ASN002
Daily dose of ASN002 for 28 days

Drug: Placebo Oral Tablet
Placebo for ASN002 for 28 days




Primary Outcome Measures :
  1. Determine the maximum tolerated dose of ASN002 [ Time Frame: 43 days ]
    Analyze the number and type of adverse events reported.


Secondary Outcome Measures :
  1. Calculate the area under the plasma concentration versus time curve [ Time Frame: 16 Days ]
    A plot of the concentrations of ASN002 in blood plasma over time.

  2. Calculate the Pharmacokinetic maximum concentration [ Time Frame: 16 Days ]
    Maximum concentration of ASN002 achieved after dosing.

  3. Calculate the Pharmacokinetic Half-life [ Time Frame: 16 Days ]
    The time required for ASN002 concentration to decrease by 50%

  4. Change from baseline in the Investigator Global Assessment [ Time Frame: 28 days ]
    determine overall severity of atopic dermatitis

  5. Change from baseline in the subject-reported puritis (itch) score [ Time Frame: 28 days ]
    Rating of puritis based degree, duration, direction, disability, and distribution

  6. Change from baseline in EASI score [ Time Frame: 28 days ]
    Measurement of area and severity of atopic dermatitis


Other Outcome Measures:
  1. Change from baseline in pharmacodynamics biomarkers in serum [ Time Frame: 28 days ]
    Measurement of inflammatory markers including immune markers and CRP

  2. Change from baseline in pharmacodynamics biomarkers in skin [ Time Frame: 28 ]
    Epidermal thickness and barrier markers from skin biopsies



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • Written informed consent obtained prior to any study-related procedure being performed;
  • Male or female, 18≤ years and ≤75 years of age with chronic AD for at least 6 months.
  • At least 10% body surface area (BSA) of AD involvement at the baseline visits
  • Has a body mass index (BMI) ≤35 kg/m2
  • History of inadequate response to topical corticosteroids or calcineurin inhibitors as treatment for AD within 1 year before the screening visit.
  • Willing to apply only a basic bland emollient once or twice-daily for at least 7 days before the baseline visit.
  • Willing to comply with discontinuation of certain treatments for AD, as directed by the Investigator.
  • Willing to use medically effective methods of birth control
  • Females of reproductive potential must have a negative serum pregnancy test at screening and negative urine pregnancy test at Day 1..
  • Willing and able to comply with clinic visits and study-related procedures

Exclusion criteria:

  • Clinically infected atopic dermatitis.
  • 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 < 1.75 x 103 /μL, Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) > 1.5 x the upper limit of normal (ULN), Total bilirubin > ULN, Creatinine > ULN
  • A serious uncontrolled condition including hypertension, history of 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.
  • Any condition requiring the use of anticoagulants.
  • History of hypertrophic scarring or keloid formation in scars or suture sites.
  • 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.
  • Has used oral or intravenous treatments (other than biologics) that could affect atopic dermatitis less than 4 weeks prior to Day 1.
  • Has received any marketed or investigational biological agent within 12 weeks or 5 half-lives (whichever is longer) prior to Day 1.
  • Currently receiving a non-biological investigational product or device or has received one within 4 weeks Day 1.
  • Excessive sun exposure, is planning a trip to a sunny climate, or has used tanning booths within 4 weeks prior to baseline (Day 1), or is not willing to minimize natural and artificial sunlight exposure during the study.
  • Has received or plans to receive a live attenuated vaccine within 4 weeks prior to Day 1 throughout the follow up period.
  • Planned major surgical procedure during the length of the patient's participation in this study

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): NCT03139981


Locations
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United States, California
Center for Dermatology Clinical Research, Inc.
Fremont, California, United States, 94538
Dermatology Research Associates
Los Angeles, California, United States, 30045
TCR Medical Corporation
San Diego, California, United States, 92123
United States, Florida
Olympian Clinical Research
Tampa, Florida, United States, 33609
Forward Clinical Trials, Inc.
Tampa, Florida, United States, 33624
United States, Kentucky
Dermatology Specialists Research
Louisville, Kentucky, United States, 40241
United States, Texas
Center for Clinical Studies, Ltd., LLP
Houston, Texas, United States, 77004
Progressive Clinical Research, P.A.
San Antonio, Texas, United States, 78229
United States, Virginia
Virginia Clinical Research, Inc.
Norfolk, Virginia, United States, 23507
Canada
Innovaderm Research
Montréal, Canada
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: NCT03139981     History of Changes
Other Study ID Numbers: ASN002AD-101
First Posted: May 4, 2017    Key Record Dates
Last Update Posted: January 2, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases