Trial · NCT05162586
The WILLOW Study With M5049 in SLE and CLE (SCLE and/or DLE) (WILLOW)
NCT05162586, Phase 2, Completed, EMD Serono Research & Development Institute, Inc.; results first posted 2025-12-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. The WILLOW Study With M5049 in SLE and CLE (SCLE and/or DLE) (WILLOW). Trials, record NCT05162586. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05162586
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The WILLOW Study With M5049 in SLE and CLE (SCLE and/or DLE) (WILLOW)
- NCT number
- NCT05162586
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 456 participants, actual
- Lead sponsor
- EMD Serono Research & Development Institute, Inc.
- Conditions
- Systemic Lupus Erythematosus
- Interventions
- Enpatoran low dose, Enpatoran medium dose, Enpatoran high dose, Placebo
- First posted
- 2021-12-17
- Last updated
- 2025-12-01
- Other registries' IDs
- eudract:2021-004648-27
- Results first posted
- 2025-12-01
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cohort A: Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index-A (CLASI-A) Total Score at Week 16 | Baseline, week 16 | The CLASI (Cutaneous Lupus Erythematosus Disease Area and Severity Index) was a validated instrument used to assess disease activity (CLASI-A) and damage in lupus erythematosus. The activity scale included erythema, scale/hypertrophy, active alopecia, recent hair loss, and mucous membrane disease, while the damage scale measured dyspigmentation, atrophy, and scarring. CLASI-A scores ranged from 0 to 70, with mild, moderate, and severe disease corresponding to scores of 0-9, 10-20, and 21-70, respectively. Erythema and scale/hypertrophy sub-scores were computed across 13 body areas, with maximum scores of 39 and 26, respectively. The remaining 5 points reflected contributions from active alopecia (0-3), recent hair loss (0-1), and mucous membrane involvement (0-1), completing the total CLASI-A activity score. Directionality reflected worsening with higher scores and improvement with lower scores. |
| Primary | Cohort B: Number of Participants With British Isles Lupus Assessment Group (BILAG)-Based Composite Lupus Assessment (BICLA) Response at Week 24 | At Week 24 | BILAG-based BICLA response is defined as participants meeting all of the following criteria: 1. Improvement in baseline BILAG scores in all organ systems with moderate or severe disease activity-i.e., all grade A scores (severe disease requiring high-dose therapy) must improve to B (moderate), C (mild), or D (no activity); all grade B scores (moderate disease requiring moderate therapy) must improve to C or D; 2. No new BILAG A scores and no more than one new BILAG B score; 3. No worsening in total SLEDAI-2K score from baseline; 4. No significant deterioration (≤10%) in physician's global assessment; and 5. No treatment failure, defined as initiation of non-protocol therapy. Directionality is toward clinical improvement and disease stabilization. |
| Secondary | Cohort A and B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events (AEs) of Special Interest | From screening upto safety follow up period (up to approximately 33 weeks) | An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether considered related to the medicinal product or protocol-specified procedure. Serious AE was defined AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAE was defined as events with onset date or worsening during the on-treatment period. TEAEs included serious TEAEs and non-serious TEAEs. Adverse events of special interest (AESI) are serious or non-serious AEs that are of clinical interest and were closely followed. |
| Secondary | Cohort A and B: Number of Participants With Abnormal Laboratory Parameters | From screening upto safety follow up period (up to approximately 33 weeks) | Laboratory parameters included hematology, biochemistry, Urinalysis, Renal Toxicity and Hepatotoxicity. Number of Participants with Abnormal laboratory parameters (severity of grade greater or equal to 3) were reported. Severity of grade 3 or higher TEAEs were graded using National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 toxicity grades, as follows: Grade 3 = Severe; Grade 4 = Life-threatening and Grade 5 = Death. |
| Secondary | Cohort A and B: Number of Participants With Clinically Important Increases in QT Interval Corrected Using Fridericia's Formula (QTcF) | From screening upto safety follow up period (up to approximately 33 weeks) | 12-lead ECG recordings included rhythm, heart rate (as measured by RR interval), PR interval, QRS duration, and QT interval. The corrected QT interval (QTcF) was calculated using Fridericia's formula. 12-lead ECG recordings were obtained after the participants have rested for at least 10 minutes in semisupine position. Clinical importance was determined by the investigator. The number of participants with clinically important increases in QTCF findings were reported. |
| Secondary | Cohort A and Cohort B: Change From Baseline in Cutaneous Lupus Activity Investigator's Global Assessment (CLA-IGA) Scale Score at Week 16 and Week 24 | Baseline and at Week 16 and Week 24 | The Cutaneous Lupus Activity Investigator's Global Assessment (CLA-IGA) is a validated clinician-reported outcome measure used to assess disease severity in participants with cutaneous lupus erythematosus. It is based on a 5-point ordinal scale that evaluates overall lesion characteristics, where 0 indicates "clear" skin and 4 represents "severe" disease. The scale includes the following categories: 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), and 4 (severe). |
| Secondary | Cohort A and Cohort B: Change From Baseline in Physician's Global Assessment of Cutaneous Lupus Disease Activity Score at Week 16 and 24 | Baseline and at Week 16 and Week 24 | The Physician's Global Assessment of Disease Activity was recorded using the 100 millimeter horizontal Visual Analog Scale (VAS). The score reflects the clinician's integrated judgment based on clinical signs, symptoms, laboratory findings, and patient-reported outcomes. PGA is used to quantify disease severity and monitor treatment response over time. Physician rated participant's disease activity on a scale ranged from 0-100 millimeter (mm), where 0 indicated no disease activity and 100 represented maximum disease activity. |
| Secondary | Cohort B: Number of Participants With Both BICLA Response and With Clinically Meaningful Corticosteroids (CS) Reduction | At week 24 (BICLA Response) and Day 1 upto Week 24 (CS Reductions) | BICLA (BILAG-Based Composite Lupus Assessment) defines response as improvement in all baseline BILAG A scores to B, C, or D and all B scores to C or D, with no new A scores and no more than one new B score. Responders must also show no worsening in SLEDAI-2K or Physician's Global Assessment (defined as ≥0.3-point increase). Corticosteroid (CS) reduction is defined as a decrease in daily prednisone-equivalent dose from ≥10 mg at Day 1 to ≤5 mg by Week 12, sustained through Week 24. BILAG grades reflect disease severity: A = severe disease requiring high-dose therapy; B = moderate disease requiring moderate therapy; C = mild stable disease; D = no current activity. |
| Secondary | Cohort A and B: Number of Participants With Clinically Meaningful Corticosteroids (CS) Reduction | Day 1 up to Week 24 | CS reduction is defined as the reduction of daily prednisone-equivalent dose from \>= 10 mg at Day 1 to \<= 5 mg by the Week 12 visit and sustained through Week 24. The number of participants with Clinically Meaningful CS Reduction were reported. |
| Secondary | Cohort A: Number of Participants With CLA-IGA Score 0 or 1 at Week 16 and Week 24 | At Week 16 and Week 24 | The Cutaneous Lupus Activity Investigator's Global Assessment (CLA-IGA) is a validated clinician-reported outcome measure used to assess disease severity in participants with cutaneous lupus erythematosus. It is based on a 5-point ordinal scale that evaluates overall lesion characteristics, where 0 indicates "clear" skin and 4 represents "severe" disease. The scale includes the following categories: 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), and 4 (severe). The number of participants with CLA-IGA score 0 or 1 at Week 16 and Week 24 were reported. |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Cohort A: Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index-A (CLASI-A) Total Score at Week 16 | Baseline, week 16 | The Full Analysis Set (FAS) included all participants randomized in the cohort to which they were eligible. Participants who were randomized in error were excluded from FAS. Overall number of participants analyzed refers to those evaluable for the outcome measure, | scores on a scale | MEAN |
| PRIMARY | Cohort B: Number of Participants With British Isles Lupus Assessment Group (BILAG)-Based Composite Lupus Assessment (BICLA) Response at Week 24 | At Week 24 | The Full Analysis Set (FAS) included all participants randomized in the cohort to which they were eligible. Participants who were randomized in error were excluded from FAS. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Cohort A and B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events (AEs) of Special Interest | From screening upto safety follow up period (up to approximately 33 weeks) | The Safety Analysis Set (SAF) included all participants, who were administered any dose of any study intervention. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Cohort A and B: Number of Participants With Abnormal Laboratory Parameters | From screening upto safety follow up period (up to approximately 33 weeks) | The Safety Analysis Set (SAF) included all participants, who were administered any dose of any study intervention. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Cohort A and B: Number of Participants With Clinically Important Increases in QT Interval Corrected Using Fridericia's Formula (QTcF) | From screening upto safety follow up period (up to approximately 33 weeks) | The Safety Analysis Set (SAF) included all participants, who were administered any dose of any study intervention. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Cohort A and Cohort B: Change From Baseline in Cutaneous Lupus Activity Investigator's Global Assessment (CLA-IGA) Scale Score at Week 16 and Week 24 | Baseline and at Week 16 and Week 24 | The FAS included all participants randomized in the cohort to which they were eligible. Overall number of participants analyzed refers to those evaluable for the outcome measure, while number analyzed refers to those evaluable at specific timepoints. Participants who were randomized in error were excluded from FAS. | units on a scale | MEAN |
| SECONDARY | Cohort A and Cohort B: Change From Baseline in Physician's Global Assessment of Cutaneous Lupus Disease Activity Score at Week 16 and 24 | Baseline and at Week 16 and Week 24 | The FAS included all participants randomized in the cohort to which they were eligible. Overall number of participants analyzed refers to those evaluable for the outcome measure, while number analyzed refers to those evaluable at specific timepoints. Participants who were randomized in error were excluded from FAS. | millimeter | MEAN |
| SECONDARY | Cohort B: Number of Participants With Both BICLA Response and With Clinically Meaningful Corticosteroids (CS) Reduction | At week 24 (BICLA Response) and Day 1 upto Week 24 (CS Reductions) | The FAS included all participants randomized in the cohort to which they were eligible. Overall number of participants analyzed refers to those evaluable for the outcome measure. Participants who were randomized in error were excluded from FAS. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Cohort A and B: Number of Participants With Clinically Meaningful Corticosteroids (CS) Reduction | Day 1 up to Week 24 | The FAS included all participants randomized in the cohort to which they were eligible. Participants who were randomized in error were excluded from FAS. Overall number of participants analyzed refers to those evaluable for the outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Cohort A: Number of Participants With CLA-IGA Score 0 or 1 at Week 16 and Week 24 | At Week 16 and Week 24 | The FAS included all participants randomized in the cohort to which they were eligible. Participants who were randomized in error were excluded from FAS. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 outcomesResults by group180
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Cohort A: Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index-A (CLASI-A) Total Score at Week 16 | Cohort A: Placebo | -5.0 | Standard Deviation 3.94 | scores on a scale | |
| Cohort A: Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index-A (CLASI-A) Total Score at Week 16 | Cohort A: Enpatoran 25 mg | -9.0 | Standard Deviation 4.60 | scores on a scale | |
| Cohort A: Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index-A (CLASI-A) Total Score at Week 16 | Cohort A: Enpatoran 50 mg | -10.2 | Standard Deviation 6.77 | scores on a scale | |
| Cohort A: Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index-A (CLASI-A) Total Score at Week 16 | Cohort A: Enpatoran 100 mg | -9.7 | Standard Deviation 5.84 | scores on a scale | |
| Cohort B: Number of Participants With British Isles Lupus Assessment Group (BILAG)-Based Composite Lupus Assessment (BICLA) Response at Week 24 | Cohort B (Part 1 + Part 2): Placebo | 37 | Participants | ||
| Cohort B: Number of Participants With British Isles Lupus Assessment Group (BILAG)-Based Composite Lupus Assessment (BICLA) Response at Week 24 | Cohort B (Part 2): Enpatoran 25 mg | 41 | Participants | ||
| Cohort B: Number of Participants With British Isles Lupus Assessment Group (BILAG)-Based Composite Lupus Assessment (BICLA) Response at Week 24 | Cohort B (Part 2): Enpatoran 50 mg | 36 | Participants | ||
| Cohort B: Number of Participants With British Isles Lupus Assessment Group (BILAG)-Based Composite Lupus Assessment (BICLA) Response at Week 24 | Cohort B (Part 1 + Part 2): Enpatoran 100 mg | 56 | Participants | ||
| Cohort A and B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events (AEs) of Special Interest | Cohort A: Placebo | TEAEs | 12 | Participants | |
| Cohort A and B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events (AEs) of Special Interest | Cohort A: Enpatoran 25 mg | TEAEs | 15 | Participants |
1 to 10 of 180Source ClinicalTrials.gov
See all 180 results by groupParticipant flow48
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort A: Placebo | 26 | |
| Overall Study | STARTED | Cohort A: Enpatoran 25 mg | 24 | |
| Overall Study | STARTED | Cohort A: Enpatoran 50 mg | 26 | |
| Overall Study | STARTED | Cohort A: Enpatoran 100 mg | 26 | |
| Overall Study | STARTED | Cohort B (Part 1 + Part 2): Placebo | 95 | |
| Overall Study | STARTED | Cohort B (Part 2): Enpatoran 25 mg | 71 | |
| Overall Study | STARTED | Cohort B (Part 2): Enpatoran 50 mg | 74 | |
| Overall Study | STARTED | Cohort B (Part 1 + Part 2): Enpatoran 100 mg | 114 | |
| Overall Study | Participants With BILAG≥1A/2B Randomized in Error Due to Systemic Disease Activity | Cohort A: Placebo | 0 | |
| Overall Study | Participants With BILAG≥1A/2B Randomized in Error Due to Systemic Disease Activity | Cohort A: Enpatoran 25 mg | 1 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 participant flowAdverse events272
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 | Diarrhoea | Gastrointestinal disorders | Cohort A: Placebo | 0 | 26 | |
| other | Diarrhoea | Gastrointestinal disorders | Cohort A: Enpatoran 25 mg | 0 | 24 | |
| other | Diarrhoea | Gastrointestinal disorders | Cohort A: Enpatoran 50 mg | 2 | 26 | |
| other | Diarrhoea | Gastrointestinal disorders | Cohort A: Enpatoran 100 mg | 2 | 26 | |
| other | Diarrhoea | Gastrointestinal disorders | Cohort B (Part 1 + Part 2): Placebo | 7 | 95 | |
| other | Diarrhoea | Gastrointestinal disorders | Cohort B (Part 2): Enpatoran 25 mg | 4 | 71 | |
| other | Diarrhoea | Gastrointestinal disorders | Cohort B (Part 2): Enpatoran 50 mg | 0 | 74 | |
| other | Diarrhoea | Gastrointestinal disorders | Cohort B (Part 1 + Part 2): Enpatoran 100 mg | 0 | 114 | |
| other | Upper respiratory tract infection | Infections and infestations | Cohort A: Placebo | 2 | 26 | |
| other | Upper respiratory tract infection | Infections and infestations | Cohort A: Enpatoran 25 mg | 2 | 24 |
1 to 10 of 272Source ClinicalTrials.gov
See all 272 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort A: Placebo | 0 | 26 |
| Total, all-cause mortality | Cohort A: Enpatoran 25 mg | 0 | 24 |
| Total, all-cause mortality | Cohort A: Enpatoran 50 mg | 0 | 26 |
| Total, all-cause mortality | Cohort A: Enpatoran 100 mg | 0 | 26 |
| Total, all-cause mortality | Cohort B (Part 1 + Part 2): Placebo | 0 | 95 |
| Total, all-cause mortality | Cohort B (Part 2): Enpatoran 25 mg | 0 | 71 |
| Total, all-cause mortality | Cohort B (Part 2): Enpatoran 50 mg | 0 | 74 |
| Total, all-cause mortality | Cohort B (Part 1 + Part 2): Enpatoran 100 mg | 0 | 114 |
| Total, other adverse events | Cohort A: Placebo | 8 | 26 |
| Total, other adverse events | Cohort A: Enpatoran 25 mg | 4 | 24 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
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.
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GET https://conductscience.org/api/trials/v1/NCT05162586/registered?page=2