Study of NM8074 in Patients With Immunoglobulin A Nephropathy (IgAN)

NCT06454110 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: NM8074-IGAN-601
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a Phase II, open-label study designed to To evaluate the safety and efficacy of NM8074 in reducing proteinuria relative to baseline in IgAN patients after 99 days of treatment.

Conditions

IgA Nephropathy

Outcome Measures

Primary Outcomes (1)

• Change from Baseline or Percent Change from Baseline in urine protein to creatinine concentration ratio

  Up to Study Day 99

Secondary Outcomes (13)

• Change from Baseline or Percent Change from Baseline in eGFR

  Up to Study Day 155

• Change from Baseline or Percent Change from Baseline in Serum Creatinine

  Up to Study Day 155

• Change from Baseline or Percent Change from Baseline in Hematuria

  Up to Study Day 155

• Change from Baseline or Percent Change from Baseline in Urine Albumin to Creatinine concentration ratio

  Up to Study Day 155

• Change from Baseline or Percent Change from Baseline in Bb plasma levels

  Up to Study Day 155

Other Outcomes (6)

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

  Up to Study Day 155

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

  Up to Study Day 155

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

  Up to Study Day 155

Study Arms (1)

Cohort 1

EXPERIMENTAL

All subjects will be administered 17 mg/kg of NM8074 intravenously every week, for a total of 15 doses from Day 1 to Day 99 of the Treatment Period.

Drug: NM8074

Interventions

NM8074 DRUG

NM8074 will be administered as an intravenous infusion. All subjects will be administered 17 mg/kg of NM8074 intravenously weekly for a total of 15 doses from Day 1 to Day 99 of the Treatment Period.

Cohort 1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients ≥18 years of age at the time of consent.
• A body mass index (BMI) within the range of 15 - 38 kg/m2. BMI = Body weight (kg) / \[Height (m)\]2.
• Confirmation of IgA Nephropathy verified by biopsy performed within the previous three years.
• All patients must be vaccinated prior to dosing with MenACWY Menactra® polysaccharide diphtheria toxoid conjugate vaccination against Neisseria meningitidis serogroups A, C, Y, and W-135. MenB meningococcal serogroup B vaccine (Bexsero®) will be administered per local guidelines.
• Hemoglobin ≥ 10g/dL and platelet count ≥ 100,000/mm3
• Female and male participates must agree to use contraceptives

You may not qualify if:

• Evidence of severe urinary obstruction or difficulty in voiding; any urinary tract disorder other than IgAN at screening and before dosing with NM8074.
• Require dialysis or plasma exchange within 12 weeks prior to screening.
• Presence of crescent formation in ≥50% of glomeruli assessed on renal biopsy.
• History of bone marrow, hematopoietic stem cells, or solid organ transplantation.
• Use of other investigational drugs at the time of enrolment, or within 5 half-lives of enrolment or within 3 months to study day 1 whichever is longer.
• Severe concurrent co-morbidities not amenable to active treatment, e.g., patients with severe kidney disease (CKD stage 4, chronic dialysis).
• Clinically significant abnormal ECG during screening.
• Currently active systemic infection or suspicion of active bacterial, viral, or fungal infection within 2 weeks prior to first dose, or history of unexplained, recurrent bacterial infections.
• Has a currently active or known history of meningococcal disease or N. meningitidis infection.
• Clinically significant medical or psychological conditions or risk factors that, as per the Investigator's judgment, could hinder the patient's participation in the study, introduce additional risks for the patient, or complicate the evaluation of the patient or study outcomes.
• Pregnant, planning to become pregnant, or nursing female subjects.
• Females with a positive pregnancy test result at Screening or on Day 1.

Sponsors & Collaborators

• NovelMed Therapeutics: lead

Related Publications (5)

• Kim SJ, Koo HM, Lim BJ, Oh HJ, Yoo DE, Shin DH, Lee MJ, Doh FM, Park JT, Yoo TH, Kang SW, Choi KH, Jeong HJ, Han SH. Decreased circulating C3 levels and mesangial C3 deposition predict renal outcome in patients with IgA nephropathy. PLoS One. 2012;7(7):e40495. doi: 10.1371/journal.pone.0040495. Epub 2012 Jul 6.

  PMID: 22792353 BACKGROUND

• Lafayette RA, Kelepouris E. Immunoglobulin A Nephropathy: Advances in Understanding of Pathogenesis and Treatment. Am J Nephrol. 2018;47 Suppl 1:43-52. doi: 10.1159/000481636. Epub 2018 May 31.

  PMID: 29852501 BACKGROUND

• Duval A, Caillard S, Fremeaux-Bacchi V. The complement system in IgAN: mechanistic context for therapeutic opportunities. Nephrol Dial Transplant. 2023 Nov 30;38(12):2685-2693. doi: 10.1093/ndt/gfad140.

  PMID: 37385820 BACKGROUND

• Medjeral-Thomas NR, Cook HT, Pickering MC. Complement activation in IgA nephropathy. Semin Immunopathol. 2021 Oct;43(5):679-690. doi: 10.1007/s00281-021-00882-9. Epub 2021 Aug 11.

  PMID: 34379175 BACKGROUND

• Stefan G, Jullien P, Masson I, Alamartine E, Mariat C, Maillard N. Circulating alternative pathway complement cleavage factor Bb is associated with vascular lesions and outcomes in IgA nephropathy. Nephrol Dial Transplant. 2023 Nov 8;38(Suppl 2):ii11-ii18. doi: 10.1093/ndt/gfad163.

  PMID: 37816675 BACKGROUND

MeSH Terms

Conditions

Glomerulonephritis, IGA

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Rekha Bansal, PhD

CONTACT

2164402696; clinicalsae@novelmed.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study will enroll a planned total of 10 patients as subjects for the trial, with extra enrollment if needed, at the discretion of the Investigator. All subjects will be administered 17 mg/kg of NM8074 intravenously every week, for a total of 15 doses from Day 1 to Day 99 of the Treatment Period.

Study Record Dates

• First Submitted: June 6, 2024
• First Posted: June 12, 2024
• Study Start (Estimated): February 1, 2028
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2031
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share