NL-OMON54950RecruitingPhase 3
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) - DELTA2
eo Pharma0 sites44 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Enrollment
- 44
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 64 (—)
Inclusion Criteria
- •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.
Exclusion Criteria
- •- 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.
Investigators
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