NCT06887738

Study of NM8074 in Patients with Dermatomyositis (DM)

A Proof-of-Concept Phase II, Open-Label Study of NM8074 in Patients with Dermatomyositis (DM)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (estimated)
• Sponsor: NovelMed Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase II, open-label, multicenter study to evaluate the safety and efficacy of NM8074 administered via intravenous infusion in patients with Dermatomyositis (DM).

Detailed description

The Proposed Study, NM8074-DM-701 will enroll a planned number of eight (8) DM subjects, with the potential to enroll more patients. The total duration of the study for all subjects will include a 30-day screening period, dosing for a 12-week Treatment Period, followed by an observation period of 6-weeks. All subjects will be administered 20 mg/kg of NM8074 intravenously every week for a total of 12 doses from Day 1 to Day 78 of the Treatment Period.

Conditions

• Dermatomyositis

Interventions

Type	Name	Description
DRUG	NM8074	NM8074 will be administered as an intravenous infusion at a dose of 20mg/kg

Timeline

• Start date: 2026-06-01
• Primary completion: 2027-11-01
• Completion: 2028-12-01
• First posted: 2025-03-20
• Last updated: 2025-03-25

Regulatory

• FDA-regulated drug study