A Study To Evaluate ASN002 In Subjects With Atopic Dermatitis

Dermatitis, Atopic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03139981
• Other study ID #: ASN002AD-101
• Status: Completed
• Phase: Phase 1
• Start date: April 12, 2017
• Est. completion date: December 5, 2017

Study information

• Verified date: December 2017
• Source: Asana BioSciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 5, 2017
• Est. primary completion date: November 5, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis Eczema
• Dermatitis, Atopic
• Dermatitis, Eczematous
• Eczema

Intervention

Drug:
• ASN002
Daily dose of ASN002 for 28 days
• Placebo Oral Tablet
Placebo for ASN002 for 28 days

Locations

Country	Name	City	State
Canada	Innovaderm Research	Montréal
United States	Center for Dermatology Clinical Research, Inc.	Fremont	California
United States	Center for Clinical Studies, Ltd., LLP	Houston	Texas
United States	Dermatology Research Associates	Los Angeles	California
United States	Dermatology Specialists Research	Louisville	Kentucky
United States	Virginia Clinical Research, Inc.	Norfolk	Virginia
United States	Progressive Clinical Research, P.A.	San Antonio	Texas
United States	TCR Medical Corporation	San Diego	California
United States	Forward Clinical Trials, Inc.	Tampa	Florida
United States	Olympian Clinical Research	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Asana BioSciences

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline in pharmacodynamics biomarkers in serum	Measurement of inflammatory markers including immune markers and CRP	28 days
Other	Change from baseline in pharmacodynamics biomarkers in skin	Epidermal thickness and barrier markers from skin biopsies	28
Primary	Determine the maximum tolerated dose of ASN002	Analyze the number and type of adverse events reported.	43 days
Secondary	Calculate the area under the plasma concentration versus time curve	A plot of the concentrations of ASN002 in blood plasma over time.	16 Days
Secondary	Calculate the Pharmacokinetic maximum concentration	Maximum concentration of ASN002 achieved after dosing.	16 Days
Secondary	Calculate the Pharmacokinetic Half-life	The time required for ASN002 concentration to decrease by 50%	16 Days
Secondary	Change from baseline in the Investigator Global Assessment	determine overall severity of atopic dermatitis	28 days
Secondary	Change from baseline in the subject-reported puritis (itch) score	Rating of puritis based degree, duration, direction, disability, and distribution	28 days
Secondary	Change from baseline in EASI score	Measurement of area and severity of atopic dermatitis	28 days