Chronic Hand DermatitisPhase 2NCT03728504
Study to Evaluate ASN002 in Subjects With Moderate To Severe Chronic Hand Eczema
A Phase 2 study testing ASN002 in people with Chronic Hand Dermatitis, run by Asana BioSciences at 23 sites in 2 countries.
Trial summary
Randomized double-blind/placebo study to evaluate the efficacy of ASN002 in subjects with severe chronic hand eczema. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Hand Dermatitis
- What is being tested?
- ASN002
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 97 participants
- Where
- 23 sitesin 2 countries
- Study dates
- 3 Jan 2019to 29 Apr 2020
- 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
- Written informed consent obtained prior to any study-related procedure being performed
- Male or female subject, aged 18 to 75 years, inclusive, at the time of consent.
- Subject has a history of severe CHE for at least 6 months prior to baseline
- Subject has hand eczema refractory to high potency or ultra-high potency topical corticosteroids
- Subject has moderate to severe CHE at Day 1, as defined by a hand PGA 3 or 4.
- Subject has been using an emollient on their hands and feet (except those containing urea or salicylic acid) every day at the same frequency for at least 1 week prior to Day 1
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- Subject has a body mass index (BMI) ≤ 38 kg/m2.
- Female subject of childbearing potential has had a negative serum pregnancy test at screening and negative urine pregnancy test on Day 1.
- Willing and able to comply with clinical visits and study related procedures.
Who cannot join
- 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 < 1.80 x 103 /μL, Lymphocytes <0.9 x 103 /μL, Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) > 2x the upper limit of normal (ULN),Total bilirubin > 1.2x ULN (except for elevated indirect bilirubin secondary to Gilbert's syndrome), Creatinine > ULN
- A serious uncontrolled condition including hypertension, active 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.
- Active skin infections of the hands and/or feet
- 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.
- Subject has received any marketed or investigational biological agent within 12 weeks or 5 half-lives (whichever is longer) prior to Day 1.
Trial locations and contacts
23 sites in 2 countries.
23 sites in 2 countries
United States17 sites
Pinnacle Research Group, LLC
Anniston, Alabama, 36207
Dermatologists of Greater Colombus
Bexley, Ohio, 43209
Advanced Clinical Research
Boise, Idaho, 83713
BTC Network
Fort Gratiot, Michigan, 48059
Minnesota Clinical Research Center
Fridley, Minnesota, 55432
Sweet Hope Research Specialty, Inc
Hialeah, Florida, 33016
Maryland Laser Skin and Vein
Hunt Valley, Maryland, 21030
Dawes Fretzin Clinical Research Group
Indianapolis, Indiana, 46256
Dermatology Research Associates
Los Angeles, California, 90045
Dermatology Specialists Research
Louisville, Kentucky, 40241
RM Medical Research, Inc.
Miami, Florida, 33174
DelRicht Research
New Orleans, Louisiana, 70115
Virginia Clinical Research, Inc.
Norfolk, Virginia, 23502
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112
ActivMed Practices and Research, Inc.
Portsmouth, New Hampshire, 03801
Progressive Clinical Research
San Antonio, Texas, 78213
Dermatology Specialists of Spokane
Spokane, Washington, 99202
Canada6 sites
SimcoDerm Medical and Surgical Dermatology Centre
Barrie, Ontario, 73112
Wei Jing Loo Medicine Professional Corp.
London, Ontario, N6H5L5
Lynderm Research Inc.
Markham, Ontario, L3P1X2
Innovaderm Research, Inc.
Montreal, H2K4L5
Centre de Recherche Dermatologique du Quebec metropolitain
Québec, G1V4X7
G. Daniel Schachter Medicine Professional
Toronto, Ontario, M4W2N2
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of ASN002 in Subjects With Moderate To Severe Chronic Hand Eczema Refractory to Corticosteroid Therapy
Randomized double-blind/placebo study to evaluate the efficacy of ASN002 in subjects with severe chronic hand eczema.
Read the detailed description
This is a placebo controlled study where subjects with severe chronic hand eczema will be randomized (1:1:1) to receive ASN002 at 40 mg, 80 mg, or placebo once daily for 16 weeks (Part A). Then, in Part B, subjects who were assigned to placebo in the first part of the study will receive the highest dose of ASN002 (80 mg) for the rest of the treatment period (up to Week 32). The subjects who were assigned ASN002 in the first part of the study will continue on the same assigned treatment dose during the second part of the study (Week 16 to Week 32). The total treatment period of 32 weeks will be followed by a 4 week follow-up period.This study will also characterize the pharmacokinetics and pharmacodynamics of ASN002 through blood sampling and three or four biopsies from subjects who consent.
- Conditions
- Chronic Hand Dermatitis
- Being tested
- ASN002, Placebo Oral Tablet
- Keywords
- eczema, hand eczema, hand dermatitis
- Medical subject headings
- 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 32 weeks
Placebo Oral TabletDrug
Daily dose of Placebo Oral Tablet for 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| ASN002 40 mg | Experimental | 40 mg ASN002 Receives: Drug: ASN002 |
| ASN002 80 mg | Experimental | 80 mg ASN002 Receives: Drug: ASN002 |
| Placebo oral tablet | Placebo comparator | Matching placebo for ASN002 doses Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in Modified Total Lesion Symptom Score (mTLSS)
Percent change from baseline in hand mTLSS at Week 16. The mTLSS is an assessment of the severity of each of the following: erythema, scaling, lichenification/hyperkeratosis, vesicles, edema, fissures, and pruritus/pain. Each of these are rated using a 4-point severity scale. The ratings are added to create a total mTLSS calculated as the sum of assigned individual scores with a maximum value of 21 (most severe disease) and a minimum of 0 (no disease)
Measured: 16 weeks
Secondary outcomes (2)
Change From Baseline in Hand Physician Global Assessment (PGA)
Proportion of participants with a response of Physicians Global Assessment achieving clear (0) or almost clear (1)
Measured: 16 weeks
Change From Baseline in Hand Patient Global Assessment (PaGA)
Reduction of PaGA compared to baseline where marked improvement was noted with at least 75% clear
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2018
- Study start3 Jan 2019
- Primary completion29 Apr 2020
- Study completion29 Apr 2020
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Hand 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asana BioSciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Zammit, Ph.D., Study director, Asana BioSciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03728504
- Sponsor's protocol ID
- ASN002AD-202
- Status last verified
- May 2023
- First submitted
- 31 Oct 2018
- Last updated
- 9 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bar J, Del Duca E, David E, Bose S, Chefitz G, Brunner PM, Bissonnette R, Guttman-Yassky E. Skin Tape Stripping Reveals Distinct Biomarker Profiles in Chronic Hand Eczema of Patients With and Without Comorbid Atopic Dermatitis. Allergy. 2025 Aug;80(8):2271-2285. doi: 10.1111/all.16466. Epub 2025 Jan 6.
PubMed 39760239
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of ASN002 in Subjects With Moderate To Severe Chronic Hand Eczema Refractory to Corticosteroid Therapy
- ClinicalTrials.gov ID
- NCT03728504
- Acronym / sponsor ID
- ASN002AD-202
- Conditions
- Chronic Hand Dermatitis
- Keywords
- eczema, hand eczema, hand dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Asana BioSciencesIndustry (pharma, biotech, devices)
- Study start
- 3 Jan 2019 (actual)
- Primary completion
- 29 Apr 2020 (actual)
- Study completion
- 29 Apr 2020 (actual)
- First posted
- 2 Nov 2018 (actual)
- Results
- Posted 9 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized double-blind/placebo study to evaluate the efficacy of ASN002 in subjects with severe chronic hand eczema.
Detailed description
This is a placebo controlled study where subjects with severe chronic hand eczema will be randomized (1:1:1) to receive ASN002 at 40 mg, 80 mg, or placebo once daily for 16 weeks (Part A). Then, in Part B, subjects who were assigned to placebo in the first part of the study will receive the highest dose of ASN002 (80 mg) for the rest of the treatment period (up to Week 32). The subjects who were assigned ASN002 in the first part of the study will continue on the same assigned treatment dose during the second part of the study (Week 16 to Week 32). The total treatment period of 32 weeks will be followed by a 4 week follow-up period.This study will also characterize the pharmacokinetics and pharmacodynamics of ASN002 through blood sampling and three or four biopsies from subjects who consent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ASN002 40 mg | Experimental | Drug: ASN00240 mg ASN002 |
| ASN002 80 mg | Experimental | Drug: ASN00280 mg ASN002 |
| Placebo oral tablet | Placebo comparator | Drug: Placebo Oral TabletMatching placebo for ASN002 doses |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Written informed consent obtained prior to any study-related procedure being performed
- Male or female subject, aged 18 to 75 years, inclusive, at the time of consent.
- Subject has a history of severe CHE for at least 6 months prior to baseline
- Subject has hand eczema refractory to high potency or ultra-high potency topical corticosteroids
- Subject has moderate to severe CHE at Day 1, as defined by a hand PGA 3 or 4.
Key exclusion criteria (8 listed)
- 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 < 1.80 x 103 /μL, Lymphocytes <0.9 x 103 /μL, Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) > 2x the upper limit of normal (ULN),Total bilirubin > 1.2x ULN (except for elevated indirect bilirubin secondary to Gilbert's syndrome), Creatinine > ULN
- A serious uncontrolled condition including hypertension, active 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.
- Active skin infections of the hands and/or feet
- 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
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 32 weeks | Drug | ASN002 40 mg, ASN002 80 mg |
| Placebo Oral TabletDaily dose of Placebo Oral Tablet for 16 weeks | Drug | Placebo oral tablet |
Primary outcome
Percent Change From Baseline in Modified Total Lesion Symptom Score (mTLSS)
Time frame: 16 weeks
Percent change from baseline in hand mTLSS at Week 16. The mTLSS is an assessment of the severity of each of the following: erythema, scaling, lichenification/hyperkeratosis, vesicles, edema, fissures, and pruritus/pain. Each of these are rated using a 4-point severity scale. The ratings are added to create a total mTLSS calculated as the sum of assigned individual scores with a maximum value of 21 (most severe disease) and a minimum of 0 (no disease)
2 secondary outcomes
Change From Baseline in Hand Physician Global Assessment (PGA)
Time frame: 16 weeks
Change From Baseline in Hand Patient Global Assessment (PaGA)
Time frame: 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39760239Bar J, Del Duca E, David E, Bose S, Chefitz G, Brunner PM, Bissonnette R, Guttman-Yassky E. Skin Tape Stripping Reveals Distinct Biomarker Profiles in Chronic Hand Eczema of Patients With and Without Comorbid Atopic Dermatitis. Allergy. 2025 Aug;80(8):2271-2285. doi: 10.1111/all.16466. Epub 2025 Jan 6.
- Individual participant dataSharing planned: Undecided
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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
23 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 Chronic Hand Dermatitis, run by Asana BioSciences at 23 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 9 inclusion and 8 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: finished, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 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. Some participants in this study may receive a placebo. 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 9 May 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?
Percent Change From Baseline in Modified Total Lesion Symptom Score (mTLSS) (time frame: 16 weeks). 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 NCT03728504, which also lists 1 linked publication.
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 9 May 2023.