Study of NM8074 in Patients with Dermatomyositis (DM)

ConditionDermatomyositis

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorNovelMed Therapeutics

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

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

Treatment groups

8 Participants

are divided into 1 treatment group

Group A: Cohort 1Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

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

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

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

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

Other outcomes

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

Time frame

Up to Study Day 127

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

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

Time frame

Up to Study Day 127

Maximum plasma concentration (Cmax)

Time frame

Up to Study Day 127

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NovelMed Therapeutics

Lead sponsor

Source ClinicalTrials.gov

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