Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
The proposed study, NM8074-C3G-101, will enroll a planned number of 18 patients, with the potential to enroll more patients. There will be 3 cohorts with 6 patients each dosed at 5, 10, or 20 mg/kg depending on which cohort they are assigned to. Enrollment in the subsequent higher dose level cohort will occur after the previous cohort has been evaluated for safety.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | 6 subjects will receive NM8074 at 5 mg/kg weekly. |
|
| Cohort 2 | Experimental | 6 subjects will receive NM8074 at 10 mg/kg every 2 weeks. |
|
| Cohort 3 | Experimental | 6 subjects will receive NM8074 at 20 mg/kg every 2 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NM8074 | Drug | NM8074 will be administered as an intravenous infusion. Multiple dosing duration will range from 5 to 9 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Monitoring for incidence of Adverse Events (AEs)/Serious Adverse Events (SAEs) | Up to Study Day 50 for Cohort 1 and up to study day 84 for Cohort 2 and 3 | |
| Change from Baseline or Percent Change from Baseline in Urine Protein to Creatine Concentration Ratio (UPCR) | Up to Study Day 50 for Cohort 1 and up to study day 84 for Cohort 2 and 3 | |
| Change from Baseline or Percent Change from Baseline in Urine Albumin to Creatinine Concentration Ratio (UACR) | Up to Study Day 50 for Cohort 1 and up to study day 84 for Cohort 2 and 3 | |
| Ratio to Baseline of UPCR and UACR | Derived from 24h urine collection | Up to Study Day 50 for Cohort 1 and up to study day 84 for Cohort 2 and 3 |
| Change from Baseline or Percent Change from Baseline in Estimated Glomerular Filtration Rate (eGFR) | Up to Study Day 50 for Cohort 1 and up to study day 84 for Cohort 2 and 3 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Up to Study Day 50 for Cohort 1 and up to study day 84 for Cohort 2 and 3 | |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline or Percent Change from Baseline in Levels of Complement Component C3b via Classical Pathway (CP) of Complement Activity. | Up to Study Day 50 for Cohort 1 and up to study day 84 for Cohort 2 and 3 | |
| Change from Baseline or Percent Change from Baseline in Levels of Membrane Attack Complex (MAC) via Classical Pathway (CP) of Complement Activity. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rekha Bansal | Contact | 216-440-2696 | clinicalsae@novelmed.com |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study will enroll a planned number of 18 patients as subjects for the trial with the potential for more enrollment. Each cohort will consist of 6 subjects in a total of three cohorts at doses of 5, 10, or 20 mg/kg NM8074. No more than two to three subjects will be dosed in a single day. Safety data will be assessed and reviewed by the Sponsor and Study Investigators for dosed subjects prior to dose escalation or dosing of the rest of the study subjects within the Cohort. Dose escalation will occur only after four (4) subjects have been dosed and safety data has been evaluated.
Not provided
Not provided
Not provided
Not provided
| Up to Study Day 50 for Cohort 1 and up to study day 84 for Cohort 2 and 3 |
| Change from Baseline or Percent Change from Baseline in Serum C3 Levels | Up to Study Day 50 for Cohort 1 and up to study day 84 for Cohort 2 and 3 |
| 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. | Up to Study Day 50 for Cohort 1 and up to study day 84 for Cohort 2 and 3 |
| Change from Baseline or Percent Change from Baseline in Quality of Life (QoL) Assessed via the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale, Version 4. | The FACIT-fatigue scale is a 13-item patient-reported measure of fatigue with a 7-day recall period. Items are scored on a 0 - 4 response scale ranging from "Not at all" to "Very much so". All items are summed to create a single fatigue score with a range from 0 to 52 with a better quality of life indicated by a higher score. | Up to Study Day 50 for Cohort 1 and up to study day 84 for Cohort 2 and 3 |
| Change from Baseline or Percent Change from Baseline in Quality of Life (QoL) Assessed via the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 Scale (QLQ- C30), Version 3.0 | All EORTC QLQ-C30 scales and single-item measures range from 0 to 100. This includes 3 symptom scales (fatigue, pain, nausea and vomiting), 5 functional scales (physical, role, cognitive, emotional, and social), single-item questions addressing symptoms like insomnia, dyspnea, loss of appetite, and others that are commonly reported by cancer patients, and the perceived financial impact of the disease. A higher score is associated with a greater quality of life for global health status. | Up to Study Day 50 for Cohort 1 and up to study day 84 for Cohort 2 and 3 |
| Changes in plasma concentration of NM8074 | Up to Study Day 50 for Cohort 1 and up to study day 84 for Cohort 2 and 3 |
| Maximum plasma concentration (Cmax) | Up to Study Day 50 for Cohort 1 and up to study day 84 for Cohort 2 and 3 |
| Time corresponding to Cmax (tmax) | Up to Study Day 50 for Cohort 1 and up to study day 84 for Cohort 2 and 3 |
| Area under the drug concentration-time curves (AUC0-t) | Up to Study Day 50 for Cohort 1 and up to study day 84 for Cohort 2 and 3 |
| Change from Baseline or Percent Change from Baseline in Levels of Complement Component C3b via Alternative Pathway (AP) of Complement Activity | Up to Study Day 50 for Cohort 1 and up to study day 84 for Cohort 2 and 3 |
| Change from Baseline or Percent Change from Baseline in Levels of Membrane Attack Complex (MAC) via Alternative Pathway (AP) of Complement Activity | Up to Study Day 50 for Cohort 1 and up to study day 84 for Cohort 2 and 3 |
| Up to Study Day 50 for Cohort 1 and up to study day 84 for Cohort 2 and 3 |