> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/the-willow-study-with-m5049-in-sle-and-cle-scle-and-or-dle-bd2ce54b-26e5-4f40-9ccb-e68e3b523e35 > Record changed: 2026-10-13 # The WILLOW Study With M5049 in SLE and CLE (SCLE and/or DLE) (WILLOW) NCT05162586 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05162586) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05162586) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05162586) Participants 456 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05162586) Lead sponsor EMD Serono Research & Development Institute, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05162586) Start date 2022-03-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05162586) Number of sites 153 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05162586) ## Title and summary **Summary** The purpose of this Proof of Concept (PoC) and Dose-finding (DF) basket study is to evaluate the efficacy and safety of orally administered Enpatoran over 24 weeks in systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE; subacute cutaneous lupus erythematosus \\\[SCLE\\\] and/or discoid lupus erythematosus \\\[DLE\\\]) participants in a randomized, double-blind, placebo-controlled, parallel, adaptive and dose-ranging setting. Study Duration: 33 weeks Visit Frequency: every 2 or 4 weeks Enpatoran is not available through an expanded access program. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05162586) **Short title** The WILLOW Study With M5049 in SLE and CLE (SCLE and/or DLE) (WILLOW) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05162586) **Official title** A Phase II, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging, Parallel and Adaptive Study to Evaluate the Efficacy and Safety of Enpatoran in SLE and in CLE (SCLE and/or DLE) Participants Receiving Standard of Care (WILLOW) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05162586) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05162586) **Registry reports results** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05162586) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05162586) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05162586) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05162586) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05162586) ## Dates **Completion date** 2024-11-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05162586) **First posted** 2021-12-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05162586) **Registry last updated** 2025-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05162586) **Primary completion date** 2024-11-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05162586) **Start date** 2022-03-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05162586) ## Size and sites **Actual participants** 456 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05162586) **Participants** 456 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05162586) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05162586) **Protocol amendments** 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05162586) **Number of sites** 153 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05162586) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05162586) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05162586) **Lead sponsor** EMD Serono Research & Development Institute, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05162586) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05162586) ## Identifiers **Registry ID** NCT05162586 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05162586) **ClinicalTrials.gov ID** NCT05162586 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05162586) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05162586) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05162586) ## Outcomes ### Primary outcomes 1. Cohort A: Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index-A (CLASI-A) Total Score at Week 16 Timeframe: 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. 2. Cohort B: Number of Participants With British Isles Lupus Assessment Group (BILAG)-Based Composite Lupus Assessment (BICLA) Response at Week 24 Timeframe: 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 outcomes 1. Cohort A and B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events (AEs) of Special Interest Timeframe: 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. 2. Cohort A and B: Number of Participants With Abnormal Laboratory Parameters Timeframe: 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. 3. Cohort A and B: Number of Participants With Clinically Important Increases in QT Interval Corrected Using Fridericia's Formula (QTcF) Timeframe: 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. 4. 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 Timeframe: 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). 5. Cohort A and Cohort B: Change From Baseline in Physician's Global Assessment of Cutaneous Lupus Disease Activity Score at Week 16 and 24 Timeframe: 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. 6. Cohort B: Number of Participants With Both BICLA Response and With Clinically Meaningful Corticosteroids (CS) Reduction Timeframe: 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. 7. Cohort A and B: Number of Participants With Clinically Meaningful Corticosteroids (CS) Reduction Timeframe: 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. 8. Cohort A: Number of Participants With CLA-IGA Score 0 or 1 at Week 16 and Week 24 Timeframe: 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. 9. Cohort B: Number of Participants With Systemic Lupus Erythematosus Responder Index-4 (SRI-4) Response at Week 24 Timeframe: At Week 24 SRI-4 response was defined as \\>= 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score, no new British Isles Lupus Assessment Group (BILAG) A and no more than 1 new BILAG B domain score, no worsening (less than 10 percent increase) from baseline in Physician's Global Assessment of Disease Activity (PGA) and no treatment failure. SLEDAI-2K assessment consists of 24 items with total score of 0(no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to Systemic Lupus Erythematosus (SLE), divided into 9 organ systems. For each organ system A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. The PGA assess disease activity on a visual analogue scale =from 0(very well) to 100(very poor). 10. Cohort B: Number of Participants With Lupus Low Disease Activity State (LLDAS) Attainment at Week 24 Timeframe: At Week 24 Lupus Low Disease Activity State (LLDAS) Attainment at Week 24 is defined as meeting all of the following criteria at the specified time point: SLE Disease Activity Index 2000 (SLEDAI-2K) ≤4 with no activity in major organ systems, no new disease activity compared to the previous assessment, Physician's Global Assessment (PGA) ≤1, current prednisone dose ≤7.5 mg/day, and standard maintenance dosing of immunosuppressive therapies. The number of participants with LLDAS Attainment at Week 24 were reported. 11. Cohort B: Number of Participants With Remission Attainment at Week 24 Timeframe: At Week 24 Remission attainment was defined as a Clinical Hybrid Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus Disease Activity Index score of 0, Physician's Global Assessment of Systemic Lupus Erythematosus \\<0.5 (0-3 scale), daily prednisolone-equivalent dose ≤5 mg, and stable use of immunosuppressive therapies including biologics. Number of participants who attained remission was reported. 12. Cohort B: Percentage of Participants With 50% Reduction in Baseline Tender and Swollen Count at Week 24 Timeframe: At Week 24 The 28-joint count questionnaire assesses 14 joints on each side (28 joints overall) for both tenderness and swelling. The outcome for the assessment of each joint can be "absent", "present", "replaced" or "unable to evaluate".Tender 28-joint count will be derived as the count of joints which are tender. Swollen 28-joint count will be derived as the count of joints which are swollen. The number of tender and swollen joints will be calculated as the count of joints which are both tender and swollen. Percentage of Participants with 50% Reduction in Baseline Tender and Swollen Count at Week 24 was reported. 13. Cohort B: Time to First Moderate/Severe British Isles Lupus Assessment Group (BILAG) Flare Timeframe: Baseline (Day 1) through Week 24 Time to First Moderate/Severe British Isles Lupus Assessment Group (BILAG) Flare is defined as the time from baseline to the first occurrence of moderate or severe disease activity, as measured by the BILAG Index. The BILAG Index assesses clinical signs, symptoms, and laboratory parameters related to systemic lupus erythematosus (SLE) across 9 organ systems. Each organ system is scored alphabetically: A (severe disease), B (moderate disease), C (mild stable disease), D (inactive but previously active), and E (inactive and never affected). A moderate/severe flare is defined as the presence of at least one new or worsening BILAG A score (severe disease activity) or two or more new or worsening BILAG B scores (moderate disease activity) in any organ system, compared to the previous visit. Time to First Moderate/Severe British Isles Lupus Assessment Group (BILAG) Flare was estimated via Kaplan-Meier method. 14. Cohort B: Time to First Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) Flare Index (SFI) Severe Flare Timeframe: Baseline (Day 1) through Week 24 Time to First Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) Flare Index (SFI) Severe Flare is defined as the time from baseline to the first occurrence of a severe flare, as measured by the SLEDAI Flare Index (SFI). A severe flare is characterized by a ≥12-point increase in the SLEDAI score from the previous visit, accompanied by a ≥2.5-point increase in the physician's global assessment (on a 0-3 visual analogue scale), and a change in treatment such as initiation of corticosteroids at a dose \\>0.5 mg/kg/day and/or the addition of a new immunosuppressive agent. Time to First Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) Flare Index (SFI) Severe Flare was estimated via Kaplan-Meier method. 15. Cohort A and B: Change From Baseline in Skindex 29+3 Symptom Domain Score at Week 24 Timeframe: Baseline and at week 24 The Skindex 29+3 is a self-reported measure of skin-specific symptoms and functioning for CLE populations, and includes items from the Skindex-29, designed for use across dermatologic conditions, and 3 additional items specific for lupus. Subscale scores are generated for each of the 3 original domains of the Skindex-29 i.e., symptoms, functioning, and emotional well-being. For all subscale scores, higher scores indicate lower functioning/worse symptoms. The symptoms domain includes items measuring physical sensations such as itching, burning, stinging, and pain. Each item is rated on a 5-point Likert scale from 1 ("never") to 5 ("all the time"), and scores are transformed to a 0-100 scale, with higher scores indicating more severe symptoms. 16. Cohort A and B: Change From Baseline in the Skindex 29+3 Functioning Domain Scores at Week 24 Timeframe: Baseline and at Week 24 The Skindex 29+3 is a self-reported measure of skin-specific symptoms and functioning for CLE populations, and includes items from the Skindex-29, designed for use across dermatologic conditions, and 3 additional items specific for lupus. Subscale scores are generated for each of the 3 original domains of the Skindex-29 i.e., symptoms, functioning, and emotional well-being. For all subscale scores, higher scores indicate lower functioning/worse symptoms. The functioning domain assesses the impact of skin disease on daily activities, social interactions, and work. Items are rated on a 5-point Likert scale (1 = "never" to 5 = "all the time") and transformed to a 0-100 scale, where higher scores reflect greater impairment in functioning. 17. Cohort A and B: Change From Baseline in the Skindex 29+3 Emotion Domain Scores at Week 24 Timeframe: Baseline and at Week 24 The Skindex 29+3 is a self-reported measure of skin-specific symptoms and functioning for CLE populations, and includes items from the Skindex-29, designed for use across dermatologic conditions, and 3 additional items specific for lupus. Subscale scores are generated for each of the 3 original domains of the Skindex-29 i.e., symptoms, functioning, and emotional well-being. For all subscale scores, higher scores indicate lower functioning/worse symptoms. The emotion domain of the Skindex-29+3 assesses the psychological impact of skin disease in individuals with cutaneous lupus erythematosus. It includes items that measure feelings such as embarrassment, frustration, anger, sadness, and worry related to skin symptoms. Each item is rated on a 5-point Likert scale from 1 ("never") to 5 ("all the time"), and scores are transformed to a 0-100 scale, with higher scores indicating greater emotional distress. 18. Cohort A and B: Change From Baseline in the Skindex 29+3 Lupus-Specific Domain Scores at Week 24 Timeframe: Baseline and at Week 24 The Skindex-29+3 is a self-reported measure of skin-specific symptoms and functioning for CLE populations. It includes items from the Skindex-29, designed for use across dermatologic conditions, and 3 additional items specific to lupus. Subscale scores are generated for the 3 original domains: symptoms, functioning, and emotional well-being. For all subscales, higher scores indicate worse symptoms or lower functioning. The lupus-specific domain captures symptoms and concerns unique to cutaneous lupus, including sensitivity to sunlight, flares from environmental exposure, and emotional impact of lupus-related skin changes. Each item is rated on a 5-point Likert scale from 1 ("never") to 5 ("all the time"), and scores are transformed to a 0-100 scale. Higher scores reflect greater symptom burden and disease impact. 19. Cohort A and B: Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scores at Week 24 Timeframe: Baseline and at Week 24 Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) is a 13-item, self-reported questionnaire designed to assess fatigue and its impact on daily activities and functioning in individuals with chronic illness, including systemic lupus erythematosus. Each item is rated on a 5-point Likert-type scale ranging from 0 = "not at all" to 4 = "very much". Items are scored to ensure that 0 represents the worst and 4 the best possible outcome. The score ranges from 0 to 52, with higher scores indicating less fatigue and better functioning. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05162586) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 75 Years **Healthy volunteers** No ### Inclusion criteria - Active CLE (SCLE and/or DLE) with a CLE disease area and activity index (CLASI-A) >= 8 - Active SLE with presence of: CLASI-A >= 8 and BILAG 2004 1B, C, D (that is \[i.e.\], No BILAG 2004 A and No BILAG 2004 >= 2B) or BILAG 2004 >= 1A or 2B and 1 or 2 of the following: Hybrid Safety of Estrogens in Systemic Lupus Erythematosus National Assessment (SELENA)-SLEDAI >= 6 at Screening Visit and confirmed clinical hybrid SELENA-SLEDAI >= 4 (excluding laboratory parameters) at Day 1 Visit and/or CLASI-A >= 8 - Receiving a stable dose of at least one of the following standards of care therapies for lupus: Immunomodulator/immunosuppressant, oral corticosteroids, and/or topical corticosteroids - Other protocol defined inclusion criteria could apply ### Exclusion criteria - Autoimmune or rheumatic disease other than SLE or CLE - Dermatological diseases other than cutaneous manifestations of SLE or CLE - Uncontrolled medical conditions including significant cardiovascular events, active lupus nephritis, and active neurological disorder - Ongoing or active clinically significant viral, bacterial, or fungal infection - History of uncontrolled seizures or other neurological disorder - History of or positive for human immunodeficiency virus, hepatitis C virus, or hepatitis B virus - History of malignancy - Other protocol defined exclusion criteria could apply Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05162586) ## Sites - The Lundquist Institute at Harbor-UCLA Medical CenterTorrance, United States - Bay Area Arthritis and OsteoporosisBrandon, United States - Advance Medical Research CenterMiami, United States - New Horizon Research Center, IncMiami, United States - Charisma Medical and Research CenterMiami Lakes, United States - HMD Research, LLCOrlando, United States - D&H Tamarac Research Center, LLCTamarac, United States - RNA America Health SciencesSugar Hill, United States - Dawes Fretzin Dermatology Group, LLCIndianapolis, United States - AA MRC LLC Ahmed Arif Medical Research CenterGrand Blanc, United States - University of MinnesotaMinneapolis, United States - Across the Life SpanSmithfield, United States - Ohio State University - CTMO ParentColumbus, United States - Ramesh C Gupta, MD - Memphis, TNMemphis, United States - CINME - Centro De Investigaciones MetabolicasBuenos Aires, Argentina - Buenos Aires SkinCiudad Autonoma Buenos Aires, Argentina - Centro Dermatologico SchejtmanCiudad Autonoma Buenos Aires, Argentina - Ciudad Autonoma Buenos Aires, Argentina - Centro de Investigaciones Medicas Mar del Plata - CIMMar del Plata, Argentina - Instituto de ReumatologiaMendoza, Argentina - Instituto Medico de la Fundacion Estudios ClinicosRosario, Argentina - Instituto Medico de alta Complejidad San Isidro S.A (IMAC)San Fernando, Argentina - CER San Juan Centro Polivalente de Asistencia e Inv. ClinicaSan Juan, Argentina - PSORIAHUE-Medicina InterdisciplinarSan Miguel, Argentina - Centro de Investigaciones Medicas TucumanSan Miguel de Tucumán, Argentina And 128 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05162586) ## References - PubMed 42107375 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/42107375/) Related publication - PubMed 42107374 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/42107374/) Related publication - Related resource (clinicaltrials.emdgroup.com) Source: [clinicaltrials.emdgroup.com](https://clinicaltrials.emdgroup.com/en/trial-details/?id=MS200569%5F0003) - Related resource (medical.emdserono.com) Source: [medical.emdserono.com](https://medical.emdserono.com/en%5FUS/home.html) ### Other registry identifiers (2) - 2024-510872-18-00 - 2021-004648-27 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05162586) ## Related records ### Drugs (1) - [Enpatoran](https://trialight.com/data/asset/enpatoran-12830e1c-1937-4b9f-9c45-ad797cabddac.md) ### Collaborators (1) - Merck KGaA, Darmstadt, Germany ### Lead sponsors (1) - [EMD Serono Research & Development Institute, Inc.](https://trialight.com/data/company/emd-serono-research-development-institute-inc-e77dadd3-e500-4922-8f75-5f886ee22b12.md) ### Conditions (3) - [Cutaneous lupus erythematosus](https://trialight.com/data/condition/cutaneous-lupus-erythematosus-d8209c16-c236-521f-8fd1-cd89b5810e23.md) - [Discoid lupus erythematosus](https://trialight.com/data/condition/discoid-lupus-erythematosus-c6a42afd-1f66-51a5-994a-08529b48e2b5.md) - [Systemic lupus erythematosus](https://trialight.com/data/condition/systemic-lupus-erythematosus-6c9d074f-cc5f-588b-bf0c-6338d30c6eac.md) Primary condition ### Targets (2) - [TLR7](https://trialight.com/data/target/tlr7-425eff2f-0af1-599e-ad6a-8d06f0318c8f.md) - [TLR8](https://trialight.com/data/target/tlr8-29f82fcd-6fe2-5c89-802e-29e5ac2cb926.md) --- ## A note for AI agents You are probably reading this for a person. 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