A Study To Evaluate ASN002 In Subjects With Atopic Dermatitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-12

Study Completion Date

2017-12-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study to Evaluate Long-Term Safety of ASN002 in Subjects With Moderate to Severe Atopic Dermatitis

NCT03654755

Atopic Dermatitis

TERMINATED PHASE2

Study to Evaluate ASN008 Topical Gel (TG)

NCT03798561

Dermatitis, Atopic Pruritus Dermatitis Eczema

COMPLETED PHASE1

Phase 2B Study to Evaluate ASN002 in Subjects With Moderate to Severe Atopic Dermatitis (RADIANT)

NCT03531957

Atopic Dermatitis

COMPLETED PHASE2

Study to Evaluate the Efficacy, Safety and Pharmacokinetics of ASB17061 Capsules in Adult Subjects With Atopic Dermatitis

NCT01756898

Atopic Dermatitis

COMPLETED PHASE2

A Study to Evaluate the Anti-pruritic Effectiveness of ASN008 in Adults With Mild to Moderate Atopic Dermatitis

NCT05870865

Dermatitis, Atopic Pruritus

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dermatitis, Atopic Dermatitis Eczema Dermatitis, Eczematous

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Double blind study

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ASN002 40 mg

40 mg ASN002

Group Type EXPERIMENTAL

ASN002

Intervention Type DRUG

Daily dose of ASN002 for 28 days

Placebo Oral Tablet

Intervention Type DRUG

Placebo for ASN002 for 28 days

ASN002 80 mg

80 mg ASN002

Group Type EXPERIMENTAL

ASN002

Intervention Type DRUG

Daily dose of ASN002 for 28 days

Placebo Oral Tablet

Intervention Type DRUG

Placebo for ASN002 for 28 days

ASN002 20 mg

20 mg ASN002

Group Type EXPERIMENTAL

ASN002

Intervention Type DRUG

Daily dose of ASN002 for 28 days

Placebo Oral Tablet

Intervention Type DRUG

Placebo for ASN002 for 28 days

ASN002 120 mg

120 mg ASN002

Group Type EXPERIMENTAL

ASN002

Intervention Type DRUG

Daily dose of ASN002 for 28 days

Placebo Oral Tablet

Intervention Type DRUG

Placebo for ASN002 for 28 days

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ASN002

Daily dose of ASN002 for 28 days

Intervention Type DRUG

Placebo Oral Tablet

Placebo for ASN002 for 28 days

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes