Trial · NCT07332481
A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease
NCT07332481, Phase 3, Recruiting, EMD Serono Research & Development Institute, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease. Trials, record NCT07332481. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07332481
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease
- NCT number
- NCT07332481
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 202 participants, estimated
- Lead sponsor
- EMD Serono Research & Development Institute, Inc.
- Conditions
- Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE)
- Interventions
- Enpatoran, Placebo, Standard of care (SoC)
- First posted
- 2026-01-12
- Last updated
- 2026-11-04
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) 70 Response, Defined as >= 70 Percent (%) Decrease in CLASI-A Score From Baseline | At Week 24 | |
| Secondary | Percentage of Participants With British Isles Lupus Assessment Group Based Composite Lupus Assessment (BICLA) Response | At Week 24 | A BICLA response is defined as British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004) -improvement without worsening (A scores at Baseline improved to B, C or D; B scores improved to C or D; no new A scores and less than or equal to \[\<=\] 1 new B.); Here, score A ("Active"): Severely active disease; score B ("Beware"): Moderately active disease; score C ("Contentment"): Mild stable disease; score D ("Discount"): Inactive now but previously active; -no worsening in disease activity (no new BILAG 2004 A scores and \<= 1 new B score); -no worsening of total Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score from Baseline; -no significant deterioration (less than \[\<\] 10% worsening) in visual analog Physician's Global Assessment (PGA) and -no treatment failure i.e. protocol-prohibited medications as determined by Endpoint Adjudication Committee (EAC) or premature discontinuation from study treatment). |
| Secondary | Number of Participants With Treatment Emergent adverse events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESI) | From Day 1 to Week 24 | |
| Secondary | Number of Participants With Abnormal (greater than and equal to [>=] Grade 3) laboratory parameters | From Day 1 to Week 24 | |
| Secondary | Percentage of Participants With CLASI-50 Response, Defined as >=50% Decrease in CLASI-A Score From Baseline | At Weeks 4 and 24 | |
| Secondary | Percentage of Participants With CLASI-A less than and equal to (<=) 3 at Week 24 | At Week 24 | CLASI-A assesses the signs of CLE disease activity including erythema, scale, and hypertrophy, active alopecia, and mucous membrane disease, Scores range from 0 to 70 points for CLASI-A score. Mild, moderate, and severe disease corresponds with CLASI activity score ranges of 0 to 9, 10 to 20, and 21 to 70, respectively. Higher scores indicate more disease activity. |
| Secondary | Percentage of Participants With BICLA Response and Clinically Meaningful Corticosteroid (CS) Reduction | Day 1 up to Week 12 and thereafter upto Week 24 | BICLA Response and clinically meaningful CS reduction, is defined as reduction of daily prednisone-equivalent dose from \>= 10 milligrams (mg) at Day 1 to \<= 5 mg by the Week 12 visit and sustained through Week 24. |
| Secondary | Change from Baseline in Worst Itch Numeric Rating Scale (NRS) Score at Week 24 | Baseline and at Week 24 | The Worst Itch NRS is a self-rated single item scale designed for assessing worst itch in the past 7 days. The scale utilizes 11-point NRS, scored from of 0 (no itch) to 10 (worst imaginable itch). |
| Secondary | Change from Baseline in CLASI-A Erythema at Week 24 | Baseline and at Week 24 | CLASI-A assesses the signs of CLE disease activity including erythema, scale, and hypertrophy, active alopecia, and mucous membrane disease, Scores range from 0 to 70 points for CLASI-A score. Mild, moderate, and severe disease corresponds with CLASI activity score ranges of 0 to 9, 10 to 20, and 21 to 70, respectively. Higher scores indicate more disease activity. |
| Secondary | Change from Baseline in CLASI-A Scale/Hypertrophy at Week 24 | Baseline and at Week 24 | CLASI-A assesses the signs of CLE disease activity including erythema, scale, and hypertrophy, active alopecia, and mucous membrane disease, Scores range from 0 to 70 points for CLASI-A score. Mild, moderate, and severe disease corresponds with CLASI activity score ranges of 0 to 9, 10 to 20, and 21 to 70, respectively. Higher scores indicate more disease activity. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
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/NCT07332481
GET https://conductscience.org/api/trials/v1/NCT07332481/registered