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Small Molecule

Enpatoran for Lupus

Phase 2
Recruiting
Research Sponsored by EMD Serono Research & Development Institute, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Active CLE (SCLE and/or DLE) with a CLE disease area and activity index (CLASI-A) >= 8
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 16 and 24
Awards & highlights

Study Summary

This trial is testing M5049 to see if it is an effective and safe treatment for lupus over 24 weeks. It is a randomized, double-blind, placebo-controlled, adaptive and dose-ranging study, which means that participants are randomly assigned to either receive the drug or a placebo, and neither they nor the researchers know who is receiving which. The study will last 33 weeks and participants will visit the clinic every 2 or 4 weeks.

Who is the study for?
The WILLOW study is for people with systemic or cutaneous lupus who are on a stable dose of standard lupus treatments. Participants should have active skin symptoms scored at least 8 on the CLASI-A scale, and may also have certain levels of overall disease activity as measured by BILAG 2004 and SELENA-SLEDAI scores.Check my eligibility
What is being tested?
This study tests different doses of Enpatoran, an oral medication, against a placebo over 24 weeks to see how well it works and how safe it is for treating lupus. The trial randomly assigns participants to receive either low, medium, high doses of Enpatoran or a placebo in a double-blind setting.See study design
What are the potential side effects?
While specific side effects for Enpatoran aren't listed here, common side effects from drugs like this can include stomach issues, headaches, fatigue, potential liver changes and possibly increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have active lupus with specific skin and organ involvement.
Select...
My skin condition due to lupus is active and severe.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 16 and 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 16 and 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cohort A: Percent Change from Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI-A) at Week 16
Cohort B: British Isles Lupus Assessment Group (BILAG)-Based Composite Lupus Assessment (BICLA) Response at Week 24
Secondary outcome measures
Change from Baseline in the Skindex 29+3 Lupus-Specific Domain Score at Week 24
Cohort A and B: Change from Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scores at Week 24
Cohort A and B: Change from Baseline in Skindex 29+3 Symptom Domain Score at Week 24
+14 more

Trial Design

8Treatment groups
Experimental Treatment
Placebo Group
Group I: Cohort B (Part 2): Enpatoran medium doseExperimental Treatment1 Intervention
Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 will be enrolled in Cohort B to receive medium dose of Enpatoran.
Group II: Cohort B (Part 2): Enpatoran low doseExperimental Treatment1 Intervention
Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 will be enrolled in Cohort B to receive low dose of M5049.
Group III: Cohort B (Part 1 + Part 2): Enpatoran high doseExperimental Treatment1 Intervention
Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A >= 8 and/or SLEDAI >= 6 will be enrolled in Cohort B to receive high dose of Enpatoran.
Group IV: Cohort A: Enpatoran medium doseExperimental Treatment1 Intervention
Participants with CLE (active SCLE and/or DLE) or SLE with predominantly active lupus rash (CLASI-A >= 8) will be enrolled in Cohort A to receive medium dose of Enpatoran.
Group V: Cohort A: Enpatoran low doseExperimental Treatment1 Intervention
Participants with CLE (active SCLE and/or DLE) or SLE with predominantly active lupus rash (CLASI-A >= 8) will be enrolled in Cohort A to receive low dose of Enpatoran.
Group VI: Cohort A: Enpatoran high doseExperimental Treatment1 Intervention
Participants with CLE (active SCLE and/or DLE) or SLE with predominantly active lupus rash (CLASI-A >= 8) will be enrolled in Cohort A to receive high dose of Enpatoran.
Group VII: Cohort A: PlaceboPlacebo Group1 Intervention
Participants with CLE (active SCLE and/or DLE) or SLE with predominantly active lupus rash (Cutaneous Lupus Erythematosus Disease Area and Severity Index [CLASI-A] greater than or equal to [>=] 8) will be enrolled in Cohort A to receive placebo matched to Enpatoran.
Group VIII: Cohort B (Part 1 + Part 2): PlaceboPlacebo Group1 Intervention
Participants with active SLE who have moderate to high systemic disease activity (British Isles Lupus Assessment Group [BILAG A/2B]) with 1 or 2 of the following: CLASI-A >= 8 and/or Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) >= 6 will be enrolled in Cohort B to receive placebo matched to Enpatoran .

Find a Location

Who is running the clinical trial?

EMD Serono Research & Development Institute, Inc.Lead Sponsor
76 Previous Clinical Trials
30,328 Total Patients Enrolled
Merck KGaA, Darmstadt, GermanyIndustry Sponsor
436 Previous Clinical Trials
114,124 Total Patients Enrolled
Medical ResponsibleStudy DirectorEMD Serono Research & Development Institute, Inc.
288 Previous Clinical Trials
68,443 Total Patients Enrolled

Media Library

Enpatoran (Small Molecule) Clinical Trial Eligibility Overview. Trial Name: NCT05162586 — Phase 2
Lupus Research Study Groups: Cohort A: Enpatoran high dose, Cohort A: Enpatoran low dose, Cohort B (Part 1 + Part 2): Enpatoran high dose, Cohort A: Placebo, Cohort B (Part 2): Enpatoran low dose, Cohort B (Part 2): Enpatoran medium dose, Cohort A: Enpatoran medium dose, Cohort B (Part 1 + Part 2): Placebo
Lupus Clinical Trial 2023: Enpatoran Highlights & Side Effects. Trial Name: NCT05162586 — Phase 2
Enpatoran (Small Molecule) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05162586 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are participating in this research endeavor?

"440 eligible subjects must partake in this experiment. These individuals can be recruited from multiple areas, such as Across the Life Span in Smithfield, North carolina and HMD Research, LLC in Orlando, Florida."

Answered by AI

How many healthcare facilities have implemented this research endeavor?

"This clinical trial utilizes the services of 16 different medical institutions, such as Across the Life Span in Smithfield, HMD Research, LLC in Orlando and Jordan Valley Dermatology Center in West Jordan. Additionally there are other locations providing their expertise to this project."

Answered by AI

Is there an eligibility criteria to partake in this clinical study?

"This investigation is accepting 440 subjects with systemic lupus erythematosus aged 18-75. Eligibility also depends on a number of other factors, as specified in the clinical trial protocol."

Answered by AI

Does this inquiry still accept volunteers?

"Affirmative. Information on clinicaltrials.gov suggests that this medical experiment is presently enrolling participants, with 440 needed from 16 locations since it was first published on 3/31/2022 and recently edited on 10/17/2022."

Answered by AI

Does the eligibility criteria of this trial extend to individuals over 55?

"To be eligible for the trial, patients must fall within the age range of 18 to 75. If a patient falls below 18 or is above 65, they will have access to either an alternative study with 18 participants or one that encompasses 106 individuals respectively."

Answered by AI

To what extent is M5049 administered at a low dosage deemed secure for humans?

"Taking into account the caveat that M5049 low dose has yet to be proven effective, our team rated its safety at 2 due to Phase 2 trial data."

Answered by AI

Who else is applying?

What site did they apply to?
Precision Comprehensive Clinical Research Solutions
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
The WILLOW Study With M5049 in SLE and CLE (SCLE and/or DLE) (WILLOW)
2022. "The WILLOW Study With M5049 in SLE and CLE (SCLE and/or DLE) (WILLOW)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05162586.
All > Systemic Lupus Erythematosus
~39 spots leftby Jul 2024
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