An open-label multi-site extension trial in subjects who completed the LP0133-1401 (DELTA 1) or LP0133-1402 (DELTA 2) trials

A phase 3 extension trial of DELTA 1 and DELTA 2 to evaluate the long-term safety of a twice-daily treatment with delgocitinib cream 20 mg/g as needed for up to 36 weeks in adult subjects with chronic hand eczema (DELTA 3)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-002962-15-DE

Enrollment

600

Registered

2021-07-02

Start date

2021-10-22

Completion date

Unknown

Last updated

2024-09-23

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

Conditions

Chronic Hand Eczema MedDRA version: 23.1 Level: LLT Classification code 10084778 Term: Chronic hand eczema System Organ Class: 100000004858

Interventions

Product Name: Delgocitinib cream Product Code: LEO 124249 Pharmaceutical Form: Cream INN or Proposed INN: Delgocitinib CAS Number: 1263774-59-9 Current Sponsor code: LEO 124249 Other descriptive name:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Signed and dated informed consent has been obtained prior to any protocol related procedures. • The baseline visit in this extension trial must coincide with the Week 16 (end-of-treatment) visit in the parent trial. • Subjects must have met eligibility criteria at screening and baseline in the parent trial. • Subjects must have completed the treatment period in the parent trial (to be assessed at baseline visit in this extension trial). • Subjects must have complied with the clinical trial protocol in the parent trial to the satisfaction of the investigator. • A woman of childbearing potential must use an acceptable method of birth control throughout the trial up until the end-of-treatment/early termination visit. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 540 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60

Exclusion criteria

Exclusion criteria: • Subjects who prematurely discontinued treatment with the investigational medicinal product (IMP) or initiated rescue medication in the parent trial. • Subjects who experienced any AE during participation in the parent trial, which precludes further treatment with delgocitinib cream 20 mg/g in the judgement of the investigator. • Any medical or psychiatric condition that could put the subject at undue risk by participating in the trial, or which, by the investigator's judgment, makes the subject inappropriate for the trial. • Current participation in any other interventional clinical trial, except for parent trials.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the long-term safety of an as-needed treatment with twice-daily applications of delgocitinib cream 20 mg/g.;Secondary Objective: To evaluate the long-term efficacy of an as-needed treatment with twice-daily applications of delgocitinib cream 20 mg/g.;Primary end point(s): Number of treatment-emergent AEs from baseline up to Week 38.;Timepoint(s) of evaluation of this end point: Week 38	—

Measure

Time frame

Main Objective: To evaluate the long-term safety of an as-needed treatment with twice-daily applications of delgocitinib cream 20 mg/g.;Secondary Objective: To evaluate the long-term efficacy of an as-needed treatment with twice-daily applications of delgocitinib cream 20 mg/g.;Primary end point(s): Number of treatment-emergent AEs from baseline up to Week 38.;Timepoint(s) of evaluation of this end point: Week 38

—

Secondary

Measure	Time frame
Secondary end point(s): • IGA-CHE score at each scheduled visit from baseline up to Week 36. • IGA-CHE score of 0 (clear) or 1 (almost clear) at each scheduled visit from baseline up to Week 36. • HECSI score at each scheduled visit from baseline up to Week 36. • HECSI-75 at each scheduled visit from baseline up to Week 36. • HECSI-90 at each scheduled visit from baseline up to Week 36. ;Timepoint(s) of evaluation of this end point: Timepoint for evaluation described in each endpoint.	—

Measure

Time frame

Secondary end point(s): • IGA-CHE score at each scheduled visit from baseline up to Week 36. • IGA-CHE score of 0 (clear) or 1 (almost clear) at each scheduled visit from baseline up to Week 36. • HECSI score at each scheduled visit from baseline up to Week 36. • HECSI-75 at each scheduled visit from baseline up to Week 36. • HECSI-90 at each scheduled visit from baseline up to Week 36. ;Timepoint(s) of evaluation of this end point: Timepoint for evaluation described in each endpoint.

—

Countries

Belgium, Canada, Denmark, France, Germany, Italy, Netherlands, Poland, Russian Federation, Spain, United Kingdom

Contacts

Public ContactGlobal Regulatory Affairs

LEO Pharma A/S

raleodk@leo-pharma.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026