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Unknown

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 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

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.

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

M5049 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT05650567 — Phase 2
Polymyositis Research Study Groups: Open Label Extension (OLE) Period: M5049 high dose, DBPC Period: Placebo, Double-blind Placebo Controlled (DBPC) Period: M5049 high dose
Polymyositis Clinical Trial 2023: M5049 Highlights & Side Effects. Trial Name: NCT05650567 — Phase 2
M5049 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05650567 — Phase 2
~6 spots leftby Apr 2025