Phase 3
Completed N=801
Open-label Multi-site Extension Trial in Subjects Who Completed the DELTA 1 or DELTA 2 Trials
Chronic Hand Eczema
Source: ClinicalTrials.gov NCT04949841 ↗
Enrolled (actual)
801
Serious AEs
3.4%
Results posted
Jan 2025
Primary outcomePrimary: Number of Treatment-emergent Adverse Events From Baseline up to Week 38 — 1238 events
◆ Published Evidence
Established
26citations · ~26 / year
Long-term safety and efficacy of delgocitinib cream for up to 52 weeks in adults with Chronic Hand Eczema: Results of the phase 3 open-label extension DELTA 3 trial following the DELTA 1 and 2 trials.
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.
Linked Publications
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Long-term safety and efficacy of delgocitinib cream for up to 52 weeks in adults with Chronic Hand Eczema: Results of the phase 3 open-label extension DELTA 3 trial following the DELTA 1 and 2 trials.
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 | — |
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.
Data sourced from ClinicalTrials.gov (NCT04949841) and the linked publication. 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. Informational only — not medical advice.