Phase 2
N=97
Study to Evaluate ASN002 in Subjects With Moderate To Severe Chronic Hand Eczema
Chronic Hand Dermatitis
Bottom Line
View on ClinicalTrials.gov: NCT03728504 ↗Enrolled (actual)
97
Serious AEs
3.1%
Results posted
May 2023
Primary outcome: Primary: Percent Change From Baseline in Modified Total Lesion Symptom Score (mTLSS) — -49.5; -71.3; -29.9 percentage change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- ASN002 (Drug); Placebo Oral Tablet (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Asana BioSciences
- Primary completion
- Apr 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Modified Total Lesion Symptom Score (mTLSS) |
-49.5; -71.3; -29.9 | — |
| SECONDARY Change From Baseline in Hand Physician Global Assessment (PGA) |
7; 10; 2 | — |
| SECONDARY Change From Baseline in Hand Patient Global Assessment (PaGA) |
7; 7; 2 | — |
Summary
Randomized double-blind/placebo study to evaluate the efficacy of ASN002 in subjects with severe chronic hand eczema.
Eligibility Criteria
Inclusion Criteria
- 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
- 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.
Exclusion Criteria
- Presence of any of the following laboratory abnormalities at the screening visit: Hemoglobin 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.
Data sourced from ClinicalTrials.gov (NCT03728504). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.