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)

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) - DELTA3

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON51146

Enrollment

Registered

2021-05-31

Start date

2022-01-28

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 handeczema

Interventions

Name of IMP: delgocitinib cream Active substance: delgocitinib Dosage form: cream Concentration: 20 mg / g Dose and method of administration: apply topically twice daily

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 1. Signed and dated informed consent has been obtained prior to any protocol-related procedures. 2. The baseline visit in this extension trial must coincide with the Week 16 (end-of-treatment) visit in the parent trial. 3. Subjects must have met eligibility criteria at screening and baseline in the parent trial. 4. Subjects must have completed the treatment period in the parent trial (to be assessed at baseline visit in this extension trial). 5. Subjects must have complied with the clinical trial protocol in the parent trial to the satisfaction of the investigator. 6. 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

Exclusion criteria: 1. Subjects who prematurely discontinued treatment with IMP or initiated rescue medication in the parent trial. 2. Subjects 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. 3. 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. 4. Current participation in any other interventional clinical trial, except for parent trial.

Design outcomes

Primary

Measure	Time frame
Number of treatment-emergent AEs from baseline up to Week 38.	—

Secondary

Measure	Time frame
• 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.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)