Trial · NCT04857034
A Study to Evaluate Efficacy and Safety of Deucravacitinib in Participants With Active Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE)
NCT04857034, Phase 2, Active not recruiting, Bristol-Myers Squibb; results first posted 2025-09-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate Efficacy and Safety of Deucravacitinib in Participants With Active Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE). Trials, record NCT04857034. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04857034
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate Efficacy and Safety of Deucravacitinib in Participants With Active Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE)
- NCT number
- NCT04857034
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 74 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Lupus Erythematosus, Discoid, Lupus Erythematosus, Subacute Cutaneous
- Interventions
- Deucravacitinib, Placebo
- First posted
- 2021-04-23
- Last updated
- 2025-09-10
- Other registries' IDs
- eudract:2020-000071-21
- Results first posted
- 2025-09-10
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage Change From Baseline in CLASI Activity Score at Week 16 | From first dose to Week 16 (approximately 16 weeks) | The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) is a validated clinical tool designed to assess skin involvement in cutaneous lupus erythematosus (CLE). It separately scores: * Disease activity (e.g., erythema, scale, mucous membrane involvement, alopecia) * Damage (e.g., dyspigmentation, scarring) CLASI enables classification of disease severity: Mild: Activity score 0-9 Moderate: 10-20 Severe: 21-70 |
| Secondary | Percentage of Participants With an Improvement of ≥ 50% From Baseline in the CLASI-A Score (CLASI-50). | From first dose to Week 16 (approximately 16 weeks) | The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) is a validated clinical tool designed to assess skin involvement in cutaneous lupus erythematosus (CLE). It separately scores: * Disease activity (e.g., erythema, scale, mucous membrane involvement, alopecia) * Damage (e.g., dyspigmentation, scarring) CLASI enables classification of disease severity: Mild: Activity score 0-9 Moderate: 10-20 Severe: 21-70 |
| Secondary | Percentage of Participants Who Have Disease Improvement as Defined by a Reduction in CLASI-A of ≥ 4 Points From Baseline. | From first dose to Week 16 (approximately 16 weeks) | The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) is a validated clinical tool designed to assess skin involvement in cutaneous lupus erythematosus (CLE). It separately scores: * Disease activity (e.g., erythema, scale, mucous membrane involvement, alopecia) * Damage (e.g., dyspigmentation, scarring) CLASI enables classification of disease severity: Mild: Activity score 0-9 Moderate: 10-20 Severe: 21-70 |
| Secondary | Mean Change From Baseline in CLASI-A Score. | From first dose to Week 16 (approximately 16 weeks) | The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) is a validated clinical tool designed to assess skin involvement in cutaneous lupus erythematosus (CLE). It separately scores: * Disease activity (e.g., erythema, scale, mucous membrane involvement, alopecia) * Damage (e.g., dyspigmentation, scarring) CLASI enables classification of disease severity: Mild: Activity score 0-9 Moderate: 10-20 Severe: 21-70 |
| Secondary | Percentage of Participants Who Have a Complete Response (CR) on CLASI-A Defined as a Score of "0". | From first dose to Week 16 (approximately 16 weeks) | The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) is a validated clinical tool designed to assess skin involvement in cutaneous lupus erythematosus (CLE). It separately scores: * Disease activity (e.g., erythema, scale, mucous membrane involvement, alopecia) * Damage (e.g., dyspigmentation, scarring) CLASI enables classification of disease severity: Mild: Activity score 0-9 Moderate: 10-20 Severe: 21-70 Complete Response (CR) on CLASI-A defined as a score of "0". |
| Secondary | Number of Participants With Safety Related Events in the Placebo Controlled Period | From signing informed consent to end of safety follow up period (Approximately 60 weeks) | Number of participants with safety related events in the placebo controlled period |
| Secondary | Number of Participants With Safety Related Events in the Active Treatment Period | From signing informed consent to end of safety follow up period (Approximately 60 weeks) | Number of participants with safety related events in the active treatment period |
| Secondary | Number of Participants With Clinically Significant Laboratory Abnormalities in the Placebo Controlled Period | From signing informed consent to end of safety follow up period (Approximately 60 weeks) | Number of participants with clinically significant laboratory abnormalities in the placebo controlled period |
| Secondary | Number of Participants With Clinically Significant Laboratory Abnormalities in the Active Treatment Period | From signing informed consent to end of safety follow up period (Approximately 60 weeks) | Number of participants with clinically significant laboratory abnormalities in the active treatment period |
| Secondary | Number of Participants With Clinically Significant Vital Sign Abnormalities in the Placebo Controlled Period | From signing informed consent to end of safety follow up period (Approximately 60 weeks) | Number of participants with clinically significant vital sign abnormalities in the placebo controlled period |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage Change From Baseline in CLASI Activity Score at Week 16 | From first dose to Week 16 (approximately 16 weeks) | All Treated Participants in the Placebo Controlled Period with a post baseline measurement in CLASI-A | Percentage change from baseline | MEAN |
| SECONDARY | Percentage of Participants With an Improvement of ≥ 50% From Baseline in the CLASI-A Score (CLASI-50). | From first dose to Week 16 (approximately 16 weeks) | All Treated Participants in the Placebo Controlled Period with a post baseline measurement in CLASI-A | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Have Disease Improvement as Defined by a Reduction in CLASI-A of ≥ 4 Points From Baseline. | From first dose to Week 16 (approximately 16 weeks) | All Treated Participants in the Placebo Controlled Period with a post baseline measurement in CLASI-A | Percentage of participants | NUMBER |
| SECONDARY | Mean Change From Baseline in CLASI-A Score. | From first dose to Week 16 (approximately 16 weeks) | All Treated Participants in the Placebo Controlled Period with a post baseline measurement in CLASI-A | Score on a Scale | MEAN |
| SECONDARY | Percentage of Participants Who Have a Complete Response (CR) on CLASI-A Defined as a Score of 0. | From first dose to Week 16 (approximately 16 weeks) | All Treated Participants in the Placebo Controlled Period with a post baseline measurement in CLASI-A | Percentage of Participants | NUMBER |
| SECONDARY | Number of Participants With Safety Related Events in the Placebo Controlled Period | From signing informed consent to end of safety follow up period (Approximately 60 weeks) | All Treated Population in the Placebo Controlled Period | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Safety Related Events in the Active Treatment Period | From signing informed consent to end of safety follow up period (Approximately 60 weeks) | All Treated Population in the active treatment period | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Laboratory Abnormalities in the Placebo Controlled Period | From signing informed consent to end of safety follow up period (Approximately 60 weeks) | All Treated Population in the Placebo Controlled Period | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Laboratory Abnormalities in the Active Treatment Period | From signing informed consent to end of safety follow up period (Approximately 60 weeks) | All Treated Population in the active treatment period | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Vital Sign Abnormalities in the Placebo Controlled Period | From signing informed consent to end of safety follow up period (Approximately 60 weeks) | All Treated Population in the Placebo Controlled Period | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group79
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage Change From Baseline in CLASI Activity Score at Week 16 | Placebo-Controlled Period: Treatment 1 | -48.56 | Standard Deviation 44.684 | Percentage change from baseline | |
| Percentage Change From Baseline in CLASI Activity Score at Week 16 | Placebo-Controlled Period: Treatment 2 | -48.93 | Standard Deviation 33.302 | Percentage change from baseline | |
| Percentage Change From Baseline in CLASI Activity Score at Week 16 | Placebo-Controlled Period: Placebo | -27.31 | Standard Deviation 29.716 | Percentage change from baseline | |
| Percentage of Participants With an Improvement of ≥ 50% From Baseline in the CLASI-A Score (CLASI-50). | Placebo-Controlled Period: Treatment 1 | 60.0 | Percentage of participants | ||
| Percentage of Participants With an Improvement of ≥ 50% From Baseline in the CLASI-A Score (CLASI-50). | Placebo-Controlled Period: Treatment 2 | 54.2 | Percentage of participants | ||
| Percentage of Participants With an Improvement of ≥ 50% From Baseline in the CLASI-A Score (CLASI-50). | Placebo-Controlled Period: Placebo | 21.7 | Percentage of participants | ||
| Percentage of Participants Who Have Disease Improvement as Defined by a Reduction in CLASI-A of ≥ 4 Points From Baseline. | Placebo-Controlled Period: Treatment 1 | 60.0 | Percentage of participants | ||
| Percentage of Participants Who Have Disease Improvement as Defined by a Reduction in CLASI-A of ≥ 4 Points From Baseline. | Placebo-Controlled Period: Treatment 2 | 66.7 | Percentage of participants | ||
| Percentage of Participants Who Have Disease Improvement as Defined by a Reduction in CLASI-A of ≥ 4 Points From Baseline. | Placebo-Controlled Period: Placebo | 39.1 | Percentage of participants | ||
| Mean Change From Baseline in CLASI-A Score. | Placebo-Controlled Period: Treatment 1 | -9.8 | Standard Deviation 12.69 | Score on a Scale |
1 to 10 of 79Source ClinicalTrials.gov
See all 79 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Placebo-Controlled Period | STARTED | Placebo-Controlled Period: Treatment 1 | 25 | |
| Placebo-Controlled Period | STARTED | Placebo-Controlled Period: Treatment 2 | 25 | |
| Placebo-Controlled Period | STARTED | Placebo-Controlled Period: Placebo | 24 | |
| Placebo-Controlled Period | STARTED | Active-Treatment Period: Treatment 1 | 0 | |
| Placebo-Controlled Period | STARTED | Active-Treatment Period: Treatment 2 | 0 | |
| Placebo-Controlled Period | COMPLETED | Placebo-Controlled Period: Treatment 1 | 21 | |
| Placebo-Controlled Period | COMPLETED | Placebo-Controlled Period: Treatment 2 | 20 | |
| Placebo-Controlled Period | COMPLETED | Placebo-Controlled Period: Placebo | 22 | |
| Placebo-Controlled Period | COMPLETED | Active-Treatment Period: Treatment 1 | 0 | |
| Placebo-Controlled Period | COMPLETED | Active-Treatment Period: Treatment 2 | 0 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events854
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 | Lymphadenopathy | Blood and lymphatic system disorders | Placebo-Controlled Period - DEUC 3 mg BID | 1 | 25 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Placebo-Controlled Period - DEUC 6 mg BID | 1 | 24 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Placebo-Controlled Period - Placebo BID | 0 | 24 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Active Treatment Period - DEUC 3 mg BID | 1 | 16 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Active Treatment Period - DEUC 6 mg BID | 0 | 20 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Active Treatment Period - Placebo-DEUC 3 mg BID | 0 | 9 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Active Treatment Period - Placebo-DEUC 6 mg BID | 0 | 9 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo-Controlled Period - DEUC 3 mg BID | 2 | 25 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo-Controlled Period - DEUC 6 mg BID | 2 | 24 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo-Controlled Period - Placebo BID | 0 | 24 |
1 to 10 of 854Source ClinicalTrials.gov
See all 854 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo-Controlled Period - DEUC 3 mg BID | 0 | 25 |
| Total, all-cause mortality | Placebo-Controlled Period - DEUC 6 mg BID | 0 | 24 |
| Total, all-cause mortality | Placebo-Controlled Period - Placebo BID | 0 | 24 |
| Total, all-cause mortality | Active Treatment Period - DEUC 3 mg BID | 0 | 16 |
| Total, all-cause mortality | Active Treatment Period - DEUC 6 mg BID | 0 | 20 |
| Total, all-cause mortality | Active Treatment Period - Placebo-DEUC 3 mg BID | 0 | 9 |
| Total, all-cause mortality | Active Treatment Period - Placebo-DEUC 6 mg BID | 0 | 9 |
| Total, other adverse events | Placebo-Controlled Period - DEUC 3 mg BID | 15 | 25 |
| Total, other adverse events | Placebo-Controlled Period - DEUC 6 mg BID | 15 | 24 |
| Total, other adverse events | Placebo-Controlled Period - Placebo BID | 8 | 24 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT04857034
GET https://conductscience.org/api/trials/v1/NCT04857034/results?page=2