Phase 3 N=801 Treatment

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

Chronic Hand Eczema

Bottom Line

View on ClinicalTrials.gov: NCT04949841 ↗

Enrolled (actual)

801

Serious AEs

3.4%

Results posted

Jan 2025

Primary outcome: Primary: Number of Treatment-emergent Adverse Events From Baseline up to Week 38 — 1238 events

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Delgocitinib (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: LEO Pharma
Primary completion: Sep 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Treatment-emergent Adverse Events From Baseline up to Week 38	1238	—
SECONDARY Number of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36	77; 83; 345; 243; 53; 58	—
SECONDARY Number of Participants With IGA-CHE Score of 0 (Clear) or 1 (Almost Clear) at Each Scheduled Visit From Baseline up to Week 36.	160; 134; 155; 155; 156; 162	—
SECONDARY HECSI Score at Each Scheduled Visit From Baseline up to Week 36	30.8; 24.3; 21.4; 20.2; 17.9; 17.8	—
SECONDARY Number of Participants With HECSI-75 at Each Scheduled Visit From Baseline up to Week 36	347; 391; 415; 411; 432; 438	—
SECONDARY Number of Participants With HECSI-90 at Each Scheduled Visit From Baseline up to Week 36	207; 195; 224; 222; 229; 239	—

Summary

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04949841). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.