Clinical trial NCT03139981: A Study To Evaluate ASN002 In Subjects With Atopic Dermatitis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dermatitis, Atopic
Dermatitis Eczema
Dermatitis, Eczematous
Keywords: eczema
Lead sponsor: Asana BioSciences
Sponsor class: INDUSTRY
First posted: 2017-05-04
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Eligibility 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

Primary outcomes:
measure: Determine the maximum tolerated dose of ASN002
timeFrame: 43 days
Secondary outcomes:
measure: Calculate the area under the plasma concentration versus time curve
timeFrame: 16 Days
measure: Calculate the Pharmacokinetic maximum concentration
timeFrame: 16 Days
measure: Calculate the Pharmacokinetic Half-life
timeFrame: 16 Days
measure: Change from baseline in the Investigator Global Assessment
timeFrame: 28 days
measure: Change from baseline in the subject-reported puritis (itch) score
timeFrame: 28 days
measure: Change from baseline in EASI score
timeFrame: 28 days
Other outcomes:
measure: Change from baseline in pharmacodynamics biomarkers in serum
timeFrame: 28 days
measure: Change from baseline in pharmacodynamics biomarkers in skin
timeFrame: 28
Locations:
city: Fremont
country: United States
facility: Center for Dermatology Clinical Research, Inc.
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: San Diego
country: United States
facility: TCR Medical Corporation
state: California
city: Tampa
country: United States
facility: Olympian Clinical Research
state: Florida
city: Tampa
country: United States
facility: Forward Clinical Trials, Inc.
state: Florida
city: Louisville
country: United States
facility: Dermatology Specialists Research
state: Kentucky
city: Houston
country: United States
facility: Center for Clinical Studies, Ltd., LLP
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research, P.A.
state: Texas
city: Norfolk
country: United States
facility: Virginia Clinical Research, Inc.
state: Virginia
city: Montréal
country: Canada
facility: Innovaderm Research
Study officials:
affiliation: Asana BioSciences
name: David Zammit, Ph.D.
role: STUDY_DIRECTOR
References: