A phase 3 clinical trial to confirm efficacy and evaluate safety of twice-daily delgocitinib cream 20 mg/g compared with cream vehicle for a 16-week treatment period in adult subjects with moderate to severe chronic hand eczema (DELTA 2)
- Conditions
- 10014982Chronic hand eczema
- Registration Number
- NL-OMON54950
- Lead Sponsor
- eo Pharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 44
• Age 18 years or above at screening.
• Diagnosis of CHE, defined as hand eczema that has persisted for more than 3
months or returned twice or more within the last 12 months.
• Disease severity graded as moderate to severe at screening and baseline
according to IGA-CHE (i.e. an IGA-CHE score of 3 or 4).
• HESD itch score (weekly average) of >=4 points at baseline.
• Subjects who have a documented recent history of inadequate response to
treatment with TCS (at any time within 1 year before the screening visit) or
for whom TCS are documented to be otherwise medically inadvisable (e.g. due to
important side effects or safety risks).
• Subjects adherent to standard non-medicated skin care including avoidance of
known and relevant irritants and allergens.
- Subjects who have a recent history of inadequate response to treatment with
topical corticosteroid (at any time within 1 year before the screening visit)
or for whom topical corticosteroids are otherwise medically inadvisable (e.g.
due to important side effects or safety risks).
- Inadequate response is defined as a history of failure to achieve and
maintain remission or a low disease activity state (comparable to an IGA CHE
score of <=2) despite treatment with a daily regimen of topical corticosteroid
of class III IV (potent to very potent) for EU and class IV I (medium potency
to very/ultra high potency) for US, applied for at least 28 days or for the
maximum duration recommended by the product prescribing information, whichever
is shorter.
- Important side effects or safety risks are those that outweigh the potential
treatment benefits and include intolerance to treatment, hypersensitivity
reactions, and significant skin atrophy as assessed by the physician.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Investigator's Global Assessment for chronic hand eczema Treatment Success<br /><br>(IGA-CHE TS, i.e. an IGA-CHE score of 0 (clear) or 1 (almost clear) with at<br /><br>least a 2-step improvement from baseline.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Percentage change in HECSI (Hand Eczema Severity Index) score from baseline to<br /><br>Week 16.<br /><br>- HECSI-75 at Week 16.<br /><br>- HECSI-75 at Week 8.<br /><br>- HECSI-90 at Week 16.<br /><br>- Investigator's Global Assessment for chronic hand eczema Treatment Success<br /><br>(IGA-CHE TS) at Week 8.<br /><br>- Investigator's Global Assessment for chronic hand eczema Treatment Success<br /><br>(IGA-CHE TS) at Week 4.</p><br>