A Phase 1/2 interventional study of NM8074 in C3 Glomerulopathy, sponsored by NovelMed Therapeutics. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-04-13.
Sponsored by NovelMed Therapeutics · Phase 1/2, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
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.
NovelMed Therapeutics is the lead sponsor of 9 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
6 subjects will receive NM8074 at 5 mg/kg weekly.
Drug: NM8074
6 subjects will receive NM8074 at 10 mg/kg every 2 weeks.
Drug: NM8074
6 subjects will receive NM8074 at 20 mg/kg every 2 weeks.
Drug: NM8074
NM8074 will be administered as an intravenous infusion. Multiple dosing duration will range from 5 to 9 weeks.
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
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
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
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
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
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.
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
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.
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
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
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
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for May 2027; primary completion for Aug 2029, 27 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Ruxoprubart
NovelMed Therapeutics