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M5049 for Myositis
Salford Royal, United Kingdom
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
Must not have
Primary diagnosis of juvenile DM, or adult participants previously diagnosed with juvenile DM
Severe interstitial lung disease defined as supplemental oxygen required at rest, or forced vital capacity (FVC) of <60 percent (%) predicted. Participants within 1 year of PM/DM diagnosis and anti-MDA5 antibody, should have been evaluated for interstitial lung disease (ILD) with high resolution computed tomography (HRCT) Chest
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Summary
This trial is testing a pill called M5049 for people with muscle diseases known as dermatomyositis (DM) and polymyositis (PM). These conditions cause muscle inflammation and weakness. The pill aims to reduce inflammation and improve muscle strength over several months.
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.
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.
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.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I was diagnosed with juvenile dermatomyositis.
Select...
I need oxygen or have severe lung issues, and I've been checked for lung disease with a special scan.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Trial 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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Polymyositis include corticosteroids, immunosuppressants, and biologics. These treatments primarily work by reducing inflammation and modulating the immune system.
Corticosteroids decrease inflammation by inhibiting multiple inflammatory pathways. Immunosuppressants, such as methotrexate and azathioprine, reduce immune system activity to prevent further muscle damage.
Biologics, like rituximab, target specific components of the immune system to reduce inflammation. The M5049 trial focuses on TLR7 and TLR8 inhibitors, which block Toll-like receptor pathways involved in immune activation and inflammation.
This is significant for Polymyositis patients as it offers a targeted approach to reduce muscle inflammation and improve muscle function, potentially with fewer side effects compared to broader immunosuppressive therapies.
P2X7 Receptor Antagonist Reduces Fibrosis and Inflammation in a Mouse Model of Alpha-Sarcoglycan Muscular Dystrophy.Activation of TLR4 induces inflammatory muscle injury via mTOR and NF-κB pathways in experimental autoimmune myositis mice.GSI Treatment Preserves Protein Synthesis in C2C12 Myotubes.
P2X7 Receptor Antagonist Reduces Fibrosis and Inflammation in a Mouse Model of Alpha-Sarcoglycan Muscular Dystrophy.Activation of TLR4 induces inflammatory muscle injury via mTOR and NF-κB pathways in experimental autoimmune myositis mice.GSI Treatment Preserves Protein Synthesis in C2C12 Myotubes.
Find a Location
Closest Location:Research Site· Rockland, MA
Who is running the clinical trial?
EMD Serono Research & Development Institute, Inc.Lead Sponsor
85 Previous Clinical Trials
22,687 Total Patients Enrolled
Merck KGaA, Darmstadt, GermanyIndustry Sponsor
446 Previous Clinical Trials
114,848 Total Patients Enrolled
Medical ResponsibleStudy DirectorMerck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
300 Previous Clinical Trials
61,133 Total Patients Enrolled
Media Library
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: Open Label Extension (OLE) Period: M5049 high dose
- Group 2: DBPC Period: Placebo
- 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.