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M5049 for Myositis
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, weeks 4, 8, 12, 16, 20 and 24
Awards & highlights
Study Summary
This trial will test a new medicine for people with dermatomyositis and polymyositis over 24 weeks to see if it's safe and effective.
Who is the study for?
This trial is for adults with moderate to severe dermatomyositis (DM) or polymyositis (PM), who have certain levels of muscle weakness, skin rash, and elevated muscle enzymes. They must be on stable medication regimens and not have other conditions like juvenile DM, inclusion body myositis, cancer-associated myositis, or severe lung disease.Check my eligibility
What is being tested?
The NEPTUNIA study tests the safety and effectiveness of a new oral drug called M5049 in treating inflammatory muscle diseases DM and PM over 24 weeks. Participants will either receive a high dose of M5049 or a placebo to compare outcomes.See study design
What are the potential side effects?
While specific side effects are not listed here, common risks may include digestive issues, allergic reactions, fatigue, liver problems due to medication intake. The exact side effects will be monitored throughout the trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, weeks 4, 8, 12, 16, 20 and 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, weeks 4, 8, 12, 16, 20 and 24
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
DBPC Period: American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Total Improvement Score (TIS) at Week 24
DBPC Period: Number of Participants with Clinically Significant Changes from Baseline in Laboratory Parameters, Vital Signs and 12-Lead Electrocardiogram (ECG) Measurements
DBPC Period: Number of Participants with Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs)
Secondary outcome measures
DBPC Period: Absolute Change from Baseline in the Core Set Measures (CSM) at Weeks 4, 8, 12, 16, 20 and 24'
DBPC Period: Change from Baseline in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) A and CDASI-D at Weeks 4, 8, 12, 16, 20 and 24
DBPC Period: Change from Baseline in Investigator's Global Assessment (IGA) Skin Activity Score at Weeks 4, 8, 12, 16, 20 and 24
+10 moreTrial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Open Label Extension (OLE) Period: M5049 high doseExperimental Treatment1 Intervention
Group II: Double-blind Placebo Controlled (DBPC) Period: M5049 high doseExperimental Treatment1 Intervention
Group III: DBPC Period: PlaceboPlacebo Group1 Intervention
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Who is running the clinical trial?
EMD Serono Research & Development Institute, Inc.Lead Sponsor
76 Previous Clinical Trials
30,820 Total Patients Enrolled
Merck KGaA, Darmstadt, GermanyIndustry Sponsor
436 Previous Clinical Trials
114,616 Total Patients Enrolled
Medical ResponsibleStudy DirectorMerck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
288 Previous Clinical Trials
68,935 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with dermatomyositis or polymyositis and have positive autoantibodies.I do not have any uncontrolled health conditions that could risk my participation in the study.I have moderate to severe muscle weakness and at least two other symptoms of myopathy.I have active myositis or a skin rash from myositis, confirmed by tests in the last 6 months.I was diagnosed with juvenile dermatomyositis.I have been diagnosed with a specific muscle disease and screened for cancer as recommended.I need oxygen or have severe lung issues, and I've been checked for lung disease with a special scan.You have another ongoing disease related to muscle inflammation, which will be decided by a committee of experts if you can participate in the trial.I am on a stable dose of corticosteroids or one non-corticosteroid medication for my muscle condition.
Research Study Groups:
This trial has the following groups:- Group 1: DBPC Period: Placebo
- Group 2: Open Label Extension (OLE) Period: M5049 high dose
- Group 3: Double-blind Placebo Controlled (DBPC) Period: M5049 high dose
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Can individuals younger than seventy-five years old participate in this experiment?
"This clinical trial is open to participants aged between 18 and 75 years old. Additionally, there are 7 trials specifically designed for individuals younger than 18 and 21 studies tailored towards enrollees over the age of 65."
Answered by AI
Is there a particular demographic which qualifies for participation in this research endeavor?
"This medical trial seeks 40 people of ages 18 to 75 who have been diagnosed with dermatomyositis. Eligibility criteria must be met in order to participate."
Answered by AI
Has the Open Label Extension (OLE) Period: M5049 high dose been sanctioned by the United States Food and Drug Administration?
"Our team assigned Open Label Extension (OLE) Period: M5049 high dose a rating of 2 on the safety scale, as there is existing data confirming its safety but none supporting efficacy."
Answered by AI
Are there any vacancies for volunteer participants in this experiment?
"Clinicaltrials.gov states that this medical study is not presently recruiting any patients. Initially posted on the 15th of December 2022, and last updated six days later, this trial has closed its recruitment window for now; however, there are 24 other trials actively looking to enrol participants at present."
Answered by AI
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