Trial · NCT03958955
Efficacy and Safety of Delgocitinib Cream in Discoid Lupus Erythematosus.
NCT03958955, Phase 2, Terminated, LEO Pharma; results first posted 2021-06-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Delgocitinib Cream in Discoid Lupus Erythematosus. Trials, record NCT03958955. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03958955
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Delgocitinib Cream in Discoid Lupus Erythematosus.
- NCT number
- NCT03958955
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 27 participants, actual
- Lead sponsor
- LEO Pharma
- Conditions
- Discoid Lupus Erythematosus
- Interventions
- Delgocitinib cream, Delgocitinib cream vehicle
- First posted
- 2019-05-22
- Last updated
- 2025-03-06
- Other registries' IDs
- eudract:2018-003615-22
- Results first posted
- 2021-06-28
- Limitations and caveats
The trial was terminated prematurely due to slow recruitment, and due to an anticipation that recruitment would become further delayed due to the COVID-19 pandemic affecting recruitment activities. The total number of subjects included in the trial therefore ended with 27 subjects randomised. 26 subjects completed the trial, as 1 subject withdrew from the trial due to an AE (moderate cutaneous lupus erythematosus \[CLE\]; reported term: cutaneous lupus erythematosus flare).
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Target Lesions With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 6. | Week 6 | The IGA is an instrument used in clinical trials to rate the severity of the subject's global disease and is based on a 5-point scale ranging from 0 (clear) to 4 (severe). In this trial, the IGA was a lesion-specific assessment and was evaluated separately for each of the 2 target lesions. |
| Secondary | Number of Adverse Events (AEs) up to Week 6. | Week 0 to Week 6 | Number of AEs from baseline to Week 6 |
| Secondary | Number of Subjects With AEs up to Week 6. | Week 0 to Week 6 | Number of subjects with AEs from baseline to Week 6 |
| Secondary | Number of Lesion-specific, Treatment-related AEs up to Week 6. | Week 0 to Week 6 | The number of lesion-specific, treatment-related AEs per target lesion will be compared for active and vehicle treatment. Lesion-specific AEs are defined as lesional/perilesional AEs (i.e. AE location within the treatment area and/or ≤2 cm from the border of a target lesion). |
| Secondary | Number of Lesions With ≥2-point Reduction in IGA Score at Week 6 Compared to Baseline. | Week 0 to Week 6 | The IGA is an instrument used in clinical trials to rate the severity of the subject's global disease and is based on a 5-point scale ranging from 0 (clear) to 4 (severe). In this trial, the IGA was a lesion-specific assessment and was evaluated separately for each of the 2 target lesions. |
| Secondary | Number of Lesions With ≥2-point Reduction in Erythema Score at Week 6 Compared to Baseline. | Week 0 to Week 6 | The erythema score is lesion-specific and based on the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) and the Revised CLASI (RCLASI) which are validated scoring systems to assess disease activity and damage in patients with cutaneous lupus erythematosus. The severity of the erythema is scored on a 4-point scale ranging from 0 to 3. The severity is scored from low to high with 0=absent and 3=dark red, purple/violaceous/crusted/haemorrhagic. |
| Secondary | Erythema Score at Week 6. | Week 6 | The erythema score is lesion-specific and based on the CLASI and the RCLASI which are validated scoring systems to assess disease activity and damage in patients with cutaneous lupus erythematosus. The severity of the erythema is scored on a 4-point scale ranging from 0 to 3. The severity is scored from low to high with 0=absent and 3=dark red, purple/violaceous/crusted/haemorrhagic. |
| Secondary | Total Skin Disease Activity Score (Sum of Scores for Erythema, Scaling/Hyperkeratosis, and Oedema/Infiltration) at Week 6. | Week 6 | The skin disease activity scores are based on the CLASI and the RCLASI which are validated scoring systems to assess disease activity and damage in patients with cutaneous lupus erythematosus. The total skin disease activity score is defined as the sum of the scores for 3 clinical signs (erythema, scaling/hyperkeratosis, oedema/infiltration) for each target lesion. For the total score and the individual clinical signs, higher scores indicate more severe symptoms. Erythema is scored on a 4-point scale ranging from 0 (absent) to 3 (dark red, purple/violaceous/crusted/haemorrhagic). Hyperkeratosis/scaling is scored on a 3-point scale from 0 (absent) to 2 (verrucous hyperkeratosis). Oedema/infiltration is scored on a 3-point scale from 0 (absent) to 2 (palpable and visible). The total skin disease activity score can therefore range from 0 to 7. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Target Lesions With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 6. | Week 6 | Per protocol (PP) analysis set. 5 subjects were excluded from the per protocol (PP) analysis set as the primary endpoint data were compromised. The PP analysis set hence comprised 22 (81.5%) subjects. Data at Week 8 was excluded from the PP analysis set for 2 subjects, as they used prohibited concomitant medication in the safety follow-up period. | lesions | NUMBER |
| SECONDARY | Number of Adverse Events (AEs) up to Week 6. | Week 0 to Week 6 | Safety analysis set. All 27 subjects were exposed to IMP. All subjects were treated with delgocitinib cream on one target lesion and with vehicle on another target lesion, and except for lesion-specific AEs, it was therefore not possible to distinguish between AEs related to delgocitinib cream or vehicle treatment. | AEs | NUMBER |
| SECONDARY | Number of Subjects With AEs up to Week 6. | Week 0 to Week 6 | Safety analysis set. All 27 subjects were exposed to IMP. All subjects were treated with delgocitinib cream on one target lesion and with vehicle on another target lesion, and except for lesion-specific AEs, it was therefore not possible to distinguish between AEs related to delgocitinib cream or vehicle treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Lesion-specific, Treatment-related AEs up to Week 6. | Week 0 to Week 6 | Safety analysis set. All 27 subjects were exposed to IMP. All subjects were treated with delgocitinib cream on one target lesion and with vehicle on another target lesion. It was therefore only possible to distinguish between AEs related to delgocitinib cream or vehicle treatment for the lesion-specific AEs. | AEs | NUMBER |
| SECONDARY | Number of Lesions With ≥2-point Reduction in IGA Score at Week 6 Compared to Baseline. | Week 0 to Week 6 | Per protocol (PP) analysis set. 5 subjects were excluded from the per protocol (PP) analysis set as the primary endpoint data were compromised. The PP analysis set hence comprised 22 (81.5%) subjects. Data at Week 8 was excluded from the PP analysis set for 2 subjects, as they used prohibited concomitant medication in the safety follow-up period. | lesions | NUMBER |
| SECONDARY | Number of Lesions With ≥2-point Reduction in Erythema Score at Week 6 Compared to Baseline. | Week 0 to Week 6 | Per protocol (PP) analysis set. 5 subjects were excluded from the per protocol (PP) analysis set as the primary endpoint data were compromised. The PP analysis set hence comprised 22 (81.5%) subjects. Data at Week 8 was excluded from the PP analysis set for 2 subjects, as they used prohibited concomitant medication in the safety follow-up period. | lesions | NUMBER |
| SECONDARY | Erythema Score at Week 6. | Week 6 | Per protocol (PP) analysis set. | scores on a scale | MEDIAN |
| SECONDARY | Total Skin Disease Activity Score (Sum of Scores for Erythema, Scaling/Hyperkeratosis, and Oedema/Infiltration) at Week 6. | Week 6 | Per protocol (PP) analysis set. 5 subjects were excluded from the per protocol (PP) analysis set as the primary endpoint data were compromised. The PP analysis set hence comprised 22 (81.5%) subjects. Data at Week 8 was excluded from the PP analysis set for 2 subjects, as they used prohibited concomitant medication in the safety follow-up period. | scores on a scale | MEDIAN |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Target Lesions With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 6. | Delgocitinib Cream 20 mg/g | 3 | lesions | ||
| Target Lesions With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 6. | Delgocitinib Cream Vehicle | 6 | lesions | ||
| Number of Adverse Events (AEs) up to Week 6. | All Subjects | 8 | AEs | ||
| Number of Subjects With AEs up to Week 6. | All Subjects | 8 | Participants | ||
| Number of Lesion-specific, Treatment-related AEs up to Week 6. | Delgocitinib Cream 20 mg/g | 2 | AEs | ||
| Number of Lesion-specific, Treatment-related AEs up to Week 6. | Delgocitinib Cream Vehicle | 0 | AEs | ||
| Number of Lesions With ≥2-point Reduction in IGA Score at Week 6 Compared to Baseline. | Delgocitinib Cream 20 mg/g | 3 | lesions | ||
| Number of Lesions With ≥2-point Reduction in IGA Score at Week 6 Compared to Baseline. | Delgocitinib Cream Vehicle | 6 | lesions | ||
| Number of Lesions With ≥2-point Reduction in Erythema Score at Week 6 Compared to Baseline. | Delgocitinib Cream 20 mg/g | 5 | lesions | ||
| Number of Lesions With ≥2-point Reduction in Erythema Score at Week 6 Compared to Baseline. | Delgocitinib Cream Vehicle | 5 | lesions |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow5
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | All Subjects | 27 | |
| Overall Study | Lesions Treated With Delgocitinib Cream | All Subjects | 27 | |
| Overall Study | Lesions Treated With Delgocitinib Cream Vehicle | All Subjects | 27 | |
| Overall Study | COMPLETED | All Subjects | 26 | |
| Overall Study | NOT COMPLETED | All Subjects | 1 |
Source ClinicalTrials.gov
Adverse events9
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 | Nasopharyngitis | Infections and infestations | All Subjects | 4 | 27 | 5 |
| other | Cutaneous lupus erythematosus | Skin and subcutaneous tissue disorders | All Subjects | 1 | 27 | 1 |
| other | Rash erythematous | Skin and subcutaneous tissue disorders | All Subjects | 1 | 27 | 1 |
| other | Middle ear inflammation | Ear and labyrinth disorders | All Subjects | 1 | 27 | 1 |
| other | Gastrointestinal disorder | Gastrointestinal disorders | All Subjects | 1 | 27 | 1 |
| other | Application site pain | General disorders | All Subjects | 1 | 27 | 2 |
| other | Application site pruritus | General disorders | All Subjects | 1 | 27 | 1 |
| other | Musculoskeletal pain | Musculoskeletal and connective tissue disorders | All Subjects | 1 | 27 | 1 |
| other | Headache | Nervous system disorders | All Subjects | 1 | 27 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | All Subjects | 0 | 27 |
| Total, other adverse events | All Subjects | 10 | 27 |
| Total, serious adverse events | All Subjects | 0 | 27 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33687069 | 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/NCT03958955
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