Trial · NCT04949841
Open-label Multi-site Extension Trial in Subjects Who Completed the DELTA 1 or DELTA 2 Trials
NCT04949841, Phase 3, Completed, LEO Pharma; results first posted 2025-01-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Open-label Multi-site Extension Trial in Subjects Who Completed the DELTA 1 or DELTA 2 Trials. Trials, record NCT04949841. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04949841
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open-label Multi-site Extension Trial in Subjects Who Completed the DELTA 1 or DELTA 2 Trials
- NCT number
- NCT04949841
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 801 participants, actual
- Lead sponsor
- LEO Pharma
- Conditions
- Chronic Hand Eczema
- Interventions
- Delgocitinib
- First posted
- 2021-07-02
- Last updated
- 2025-04-08
- Other registries' IDs
- eudract:2020-002962-15
- Results first posted
- 2025-01-20
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Treatment-emergent Adverse Events From Baseline up to Week 38 | From baseline up to Week 38 | An AE will be considered treatment emergent if it started after the baseline visit |
| Secondary | Number of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36 | From baseline up to Week 38 | The Investigator's Global Assessment for chronic hand eczema (IGA-CHE) is an instrument used in clinical trials to rate the severity of the participant's chronic hand eczema (CHE) and is based on a 5-point scale ranging from 0 (clear) to 4 (severe). |
| 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. | From baseline up to Week 38 | The Investigator's Global Assessment for chronic hand eczema (IGA-CHE) is an instrument used in clinical trials to rate the severity of the participant's chronic hand eczema (CHE) and is based on a 5-point scale ranging from 0 (clear) to 4 (severe). |
| Secondary | HECSI Score at Each Scheduled Visit From Baseline up to Week 36 | From baseline up to Week 38 | The Hand Eczema Severity Index (HECSI) is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers \[except fingertips\], palm of hands, back of hands, and wrists) by use of standard scales. The HECSI score will range from 0 (lowest possible score) to 360 (highest possible score). |
| Secondary | Number of Participants With HECSI-75 at Each Scheduled Visit From Baseline up to Week 36 | From baseline up to Week 38 | The Hand Eczema Severity Index (HECSI) is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers \[except fingertips\], palm of hands, back of hands, and wrists) by use of standard scales. The HECSI score will range from 0 (lowest possible score) to 360 (highest possible score). HECSI-75 is defined as at least 75% improvement in HECSI score from parent trial baseline. |
| Secondary | Number of Participants With HECSI-90 at Each Scheduled Visit From Baseline up to Week 36 | From baseline up to Week 38 | The Hand Eczema Severity Index (HECSI) is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers \[except fingertips\], palm of hands, back of hands, and wrists) by use of standard scales. The HECSI score will range from 0 (lowest possible score) to 360 (highest possible score). HECSI-90 is defined as at least 90% improvement in HECSI score from parent trial baseline. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Treatment-emergent Adverse Events From Baseline up to Week 38 | From baseline up to Week 38 | events | NUMBER | |
| SECONDARY | Number of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36 | From baseline up to Week 38 | Participants | COUNT_OF_PARTICIPANTS | |
| 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. | From baseline up to Week 38 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | HECSI Score at Each Scheduled Visit From Baseline up to Week 36 | From baseline up to Week 38 | score on a scale | MEAN | |
| SECONDARY | Number of Participants With HECSI-75 at Each Scheduled Visit From Baseline up to Week 36 | From baseline up to Week 38 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With HECSI-90 at Each Scheduled Visit From Baseline up to Week 36 | From baseline up to Week 38 | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group91
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Treatment-emergent Adverse Events From Baseline up to Week 38 | As-needed Treatment With Delgocitinib | 1238 | events | ||
| Number of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36 | As-needed Treatment With Delgocitinib | At baseline : 0-Clear | 77 | Participants | |
| Number of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36 | As-needed Treatment With Delgocitinib | At baseline : 1- Almost Clear | 83 | Participants | |
| Number of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36 | As-needed Treatment With Delgocitinib | At baseline : 2- Mild | 345 | Participants | |
| Number of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36 | As-needed Treatment With Delgocitinib | At baseline : 3- Moderate | 243 | Participants | |
| Number of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36 | As-needed Treatment With Delgocitinib | At baseline : 4- Severe | 53 | Participants | |
| Number of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36 | As-needed Treatment With Delgocitinib | Week 4 : 0-Clear | 58 | Participants | |
| Number of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36 | As-needed Treatment With Delgocitinib | Week 4 : 1- Almost Clear | 76 | Participants | |
| Number of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36 | As-needed Treatment With Delgocitinib | Week 4 : 2- Mild | 436 | Participants | |
| Number of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36 | As-needed Treatment With Delgocitinib | Week 4 : 3- Moderate | 189 | Participants |
1 to 10 of 91Source ClinicalTrials.gov
See all 91 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | As-needed Treatment With Delgocitinib | 801 | |
| Overall Study | COMPLETED | As-needed Treatment With Delgocitinib | 664 | |
| Overall Study | NOT COMPLETED | As-needed Treatment With Delgocitinib | 137 |
Source ClinicalTrials.gov
Adverse events43
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | COVID-19 | Infections and infestations | As-needed Treatment With Delgocitinib | 134 | 801 | 138 |
| other | Influenza | Infections and infestations | As-needed Treatment With Delgocitinib | 28 | 801 | 28 |
| other | Nasopharyngitis | Infections and infestations | As-needed Treatment With Delgocitinib | 128 | 801 | 161 |
| other | Upper respiratory tract infection | Infections and infestations | As-needed Treatment With Delgocitinib | 32 | 801 | 36 |
| other | Back pain | Musculoskeletal and connective tissue disorders | As-needed Treatment With Delgocitinib | 19 | 801 | 20 |
| other | Headache | Nervous system disorders | As-needed Treatment With Delgocitinib | 22 | 801 | 27 |
| other | Eczema | Skin and subcutaneous tissue disorders | As-needed Treatment With Delgocitinib | 17 | 801 | 21 |
| other | Hand dermatitis | Skin and subcutaneous tissue disorders | As-needed Treatment With Delgocitinib | 30 | 801 | 34 |
| serious | Myocardial infarction | Cardiac disorders | As-needed Treatment With Delgocitinib | 1 | 801 | 1 |
| serious | Abdominal incarcerated hernia | Gastrointestinal disorders | As-needed Treatment With Delgocitinib | 1 | 801 | 1 |
1 to 10 of 43Source ClinicalTrials.gov
See all 43 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | As-needed Treatment With Delgocitinib | 3 | 801 |
| Total, other adverse events | As-needed Treatment With Delgocitinib | 329 | 801 |
| Total, serious adverse events | As-needed Treatment With Delgocitinib | 27 | 801 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40081663 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04949841
GET https://conductscience.org/api/trials/v1/NCT04949841/results?page=2