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

A Phase 2 study testing ASN002 in people with Atopic Dermatitis, run by Asana BioSciences at 38 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

This is a randomized open label study to evaluate the long term safety of ASN002 in subjects with moderate to severe atopic dermatitis (AD). Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Atopic Dermatitis
What is being tested?: ASN002
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 162 participants
Where: 38 sitesin 2 countries
Study dates: 29 Sep 2018to 29 Oct 2019
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subject with a history of moderate to severe atopic dermatitis who participated in the preceding ASN002AD-201 and ASN002AD-101 study
Subject must be a candidate for prolonged open label ASN002/gusacitinib treatment according to the investigator's judgment.
Subject has been using an emollient daily for at least 1 week prior to Day 1 and agrees to continue using that same emollient daily throughout the study.
Men and women participating in the study must use medically acceptable birth control or total abstinence from sexual intercourse
Subject is willing to participate and is capable of giving informed consent. Note: Consent must be obtained prior to any study-related procedures.
Subjects must be willing to comply with all study procedures and must be available for the duration of the study.
Subject has a body mass index (BMI) ≤ 38 kg/m2.

Who cannot join

Subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study.
Subject has clinically infected atopic dermatitis.
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
Subject has a history of skin disease or presence of skin condition that, in the opinion of the investigator, would interfere with the study assessments.
Subject has a history of eczema herpeticum within 12 months, and/or a history of 2 or more episodes of eczema herpeticum in the past.
Willing to comply with discontinuation of certain treatments for AD, as directed by the Investigator.

Trial locations and contacts

38 sites in 2 countries.

Country

City, postcode or hospital

38 sites in 2 countries

United States31 sites

Pinnacle Research Group, LLC
Anniston, Alabama, 36207
Dermatologists of Greater Colombus
Bexley, Ohio, 43209
Total Skin and Dermatology Center, PC.
Birmingham, Alabama, 35205
Tufts Medical Center
Boston, Massachusetts, 02111
Corning Center for Clinical Research
Corning, New York, 14830
Dermatology Treatment and Research Center
Dallas, Texas, 75320
Revival Research
Doral, Florida, 33122
Wright State Physicians
Fairborn, Ohio, 45324
Clinical Physiology Associates
Fort Myers, Florida, 33912
Innovate Research, LLC
Fort Worth, Texas, 76244
Center for Dermatology Clinical Research, Inc.
Fremont, California, 94538
Synexus
Greer, South Carolina, 29651
DermDox Centers for Dermatology
Hazleton, Pennsylvania, 18201
The Center for Skin Research
Houston, Texas, 77056
Dawes Fretzin Clinical Research Group
Indianapolis, Indiana, 46256
Central Kentucky Research Associates, LLC
Lexington, Kentucky, 40509
L.A. Universal Research Center, Inc.
Los Angeles, California, 89148
Dermatology Research Associates
Los Angeles, California, 90045
Dermatology Specialists Research
Louisville, Kentucky, 40241
Mt. Sinai Hospital
New York, New York, 10029
Virginia Clinical Research, Inc.
Norfolk, Virginia, 23502
Unity Clinical Research
Oklahoma City, Oklahoma, 73118
Leavitt Medical Associates of Florida
Ormond Beach, Florida, 32174
Dermatology Center of Indiana, PC
Plainfield, Indiana, 46168
The Indiana Clinical Trials Center
Plainfield, Indiana, 46168
ActivMed Practices and Research, Inc.
Portsmouth, New Hampshire, 03801
Wake Research Associates, LLC
Raleigh, North Carolina, 27612
Progressive Clinical Research
San Antonio, Texas, 78213
Dermatology Consulting Services
Tampa, Florida, 33625
Forward Clinical Trials
Tampa, Florida, 33625
Vital Prospects Clinical Research Institute
Tulsa, Oklahoma, 74136

Other trials in United States

Canada7 sites

Institute of Skin Advancement Medical, Surgical, Costmetic & Laser Dermatology
Calgary, T3A2N1
Innovaderm Research, Inc.
Montreal, H2K4L5
Ontario Inc.
Ottawa, K2C3N2
York Regional Dermatology
Richmond Hill, L4C9M7
NewLab Clinical Research, Inc.
St. John's, A1C2H5
AvantDerm
Toronto, M5A3R6
SkinWISE Dermatology
Winnipeg, ABR3M3Z4

Other trials in Canada

About this study

Official title: A Phase 2, Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of ASN002 in Subjects With Moderate to Severe Atopic Dermatitis

This is a randomized open label study to evaluate the long term safety of ASN002 in subjects with moderate to severe atopic dermatitis (AD).

Read the detailed description

This is a randomized open label study where subjects with moderate to severe atopic dermatitis will roll over from the Phase 1 ASN002AD-101 (NCT03139981) and ASN002AD-201 (NCT03531957) Ph2b study and be randomized to receive ASN002 at 40mg, 60mg, or 80mg once daily for up to 24 months. This study will also characterize the pharmacokinetics of ASN002 through blood sampling from subjects who consent.

Conditions: Atopic Dermatitis
Being tested: ASN002
Keywords: eczema
Medical subject headings: Dermatitis, Atopic, Eczema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ASN002Drug
Daily dose of ASN002 for up to 110 weeks

Study groups in NCT03654755
Study group	Role	What they receive
ASN002 40 mg	Experimental	ASN002 40 mg Receives: Drug: ASN002
ASN002 60 mg	Experimental	ASN002 60 mg Receives: Drug: ASN002
ASN002 80 mg	Experimental	ASN002 80 mg Receives: Drug: ASN002

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Eczema Area Severity Index (EASI) Score
The Eczema Area and Severity Index (EASI) is a composite score ranging from 0 to 72, the higher the value the worse the disease, that takes into account the degree of erythema, induration/infiltration (papules), excoriation, and lichenification (each scored from 0 to 3 separately) for each of four body regions, with adjustment for the percentage of BSA involved for each body region and for the proportion of the body region to the whole body.
Due to early termination of the study, all efficacy analyses were descriptive in nature
Measured: 3 Months

Secondary outcomes (4)

Number of Participants Achieving an Investigator Global Assessment (IGA) Scale of Clear (0) or Almost Clear (1)
The IGA is a global assessment of the current state of the disease. It is a 5-point (0-4) morphological assessment of overall disease severity. The IGA is selected using descriptors that best describe the overall appearance of the lesions at any given point. Signs like inflammation, redness, oozing, and crusting are evaluated. The 0 is the least severe and 4 is the most severe.
Due to early termination of the study, all efficacy analyses were descriptive in nature.
Measured: 3 months
Change From Baseline in 5-D Pruritus (Itch) Scale
The 5-D Pruritus Scale is a validated questionnaire used in clinical trials to assess the degree, duration, direction, disability, and distribution of the itch to rate the their symptoms over the preceding 2-week period. Each symptoms is scored on a scale of 1 to 5, with 5 being the most affected. The total score of 5-D pruritus is a sum of the 5 scores to provide a total score range from 5 (best) to 25 (worst).
Due to early termination of the study, all efficacy analyses were descriptive in nature
Measured: 3 months
Change From Baseline in Pruritus (Itch) Numeric Rating Scale (NRS)
Intensity of itch will be measured using an NRS to indicate the intensity of the worst itching over the past 24 hours using a 0 to 10 numeric rating scale, where "0" represents "no itching" and "10" represents "worst itching imaginable" Due to early termination of the study, all efficacy analyses were descriptive in nature
Measured: 3 months
Change From Baseline in Patient-Oriented Eczema Measure (POEM)
POEM developed by Charman et al. is a self-assessment of disease severity by the participant. The POEM includes 7 questions to evaluate the number of days the signs and symptoms of eczema over the last week. The answer to each question is categorized by the frequency of the sign or symptom from no days to 7 days. Each question is scored from 0 to 4 and the sum of the questions if the POEM score. The score ranges from 0 to 28 with 0 being the least frequency and 28 showing that all the signs and symptoms occur every day. Therefore, the higher the score, the more severe the eczema. Due to early termination of the study, all efficacy analyses were descriptive in nature
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Sep 201829 Oct 2019

First posted31 Aug 2018
Study start29 Sep 2018
Primary completion29 Oct 2019
Study completion29 Oct 2019

Why it stopped: Phase 2 study results

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Atopic DermatitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 162 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03654755
Sponsor's protocol ID: ASN002AD-201-EXT
Status last verified: Sep 2023
First submitted: 16 Aug 2018
Last updated: 18 Sep 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
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RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
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RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
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RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
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All Atopic Dermatitis trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of ASN002 in Subjects With Moderate to Severe Atopic Dermatitis
ClinicalTrials.gov ID: NCT03654755
Acronym / sponsor ID: ASN002AD-201-EXT
Conditions: Atopic Dermatitis
Keywords: eczema
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Phase 2 study results
Enrolment: 162 participants (actual)
Lead sponsor: Asana BioSciencesIndustry (pharma, biotech, devices)
Study start: 29 Sep 2018 (actual)
Primary completion: 29 Oct 2019 (actual)
Study completion: 29 Oct 2019 (actual)
First posted: 31 Aug 2018 (actual)
Results: Posted 18 Sep 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a randomized open label study to evaluate the long term safety of ASN002 in subjects with moderate to severe atopic dermatitis (AD).

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
ASN002 40 mg	Experimental	Drug: ASN002ASN002 40 mg
ASN002 60 mg	Experimental	Drug: ASN002ASN002 60 mg
ASN002 80 mg	Experimental	Drug: ASN002ASN002 80 mg

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Subject with a history of moderate to severe atopic dermatitis who participated in the preceding ASN002AD-201 and ASN002AD-101 study
Subject must be a candidate for prolonged open label ASN002/gusacitinib treatment according to the investigator's judgment.
Subject has been using an emollient daily for at least 1 week prior to Day 1 and agrees to continue using that same emollient daily throughout the study.
Men and women participating in the study must use medically acceptable birth control or total abstinence from sexual intercourse
Subject is willing to participate and is capable of giving informed consent. Note: Consent must be obtained prior to any study-related procedures.

Key exclusion criteria (6 listed)

Subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study.
Subject has clinically infected atopic dermatitis.
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
Subject has a history of skin disease or presence of skin condition that, in the opinion of the investigator, would interfere with the study assessments.
Subject has a history of eczema herpeticum within 12 months, and/or a history of 2 or more episodes of eczema herpeticum in the past.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ASN002Daily dose of ASN002 for up to 110 weeks	Drug	ASN002 40 mg, ASN002 60 mg, ASN002 80 mg

Primary outcome

Change From Baseline in Eczema Area Severity Index (EASI) Score
Time frame: 3 Months
The Eczema Area and Severity Index (EASI) is a composite score ranging from 0 to 72, the higher the value the worse the disease, that takes into account the degree of erythema, induration/infiltration (papules), excoriation, and lichenification (each scored from 0 to 3 separately) for each of four body regions, with adjustment for the percentage of BSA involved for each body region and for the proportion of the body region to the whole body. Due to early termination of the study, all efficacy analyses were descriptive in nature

4 secondary outcomes

Number of Participants Achieving an Investigator Global Assessment (IGA) Scale of Clear (0) or Almost Clear (1)
Time frame: 3 months
Change From Baseline in 5-D Pruritus (Itch) Scale
Time frame: 3 months
Change From Baseline in Pruritus (Itch) Numeric Rating Scale (NRS)
Time frame: 3 months
Change From Baseline in Patient-Oriented Eczema Measure (POEM)
Time frame: 3 months

Results and safety

Results posted to the registry on 18 Sep 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ASN002 40 mg	45	0
ASN002 60 mg	41	0
ASN002 80 mg	76	0

Primary outcome: Change From Baseline in Eczema Area Severity Index (EASI) Score

Time frame: 3 Months. Mean (Standard Deviation). Unit: Change in score on a scale

Measure	ASN002 40 mg n = 22	ASN002 60 mg n = 18	ASN002 80 mg n = 42
Value	-22.88 (12.914)	-18.07 (7.687)	-17.38 (13.561)

Population analysed: The number of participants analyzed includes those that had a 3 months time point assessed before early termination of the study. Therefore, the numbers analyzed are not the same as those that started or completed the study.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Participants were to receive ASN002 once daily for up to 24 months. However, the study was early terminated approximately 12 months after initiation. The mean study treatment exposure ranged between 111.5 and 145.7 days, and the median ranged between 87.5 and 116.0 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ASN002 40 mg	0 of 45 (0%)	2 of 45 (4.4%)	0 of 45
ASN002 60 mg	0 of 41 (0%)	3 of 41 (7.3%)	0 of 41
ASN002 80 mg	1 of 76 (1.3%)	6 of 76 (7.9%)	0 of 76

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Atopic Dermatitis

Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
Dermatitis Atopic
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic Dermatitis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

David Zammit, Ph.D. study director

Asana BioSciences

38 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ASN002 in people with Atopic Dermatitis, run by Asana BioSciences at 38 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Eczema Area Severity Index (EASI) Score (time frame: 3 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03654755.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2023.