Open-label Multi-site Extension Trial in Subjects Who Completed the DELTA 1 or DELTA 2 Trials (DELTA 3)

LEO Pharma

Status and phase

Completed

Phase 3

Conditions

Chronic Hand Eczema

Treatments

Drug: Delgocitinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT04949841

U1111-1284-2216 (Other Identifier)

2020-002962-15 (EudraCT Number)

LP0133-1403

Details and patient eligibility

About

The purpose of this extension trial is to evaluate the long-term safety of delgocitinib.

Subjects will visit the clinic every 4 week to assess the safety and efficacy of the treatment, until Week 36. A final follow-up phone call is planned on Week 38.

Full description

Subject who completed 16 weeks of treatment with delgocitinib cream 20 mg/g or vehicle cream twice daily in trials DELTA 1 or DELTA 2 will be offered to roll-over to this extension trial.

Subjects will be treated with delgocitinib cream 20 mg/g twice daily only if they need it to control their chronic hand eczema. In the periods when the disease is controlled, no treatment will be administered.

Clinic visits every 4 weeks are planned (with the possibility of unscheduled visits) to investigate safety and efficacy of treatment, as well as its effect on patient-reported outcomes (PROs).

Enrollment

801 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Participants must have met eligibility criteria at screening and baseline in the parent trial (DELTA 1 or DELTA 2).
Participants must have completed the treatment period in the parent trial (to be assessed at baseline visit in this extension trial).
Participants 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.

Exclusion criteria

Participants who prematurely discontinued treatment with IMP or initiated rescue medication in the parent trial.
Participants who experienced any adverse event (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 participant at undue risk by participating in the trial, or which, by the investigator's judgment, makes the participant inappropriate for the trial.