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Study of NM8074 in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis (AAV)

ConditionAnti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNovelMed Therapeutics

About this trial

This is a Randomized, Double-Blind, Placebo-Controlled Study designed to assess safety, tolerability, and efficacy of NM8074 in AAV patients when used in combination with Standard of Care (SOC) cyclophosphamide/azathioprine or rituximab plus corticosteroids.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Clinical diagnosis of granulomatosis with polyangiitis (GPA), microscopic polyangiitis (MPA), or renal limited vasculitis.

Male and female subjects aged at least 18 years, with newly diagnosed or relapsed Associated Vasculitis (AAV) where treatment with cyclophosphamide or rituximab is needed.

At least 1 major item, or at least 3 non-major items, or at least the 2 renal items of proteinuria and hematuria on Birmingham Vasculitis Activity Score (BVAS).

Estimated glomerular filtration rate (eGFR) ≥ 20 mL/ minute.

Disqualifiers

Severe disease as determined by alveolar hemorrhage, hemoptysis, rapid onset mononeuritis multiplex or central nervous system involvement.

Patients with rapidly progressive glomerulonephritis

Any other known multi-system autoimmune disease including eosinophilic granulomatosis with polyangiitis (EGPA, Churg Strauss), systemic lupus erythematosus, Immunoglobulin A (lgA) vasculitis (HenochSchönlein purpura), rheumatoid vasculitis, Sjogren's disease, anti

glomerular basement membrane disease, or cryoglobulinemia.

Trial design

Design model

Sequential

Treatments tested in this trial

  • NM8074

    Drug

    NM8074 will be administered as an intravenous infusion. In Cohort 1, all subjects will be administered 20 mg/kg of NM8074 intravenously every two weeks for a total of 7 doses from Day 1 to Day 85 of the Treatment Period.

  • Placebo

    Drug

    Saline Placebo will be administered as an intravenous infusion. In Cohort 2, all subjects will be administered saline placebo intravenously every two weeks for a total of 7 doses from Day 1 to Day 85 of the Treatment Period.

Treatment groups

12 Participants
are divided into 2 treatment groups
Group A: NM8074Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of subjects achieving disease response at Day 85 defined as BVAS percent decrease of at least 50% from baseline.

Time frame
Up to Study Day 85

Secondary outcomes

1

Number of patients with ANCA positivity (anti-PR3 and anti-MPO)

Time frame
Up to Study Day 133
2

Change from Baseline or Percent Change from Baseline in BVAS (Birmingham Vasculitis Activity Score)

Time frame
Up to Study Day 133
3

Change from Baseline or Percent Change from Baseline in Vasculitis Damage Index (VDI)

Time frame
Up to Study Day 133
4

Change from Baseline or Percent Change from Baseline in C-reactive protein concentration

Time frame
Up to Study Day 133

Other outcomes

1

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

Time frame
Up to Study Day 133
2

Change from Baseline or Percent Change from Baseline in Factor B levels

Time frame
Up to Study Day 133
3

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

Time frame
Up to Study Day 133
4

Maximum plasma concentration (Cmax)

Time frame
Up to Study Day 133

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

This trial is not recruiting at the moment. You can still explore other options: