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Not yet recruitingNCT06887738Updated Mar 25, 2025

Study of NM8074 in Patients with Dermatomyositis (DM)

A Phase 2 interventional study of NM8074 in Dermatomyositis, sponsored by NovelMed Therapeutics. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-25.

Sponsored by NovelMed Therapeutics · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
8
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

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).

Read the 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.

02

Conditions studied

  • Dermatomyositis

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
8 participants (estimated)

Study arms

  • Experimental
    Cohort 1

    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

  • DrugNM8074

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

05

What researchers measure

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.

    Time frame: Up to Study Day 78

Secondary outcomes

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

    In DM, CDASI is a visual tool for a physician to assess the activity and damage of skin involvement in DM patients. The total activity score ranges from 0 to 100, and the damage score ranges from 0 to 32, wherein both criteria the higher score indicates more severe activity or damage of the disease in the patient.

    Time frame: Up to Study Day 78

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

    In Manual Muscle testing (MMT-8) eight specific muscle groups strengths are evaluated, each muscle group is scored on a scale from 0 (no movement) to 10 (normal strength), resulting in a maximum total score of 150 with a higher score indicating better muscle strength. Where a score \< 136 would indicate muscle weakness significant enough to classify the patient as at risk of DM. MMT-8 can contribute between 0 to 32.5 points to the TIS: If there is a significant improvement in the patient's condition of more than 30% from baseline, the maximum score of 32.5 points is awarded. If the condition worsens or shows only a slight improvement (up to 2% from baseline), then 0 points are given.

    Time frame: Up to Study Day 78

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

    The PhGA is scored on a scale from 0 (no evidence of disease activity) to 10 (extremely severe disease), with higher scores indicating greater disease severity.

    Time frame: Up to Study Day 78

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

    The PhGA is scored on a scale from 0 (no evidence of disease activity) to 10 (extremely severe disease), with higher scores indicating greater disease severity.

    Time frame: Up to Study Day 78

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

    HAQ can contribute between 0 to 10 points to the TIS: - If there is a significant improvement in the patient's condition of more than 40% from baseline, the maximum score of 10 points is awarded. If the condition worsens or shows only a slight improvement (up to 5% from baseline), then 0 points are given.

    Time frame: Up to Study Day 78

  6. Change from Baseline or Percent Change from Baseline in Extra muscular Activity (MDAAT) score

    Extra-muscular Activity can contribute between 0 to 20 points to the TIS: - If there is a significant improvement in the patient's condition of more than 40% from baseline, the maximum score of 20 points is awarded. If the condition worsens or shows only a slight improvement (up to 5% from baseline), then 0 points are given.

    Time frame: Up to Study Day 78

Other outcomes

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

    Time frame: Up to Study Day 127

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

    NM8074-mediated CP inhibition is measure via a complement CP ELISA-based assay measuring MAC formation.

    Time frame: Up to Study Day 127

  3. Change from Baseline or Percent Change from Baseline in plasma concentration of NM8074

    Time frame: Up to Study Day 127

  4. Maximum plasma concentration (Cmax)

    Time frame: Up to Study Day 127

  5. Time corresponding to Cmax (tmax)

    Time frame: Up to Study Day 127

  6. Area under the drug concentration-time curves (AUC0-t)

    Time frame: Up to Study Day 127

06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • 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. PubMed 29079590 ↗

Related links

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT06887738
Lead sponsor
NovelMed Therapeutics
Responsible party
Sponsor
First posted
Mar 20, 2025
Start date
Jun 2026 (estimated)
Primary completion
Nov 2027 (estimated)
Completion
Dec 2028 (estimated)
Last update
Mar 25, 2025

Study contacts

Rekha Bansal
Contact
clinicalsae@novelmed.com
216-440-2696

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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