Study Assessing the Safety and Efficacy of Pegcetacoplan in Post-Transplant Recurrence of C3G or IC-MPGN (NOBLE)

March 5, 2024 updated by: Apellis Pharmaceuticals, Inc.

An Open-Label, Randomized, Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of Pegcetacoplan in the Treatment of Post-Transplant Recurrence of C3G or IC-MPGN

This is a Phase 2, multicenter, open-label, randomized, controlled study designed to evaluate the safety and efficacy of pegcetacoplan in patients who have post-transplant recurrence of C3G or IC-MPGN.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1093AAS
        • Hospital Universitario Fundacion Favaloro
    • Provincia De Buenos Aires
      • Florencio Varela, Provincia De Buenos Aires, Argentina, B1888AAE
        • Hospital de Alta Complejidad en Red El Cruce Dr. Nestor Carlos Kirchner
  • Australia
      • Clayton, Australia, 3168
        • Monash Medical Centre
    • Victoria
      • Parkville, Victoria, Australia, 3050
        • The Royal Melbourne Hospital
  • Austria
      • Vienna, Austria, 1090
        • Medical University of Vienna
  • Brazil
      • Belo Horizonte, Brazil, CEP 30150-221
        • Santa Casa de Misericórdia de Belo Horizonte
      • São Paulo, Brazil, 05403-000
        • Clinical Research Center, Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
    • RS
      • Porto Alegre, RS, Brazil, 90020-090
        • Irmandade Da Santa Casa de Misericordia de Porto Alegre
    • Sao Paulo
      • Botucatu, Sao Paulo, Brazil, 18618-686
        • UPECLIN - Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu - FMB/UNESP
  • France
      • Lille, France, 59000
        • Lille Regional University Hospital Center, Claude Huriez Hospital, Department of Nephrology
      • Lyon, France, 69437
        • Hopital Edouard Herriot, Hospices Civils de Lyon
      • Montpellier, France, 34295 CEDEX 5
        • Center Hospitalier Universitaire de Montpellier
  • Italy
      • Ranica, Italy, 24020
        • Istituto di Ricerche Farmacologiche Mario Negri IRCCS
  • Netherlands
      • Nijmegen, Netherlands, 6500 HB
        • Radbound University Medical Center
  • Spain
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre, Nephrology Department
  • Switzerland
      • Lausanne, Switzerland, 1005
        • CHUV
  • United Kingdom
      • London, United Kingdom, W12 0HS
        • Imperial College Healthcare NHS Trust
      • Newcastle Upon Tyne, United Kingdom, NE7 7DN
        • Freeman Hospital
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic Arizona
    • California
      • Los Angeles, California, United States, 900033
        • Keck School of Medicine, University of Southern California
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Children's Hospital Colorado
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University, St.Louis
    • New York
      • New York, New York, United States, 10032
        • CUIMC
      • New York, New York, United States, 10016
        • NYU Langone Health Transplant Insitute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • At least 18 years of age at screening
  • Must have clinical and pathologic evidence of recurrent C3G or IC-MPGN
  • Stable (not improving) or worsening disease, in the opinion of the investigator, in the 2 months preceding the first dose of pegcetacoplan
  • eGFR ≥15 mL/min/1.73 m2, calculated by the Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) creatinine equation for adults
  • No more than 50% glomerulosclerosis or interstitial fibrosis on the screening renal allograft biopsy
  • Stable regimen for recurrent C3G/IC-MPGN for at least 4 weeks prior to the screening renal allograft biopsy and from the time of the screening renal allograft biopsy until randomization
  • Have received required vaccinations against N. meningitidis, S. pneumoniae, and H. influenzae (type B) or agree to receive vaccinations, if applicable vaccination records are not available. Vaccination is mandatory unless documented evidence exists that subjects are non-responders to vaccination.

Exclusion Criteria:

  • Absolute neutrophil count <1000 cells/mm3 during screening
  • Previous treatment with pegcetacoplan
  • Evidence of rejection on the screening renal allograft biopsy that requires treatment
  • Diagnosis or history of HIV, hepatitis B, or hepatitis C infection or positive serology at screening indicative of infection with any of these viruses
  • Weight more than 100 kg at screening
  • Hypersensitivity to pegcetacoplan or any of the excipients
  • History of meningococcal disease
  • Malignancy, except for the following:
  • Cured basal or squamous cell skin cancer
  • Curatively treated in situ disease
  • Malignancy free and off treatment for ≥5 years
  • Significant renal disease in the renal allograft secondary to another condition (eg, infection, malignancy, monoclonal gammopathy, rejection, or a medication) that would, in the opinion of the investigator, confound interpretation of the study results
  • Participation in any other investigational drug trial or exposure to other investigational agent, device, or procedure within 30 days or 5 half-lives from the last dose of the investigational agent (whichever is longer) prior to screening
  • Known or suspected hereditary fructose intolerance.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
Pegcetacoplan treatment of 1080 mg (sub-cutaneous infusion) twice weekly will be given throughout the entire study.
Drug: Pegcetacoplan
Complement (C3) Inhibitor
Other: Group 2
No intervention given during the randomized controlled portion of the study (through week 12). After week 12, subjects will receive pegcetacoplan treatment.
Drug: Pegcetacoplan
Complement (C3) Inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary efficacy endpoint is the proportion of subjects with reduction in C3c staining on renal biopsy after 12 weeks of treatment with pegcetacoplan.
Time Frame: 12 weeks after randomization
12 weeks after randomization

Secondary Outcome Measures

Outcome Measure
Time Frame
The proportion of subjects with reduction in C3c staining on renal biopsy
Time Frame: 52 weeks after randomization
52 weeks after randomization
The proportion of subjects with stabilization or improvement in estimated glomerular filtration rate (eGFR)
Time Frame: 52 weeks after randomization
52 weeks after randomization
The proportion of subjects with stabilization or improvement of serum creatinine concentration
Time Frame: 52 weeks after randomization
52 weeks after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Apellis Pharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 23, 2021

Primary Completion (Actual)

February 27, 2023

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

September 29, 2020

First Submitted That Met QC Criteria

September 29, 2020

First Posted (Actual)

October 1, 2020

Study Record Updates

Last Update Posted (Estimated)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APL2-C3G-204

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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