Efficacy and Safety of Delgocitinib Cream in Adolescents 12-17 Years of Age With Moderate to Severe Chronic Hand Eczema (DELTA TEEN)

LEO Pharma

Status and phase: Enrolling; Phase 3

Conditions: Chronic Hand Eczema

Treatments: Drug: Cream vehicle; Drug: Delgocitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT05355818

2021-006340-27 (EudraCT Number)

LP0133-1426

Details and patient eligibility

About

The purpose of this trial is to test if delgocitinib cream is effective at treating chronic hand eczema (CHE) and what side effects it may have, in children aged 12-17. There will be a range of assessments that rate the severity and extent of CHE symptoms, general health and quality of life.

Delgocitinib is a cream that suppresses specific processes in the body's response to diseases like CHE, such as inflammation.

The trial will last up to 22 weeks and has a 1-4 week screening period, a 16 week treatment period and a 2 week follow up period. During the treatment period each child will use either delgocitinib cream or a cream vehicle twice a day. Which cream each child receives is chosen randomly by a computer. The cream vehicle is made of the same ingredients as the delgocitinib cream except for the active medical ingredient. There will be 8 visits with the trial doctor.

Enrollment: 92 estimated patients

Sex: All

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.
• Subjects who have a documented history of inadequate response to treatment with TCS or for whom TCS are documented to be otherwise medically inadvisable.

Exclusion criteria

• Concurrent skin disease on the hands.

• Clinically significant infection on the hands.

• Systemic treatment with immunosuppressive drugs, immunomodulating drugs, retinoids, 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, 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 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.
  • Impede the subject's ability to complete the trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

92 participants in 2 patient groups, including a placebo group

Delgocitinib cream

Experimental group

Description:

Delgocitinib cream 20 mg/g twice daily

Treatment:

Drug: Delgocitinib

Cream vehicle

Placebo Comparator group

Description:

Cream vehicle twice daily

Treatment:

Drug: Cream vehicle