Study of NM8074 in Patients with Dermatomyositis (DM)

NCT06887738 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: NM8074-DM-701
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Dermatomyositis

Outcome Measures

Primary Outcomes (1)

• Change from Baseline or Percent Change from Baseline in the number of patients whose Total Improvement Score (TIS) has increased by ≥ 20

  TIS is a composite measure used in clinical trials that integrates the 6 Core Set Measures (CSM). TIS scores range from 0-100, with 0-19, 20-39, 40-59, and 60-100 indicating no improvement, minimal, moderate, and major improvement respectively.

  Up to Study Day 78

Secondary Outcomes (6)

• Change from baseline or Percent Change from Baseline in Cutaneous Dermatomyositis Area and Severity Index (CDASI) score

  Up to Study Day 78

• Change from Baseline or Percent Change from Baseline in Manual Muscle Testing (MMT-8) parameter

  Up to Study Day 78

• Change from Baseline or Percent Change from Baseline in Physician's Global Activity (PhGA) assessment

  Up to Study Day 78

• Change from Baseline or Percent Change from Baseline in Patient's Global Activity (PtGA) assessment

  Up to Study Day 78

• Change from Baseline or Percent Change from Baseline Health Assessment Questionnaire (HAQ) score

  Up to Study Day 78

Other Outcomes (6)

• Assessment for the presence of myositis-specific autoantibodies (MSA)

  Up to Study Day 127

• Change from Baseline or Percent Change from Baseline in Classical Pathway (CP) modulation

  Up to Study Day 127

• Change from Baseline or Percent Change from Baseline in plasma concentration of NM8074

  Up to Study Day 127

Study Arms (1)

Cohort 1

EXPERIMENTAL

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.

Drug: NM8074

Interventions

NM8074 DRUG

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

Cohort 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 League Against Rheumatism/American College of Rheumatology (2017 EULAR/ACR).
• Subjects must have proof of vaccination against Neisseria meningitidis (MenACWY and MenB), Streptococcus pneumoniae (PCV13 or PCV15 and PPSV23), and Haemophilus influenzae type b (Hib) taken at least 2 weeks prior to NM8074 administration as per national and local guidelines. If the window of vaccination is short, then patients will be prophylactically treated with appropriate antibiotics.
• Female partners of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, must have a negative pregnancy test at screening and must agree to use highly effective methods of contraception during dosing and for at least 8 weeks after stopping the investigational drug.
• Male patients and partners of child-bearing potential must agree to use contraceptives, and male patients must agree to refrain from donating sperm for the duration of the study and for at least 8 weeks after stopping the investigational drug.

You may not qualify if:

• Subjects with drug-induced myositis
• Subjects who have interstitial lung disease requiring the use of supplemental oxygen.
• 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 fungal infection within 2 weeks prior to first dose, or history of unexplained, recurrent bacterial infections.
• Subjects currently or previously diagnosed with cancer or who finished their cancer treatment within 2 years of the start of the clinical trial.
• Subjects with the history of bone marrow, hematopoietic stem cells, or solid organ transplantation.
• Has a currently active or known history of meningococcal disease or N. meningitidis infection.
• Evidence of active malignant disease or malignancies diagnosed within the previous 5 year
• Clinically significant medical or psychological conditions or risk factors that, as per the Investigator's judgment, could hinder the patient's participation in the study, introduce additional risks for the patient, or complicate the evaluation of the 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.

Sponsors & Collaborators

• NovelMed Therapeutics: lead

Related Publications (1)

• Lundberg IE, Tjarnlund A, Bottai M, Werth VP, Pilkington C, Visser M, Alfredsson L, Amato AA, Barohn RJ, Liang MH, Singh JA, Aggarwal R, Arnardottir S, Chinoy H, Cooper RG, Danko K, Dimachkie MM, Feldman BM, Torre IG, Gordon P, Hayashi T, Katz JD, Kohsaka H, Lachenbruch PA, Lang BA, Li Y, Oddis CV, Olesinska M, Reed AM, Rutkowska-Sak L, Sanner H, Selva-O'Callaghan A, Song YW, Vencovsky J, Ytterberg SR, Miller FW, Rider LG; International Myositis Classification Criteria Project consortium, The Euromyositis register and The Juvenile Dermatomyositis Cohort Biomarker Study and Repository (JDRG) (UK and Ireland). 2017 European League Against Rheumatism/American College of Rheumatology classification criteria for adult and juvenile idiopathic inflammatory myopathies and their major subgroups. Ann Rheum Dis. 2017 Dec;76(12):1955-1964. doi: 10.1136/annrheumdis-2017-211468. Epub 2017 Oct 27.

  PMID: 29079590 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Dermatomyositis

Condition Hierarchy (Ancestors)

Polymyositis; Myositis; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Central Study Contacts

Rekha Bansal

CONTACT

216-440-2696; clinicalsae@novelmed.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The proposed trial in DM subjects is designed as an open-label study.

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: March 20, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share