Overview
Sponsor-declared trial summary
Primary Membranous Nephropathy
To evaluate the efficacy of povetacicept in subjects with pMN
Key facts
- Sponsor
- Vertex Pharmaceuticals Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 19 Dec 2025 → ongoing
- Decision date (initial)
- 2025-12-12
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy
To evaluate the efficacy of povetacicept in subjects with pMN
Secondary objectives 1
- To evaluate the safety and tolerability of povetacicept in subjects with pMN
Conditions and MedDRA coding
Primary Membranous Nephropathy
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10027170 | Membranous nephropathy | 10038359 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- 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.
- Other protocol defined Inclusion/Exclusion criteria will apply
Exclusion criteria 2
- Hypersensitivity to investigational medicinal product or to any of its excipients.
- Other protocol defined Inclusion/Exclusion criteria will apply
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Proportion of Participants with Complete Clinical Remission Definition 1 (CR1) CR1 [Time Frame: At Week 72]
Secondary endpoints 3
- Proportion of Participants with Complete Clinical Remission Definition 2 (CR2). [Time Frame: At Week 72]
- Proportion of Participants with Overall Clinical Remission (OR). [Time Frame: At Week 72]
- Safety and tolerability as determined by AEs, clinical laboratory values, standard 12-lead ECGs, and vital signs
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 3
ALPN-303 Solution for Injection in Pre-filled Pen
PRD12449111 · Product
- Active substance
- Povetacicept
- Substance synonyms
- Transmembrane activator and CAML interactor,fragment 68-110 variant (K77>E10, F78>Y11, Y102>D35), fused to a IgG1 variant (C55>S, L69>A, L70>E, G72>A, C-terminal K282 deleted), ALPN-303, TACI vTD-Fc, 68-110-TNF receptor superfamily protein 13B [77-glutamic acid, 78-tyrosine, 102-asparatic acid] (human) fusion with peptide linker (GSGGGGS) fusion with IgG1 [5-serine, 19-alanine, 20-glutamic acid, 22-alanine, de-C-terminal lysine] (human gamma-1-chain C-region C-terminal fragment), dimer
- Other product name
- Povetacicept
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED PEN
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 104 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- VERTEX PHARMACEUTICALS, INCORPORATED
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/26/3205
ALPN-303 solution for injection in pre-filled syringe
PRD12198433 · Product
- Active substance
- Povetacicept
- Other product name
- Povetacicept
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 104 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- VERTEX PHARMACEUTICALS, INCORPORATED
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/26/3205
ALPN-303 solution for injection
PRD12198369 · Product
- Active substance
- Povetacicept
- Other product name
- Povetacicept
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 104 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- VERTEX PHARMACEUTICALS, INCORPORATED
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/26/3205
Comparator 3
SUB10797MIG · Substance
- Active substance
- Tacrolimus
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 00 mg/kg milligram(s)/kilogram
- Max total dose
- 00 mg/kg milligram(s)/kilogram
- Max treatment duration
- 52 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB10797MIG · Substance
- Active substance
- Tacrolimus
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 00 mg/kg milligram(s)/kilogram
- Max total dose
- 00 mg/kg milligram(s)/kilogram
- Max treatment duration
- 52 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB10797MIG · Substance
- Active substance
- Tacrolimus
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 00 mg/kg milligram(s)/kilogram
- Max total dose
- 00 mg/kg milligram(s)/kilogram
- Max treatment duration
- 52 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
Test IMP without active substance
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Vertex Pharmaceuticals Inc.
- Sponsor organisation
- Vertex Pharmaceuticals Inc.
- Address
- 50 Northern Avenue
- City
- Boston
- Postcode
- 02210-1862
- Country
- United States
Scientific contact point
- Organisation
- Vertex Pharmaceuticals Inc.
- Contact name
- Clinical Trials and Medical Info
Public contact point
- Organisation
- Vertex Pharmaceuticals Inc.
- Contact name
- Clinical Trials and Medical Info
Locations
7 EU/EEA countries · 24 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Ongoing, recruiting | 2 | 2 |
| Germany | Ongoing, recruiting | 5 | 4 |
| Hungary | Ongoing, recruiting | 3 | 1 |
| Ireland | Ongoing, recruiting | 4 | 4 |
| Italy | Ongoing, recruiting | 8 | 5 |
| Netherlands | Authorised, recruitment pending | 3 | 2 |
| Spain | Ongoing, recruiting | 5 | 6 |
| Rest of world
Korea, Republic of, China, United States, Japan, United Kingdom, Brazil, Australia
|
— | 91 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Czechia | 2026-03-16 | 2026-04-08 | |||
| Germany | 2025-12-23 | 2026-03-03 | |||
| Hungary | 2026-03-03 | 2026-03-25 | |||
| Ireland | 2026-03-24 | 2026-04-14 | |||
| Italy | 2026-02-26 | 2026-04-07 | |||
| Spain | 2025-12-19 | 2026-03-27 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 85 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol ENG 2025-521661-27-00 Redacted | 4.0 |
| Protocol (for publication) | D4_Patient facing document_PRO_1_Placeholder | 1 |
| Protocol (for publication) | D4_Patient facing document_PRO_2_Placeholder | 1 |
| Recruitment arrangements (for publication) | K1_CZE Country ICF Procedure CZ-English_VX24-AIS-D10 Public | 2.0 |
| Recruitment arrangements (for publication) | K1_DEU Recruitment Procedure Description incl ICF Proc English VX24-AIS-D10 Public | 2.0 |
| Recruitment arrangements (for publication) | K1_ESP Recruitment Procedure Description English VX24-AIS-D10 Public | 2.0 |
| Recruitment arrangements (for publication) | K1_IRL Recruitment Brochure English VX24-AIS-D10 Public | 2.0 |
| Recruitment arrangements (for publication) | K1_IRL Recruitment Other Factsheet English VX24-AIS-D10 Public | 2.0 |
| Recruitment arrangements (for publication) | K1_IRL Recruitment Other ID Card English VX24-AIS-D10 Public | 1.0 |
| Recruitment arrangements (for publication) | K1_IRL Recruitment Poster English VX24-AIS-D10 Public | 1.0 |
| Recruitment arrangements (for publication) | K1_IRL Recruitment Procedure Description English VX24-AIS-D10 Public | 2.0 |
| Recruitment arrangements (for publication) | K1_ITA Country ICF Procedure & Recruit Procedure English VX24-AIS-D10 Public | 2.0 |
| Recruitment arrangements (for publication) | K1_ITA Recruitment Brochure Italian VX24-AIS-D10 Public | 2.0 |
| Recruitment arrangements (for publication) | K1_ITA Recruitment Disease Fact Sheet Italian VX24-AIS-D10 Public | 2.0 |
| Recruitment arrangements (for publication) | K1_ITA Recruitment Other HCP Engagement Deck English VX24-AIS-D10 Public | 1.0 |
| Recruitment arrangements (for publication) | K1_ITA Recruitment Poster Italian VX24-AIS-D10 Public | 1.0 |
| Recruitment arrangements (for publication) | K1_NLD Recruitment Procedure Description English VX24-AIS-D10 Public | 2.0 |
| Recruitment arrangements (for publication) | K2_CZE Recruitment Brochure PA 3 Czech VX24-AIS-D10 Public | 2.0 |
| Recruitment arrangements (for publication) | K2_CZE Recruitment Disease Fact Sheet PA3 Czech VX24-AIS-D10 Public | 2.0 |
| Recruitment arrangements (for publication) | K2_CZE Site Staff Training Materials English VX24-AIS-D10 Public | 1.0 |
| Recruitment arrangements (for publication) | K2_DEU Recruitment Brochure German VX24-AIS-D10 Public | 2.0 |
| Recruitment arrangements (for publication) | K2_DEU Recruitment Disease Fact Sheet German VX24-AIS-D10 Public | 2.0 |
| Recruitment arrangements (for publication) | K2_DEU Recruitment Poster German VX24-AIS-D10 Public | 1.0 |
| Recruitment arrangements (for publication) | K2_DEU Site Staff Training Materials HCP slide deck English VX24-AIS-D10 Public | 1.0 |
| Recruitment arrangements (for publication) | K2_ESP Recruitment Brochure Spanish VX24-AIS-D10 Public | 2.0 |
| Recruitment arrangements (for publication) | K2_ESP Recruitment Other HCP Deck English VX24-AIS-D10 Public | 1.0 |
| Recruitment arrangements (for publication) | K2_ESP Recruitment Other Study Factsheet Spanish VX24-AIS-D10 Public | 2.0 |
| Recruitment arrangements (for publication) | K2_ESP Recruitment Poster Spanish VX24-AIS-D10 Public | 1.0 |
| Recruitment arrangements (for publication) | K2_HUN Recruitment Brochure Hungarian VX24-AIS-D10 Public | 2.0 |
| Recruitment arrangements (for publication) | K2_HUN Recruitment Dear Colleague Letter Referral Card Hungarian VX24-AIS-D10 Public | 1.1 |
| Recruitment arrangements (for publication) | K2_HUN Recruitment Dear Colleague Letter Referral Letter Hungarian VX24-AIS-D10 Public | 1.1 |
| Recruitment arrangements (for publication) | K2_HUN Recruitment Disease Fact Sheet Hungarian VX24-AIS-D10 Public | 2.0 |
| Recruitment arrangements (for publication) | K2_HUN Recruitment Poster Hungarian VX24-AIS-D10 Public | 1.0 |
| Recruitment arrangements (for publication) | K2_HUN Site Staff Training Materials HCP Recruitment English VX24-AIS-D10 Public | 1.1 |
| Recruitment arrangements (for publication) | K2_IRL Site Staff Training Materials HCP Deck English VX24-AIS-D10 Public | 1.0 |
| Recruitment arrangements (for publication) | K2_NLD Recruitment Brochure Dutch VX24-AIS-D10 Public | 2.0 |
| Recruitment arrangements (for publication) | K2_NLD Recruitment Disease Fact Sheet Dutch VX24-AIS-D10 Public | 2.0 |
| Recruitment arrangements (for publication) | K2_NLD Recruitment Other HCP Engagement Deck Dutch VX24-AIS-D10 Public | 1.0 |
| Recruitment arrangements (for publication) | K2_NLD Recruitment Poster Dutch VX24-AIS-D10 Public | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster_CZ_VX24-AIS-D10 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CZE Country ICF - Other Adult Additional Czech VX24-AIS-D10 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CZE Country ICF - Other Adult Czech VX24-AIS-D10 Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_CZE Country ICF - Privacy Adult Czech VX24-AIS-D10 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CZE Country ICF Main Adult Phase 2b Czech VX24-AIS-D10 Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_CZE Country ICF Main Adult Phase 3 Czech VX24-AIS-D10 Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_DEU Country ICF - Pregnant Form German VX24-AIS-D10 Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_DEU Country ICF Main Phase 2b German VX24-AIS-D10 Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_DEU Country ICF Main Phase 3 German VX24-AIS-D10 Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_ESP Country ICF - Pregnant Form Spanish VX24-AIS-D10 Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_ESP Country ICF Main Phase 2b Spanish VX24-AIS-D10 Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_ESP Country ICF Main Phase 3 Spanish VX24-AIS-D10 Public | 2.2 |
| Subject information and informed consent form (for publication) | L1_HUN Country ICF - Pregnant Form Adult Hungarian VX24-AIS-D10 Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_HUN Country ICF Main Adult Phase 2b Hungarian VX24-AIS-D10 Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_HUN Country ICF Main Adult Phase 3 Hungarian VX24-AIS-D10 Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_HUN Form List of Submitted documents part II Hungary VX24-AIS-D10 | 1.0 |
| Subject information and informed consent form (for publication) | L1_HUN Form VX24-AIS-D10 | 1.0 |
| Subject information and informed consent form (for publication) | L1_HUN Subject Participation Card 1 Hungarian VX24-AIS-D10 Public | 1 |
| Subject information and informed consent form (for publication) | L1_ICF Pregnant Form Adult_CZ_VX24-AIS-D10 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF-Privacy Adult Pregnant Partner_CZ_VX24-AIS-D10 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_IRL Country ICF - Pregnant Form English VX24-AIS-D10 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_IRL Country ICF Main P2b English VX24-AIS-D10 Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_IRL Country ICF Main P3 English VX24-AIS-D10 Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_ITA Country ICF - Data Protection Adult Italian VX24-AIS-D10 Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_ITA Country ICF - Pregnant Form Adult Italian VX24-AIS-D10 Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_ITA Country ICF Main Adult Phase 2b Italian VX24-AIS-D10 Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_ITA Country ICF Main Adult Phase 3 Italian VX24-AIS-D10 Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_NLD Country ICF - Pregnant Form Pregnancy ICF Dutch VX24-AIS-D10 Public | 1.2 |
| Subject information and informed consent form (for publication) | L1_NLD Country ICF Main Phase 2b Dutch VX24-AIS-D10 Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_NLD Country ICF Main Phase 3 Dutch VX24-AIS-D10 Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_NLD Country ICF Optional Vendor Dutch VX24-AIS-D10 Public | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Participation Card_CZ_VX24-AIS-D10 Public | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Tacrolimus capsule | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Tacrolimus capsule | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol lay summary CS 2025-521661-27-00 - Redacted | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol lay summary ENG 2025-521661-27-00 - Redacted | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol lay summary ES 2025-521661-27-00 - Redacted | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol lay summary HU 2025-521661-27-00 - Redacted | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol lay summary IT 2025-521661-27-00 - Redacted | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol lay summary NL 2025-521661-27-00 - Redacted | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis CS 2025-521661-27-00 Redacted | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis ENG 2025-521661-27-00 Redacted | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis ES 2025-521661-27-00 Redacted | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis HU 2025-521661-27-00 Redacted | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis IT 2025-521661-27-00 Redacted | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis NL 2025-521661-27-00 Redacted | 4.0 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-08-25 | Germany | Acceptable with conditions 2025-12-11
|
2025-12-12 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-02-20 | Germany | Acceptable 2026-05-19
|
2026-05-19 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-06-01 | Acceptable 2026-05-19
|
2026-06-01 | |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-06-03 | Acceptable 2026-05-19
|
2026-06-03 |