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)

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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON54950

Enrollment

Registered

2021-04-28

Start date

2021-09-20

Completion date

Unknown

Last updated

2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic hand eczema

Interventions

- Name of IMP: delgocitinib cream. - Active substance: delgocitinib. - Dosage form: cream. - Concentration: 20 mg/g and cream vehicle. - Dose and method of administration: topical application twice da

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Investigator's Global Assessment for chronic hand eczema Treatment Success (IGA-CHE TS, i.e. an IGA-CHE score of 0 (clear) or 1 (almost clear) with at least a 2-step improvement from baseline.	—

Secondary

Measure	Time frame
Percentage change in HECSI (Hand Eczema Severity Index) score from baseline to Week 16. - HECSI-75 at Week 16. - HECSI-75 at Week 8. - HECSI-90 at Week 16. - Investigator's Global Assessment for chronic hand eczema Treatment Success (IGA-CHE TS) at Week 8. - Investigator's Global Assessment for chronic hand eczema Treatment Success (IGA-CHE TS) at Week 4.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)