Study of NM8074 in Patients with Dermatomyositis (DM)

Last updated: March 20, 2025
Sponsor: NovelMed Therapeutics
Overall Status: Active - Not Recruiting

Phase

2

Condition

Idiopathic Inflammatory Myopathies

Lupus

Connective Tissue Diseases

Treatment

NM8074

Clinical Study ID

NCT06887738
NM8074-DM-701
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male and female patients ≥18 years of age at the time of consent.

  • A body mass index (BMI) within the range of 15 - 38 kg/m2. BMI = Body weight (kg) / [Height (m)]2.

  • Subjects diagnosed with a probable or definite DM according to 2017 European LeagueAgainst Rheumatism/American College of Rheumatology (2017 EULAR/ACR).

  • Subjects must have proof of vaccination against Neisseria meningitidis (MenACWY andMenB), Streptococcus pneumoniae (PCV13 or PCV15 and PPSV23), and Haemophilusinfluenzae type b (Hib) taken at least 2 weeks prior to NM8074 administration as pernational and local guidelines. If the window of vaccination is short, then patientswill be prophylactically treated with appropriate antibiotics.

  • Female partners of child-bearing potential (WOCBP), defined as all womenphysiologically capable of becoming pregnant, must have a negative pregnancy test atscreening and must agree to use highly effective methods of contraception duringdosing and for at least 8 weeks after stopping the investigational drug.

  • Male patients and partners of child-bearing potential must agree to usecontraceptives, and male patients must agree to refrain from donating sperm for theduration of the study and for at least 8 weeks after stopping the investigationaldrug.

Exclusion

Exclusion Criteria:

  • Subjects with drug-induced myositis

  • Subjects who have interstitial lung disease requiring the use of supplementaloxygen.

  • Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment or within 3 months to study day 1, whichever is longer.

  • History of currently active or suspicion of active bacterial, viral, or fungalinfection within 2 weeks prior to first dose, or history of unexplained, recurrentbacterial infections.

  • Subjects currently or previously diagnosed with cancer or who finished their cancertreatment within 2 years of the start of the clinical trial.

  • Subjects with the history of bone marrow, hematopoietic stem cells, or solid organtransplantation.

  • Has a currently active or known history of meningococcal disease or N. meningitidisinfection.

  • Evidence of active malignant disease or malignancies diagnosed within the previous 5year

  • Clinically significant medical or psychological conditions or risk factors that, asper the Investigator's judgment, could hinder the patient's participation in thestudy, introduce additional risks for the patient, or complicate the evaluation ofthe patient or study outcomes.

  • Pregnant, planning to become pregnant, or nursing female subjects.

  • Females with a positive pregnancy test result at Screening or on Day 1.

Study Design

Total Participants: 8
Treatment Group(s): 1
Primary Treatment: NM8074
Phase: 2
Study Start date:
June 01, 2026
Estimated Completion Date:
December 31, 2028

Study 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.