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Study of NM8074 in Adult C3 Glomerulopathy Patients

ConditionC3 Glomerulopathy
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNovelMed Therapeutics

About this trial

This is a Phase Ib, open-label, dose-escalation study designed to evaluate the safety, efficacy, and immunogenicity of NM8074 administered intravenously to patients with C3 Glomerulopathy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients ≥ 18 and ≤ 65 years at the time of consent

Diagnosis of C3 Glomerulopathy as confirmed by C3 nephropathy in biopsy within 12 months prior to enrollment

Reduced serum C3 levels (defined as less than 0.85 x lower limit of the central laboratory normal range) at Screening

Patients with confirmed proteinuria

Disqualifiers

Use of other investigational drugs at the time of enrollment

Patients with other renal diseases that would interfere with interpretation of the study

Estimated glomerular filtration rate of ≤ 20 mL/min/1.73m2 based on Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) at Screening

Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 times the upper limit of normal (xULN)

Trial design

Design model

Sequential

Treatments tested in this trial

  • NM8074

    Drug

    NM8074 will be administered as an intravenous infusion. Multiple dosing duration will range from 5 to 9 weeks.

Treatment groups

18 Participants
are divided into 3 treatment groups
Group A: Cohort 1Experimental treatment 1 intervention
Group B: Cohort 2Experimental treatment 1 intervention
Group C: Cohort 3Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Monitoring for incidence of Adverse Events (AEs)/Serious Adverse Events (SAEs)

Time frame
Up to Study Day 50 for Cohort 1 and up to study day 84 for Cohort 2 and 3
2

Change from Baseline or Percent Change from Baseline in Urine Protein to Creatine Concentration Ratio (UPCR)

Time frame
Up to Study Day 50 for Cohort 1 and up to study day 84 for Cohort 2 and 3
3

Change from Baseline or Percent Change from Baseline in Urine Albumin to Creatinine Concentration Ratio (UACR)

Time frame
Up to Study Day 50 for Cohort 1 and up to study day 84 for Cohort 2 and 3
4

Ratio to Baseline of UPCR and UACR

Derived from 24h urine collection

Time frame
Up to Study Day 50 for Cohort 1 and up to study day 84 for Cohort 2 and 3

Secondary outcomes

1

Percent Change from Baseline in Alternative Pathway (AP) of Complement Activity as Compared to Percent Change from Baseline in Classical Pathway (CP) of Complement Activity as Measured by Percent Change in Levels of Membrane Attack Complex (MAC)

Time frame
Up to Study Day 50 for Cohort 1 and up to study day 84 for Cohort 2 and 3
2

Percent Change from Baseline in Alternative Pathway (AP) of Complement Activity as Compared to Percent Change from Baseline in Classical Pathway (CP) of Complement Activity as Measured by Percent Change in Levels of Complement Component C3b

Time frame
Up to Study Day 50 for Cohort 1 and up to study day 84 for Cohort 2 and 3
3

Change from Baseline or Percent Change from Baseline in Serum C3 Levels

Time frame
Up to Study Day 50 for Cohort 1 and up to study day 84 for Cohort 2 and 3
4

Change from Baseline or Percent Change from Baseline in Glomerular Inflammation

Measured by change from baseline or percent change from baseline in the C3G Histologic Index for Disease Activity - Combined C5b-9 Strata. Scores range from 0-21 where a decrease in score indicates improvement.

Time frame
Up to Study Day 50 for Cohort 1 and up to study day 84 for Cohort 2 and 3

Other outcomes

1

Change from Baseline or Percent Change from Baseline in Levels of Complement Component C3b via Classical Pathway (CP) of Complement Activity.

Time frame
Up to Study Day 50 for Cohort 1 and up to study day 84 for Cohort 2 and 3
2

Change from Baseline or Percent Change from Baseline in Levels of Membrane Attack Complex (MAC) via Classical Pathway (CP) of Complement Activity.

Time frame
Up to Study Day 50 for Cohort 1 and up to study day 84 for Cohort 2 and 3

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: