A phase 3 clinical trial to evaluate efficacy and safety of twice daily applications of delgocitinib cream 20 mg/g compared with cream vehicle for a 16-week treatment period in adolescents 12-17 years of age with moderate to severe chronic hand eczema - DELTA-TEE

EO Pharma A/S0 sites92 target enrollmentMarch 10, 2022

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: EO Pharma A/S
Enrollment: 92
Status: Active, not recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

March 10, 2022

End Date

TBD

Last Updated

3 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

EO Pharma A/S

Eligibility Criteria

Inclusion Criteria

•\- Age 12 to 17 years at screening and baseline.
•\- 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\).
•\- Subjects who have a documented history of inadequate response to treatment with TCS (at any time within 1 year before the screening visit \- see protocol for definition of inadequate response) or for whom TCS are documented to be otherwise medically inadvisable (e.g. due to important side effects or safety risks \- see protocol for definition or important side effects or safety risks).
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 92
•F.1\.2 Adults (18\-64 years) no
•F.1\.2\.1 Number of subjects for this age range
•F.1\.3 Elderly (\>\=65 years) no
•F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

•\- Concurrent skin disease on the hands, e.g tinea manuum.
•\- Clinically significant infection (e.g. impetiginised hand eczema) on the hands.
•\- Systemic treatment with immunosuppressive drugs (e.g. methotrexate, cyclosporine, azathioprine), immunomodulating drugs, retinoids (e.g. alitretinoin), or corticosteroids within 28 days prior to baseline (steroid eyedrops and inhaled or intranasal steroids corresponding to up to 1 mg prednisolone for allergic conjunctivitis, asthma, or rhinitis are allowed).
•\- Use of tanning beds, phototherapy (e.g. UVB, UVA1, PUVA), or bleach baths on the hands within 28 days prior to baseline.
•\- Previous or current treatment with JAK inhibitors (including delgocitinib/LEO 124249\), systemic or topical.
•\- Cutaneously applied treatment with immunomodulators (e.g. PDE 4 inhibitors, pimecrolimus, tacrolimus) or TCS on the hands within 14 days prior to baseline.
•\- Use of systemic antibiotics or cutaneously applied antibiotics on the hands within 14 days prior to baseline.
•\- Other cutaneously applied therapy on the hands (except for the use of subject’s own emollients) within 7 days prior to baseline.
•\- Cutaneously applied treatments in regions other than the hands, which could interfere with clinical trial evaluations or pose a safety concern within 7 days prior to baseline.
•\- Any disorder which is not stable and could affect the safety of the subject throughout the trial or impede the subject’s ability to complete the trial.