Clinical trial • Phase II/III • Immunology|Nephrology

POVETACICEPT for Primary membranous nephropathy|Membranous nephropathy

Phase II/III trial of POVETACICEPT for Primary membranous nephropathy|Membranous nephropathy.

Overview

Trial Therapeutic Area
Immunology|Nephrology
Trial Disease
Primary membranous nephropathy|Membranous nephropathy
Trial Stage
Phase II/III
Drug Modality
Peptide/protein/enzyme|Small molecule|Other

Key dates

Initial CTIS Submission Date
25-08-2025
First CTIS Authorization Date
11-12-2025

Trial design

Randomised, tacrolimus (oral capsule) — dose and schedule not specified in provided data-controlled, adaptive Phase II/III trial across 25 sites in Czechia, Germany, Hungary and others.

Randomised
Yes
Comparator
TACROLIMUS (oral capsule) — dose and schedule not specified in provided data
Adaptive
True - The study title and description state an adaptive Phase 2b/3 design; specific adaptive elements (interim analyses, stopping rules, dose-escalation rules) are not described in the provided data.
Target Sample Size
91
Trial Duration For Participant
504

Eligibility

Recruits 91 Vulnerable population selected. Study documents include adult informed consent forms and specific pregnant participant forms (country-specific L1 ICFs listed). No paediatric participation or assent procedures are described in the provided data..

Vulnerable Population
Vulnerable population selected. Study documents include adult informed consent forms and specific pregnant participant forms (country-specific L1 ICFs listed). No paediatric participation or assent procedures are described in the provided data.

Inclusion criteria

  • {"criterion_text":"- Diagnosed with pMN with confirmatory historical biopsy. If no historical biopsy was performed that confirmed pMN, a biopsy can be performed during Screening to confirm eligibility.\n- Other protocol defined Inclusion/Exclusion criteria will apply"}

Exclusion criteria

  • {"criterion_text":"- Hypersensitivity to investigational medicinal product or to any of its excipients.\n- Other protocol defined Inclusion/Exclusion criteria will apply"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Proportion of Participants with Complete Clinical Remission Definition 1 (CR1) CR1 [Time Frame: At Week 72]","definition_or_measurement_approach":"Time Frame: At Week 72"}

Secondary endpoints

  • {"endpoint_text":"- Proportion of Participants with Complete Clinical Remission Definition 2 (CR2). [Time Frame: At Week 72]","definition_or_measurement_approach":"Time Frame: At Week 72"}
  • {"endpoint_text":"- Proportion of Participants with Overall Clinical Remission (OR). [Time Frame: At Week 72]","definition_or_measurement_approach":"Time Frame: At Week 72"}
  • {"endpoint_text":"- Safety and tolerability as determined by AEs, clinical laboratory values, standard 12-lead ECGs, and vital signs","definition_or_measurement_approach":"Safety and tolerability assessed by adverse events, clinical laboratory values, standard 12-lead ECGs, and vital signs"}

Recruitment

Planned Sample Size
91
Recruitment Window Months
26
Consent Approach
Informed consent is obtained from adult participants using country-specific adult ICFs (L1 documents). Country- and language-specific ICFs and pregnant-participant consent forms are provided (examples: English, German, Hungarian, Italian, Dutch, Spanish, Czech). No paediatric assent or consent processes are described in the provided data.

Methods

  • Use of country-specific recruitment procedure documents (K1) and recruitment materials (K2) including posters, brochures and disease fact sheets targeting patients with primary membranous nephropathy; country-specific K1/K2 documents present for Czechia, Germany, Hungary, Ireland, Italy, Spain, Netherlands.
  • Site-based recruitment through participating hospitals/clinics (nephrology departments) listed per country.

Geography

Total Number Of Sites
25
Total Number Of Participants
30

Czechia

Earliest CTIS Part Ii Submission Date
01-10-2025
Latest Decision Or Authorization Date
12-12-2025
Processing Time Days
72
Number Of Sites
2
Number Of Participants
2

Sites

Site Name
Vseobecna Fakultni Nemocnice V Praze
Department Name
D10-510: Klinika nefrologie
Principal Investigator Name
Vladimir Tesar
Principal Investigator Email
vladimir.tesar@vfn.cz
Contact Person Name
Vladimir Tesar
Contact Person Email
vladimir.tesar@vfn.cz
Site Name
Fakultni Nemocnice Kralovske Vinohrady
Department Name
D10-509: Interni klinika
Principal Investigator Name
Ivan Rychlik
Principal Investigator Email
ivan.rychlik@fnkv.cz
Contact Person Name
Ivan Rychlik
Contact Person Email
ivan.rychlik@fnkv.cz

Germany

Earliest CTIS Part Ii Submission Date
17-11-2025
Latest Decision Or Authorization Date
12-12-2025
Processing Time Days
25
Number Of Sites
4
Number Of Participants
5

Sites

Site Name
Klinikum St. Georg gGmbH
Department Name
D10-513: Nephrology
Principal Investigator Name
Ralph Wendt
Principal Investigator Email
ralph.wendt@sanktgeorg.de
Contact Person Name
Ralph Wendt
Contact Person Email
ralph.wendt@sanktgeorg.de
Site Name
Universitaetsklinikum Wuerzburg AöR
Department Name
D10-511: Innere Medizin, Nephrologie
Principal Investigator Name
Elion Hoxha
Principal Investigator Email
Hoxha_E@ukw.de
Contact Person Name
Elion Hoxha
Contact Person Email
Hoxha_E@ukw.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
D10-512: Nephrologie
Principal Investigator Name
Adrian Schreiber
Principal Investigator Email
adrian.schreiber@charite.de
Contact Person Name
Adrian Schreiber
Contact Person Email
adrian.schreiber@charite.de
Site Name
Universitaetsklinikum Leipzig AöR
Department Name
D10-538: Endokrinologie, Nephrologie, Rheumatologie
Principal Investigator Name
Jan Kowald
Principal Investigator Email
Jan.Kowald@uniklinik-leipzig.de
Contact Person Name
Jan Kowald

Hungary

Earliest CTIS Part Ii Submission Date
13-10-2025
Latest Decision Or Authorization Date
16-12-2025
Processing Time Days
64
Number Of Sites
1
Number Of Participants
3

Sites

Site Name
University Of Szeged
Department Name
D10-536 : Belgyógyászati Klinika
Principal Investigator Name
László Bitó
Principal Investigator Email
bito.laszlo.zsolt@med.u-szeged.hu
Contact Person Name
László Bitó

Ireland

Earliest CTIS Part Ii Submission Date
11-11-2025
Latest Decision Or Authorization Date
16-12-2025
Processing Time Days
35
Number Of Sites
4
Number Of Participants
4

Sites

Site Name
Beaumont Hospital
Department Name
D10-514 : Nephrology
Principal Investigator Name
Peter Conlon
Principal Investigator Email
peterconlon@beaumont.ie
Contact Person Name
Peter Conlon
Contact Person Email
peterconlon@beaumont.ie
Site Name
Cork University Hospital
Department Name
D10-537 : Nephrology
Principal Investigator Name
Michael Clarkson
Principal Investigator Email
michael.clarkson@hse.ie
Contact Person Name
Michael Clarkson
Contact Person Email
michael.clarkson@hse.ie
Site Name
University Hospital Galway
Department Name
D10-516 : Nephrology
Principal Investigator Name
Michelle O'Shaughnessy
Principal Investigator Email
M.OShaughnessy4@hse.ie
Contact Person Name
Michelle O'Shaughnessy
Contact Person Email
M.OShaughnessy4@hse.ie
Site Name
St Vincent's University Hospital
Department Name
D10-515 : Nephrology
Principal Investigator Name
John Holian
Principal Investigator Email
j.holian@svuh.ie
Contact Person Name
John Holian
Contact Person Email
j.holian@svuh.ie

Italy

Earliest CTIS Part Ii Submission Date
14-11-2025
Latest Decision Or Authorization Date
15-12-2025
Processing Time Days
31
Number Of Sites
5
Number Of Participants
8

Sites

Site Name
Istituti Clinici Scientifici Maugeri S.p.A. Sb
Department Name
D10-522: UO Nefrologia e Dialisi
Principal Investigator Name
Ciro Esposito
Principal Investigator Email
ciro.esposito@icsmaugeri.it
Contact Person Name
Ciro Esposito
Contact Person Email
ciro.esposito@icsmaugeri.it
Site Name
Azienda Ospedaliera Universitaria Federico II Di Napoli
Department Name
D10-521: UOC Nefrologia
Principal Investigator Name
Ivana Capuano
Principal Investigator Email
ivana.capuano@unina.it
Contact Person Name
Ivana Capuano
Contact Person Email
ivana.capuano@unina.it
Site Name
Fondazione IRCCS Policlinico San Matteo
Department Name
D10-524: SC Nefrologia e Dialisi - Abilitazione al Trapianto
Principal Investigator Name
Teresa Rampino
Principal Investigator Email
t.rampino@smatteo.pv.it
Contact Person Name
Teresa Rampino
Contact Person Email
t.rampino@smatteo.pv.it
Site Name
IRCCS Ospedale Policlinico San Martino
Department Name
D10-520: Clinica Nefrologica, Dialisi e Trapianto
Principal Investigator Name
Francesca Chiara Viazzi
Principal Investigator Email
francesca.viazzi@unige.it
Contact Person Name
Francesca Chiara Viazzi
Contact Person Email
francesca.viazzi@unige.it
Site Name
Azienda Universitaria Ospedaliera Consorziale Policlinico Bari
Department Name
D10-518: U.O.C. Nefrologia, Dialisi e Trapianto
Principal Investigator Name
Loreto Gesualdo
Principal Investigator Email
loreto.gesualdo@uniba.it
Contact Person Name
Loreto Gesualdo
Contact Person Email
loreto.gesualdo@uniba.it

Spain

Earliest CTIS Part Ii Submission Date
18-11-2025
Latest Decision Or Authorization Date
16-12-2025
Processing Time Days
28
Number Of Sites
7
Number Of Participants
5

Sites

Site Name
Hospital Universitario Del Vinalopo
Department Name
D10-526 : Nephrology
Principal Investigator Name
Eva Cotilla de la Rosa
Principal Investigator Email
ecotilla@vinaloposalud.com
Contact Person Name
Eva Cotilla de la Rosa
Contact Person Email
ecotilla@vinaloposalud.com
Site Name
Clinica Universidad De Navarra
Department Name
D10-543 : Nephrology
Principal Investigator Name
José María Mora-Gutiérrez
Principal Investigator Email
jmora@unav.es
Contact Person Name
José María Mora-Gutiérrez
Contact Person Email
jmora@unav.es
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
D10-530 : Nephrology
Principal Investigator Name
Mercedes Salgueira
Contact Person Name
Mercedes Salgueira
Site Name
Hospital Universitari Vall D Hebron
Department Name
D10-529: Nephrology
Principal Investigator Name
Maria Jose Soler Romeo
Principal Investigator Email
mariajose.soler@vallhebron.cat
Contact Person Name
Maria Jose Soler Romeo
Contact Person Email
mariajose.soler@vallhebron.cat
Site Name
Hospital Polusa S.A.
Department Name
D10-528 : Nephrology
Principal Investigator Name
Secundino Cigarran Guldris
Principal Investigator Email
scigarran@riberacare.com
Contact Person Name
Secundino Cigarran Guldris
Contact Person Email
scigarran@riberacare.com
Site Name
Hospital Universitario Reina Sofia
Department Name
D10-542 : Nephrology
Principal Investigator Name
Cristina Rabasco Ruiz
Principal Investigator Email
cristina.rabasco.sspa@juntadeandalucia.es
Contact Person Name
Cristina Rabasco Ruiz
Site Name
Hospital Universitario Del Vinalopo (additional listed site entry)
Department Name
D10-526 : Nephrology (duplicate listing aggregated)
Principal Investigator Name
Eva Cotilla de la Rosa
Principal Investigator Email
ecotilla@vinaloposalud.com
Contact Person Name
Eva Cotilla de la Rosa
Contact Person Email
ecotilla@vinaloposalud.com

Netherlands

Earliest CTIS Part Ii Submission Date
18-11-2025
Latest Decision Or Authorization Date
15-12-2025
Processing Time Days
27
Number Of Sites
2
Number Of Participants
3

Sites

Site Name
Radboud universitair medisch centrum Stichting
Department Name
D10-539: Nephrology
Principal Investigator Name
Anne-Els van de Logt
Principal Investigator Email
Anne-Els.vandeLogt@radboudumc.nl
Contact Person Name
Anne-Els van de Logt
Site Name
Amsterdam UMC Stichting
Department Name
D10-525: Nephrology
Principal Investigator Name
Marc Hilhorst
Principal Investigator Email
m.l.hilhorst@amsterdamumc.nl
Contact Person Name
Marc Hilhorst
Contact Person Email
m.l.hilhorst@amsterdamumc.nl

Sponsor

Primary sponsor

Full Name
Vertex Pharmaceuticals Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Investigational products

Investigational Product Name
ALPN-303 solution for injection in pre-filled syringe
Active Substance
POVETACICEPT
Modality
Peptide/protein/enzyme
Routes Of Administration
SUBCUTANEOUS INJECTION
Route
SUBCUTANEOUS INJECTION
Authorisation Status
prodAuthStatus 1
Investigational Product Name
ALPN-303 solution for injection
Active Substance
POVETACICEPT
Modality
Peptide/protein/enzyme
Routes Of Administration
SUBCUTANEOUS INJECTION
Route
SUBCUTANEOUS INJECTION
Authorisation Status
prodAuthStatus 1
Investigational Product Name
TACROLIMUS
Active Substance
TACROLIMUS
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL
Authorisation Status
prodAuthStatus 2
Investigational Product Name
Test IMP without active substance
Modality
Other

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