C3GPhase 3VALENCT05809531
An Open-Label, Nonrandomized, Multicenter Extension Study to Evaluate the Long-term Safety and Efficacy of Pegcetacoplan in Participants With C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis
A Phase 3 study testing Pegcetacoplan in people with C3G and IC-MPGN, run by Apellis Pharmaceuticals, Inc. at 47 sites in 15 countries.
Trial summary
This study is designed as a long-term extension to Study APL2-C3G-310, and is being conducted to establish the long-term safety and efficacy of pegcetacoplan in patients with C3 glomerulopathy (C3G) or immune-complex membranoproliferative glomerulonephritis (IC-MPGN). Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- C3G, IC-MPGN, C3 Glomerulopathy
- What is being tested?
- Pegcetacoplan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 47 sitesin 15 countries
- Study dates
- 29 May 2023to Jul 2027
- Phase
- Phase 3
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Completed participation in Study APL2-C3G-310 through the week 52 visit requirements
- Experienced clinical benefit from pegcetacoplan while participating in the previous trial, in the opinion of the investigator
- Must remain on a stable regimen for C3G or IC-MPGN treatment according to the requirements of Study APL2-C3G-310
- Received vaccinations against S pneumoniae, N meningitidis (types A, C, W, Y, and B), and H influenzae (type B) according to the requirements of Study APL2-C3G-310 and agree to receive any additional vaccinations recommended according to ACIP recommendations for adults or children with complement deficiencies and/or immunocompromising conditions or other similar local applicable guidelines
- Female participants of childbearing potential, defined as any woman who has experienced menarche and who is not permanently sterile or postmenopausal, must have a negative urine pregnancy test at visit 1 and must agree to use protocol-defined methods of contraception for the duration of the study through at least 90 days after receiving the last dose of pegcetacoplan
- Male participants must agree to use protocol-defined methods of contraception and agree to refrain from donating semen for the duration of the study through at least 90 days after receiving the last dose of pegcetacoplan
- Participants above the legal age of consent, in accordance with local regulations, must be willing and able to provide informed consent. The legally authorized representative of participants under the legal age of consent must be willing and able to provide informed consent; where appropriate, participants under the legal age of consent must also give their assent to participation in the study
- Willing and able to self-administer pegcetacoplan or have an identified caregiver who can perform the administration
Who cannot join
- Female participants who are or are planning to become pregnant or who are currently breastfeeding and are unwilling to discontinue for the duration of the study and for at least 90 days after the final dose of study drug
- Inability or unwillingness to cooperate with the requirements of the protocol
- Any condition that, in the opinion of the investigator, creates an undue risk for the participant by participating in the study or is likely to confound interpretation of the study results
- Evidence of ongoing drug or alcohol abuse or dependence, in the opinion of the investigator
Trial locations and contacts
47 sites in 15 countries.
47 sites in 15 countries
United States12 sites
University of Michigan Hospital (01008)
Ann Arbor, Michigan, 48109
Emory Investigational Drug Service (01021)
Atlanta, Georgia, 30322
Children's Hospital Colorado (01037)
Aurora, Colorado, 80045
Northeast Clinical Research Center LLC (01009)
Bethlehem, Pennsylvania, 18017
University of Florida, Department of Pediatric Nephrology (01010)
Gainsville, Florida, 32610
Hackensack Meridian Health (01036)
Hackensack, New Jersey, 07601
Texas Children's Hospital (01027)
Houston, Texas, 77030
Cohen Children Hospital, Pediatric Pharmacy (01022)
Hyde Park, New York, 11040
University of Iowa Hospital and Clinics (01030)
Iowa City, Iowa, 52242
Academic Medical Research Institute (01034)
Los Angeles, California, 90022
Columbia Nephrology (01039)
New York, New York, 10032
Oregon Health & Science Univ., Dept. Pediatrics (01038)
Portland, Oregon, 97239
Brazil9 sites
Santa Casa de Misericordia de Belo Horizonte (55017)
Belo Horizonte, Minas Gerais, 30150-221
HC UNESP Botucatu (55010)
Botucatu, 18618-687
Irmandade da Santa Casa Misericordia Porto Alegre (55016)
Porto Alegre, Rio Grande do Sul, 90020-090
Hospital de Clinicas de Porto Alegre (55018)
Porto Alegre, 90035-903
Real Hospital Portugues de Beneficencia (55015)
Recife, 52010-095
Ruschel Medicina E Pesquisa Clinica (55012)
Rio de Janeiro, 22270-060
Hospital De Base (55014)
São José do Rio Preto, 1500900-000
Hospital do Rim - Fundacao Oswaldo Ramos (55005)
São Paulo, 04038-002
Univ Sao Paulo, Av. Dr Eneas Carvalho de Aguiar, 155 (55007)
São Paulo, 05403-900
Italy3 sites
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (39004)
Milan, 20122
Istituto di Ricerche Farmacologiche Mario Negri IRCCS (39003)
Ranica, 24020
Ospesale Pediatrico bambino Gesu (39005)
Rome, 165
Netherlands3 sites
AMC Apotheek Goederenontvangst (31002)
Amsterdam, 1105 AZ
University Medical Center Groningen (31004)
Groningen de Brug, 9713 GZ
Radboud University Medical Center (31003)
Nijmegen, 6500 HB
Spain3 sites
Hosp. Universit. Materno-Infantil Vall d' Hebron (34006)
Barcelona, 8035
Hospital Universitario 12 de Octubre (34008)
Madrid, 28041
Hospital Universitario Dr Peset (34009)
Valencia, 46017
United Kingdom3 sites
Imperial College Hammersmith Hospital (44013)
London, W12 0HS
Royal Manchester Children's Hospital (44011)
Manchester, M13 9WL
Nottingham University Hospitals NHS Trust (44012)
Nottingham, NG7 2UH
Argentina2 sites
Hospital Privado-Universitario de Cordoba (54004)
Córdoba, CPA X5016KEH
Clinica Privada Velez Sarsfield (54007)
Córdoba, X5000
Australia2 sites
St. Vincent's Hospital Melbourne (61003)
Fitzroy, 3065
Kidney Trials Unit, Princess Alexandra Hospital (61007)
Woolloongab, Queensland, 4102
France2 sites
CHU de Bordeaux - Hopital Pellegrin (33010)
Bordeaux, 33076
Institut de transplantation urologie-nephrologie (33011)
Nantes, 44093
Japan2 sites
Seirei Hamamatsu General Hospital (81004)
Hamamatsu, Shizuoka, 430-8558
Nagasaki University Hospital (81005)
Nagasaki, Nagasaki, 852-8501
South Korea2 sites
Yonsei University College of Medicine, Sinchon Severance Hospital (82002)
Seoul, 3722
Seoul National University Hospital (82003 & 82005)
Soeul, 3080
Czechia1 site
Institute for Clinical and Experimental Medicine (42001)
Prague, 14021
About this study
Official title: An Open-Label, Nonrandomized, Multicenter Extension Study to Evaluate the Long-term Safety and Efficacy of Pegcetacoplan in Patients With C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis
This study is designed as a long-term extension to Study APL2-C3G-310, and is being conducted to establish the long-term safety and efficacy of pegcetacoplan in patients with C3 glomerulopathy (C3G) or immune-complex membranoproliferative glomerulonephritis (IC-MPGN).
- Conditions
- C3G, IC-MPGN, C3 Glomerulopathy, C3 Glomerulonephritis, Complement 3 Glomerulopathy, Complement 3 Glomerulopathy (C3G)
- Being tested
- Pegcetacoplan
- Medical subject headings
- Glomerulonephritis, Membranoproliferative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PegcetacoplanDrug
Also called APL-2
Complement (C3) Inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Pegcetacoplan administered subcutaneously | Experimental | Pegcetacoplan administered subcutaneously twice weekly according to protocol defined dosing regimen Receives: Drug: Pegcetacoplan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with a reduction in urine protein-to-creatinine ratio (uPCR) of at least 50% from the pretreatment value over time.
Measured: 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start29 May 2023
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for C3GStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Apellis Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05809531
- Sponsor's protocol ID
- APL2-C3G-314
- Other IDs
- 2023-504625-39-00, U1111-1290-7826, 2022-002833-33, 2023
- Acronym
- VALE
- Status last verified
- Mar 2026
- First submitted
- 30 Mar 2023
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Vivarelli M, Ariceta G, Borovitz Y, Dixon BP, Greenbaum LA, Licht C, Mastrangelo A, Melhem N, Fujita N, van de Kar NCAJ, Wallace D, Khankin E, Wang Z, Lopez-Lazaro L, Szamosi J, Nester CM. Pegcetacoplan for Adolescents with C3 Glomerulopathy or Primary Immune Complex Membranoproliferative GN: Phase 3 VALIANT Subgroup Analysis. Clin J Am Soc Nephrol. 2026 Aug 1;21(8):1404-1413. doi: 10.2215/CJN.0000001077. Epub 2026 May 14.
PubMed 42133432
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Nonrandomized, Multicenter Extension Study to Evaluate the Long-term Safety and Efficacy of Pegcetacoplan in Patients With C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis
- ClinicalTrials.gov ID
- NCT05809531
- Acronym / sponsor ID
- VALE / APL2-C3G-314
- Conditions
- C3G, IC-MPGN, C3 Glomerulopathy, C3 Glomerulonephritis, Complement 3 Glomerulopathy, Complement 3 Glomerulopathy (C3G)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Apellis Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 May 2023 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 12 Apr 2023 (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 study is designed as a long-term extension to Study APL2-C3G-310, and is being conducted to establish the long-term safety and efficacy of pegcetacoplan in patients with C3 glomerulopathy (C3G) or immune-complex membranoproliferative glomerulonephritis (IC-MPGN).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pegcetacoplan administered subcutaneously | Experimental | Drug: PegcetacoplanPegcetacoplan administered subcutaneously twice weekly according to protocol defined dosing regimen |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Completed participation in Study APL2-C3G-310 through the week 52 visit requirements
- Experienced clinical benefit from pegcetacoplan while participating in the previous trial, in the opinion of the investigator
- Must remain on a stable regimen for C3G or IC-MPGN treatment according to the requirements of Study APL2-C3G-310
- Received vaccinations against S pneumoniae, N meningitidis (types A, C, W, Y, and B), and H influenzae (type B) according to the requirements of Study APL2-C3G-310 and agree to receive any additional vaccinations recommended according to ACIP recommendations for adults or children with complement deficiencies and/or immunocompromising conditions or other similar local applicable guidelines
- Female participants of childbearing potential, defined as any woman who has experienced menarche and who is not permanently sterile or postmenopausal, must have a negative urine pregnancy test at visit 1 and must agree to use protocol-defined methods of contraception for the duration of the study through at least 90 days after receiving the last dose of pegcetacoplan
Key exclusion criteria (4 listed)
- Female participants who are or are planning to become pregnant or who are currently breastfeeding and are unwilling to discontinue for the duration of the study and for at least 90 days after the final dose of study drug
- Inability or unwillingness to cooperate with the requirements of the protocol
- Any condition that, in the opinion of the investigator, creates an undue risk for the participant by participating in the study or is likely to confound interpretation of the study results
- Evidence of ongoing drug or alcohol abuse or dependence, in the opinion of the investigator
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 |
|---|---|---|
| PegcetacoplanAlso: APL-2Complement (C3) Inhibitor | Drug | Pegcetacoplan administered subcutaneously |
Primary outcome
Proportion of participants with a reduction in urine protein-to-creatinine ratio (uPCR) of at least 50% from the pretreatment value over time.
Time frame: 2.5 years
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 2 Apr 2026.
- Derived from this study: PubMed 42133432Vivarelli M, Ariceta G, Borovitz Y, Dixon BP, Greenbaum LA, Licht C, Mastrangelo A, Melhem N, Fujita N, van de Kar NCAJ, Wallace D, Khankin E, Wang Z, Lopez-Lazaro L, Szamosi J, Nester CM. Pegcetacoplan for Adolescents with C3 Glomerulopathy or Primary Immune Complex Membranoproliferative GN: Phase 3 VALIANT Subgroup Analysis. Clin J Am Soc Nephrol. 2026 Aug 1;21(8):1404-1413. doi: 10.2215/CJN.0000001077. Epub 2026 May 14.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
47 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pegcetacoplan in people with C3G and IC-MPGN, run by Apellis Pharmaceuticals, Inc. at 47 sites in 15 countries.
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 8 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in United States, Brazil, Italy, Netherlands, Spain and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with a reduction in urine protein-to-creatinine ratio (uPCR) of at least 50% from the pretreatment value over time. (time frame: 2.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05809531, which also lists 1 linked publication.
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 2 Apr 2026.