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NCT03728504

Study to Evaluate ASN002 in Subjects With Moderate To Severe Chronic Hand Eczema

Completed Phase 2 Results posted Last updated 9 May 2023
What this trial tests

Phase 2 trial testing ASN002 in Chronic Hand Dermatitis in 97 participants. Completed in 29 April 2020.

Timeline
3 January 2019
Primary endpoint
29 April 2020
29 April 2020

Quick facts

Lead sponsorAsana BioSciences
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment97
Start date3 January 2019
Primary completion29 April 2020
Estimated completion29 April 2020
Sites23 locations across Canada, United States

Drugs / interventions tested

Conditions studied

Sponsor

Asana BioSciences — full company profile →

Who can join

Adults 18 to 75, any sex, with Chronic Hand Dermatitis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percent Change From Baseline in Modified Total Lesion Symptom Score (mTLSS) Primary · 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)

GroupValue95% CI
ASN002 40 mg-49.5± 40.65
ASN002 80 mg-71.3± 26.97
Placebo Oral Tablet-29.9± 38.51
Change From Baseline in Hand Physician Global Assessment (PGA) Secondary · 16 weeks

Proportion of participants with a response of Physicians Global Assessment achieving clear (0) or almost clear (1)

GroupValue95% CI
ASN002 40 mg7
ASN002 80 mg10
Placebo Oral Tablet2
Change From Baseline in Hand Patient Global Assessment (PaGA) Secondary · 16 weeks

Reduction of PaGA compared to baseline where marked improvement was noted with at least 75% clear

GroupValue95% CI
ASN002 40 mg7
ASN002 80 mg7
Placebo Oral Tablet2

Adverse events — posted to ClinicalTrials.gov

Time frame: 16 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

ASN002 40 mg
Serious: 0/33 (0%)
Deaths: 0/33
ASN002 80 mg
Serious: 2/32 (6%)
Deaths: 0/32
Placebo Oral Tablet
Serious: 1/32 (3%)
Deaths: 0/32

Serious adverse events (3 terms)

ReactionSystemASN002 40 mgASN002 80 mgPlacebo Oral Tablet
Atrial fibrillationCardiac disorders
Femur fractureInjury, poisoning and procedural complications
AlcoholismPsychiatric disorders
Other adverse events (82 terms — click to expand)

ReactionSystemASN002 40 mgASN002 80 mgPlacebo Oral Tablet
HeadacheNervous system disorders
NauseaGastrointestinal disorders
Upper respiratory tract infectionInfections and infestations
NasopharyngitisInfections and infestations
DiarrhoeaGastrointestinal disorders
VomitingGastrointestinal disorders
DizzinessNervous system disorders
HypersensitivityImmune system disorders
HypertensionVascular disorders
PyrexiaGeneral disorders
Blood potassium increasedInvestigations
Abscess limbInfections and infestations
Acute sinusitisInfections and infestations
ConjunctivitisInfections and infestations
Ear InfectionInfections and infestations
Eyelid infectionInfections and infestations
Fungal infectionInfections and infestations
GastroenteritisInfections and infestations
Oral herpesInfections and infestations
Otitis mediaInfections and infestations
PharyngitisInfections and infestations
Pilonidal cystInfections and infestations
Postoperative wound infectionInfections and infestations
Rash pustularInfections and infestations
Skin infectionInfections and infestations
TonsillitisInfections and infestations
Tooth infectionInfections and infestations
InfluenzaInfections and infestations
AgeusiaNervous system disorders
Burning sensationNervous system disorders
HyperaesthesiaNervous system disorders
NeuralgiaNervous system disorders
SciaticaNervous system disorders
ConstipationGastrointestinal disorders
Dry skinSkin and subcutaneous tissue disorders
UrticariaSkin and subcutaneous tissue disorders
AlopeciaSkin and subcutaneous tissue disorders
Dermatitis atopicSkin and subcutaneous tissue disorders
Dermatitis contactSkin and subcutaneous tissue disorders
Eczema nummularSkin and subcutaneous tissue disorders

Most-reported serious reactions: Atrial fibrillation, Femur fracture, Alcoholism.

Data from ClinicalTrials.gov NCT03728504 adverse events section.

Sponsor's own description

Randomized double-blind/placebo study to evaluate the efficacy of ASN002 in subjects with severe chronic hand eczema.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. JAK inhibitors in the treatment of atopic dermatitis.
    Chovatiya R, Paller AS. · · 2021 · cited 258× · PMID 34437922 · DOI 10.1016/j.jaci.2021.08.009
  2. Targeting the Janus Kinase Family in Autoimmune Skin Diseases.
    Howell MD, Kuo FI, Smith PA. · · 2019 · cited 180× · PMID 31649667 · DOI 10.3389/fimmu.2019.02342
  3. JAK-STAT signaling in human disease: From genetic syndromes to clinical inhibition.
    Luo Y, Alexander M, Gadina M, O'Shea JJ, et al · · 2021 · cited 92× · PMID 34625141 · DOI 10.1016/j.jaci.2021.08.004
  4. Current Insights into Immunology and Novel Therapeutics of Atopic Dermatitis.
    Kader HA, Azeem M, Jwayed SA, Al-Shehhi A, et al · · 2021 · cited 61× · PMID 34200009 · DOI 10.3390/cells10061392
  5. A Decade of JAK Inhibitors: What Have We Learned and What May Be the Future?
    Liu C, Kieltyka J, Fleischmann R, Gadina M, et al · · 2021 · cited 49× · PMID 34180156 · DOI 10.1002/art.41906
  6. Drugs for the Treatment of Chronic Hand Eczema: Successes and Key Challenges.
    Dubin C, Del Duca E, Guttman-Yassky E. · · 2020 · cited 33× · PMID 33408476 · DOI 10.2147/tcrm.s292504
  7. Jakinibs of All Trades: Inhibiting Cytokine Signaling in Immune-Mediated Pathologies.
    Alexander M, Luo Y, Raimondi G, O'Shea JJ, et al · · 2021 · cited 27× · PMID 35056105 · DOI 10.3390/ph15010048
  8. Atopic dermatitis: a comprehensive updated review of this intriguing disease with futuristic insights.
    Abdel-Mageed HM. · · 2025 · cited 16× · PMID 39918744 · DOI 10.1007/s10787-025-01642-z

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