Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Authorised, recruiting
Participants planned
527
Countries
19
Sites
60
Immunoglobulin A Nephropathy
To evaluate the efficacy of povetacicept compared with placebo in reducing proteinuria; To evaluate the efficacy of povetacicept compared with placebo in preserving renal function.
Key facts
- Sponsor
- Alpine Immune Sciences Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13], Diseases [C] - Male Urogenital Diseases [C12]
- Trial duration
- 28 Nov 2024 → ongoing
- Decision date (initial)
- 2024-11-18
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Alpine Immune Sciences, Inc.
External identifiers
- EU CT number
- 2024-514135-17-00
- WHO UTN
- U1111-1309-6958
- ClinicalTrials.gov
- NCT06564142
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
To evaluate the efficacy of povetacicept compared with placebo in reducing proteinuria; To evaluate the efficacy of povetacicept compared with placebo in preserving renal function.
Secondary objectives 2
- 2. To evaluate the efficacy of povetacicept compared with placebo on slowing kidney failure.
- 1. To evaluate the effect of povetacicept compared with placebo on Gd-IgA1 and hematuria
Conditions and MedDRA coding
Immunoglobulin A Nephropathy
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | PT | 10029151 | Nephropathy | 100000004857 |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2023-507067-19-00 | Open-Label Study to Assess the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Povetacicept in Subjects with Autoimmune Cytopenias (RUBY-4) | Alpine Immune Sciences Inc. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- 1. Diagnosed IgAN, with biopsy confirmation
- 2. 24 hour proteinuria excretion greater than or equal to (≥)1.0 gram per day (g/day) or 24-hour uPCR ≥0.75 gram per gram (g/g).
- 3. Estimated glomerular filtration rate (eGFR) - ≥ 30 mL/min/1.73m2.
- 4. Stable angiotensin converting enzyme inhibitor (ACEi) or angiotensin II receptor blocker (ARBs) as per protocol specification.
Exclusion criteria 3
- 1. Have received any immunosuppressive treatment or procedures (including corticosteroids, oral immunosuppressive agents, B cell or plasma cell targeted therapies, complement targeted therapies, herbal medicines per protocol, and tonsillectomy) within a wash-out period per protocol.
- 2. Rapidly progressive glomerulonephritis with eGFR reduction >50% within 12 weeks of the start of screening.
- 3. Other protocol defined Inclusion/Exclusion criteria may apply.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- 1. Change From Baseline in 24-hour Urine Protein to Creatinine Ratio (uPCR) at Week 36 [Time Frame: From Baseline at Week 36].
- 2. Total Estimated Glomerular Filtration Rate (eGFR) Slope Through Week 104 [Time Frame: From Baseline Through Week 104].
Secondary endpoints 4
- 3. Change From Baseline in eGFR at Week 104 [Time Frame: From Baseline at Week 104].
- 4. Time to Kidney Disease Progression Through Week 104 Kidney disease progression defined as greater than or equal to (≥) 30% decline in eGFR, end stage kidney disease, or non-accidental death. [Time Frame: From Baseline Through Week 104].
- 1. Change from baseline in serum Gd-IgA1 at Week 36
- 2. Proportion of subjects to achieve hematuria resolution at Week 36 (among subjects with hematuria at baseline)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
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/3/25/3043
ALPN-303 solution for injection
PRD11395570 · 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/3/25/3043
Placebo 2
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
Test IMP ALPN-303 pre-filled syringe 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
Alpine Immune Sciences Inc.
- Sponsor organisation
- Alpine Immune Sciences Inc.
- Address
- 188 East Blaine Street
- City
- Seattle
- Postcode
- 98102-3983
- Country
- United States
Scientific contact point
- Organisation
- Alpine Immune Sciences Inc.
- Contact name
- Vertex Pharmaceuticals Inc., Clinical Trials and Medical Info
Public contact point
- Organisation
- Alpine Immune Sciences Inc.
- Contact name
- Vertex Pharmaceuticals Inc., Clinical Trials and Medical Info
Third parties 13
| Organisation | City, country | Duties |
|---|---|---|
| PPD Global Central Labs ORG-100046496
|
Zaventem, Belgium | Laboratory analysis |
| Medpace Finland Oy ORG-100009147
|
Helsinki, Finland | On site monitoring, Code 10, Code 11, Code 2, Interactive response technologies (IRT), Code 5, Data management, Code 8 |
| PPD Development LP ORG-100011560
|
Wilmington, United States | Laboratory analysis |
| Inivata Limited ORG-100046830
|
Cambridge, United Kingdom | Laboratory analysis |
| Fisher Clinical Services Inc. ORG-100014726
|
Mount Prospect, United States | Other |
| Veeva Systems Inc. ORG-100006053
|
Pleasanton, United States | Code 5, Data management |
| Suvoda LLC ORG-100043523
|
Conshohocken, United States | Interactive response technologies (IRT) |
| Bioagilytix Labs LLC ORG-100013030
|
Morrisville, United States | Laboratory analysis |
| Scout Clinical ORG-100042228
|
Dallas, United States | Code 5 |
| EPL Pathology Archives LLC ORG-100042096
|
Leesburg, United States | Other |
| Nephropathology Associates PLC ORG-100044668
|
Little Rock, United States | Laboratory analysis |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Code 5 |
| G1 Therapeutics Inc. ORG-100007307
|
Durham, United States | Other |
Locations
19 EU/EEA countries · 60 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruitment ended | 3 | 2 |
| Belgium | Ended | 5 | 3 |
| Croatia | Ongoing, recruitment ended | 8 | 3 |
| Czechia | Ongoing, recruitment ended | 12 | 2 |
| Denmark | Ongoing, recruitment ended | 10 | 2 |
| Estonia | Ongoing, recruitment ended | 6 | 2 |
| Finland | Ended | 2 | 2 |
| France | Ongoing, recruitment ended | 15 | 10 |
| Germany | Ongoing, recruitment ended | 14 | 5 |
| Hungary | Ongoing, recruitment ended | 5 | 1 |
| Ireland | Ongoing, recruitment ended | 7 | 3 |
| Italy | Ongoing, recruitment ended | 12 | 1 |
| Latvia | Ongoing, recruitment ended | 6 | 2 |
| Lithuania | Ongoing, recruitment ended | 6 | 2 |
| Netherlands | Ongoing, recruitment ended | 12 | 2 |
| Norway | Ongoing, recruitment ended | 8 | 2 |
| Poland | Ongoing, recruitment ended | 15 | 2 |
| Spain | Ongoing, recruitment ended | 20 | 9 |
| Sweden | Ongoing, recruitment ended | 15 | 5 |
| Rest of world
Taiwan, United Kingdom, United States, Mexico, Australia, Canada, China, Israel, Saudi Arabia, Brazil, Korea, Republic of, Turkey, Hong Kong, Japan
|
— | 346 | — |
Investigational sites
Klinikum Wels-Grieskirchen GmbH
Department of Internal Medicine IV-Nephrology and Oncology, Grieskirchner Strasse 42, 4600, Wels
Vorarlberger Krankenhaus-Betriebsgesellschaft mbH
Department of Internal Medicine III – Nephrology, Dialysis and Hypertensiology, Carinagasse 47, 6800, Feldkirch
UZ Leuven
Nephrology, Herestraat 49, 3000, Leuven
Ziekenhuis Oost Limburg
Nephrology, Synaps Park 1, 3600, Genk
Algemeen Ziekenhuis Delta
Nierziekten-dialyse, Brugsesteenweg 90, 8800, Roeselare
Klinicka bolnica Merkur
Department of nephrology, Ulica Ivana Zajca 19, 10000, Zagreb
Clinical Hospital Dubrava
Department for nephrology and dialyses, Avenija Gojka Suska 6, Zagreb, Grad Zagreb
Poliklinika Solmed d.o.o.
N/A, Preradoviceva Ulica 20, Zagreb, Grad Zagreb
Nemocnice AGEL Novy Jicin a.s.
Oddělení nefrologie a hemodialýzy, Purkynova 2138/16, 741 01, Novy Jicin
Fakultni Nemocnice Brno
Interní gastroenterologická klinika, Jihlavska 340/20, Bohunice, Brno
Aalborg University Hospital
Department of Nephrology, Mølleparkvej 4, 9000 Aalborg, Moelleparkvej 4, 9000, Aalborg
Rigshospitalet
Department of Kidney Diseases, Inge Lehmanns Vej 5 og 7, 2100, Copenhagen, Inge Lehmanns Vej 7, 2100, Copenhagen Oe
Tartu University Hospital
-, A006, L. Puusepa Tn 8, Tartu Linn
North Estonia Medical Centre Foundation
-, J. Sutiste Tee 19, Mustamae Linnaosa, Tallinn
Satucon Oy
Research Site, Viestikatu 7 C, 70600, Kuopio
Tampere University Hospital
Kidney Unit, Elamanaukio 2, 33520, Tampere
Centre Hospitalier De Valenciennes
Nephrology, 114 Avenue Desandrouin, 59300, Valenciennes
Assistance Publique Hopitaux De Paris
Nephrology, 4 Rue De La Chine, 75020, Paris
Assistance Publique Hopitaux De Paris
Nephrology, 51 Av Du Mal De Lattre De Tassigny, 94000, Creteil
Centre Hospitalier Universitaire De Nantes
Nephrology and clinical immunology, 30 Boulevard Jean Monnet, 44000, Nantes
Centre Hospitalier Universitaire De Saint Etienne
Nephrology, Avenue Albert Raimond, 42270, Saint Priest En Jarez
Assistance Publique Hopitaux De Paris
Nephrology, 20 Rue Leblanc, 75015, Paris
Centre Hospitalier Regional De Marseille
Nephrology and Renal transplantation, 147 Boulevard Baille, 13005, Marseille
University Of Bordeaux
Nephrology, 1 Place Amelie Raba Leon, Cs 91286, Bordeaux Cedex
Centre Hospitalier Du Puy
Nephrology and hemodialysis, 12 Boulevard Docteur Chantemesse, 43000, Le Puy-En-Velay
Hopital Necker Enfants Malades
Nephrology and Renal transplantation, 149 Rue De Sevres, 75015, Paris
Universitaetsklinikum Aachen AöR
Division of Nephrology and Clinical Immunology, Pauwelsstrasse 30, 52074, Aachen
Klinikum St. Georg gGmbH
Klinik für Nephrologie, Delitzscher Strasse 141, Eutritzsch, Leipzig
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Nephrologie, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Charite Universitaetsmedizin Berlin KöR
Nephrology and Intensive Medical Care, Chariteplatz 1, Mitte, Berlin
Universitaet Leipzig
Medical Department III, Liebigstrasse 20, Zentrum-Suedost, Leipzig
University Of Pecs
II. sz. Belgyógyászati Klinika és Nephrológiai, Diabetológiai Centrum; Nephrológia, Pacsirta Utca 1, 7624, Pecs
Cork University Hospital
Renal Medicine, Wilton, T12 DC4A, Cork
University Hospital Waterford
Nephrology and General Internal Medicine, Dunmore Road, X91 ER8E, Waterford
University Hospital Galway
Nephrology, Newcastle Road, H91 YR71, Galway
University Of Bari Aldo Moro
U.O.C. Nefrologia, Dialisi e Trapianto, Piazzale Giulio Cesare 11, 70124, Bari
Vidzemes Slimnica SIA
-, Jumaras Iela 195, 4201, Valmiera
Pauls Stradins Clinical University Hospital
-, Pilsonu Iela 13, 1002, Riga
Vilniaus Universiteto Ligonine Santaros Klinikos Vsi
Nephrology, Santariskiu G 2, Vilniaus M. Sav., Vilnius
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos
Nephrology, Eiveniu G. 2, Kauno M. Sav., Kaunas
Radboud universitair medisch centrum / RADBOUDUMC
Nephrology, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Universitair Medisch Centrum Groningen
Internal Medicine, Hanzeplein 1, 9713 GZ, Groningen
Helse Bergen HF
Department of Medicine, Jonas Lies Vei 65, 5021, Bergen
Oslo University Hospital HF
Department of Nephrology, P. O. Box 4950, 0424, Oslo
Scm Sp. z o.o.
N/A, Ul. Grzegorzecka 67c/u6, 31-559, Cracow
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
Klinika Chorób Wewnętrznych, Nefrologii i Transplantologii, Ul. Woloska 137, 02-507, Warsaw
Hospital Universitario Dr Peset Aleixandre
Nephrology, Avinguda De Gaspar Aguilar 90, 46017, Valencia
Clinica Universidad De Navarra
Nephrology, Calle Marquesado De Santa Marta 1, 28027, Madrid
Hospital Universitario Virgen De La Macarena
Nephrology, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Complexo Hospitalario Universitario De Santiago
Nephrology, Calle Choupana Da S/n, 15706, Santiago De Compostela
Hospital Universitario Puerta De Hierro De Majadahonda
Nephrology, Calle De Joaquin Rodrigo 2, 28222, Majadahonda
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida
Nephrology, Avinguda De L'alcalde Rovira Roure 80, 25196, Lleida
Clinica Universidad De Navarra
Nephrology, Pio XII Etorbidea 36, 31008, Pamplona
Hospital Universitario Fundacion Jimenez Diaz
Nephrology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitario Ramon Y Cajal
Nephrology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Njurmottagningen, Bla Straket 5, Goteborgs Annedal, Goteborg
Danderyds Sjukhus AB
Njurmedicinska kliniken, Morbygardsvagen 88, 182 88, Danderyd
Region Oestergoetland
Njurmedicinska kliniken, Universitetssjukhuset i Linköping, Universitetssjukhuset I, 58185, Linkoping
Karolinska University Hospital
Njurmedicin, Hälsovägen 13 141 57 Huddinge, Halsovagen, Flemingsberg, Huddinge
Uppsala University Hospital
Department of Medical Science, Akademiska Sjukhuset, 751 85, Uppsala
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 |
|---|---|---|---|---|---|
| Austria | 2025-03-07 | 2025-03-27 | 2025-11-03 | ||
| Belgium | 2025-07-01 | 2026-01-20 | 2025-09-23 | 2025-11-03 | |
| Croatia | 2025-03-31 | 2025-04-03 | 2025-11-03 | ||
| Czechia | 2025-02-19 | 2025-04-03 | 2025-11-03 | ||
| Denmark | 2024-12-23 | 2025-02-13 | 2025-11-03 | ||
| Estonia | 2024-12-19 | 2025-03-04 | 2025-11-03 | ||
| Finland | 2025-08-20 | 2025-09-23 | |||
| France | 2024-11-29 | 2025-01-02 | 2025-11-03 | ||
| Germany | 2025-01-21 | 2025-03-03 | 2025-11-03 | ||
| Hungary | 2025-01-16 | 2025-02-26 | 2025-11-03 | ||
| Ireland | 2025-06-02 | 2025-06-18 | 2025-11-03 | ||
| Italy | 2025-03-11 | 2025-05-20 | 2025-11-03 | ||
| Latvia | 2025-01-09 | 2025-02-19 | 2025-11-03 | ||
| Lithuania | 2024-12-19 | 2025-02-06 | 2025-11-03 | ||
| Netherlands | 2024-12-23 | 2025-02-05 | 2025-11-03 | ||
| Norway | 2025-02-26 | 2025-02-27 | 2025-11-03 | ||
| Poland | 2024-11-28 | 2024-12-12 | 2025-11-03 | ||
| Spain | 2024-12-11 | 2025-02-13 | 2025-11-03 | ||
| Sweden | 2025-01-31 | 2025-04-09 | 2025-11-03 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 440 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_EN_2024-514135-17_Alpine Immune Sciences_redacted | 7.1 |
| Protocol (for publication) | D4_Patient facing document_DE_FACIT-FatigueScale_Alpine Immune Sciences | 4 |
| Protocol (for publication) | D4_Patient facing document_DE_PRO_Alpine Immune Sciences_blank | NA |
| Protocol (for publication) | D4_Patient facing document_DK_FACIT-FatigueScale_Alpine Immune Sciences | 4 |
| Protocol (for publication) | D4_Patient facing document_DK_PRO_Alpine Immune Sciences_blank | NA |
| Protocol (for publication) | D4_Patient facing document_EN_PRO_Alpine Immune Sciences_blank | NA |
| Protocol (for publication) | D4_Patient facing document_FR_FACIT-FatigueScale_Alpine Immune Sciences | 4 |
| Protocol (for publication) | D4_Patient facing document_FR_PRO_Alpine Immune Sciences_blank | NA |
| Protocol (for publication) | D4_Patient facing document_HR_FACIT-FatigueScale_Alpine Immune Sciences | 4 |
| Protocol (for publication) | D4_Patient facing document_HU_FACIT-FatigueScale_Alpine Immune Sciences | 4 |
| Protocol (for publication) | D4_Patient facing document_IT_FACIT-FatigueScale_Alpine Immune Sciences | 4 |
| Protocol (for publication) | D4_Patient facing document_ITA_PRO_Alpine Immune Sciences_blank | NA |
| Protocol (for publication) | D4_Patient facing document_LT_PRO_Alpine Immune Sciences_blank | NA |
| Protocol (for publication) | D4_Patient facing document_NL_FACIT-FatigueScale_Alpine Immune Sciences | 4 |
| Protocol (for publication) | D4_Patient facing document_NL_PRO_Alpine Immune Sciences_blank | NA |
| Protocol (for publication) | D4_Patient facing document_PRO_Alpine Immune Sciences_blank | NA |
| Protocol (for publication) | D4_Patient facing document_RUS_FACIT-FatigueScale_Alpine Immune Sciences | 4 |
| Protocol (for publication) | D4_Patient facing document_SE_PRO_Alpine Immune Sciences_blank | NA |
| Protocol (for publication) | D4_Patient facing documents_AT_24hrUrineCoolerBoxLabel_Alpine Immune Sciences | 1 |
| Protocol (for publication) | D4_Patient facing documents_AT_24hrUrineInstructions_Alpine Immune Sciences | 2 |
| Protocol (for publication) | D4_Patient facing documents_AT_24hrUrineRemindersSticker_Alpine Immune Sciences | 1 |
| Protocol (for publication) | D4_Patient facing documents_AT_24hrUrineTimesheet_Alpine Immune Sciences | 1 |
| Protocol (for publication) | D4_Patient facing documents_AT_PRO_Alpine Immune Sciences_blank | NA |
| Protocol (for publication) | D4_Patient facing documents_CZ_24hrUrineCoolerBoxLabel_Alpine Immune Sciences | 1 |
| Protocol (for publication) | D4_Patient facing documents_CZ_24hrUrineInstructions_Alpine Immune Sciences | 2 |
| Protocol (for publication) | D4_Patient facing documents_CZ_24hrUrineRemindersSticker_Alpine Immune Sciences | 1 |
| Protocol (for publication) | D4_Patient facing documents_CZ_24hrUrineTimesheet_Alpine Immune Sciences | 1 |
| Protocol (for publication) | D4_Patient facing documents_CZ_FACIT-FatigueScale_Alpine Immune Sciences | 4 |
| Protocol (for publication) | D4_Patient facing documents_CZ_PRO_Alpine Immune Sciences_blank | NA |
| Protocol (for publication) | D4_Patient facing documents_DE_24hrUrineCoolerBoxLabel_Alpine Immune Sciences | 1 |
| Protocol (for publication) | D4_Patient facing documents_DE_24hrUrineInstructions_Alpine Immune Sciences | 2 |
| Protocol (for publication) | D4_Patient facing documents_DE_24hrUrineRemindersSticker_Alpine Immune Sciences | 1 |
| Protocol (for publication) | D4_Patient facing documents_DE_24hrUrineTimesheet_Alpine Immune Sciences | 1 |
| Protocol (for publication) | D4_Patient facing documents_DK_24hrUrineCoolerBoxLabel_Alpine Immune Sciences | 1 |
| Protocol (for publication) | D4_Patient facing documents_DK_24hrUrineInstructions_Alpine Immune Sciences | 2 |
| Protocol (for publication) | D4_Patient facing documents_DK_24hrUrineRemindersSticker_Alpine Immune Sciences | 1 |
| Protocol (for publication) | D4_Patient facing documents_DK_24hrUrineTimesheet_Alpine Immune Sciences | 1 |
| Protocol (for publication) | D4_Patient facing documents_EE_24hrUrineCoolerBoxLabel_Alpine Immune Sciences | 1 |
| Protocol (for publication) | D4_Patient facing documents_EE_24hrUrineInstructions_Alpine Immune Sciences | 2 |
| Protocol (for publication) | D4_Patient facing documents_EE_24hrUrineRemindersSticker_Alpine Immune Sciences | 1 |
| Protocol (for publication) | D4_Patient facing documents_EE_24hrUrineTimesheet_Alpine Immune Sciences | 1 |
| Protocol (for publication) | D4_Patient facing documents_EE_24hUrineInstructions_AlpineImmuneSciences_TC | 2 |
| Protocol (for publication) | D4_Patient facing documents_EE_FACIT-FatigueScale_Alpine Immune Sciences | 4 |
| Protocol (for publication) | D4_Patient facing documents_EE_PRO_Alpine Immune Sciences_blank | 2 |
| Protocol (for publication) | D4_Patient facing documents_EE_RU_24hUrineInstructions_AlpineImmuneSciences_TC | 2 |
| Protocol (for publication) | D4_Patient facing documents_EE_RUS_24hrUrineCoolerBoxLabel_Alpine Immune Sciences | 1 |
| Protocol (for publication) | D4_Patient facing documents_EE_RUS_24hrUrineInstructions_Alpine Immune Sciences | 2 |
| Protocol (for publication) | D4_Patient facing documents_EE_RUS_24hrUrineRemindersSticker_Alpine Immune Sciences | 1 |
| Protocol (for publication) | D4_Patient facing documents_EE_RUS_24hrUrineTimesheet_Alpine Immune Sciences | 1 |
| Protocol (for publication) | D4_Patient facing documents_EN_24hrUrineCoolerBoxLabel_Alpine Immune Sciences | 1 |
| Protocol (for publication) | D4_Patient facing documents_EN_24hrUrineInstructions_Alpine Immune Sciences | 2 |
| Protocol (for publication) | D4_Patient facing documents_EN_24hrUrineRemindersSticker_Alpine Immune Sciences | 1 |
| Protocol (for publication) | D4_Patient facing documents_EN_24hrUrineTimesheet_Alpine Immune Sciences | 1 |
| Protocol (for publication) | D4_Patient facing documents_EN_FACIT-FatigueScale_Alpine Immune Sciences | 4 |
| Protocol (for publication) | D4_Patient facing documents_ENG_24hrUrineInstructions_Alpine Immune Sciences_TC | 2 |
| Protocol (for publication) | D4_Patient facing documents_ES_24hrUrineCoolerBoxLabel_Alpine Immune Sciences | 1 |
| Protocol (for publication) | D4_Patient facing documents_ES_24hrUrineInstructions_Alpine Immune Sciences | 3.0 |
| Protocol (for publication) | D4_Patient facing documents_ES_24hrUrineInstructions_Alpine Immune Sciences_TC | 3.0 |
| Protocol (for publication) | D4_Patient facing documents_ES_24hrUrineRemindersSticker_Alpine Immune Sciences | 1 |
| Protocol (for publication) | D4_Patient facing documents_ES_24hrUrineTimesheet_Alpine Immune Sciences | 1 |
| Protocol (for publication) | D4_Patient facing documents_ES_FACIT-FatigueScale_Alpine Immune Sciences | 4 |
| Protocol (for publication) | D4_Patient facing documents_ES_PRO_Alpine Immune Sciences_blank | NA |
| Protocol (for publication) | D4_Patient facing documents_FR_24hrUrineCoolerBoxLabel_Alpine Immune Sciences | 1 |
| Protocol (for publication) | D4_Patient facing documents_FR_24hrUrineInstructions_Alpine Immune Sciences | 2 |
| Protocol (for publication) | D4_Patient facing documents_FR_24hrUrineInstructions_Alpine Immune Sciences_TC | 2 |
| Protocol (for publication) | D4_Patient facing documents_FR_24hrUrineRemindersSticker_Alpine Immune Sciences | 1 |
| Protocol (for publication) | D4_Patient facing documents_FR_24hrUrineTimesheet_Alpine Immune Sciences | 1 |
| Protocol (for publication) | D4_Patient facing documents_HR_24hrUrineCoolerBoxLabel_Alpine Immune Sciences | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_HR_24hrUrineInstructions_Alpine Immune Sciences | 2 |
| Protocol (for publication) | D4_Patient facing documents_HR_24hrUrineRemindersSticker_Alpine Immune Sciences | 1 |
| Protocol (for publication) | D4_Patient facing documents_HR_24hrUrineTimesheet_Alpine Immune Sciences Inc | 1 |
| Protocol (for publication) | D4_Patient facing documents_HR_PRO_Alpine Immune Sciences_blank | NA |
| Protocol (for publication) | D4_Patient facing documents_HU_24hrUrineCoolerBoxLabel_Alpine Immune Sciences | 1 |
| Protocol (for publication) | D4_Patient facing documents_HU_24hrUrineInstructions_Alpine Immune Sciences | 2 |
| Protocol (for publication) | D4_Patient facing documents_HU_24hrUrineInstructions_Alpine Immune Sciences_TC | 2 |
| Protocol (for publication) | D4_Patient facing documents_HU_24hrUrineRemindersSticker_Alpine Immune Sciences | 1 |
| Protocol (for publication) | D4_Patient facing documents_HU_24hrUrineTimesheet_Alpine Immune Sciences | 1 |
| Protocol (for publication) | D4_Patient facing documents_HU_PRO_Alpine Immune Sciences_blank | NA |
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| Protocol (for publication) | D4_Patient facing documents_IE_24hrUrineInstructions_Alpine Immune Sciences | 2 |
| Protocol (for publication) | D4_Patient facing documents_IE_24hrUrineInstructions_Alpine Immune Sciences_TC | 2 |
| Protocol (for publication) | D4_Patient facing documents_IE_24hrUrineRemindersSticker_Alpine Immune Sciences | 1 |
| Protocol (for publication) | D4_Patient facing documents_IE_24hrUrineTimesheet_Alpine Immune Sciences | 1 |
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| Protocol (for publication) | D4_Patient facing documents_IT_24hrUrineRemindersSticker_Alpine Immune Sciences | 1 |
| Protocol (for publication) | D4_Patient facing documents_IT_24hrUrineTimesheet_Alpine Immune Sciences | 1 |
| Protocol (for publication) | D4_Patient facing documents_ITA_24hrUrineInstructions_Alpine Immune Sciences TC | 2 |
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| Protocol (for publication) | D4_Patient facing documents_LT_24hrUrineInstructions_Alpine Immune Sciences | 2 |
| Protocol (for publication) | D4_Patient facing documents_LT_24hrUrineRemindersSticker_Alpine Immune Sciences | 1 |
| Protocol (for publication) | D4_Patient facing documents_LT_24hrUrineTimesheet_Alpine Immune Sciences | 1 |
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| Protocol (for publication) | D4_Patient facing documents_LV_24hrUrineTimesheet_Alpine Immune Sciences | 1 |
| Protocol (for publication) | D4_Patient facing documents_LV_24hUrineInstructions_AlpineImmuneSciences_TC | 2 |
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| Protocol (for publication) | D4_Patient facing documents_LV_RU_24hUrineInstructions_AlpineImmuneSciences_TC | 2 |
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| Protocol (for publication) | D4_Patient facing documents_PL_24hrUrineTimesheet_Alpine Immune Sciences | 1 |
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| Subject information and informed consent form (for publication) | L1_SIS and ICF_Travel Data Use Consent_Alpine Immune Sciences | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Travel Data Use Consent_Alpine Immune Sciences | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Travel ICF_Alpine | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ Advarra Patient Engagement Portal_Alpine Immune Sciences Inc | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ ParticipantEmergencyContactCard _Alpine_redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ ParticipantEngagementMessage1_Alpine Immune Sciences Inc | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ ParticipantEngagementMessage2_Alpine Immune Sciences Inc | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ ParticipantEngagementMessage3_Alpine Immune Sciences Inc | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ ParticipantEngagementMessage4_Alpine Immune Sciences Inc | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ ParticipantEngagementMessage5_Alpine Immune Sciences Inc | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ ParticipantEngagementMessage6_Alpine Immune Sciences Inc | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ ParticipantThankYou1_5 Years_Alpine Immune Sciences Inc | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_3D Secure Terms of Use_Alpine | 10.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_3D Secure Terms of Use_Alpine | 10.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Bank Transfer FAQ_Alpine | 10.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Bank Transfer FAQ_Alpine | 10.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Bank Transfer Standard Message Template_Alpine | 10.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Bank Transfer Standard Message Template_Alpine | 10.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ClinCard Card Carrier_Alpine | 10.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ClinCard Card Carrier_Alpine | 10.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ClinCard Cardholder FAQ_Alpine | 11.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ClinCard Cardholder FAQ_Alpine | 11.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ClinCard Cardholder Msg Templates_Alpine | 10.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ClinCard Cardholder Msg Templates_Alpine | 10.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ClinCard Cardholder Website Screenshots_Alpine | 10.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ClinCard Fee Schedule_Alpine | 10.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ClinCard Fee Schedule_Alpine | 10.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ClinCard Generic Image_Alpine | 10.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ClinCard Generic Image_Alpine | 10.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ClinCard Privacy Policy_Alpine | 10.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ClinCard_Privacy Policy_Alpine | 10.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ConneX Travel Contact Card_Alpine | 10.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ConneX Travel Contact Card_Alpine | 10.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ConneX Travel Reference Guide for Participants_Alpine | 10.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ConneX Travel Reference Guide for Participants_Alpine | 10.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Emergency Card_Alpine | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Emergency Card_Redacted_Alpine | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_EU Dispute Form_Alpine | 10.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_EU Dispute Form_Alpine | 10.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_GP Letter_Alpine Immune Sciences Inc | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_KYC_Alpine | 10.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_KYC_Alpine | 10.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Participant Handbook_Alpine_redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Participant Handbook_Redacted_Alpine | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Participant Thank You-EOS_Alpine_redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Participant Thank You-EOS_Redacted_Alpine | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Participant Thank You-First Year_Alpine_redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Participant Thank You-First Year_Redacted_Alpine | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ParticipantEngagementMessage1_Alpine | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ParticipantEngagementMessage2_Alpine | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ParticipantEngagementMessage3_Alpine | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ParticipantEngagementMessage4_Alpine | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ParticipantEngagementMessage5_Alpine | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ParticipantEngagementMessage6_Alpine | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ParticipantHandbook _Alpine Immune Sciences Inc_redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ParticipantThankYou1-5_Years_LV_Alpine Immune Sciences | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ParticipantThankYou1-5Years_EE_Alpine Immune Sciences | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ParticipantThankYou1-5Years_RU_Alpine Immune Sciences | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ParticipantThankYou1-5Years_RU_Alpine Immune Sciences | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ParticipantThankYou1AndHalfYears | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ParticipantThankYouEOS_Alpine Immune Sciences Inc | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ParticipantThankYouFirstYear_Alpine | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient emergency card_Alpine | HU V4 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Visa Request Initiation Form_Alpine | 10.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information materials_Bank Transfer FAQ_EE_Alpine Immune Sciences | 10.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information materials_Bank Transfer Standard Message Template_EE_Alpine | 10.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information materials_Bank Transfer Standard Message Template_LV_Alpine IS | 10.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information materials_Bank Transfer Standard Message Template_RU_Alpine | 10.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information materials_Bank Transfer Standard Message Template_RUS_Alpine IS | 10.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information materials_ClinCard Cardholder FAQ_EE_Alpine Immune Sciences | 11.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information materials_ClinCard_Card_Carrier_EE_Alpine Immune Sciences | 10.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information materials_ConneX Travel Contact Card_EE_Alpine | 10.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information materials_ConneX Travel Contact Card_IC_LV_Alpine Immune Sciences | 10.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information materials_ConneX Travel Contact Card_IC_RUS_Alpine Immune Sciences | 10.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information materials_ConneX Travel Contact Card_RU_Alpi | 10.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information materials_ConneXTravelReferenceGuide_EE_Alpine IS | 10.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information materials_ConneXTravelReferenceGuide_RU_Alpi | 10.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information materials_ConneXTravelReferenceGuideforParticipants_LV_Alpine IS | 10.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information materials_ConneXTravelReferenceGuideforParticipants_RUS_Alpine IS | 10.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information materials_ParticipantHandbook_EE_Alpine_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information materials_ParticipantHandbook_LV_Alpine Immune Sciences_Redacted | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information materials_ParticipantHandbook_RU_CL_Alpine Immune Sciences_Redacted | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information materials_ParticipantHandbook_RUS_Alpine_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information materials_ParticipantThankYouEOS_EE_Alpine Immune Sciences_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information materials_ParticipantThankYouEOS_LV_Alpine Immune Sciences_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information materials_ParticipantThankYouEOS_RUS_Alpine Immune Sciences_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information materials_ParticipantThankYouEOS_RUS_Alpine Immune Sciences_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information materials_ParticipantThankYouFirstYear_EE_Alpine_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information materials_ParticipantThankYouFirstYear_LV_Alpine IS_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information materials_ParticipantThankYouFirstYear_RUS_Alpine IS_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information materials_ParticipantThankYouFirstYear_RUS_Alpine_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information materials_PE Card_EE_Alpine Immune Sciences_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information materials_PE Card_LV_Alpine Immune Sciences_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information materials_PE Card_RUS_Alpine Immune Sciences_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information materials_PE Card_RUS_Alpine Immune Sciences_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information materilas_3D Secure Terms of Use_EE_Alpine | 10.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information materilas_3D Secure Terms of Use_RU_Alpine | 10.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information materilas_Bank Transfer FAQ_LV_Alpine Immune Sciences | 10.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information materilas_Bank Transfer FAQ_RU_Alpine Immune Sciences | 10.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information materilas_Bank Transfer FAQ_RUS_Alpine Immune Sciences | 10.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information materilas_ClinCard Cardholder FAQ_RU_Alpine Immune Sciences | 11.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information materilas_ClinCard_Card_Carrier_RU_Alpine Immune Sciences | 10.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information materilas_ClinCard_Fee_Schedule_EE_Alpine Immune Sciences | 10.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information materilas_ClinCard_Fee_Schedule_RU_Alpine Immune Sciences | 10.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information materilas_ClinCard_Generic_Image_EE_Alpine Immune Sciences | 10.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information materilas_ClinCardCardholderMsgTemplates_EE_Alpine | 10.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information materilas_ClinCardCardholderMsgTemplates_RU_Alpine | 10.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information materilas_EU Dispute Form_EE_Alpine Immune Sciences | 10.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information materilas_EU Dispute Form_RU_Alpine Immune Sciences | 10.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information materilas_KYC_EE_Alpine Immune Sciences | 10.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information materilas_KYC_RU_Alpine Immune Sciences | 10.1 |
| Subject information and informed consent form (for publication) | L2_Site-specific contact information list_Alpine_redacted | N/A |
| Subject information and informed consent form (for publication) | L3_GP Letter_Alpine | 2.0 |
| Synopsis of the protocol (for publication) | D1_ Protocol Lay Summary_CZ_2024-514135-17_Alpine Immune Sciences | 7.1 |
| Synopsis of the protocol (for publication) | D1_ Protocol Lay Summary_ES_2024-514135-17_Alpine Immune Sciences | 7.1 |
| Synopsis of the protocol (for publication) | D1_ Protocol Lay Summary_FR_2024-514135-17_Alpine Immune Sciences | 7.1 |
| Synopsis of the protocol (for publication) | D1_ Protocol Lay Summary_IT_2024-514135-17_Alpine Immune Sciences | 7.1 |
| Synopsis of the protocol (for publication) | D1_ Protocol Lay Summary_LT_2024-514135-17_Alpine Immune Sciences | 7.1 |
| Synopsis of the protocol (for publication) | D1_ Protocol Lay Summary_PL_2024-514135-17_Alpine Immune Sciences | 7.1 |
| Synopsis of the protocol (for publication) | D1_ Protocol Lay Summary_SE_2024-514135-17_Alpine Immune Sciences | 7.1 |
| Synopsis of the protocol (for publication) | D1_Protocol Lay Summary_EN_2024-514135-17_Alpine Immune Sciences | 7.1 |
| Synopsis of the protocol (for publication) | D1_Protocol Lay Summary_NL_2024-514135-17_Alpine Immune Sciences | 7.1 |
| Synopsis of the protocol (for publication) | D1_Protocol Lay Summary_NO_2024-514135-17_Alpine Immune Sciences | 7.1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_CZ_2024-514135-17_Alpine Immune Sciences_redacted | 7.1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_DE for AT_2024-514135-17_Alpine Immune Sciences_redacted | 7.1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_EN_2024-514135-17_Alpine Immune Sciences_redacted | 7.1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ES_2024-514135-17_Alpine Immune Sciences_redacted | 7.1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_HR_2024-514135-17_Alpine Immune Sciences_redacted | 7.1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_HU_2024-514135-17_Alpine Immune Sciences_redacted | 7.1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_IT_2024-514135-17_Alpine Immune Sciences_redacted | 7.1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_LT_2024-514135-17_Alpine Immune Sciences_redacted | 7.1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_NL_2024-514135-17_Alpine Immune Sciences_redacted | 7.1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_PL_2024-514135-17_Alpine Immune Sciences_redacted | 7.1 |
| Synopsis of the protocol (for publication) | D1_Protocol technical synopsis_FR_2024-514135-17_Alpine Immune Sciences_redacted | 7.1 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-26 | Sweden | Acceptable 2024-11-11
|
2024-11-11 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-11-20 | Acceptable 2024-11-11
|
2024-11-20 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-01-08 | Sweden | Acceptable 2025-03-10
|
2025-03-10 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-04-23 | Acceptable 2025-03-10
|
2025-04-23 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-06-20 | Sweden | Acceptable 2025-09-16
|
2025-09-16 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-10-16 | Sweden | Acceptable 2026-01-27
|
2026-01-28 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2026-02-16 | Sweden | Acceptable 2026-01-27
|
2026-02-16 |
| 8 | SUBSTANTIAL MODIFICATION | SM-6 | 2026-02-17 | Sweden | Acceptable 2026-04-13
|
2026-04-13 |