C3 GlomerulopathyPhase 1/2NCT05647811
Study of NM8074 in Adult C3 Glomerulopathy Patients
A Phase 1/2 study testing NM8074 in people with C3 Glomerulopathy, run by NovelMed Therapeutics.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- C3 Glomerulopathy
- What is being tested?
- NM8074
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- May 2027to Jul 2030
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Willing and able to understand and complete informed consent procedures, including signing and dating the informed consent form (ICF), and comply with the study visit schedule
- Women 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 1 week after stopping of investigational drug
Show all 9Show fewer
- Males must agree to use contraceptives and refrain from donating sperm for the duration of the study
- Patients must have documentation of previous vaccination or be willing to be vaccinated prior to dosing with NM8074. All patients will be vaccinated against Neisseria meningitidis, Streptococcus pneumoniae and Haemophilus influenzae according to the most current Advisory Committee on Immunization Practices (ACIP) recommendations.
- Estimated glomerular filtration (eGFR) rate of ≤ 60 ml/min but ≥ 20 ml/min
Who cannot join
- 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)
- Has a known history of meningococcal disease or N. meningitidis
- Currently active systemic infection or suspicion of active bacterial, viral, or fungal infection that requires antibiotic, antifungal, antiparasitic, or antiviral mediations
Show all 11Show fewer
- Temperature > 38°C for more than two weeks prior to screening
- History of renal organ transplantation
- Pregnant, planning to become pregnant, or nursing female subjects
- C3G patients currently under complement blocker treatments
- Participation in any experimental small molecule or non-antibody therapy within 60 days prior to dosing on Day 1 (participation in observational studies and/or registry studies is permitted)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase Ib, Open Label, Dose Escalation Study of NM8074 in Subjects With C3 Glomerulopathy (C3G)
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.
Read the detailed description
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.
- Conditions
- C3 Glomerulopathy
- Being tested
- NM8074
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NM8074Drug
NM8074 will be administered as an intravenous infusion. Multiple dosing duration will range from 5 to 9 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 6 subjects will receive NM8074 at 5 mg/kg weekly. Receives: Drug: NM8074 |
| Cohort 2 | Experimental | 6 subjects will receive NM8074 at 10 mg/kg every 2 weeks. Receives: Drug: NM8074 |
| Cohort 3 | Experimental | 6 subjects will receive NM8074 at 20 mg/kg every 2 weeks. Receives: Drug: NM8074 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monitoring for incidence of Adverse Events (AEs)/Serious Adverse Events (SAEs)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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)
Measured: Up to Study Day 50 for Cohort 1 and up to study day 84 for Cohort 2 and 3
Secondary outcomes (12)
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)
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Up to Study Day 50 for Cohort 1 and up to study day 84 for Cohort 2 and 3
Maximum plasma concentration (Cmax)
Measured: Up to Study Day 50 for Cohort 1 and up to study day 84 for Cohort 2 and 3
Time corresponding to Cmax (tmax)
Measured: 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)
Measured: 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
Measured: 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
Measured: Up to Study Day 50 for Cohort 1 and up to study day 84 for Cohort 2 and 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2022
- Study startMay 2027 (estimated)
- Primary completionAug 2029 (estimated)
- Study completionJul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for C3 GlomerulopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NovelMed Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05647811
- Sponsor's protocol ID
- NM8074-C3G-101
- Status last verified
- Apr 2026
- First submitted
- 18 Nov 2022
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib, Open Label, Dose Escalation Study of NM8074 in Subjects With C3 Glomerulopathy (C3G)
- ClinicalTrials.gov ID
- NCT05647811
- Acronym / sponsor ID
- NM8074-C3G-101
- Conditions
- C3 Glomerulopathy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- NovelMed TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- May 2027 (estimated)
- Primary completion
- Aug 2029 (estimated)
- Study completion
- Jul 2030 (estimated)
- First posted
- 13 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: NM80746 subjects will receive NM8074 at 5 mg/kg weekly. |
| Cohort 2 | Experimental | Drug: NM80746 subjects will receive NM8074 at 10 mg/kg every 2 weeks. |
| Cohort 3 | Experimental | Drug: NM80746 subjects will receive NM8074 at 20 mg/kg every 2 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
- Willing and able to understand and complete informed consent procedures, including signing and dating the informed consent form (ICF), and comply with the study visit schedule
Key exclusion criteria (11 listed)
- 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)
- Has a known history of meningococcal disease or N. meningitidis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NM8074NM8074 will be administered as an intravenous infusion. Multiple dosing duration will range from 5 to 9 weeks. | Drug | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
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
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
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
Ratio to Baseline of UPCR and UACR
Time frame: Up to Study Day 50 for Cohort 1 and up to study day 84 for Cohort 2 and 3
Derived from 24h urine collection
Change from Baseline or Percent Change from Baseline in Estimated Glomerular Filtration Rate (eGFR)
Time frame: Up to Study Day 50 for Cohort 1 and up to study day 84 for Cohort 2 and 3
12 secondary outcomes
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
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
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
Change from Baseline or Percent Change from Baseline in Glomerular Inflammation
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: Up to Study Day 50 for Cohort 1 and up to study day 84 for Cohort 2 and 3
Maximum plasma concentration (Cmax)
Time frame: Up to Study Day 50 for Cohort 1 and up to study day 84 for Cohort 2 and 3
Time corresponding to Cmax (tmax)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: Up to Study Day 50 for Cohort 1 and up to study day 84 for Cohort 2 and 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for C3 Glomerulopathy
RecruitingPhase 3
Study of Efficacy and Safety of Iptacopan in Patients With C3 Glomerulopathy.
C3G
Not yet recruitingPhase 3
A Study to Assess the Efficacy and Safety of Pegcetacoplan for the Prevention of Recurrent C3G or Primary IC-MPGN in Kidney Transplant Recipients
C3 Glomerulopathy (C3G), Primary Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN), Recurrent Glomerular Disease After Kidney Transplantation
Not yet recruitingObservational study
Pilot STUDY to Monitor Ex-vivo the Biological Effects of the C3 Inhibitor, PEGCETACOPLAN, on Activation of Complement in Fluid Phase and on Podocytes in Patients With C3G and Primary IC-MPGN
Glomerulopathy, C3G
RecruitingPhase 1
A Clinical Trial to Test the Safety, Tolerability, and How the Body Processes CPV-104 in Healthy People and Patients With C3-Glomerulopathy
C3 Glomerulopathy (C3G), Healthy Adult Participants
RecruitingPhase 2
A Phase 2 Study to Evaluate the Safety, PD, PK, and Clinical Activity of ADX-097 in Participants With IgAN, LN or C3G
IgA Nephropathy, Lupus Nephritis (LN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing NM8074 in people with C3 Glomerulopathy, run by NovelMed Therapeutics.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rekha Bansal (216-440-2696, clinicalsae@novelmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.