Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
72
Countries
12
Sites
21
Primary Biliary Cholangitis (PBC)
The primary objective is to assess the effects of the combination of OCA and BZF on alkaline phosphatase (ALP) in comparison to BZF alone in subjects with PBC.
Key facts
- Sponsor
- Intercept Pharmaceuticals Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 20 Sep 2019 → 15 Oct 2025
- Decision date (initial)
- 2024-06-14
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
- Funding sources
- Intercept Pharmaceuticals, Inc.
External identifiers
- EU CT number
- 2024-513762-18-00
- EudraCT number
- 2018-002575-17
- ClinicalTrials.gov
- NCT04594694
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic, Efficacy, Pharmacodynamic, Therapy, Pharmacogenetic, Safety
The primary objective is to assess the effects of the combination of OCA and BZF on alkaline phosphatase (ALP) in comparison to BZF alone in subjects with PBC.
Secondary objectives 1
- The secondary objectives are to assess the effects of the combination of OCA and BZF in comparison to BZF alone in subjects with PBC on the following: - Biochemical disease markers, including ALP, GGT, ALT, AST, total and conjugated bilirubin and a lipid panel - Biomarkers of bile acid synthesis and homeostasis, including 7α- hydroxy-4-cholesten-3-one (C4) and bile acids - Safety and tolerability
Conditions and MedDRA coding
Primary Biliary Cholangitis (PBC)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10036680 | Primary biliary cirrhosis | 10019805 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- A definite or probable diagnosis of PBC (consistent with the EASL and the AASLD guidelines [Lindor 2009, EASL 2017])
- Qualifying ALP and/or bilirubin liver biochemistry values
- Age ≥18 years
- Taking UDCA for at least 12 months (stable dose for ≥3 months) before Day 1 or no UDCA for 3 months before Day 1
Exclusion criteria 7
- History or presence of other concomitant liver diseases
- Clinical complications of PBC
- History or presence of decompensating events
- History of or current gallbladder diseases
- If female, known pregnancy, or has a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating
- Treatment with commercially available OCA or participation in a previous study involving OCA
- Note: Other protocol defined Inclusion/Exclusion criteria may apply
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Change in ALP from baseline to Week 12 in the DB Period
Secondary endpoints 4
- The response rates of ≥10%, ≥20%, ≥30%, and ≥40% reduction from baseline and normalization rates of ALP at Week 12
- Normalization rates at Week 12 of GGT, ALT, AST, ALP, total and conjugated bilirubin, and a lipid panel
- Change from baseline to Week 12 in GGT, ALT, AST, and total and conjugated bilirubin, and a lipid panel
- Change from baseline to Week 12 in 7α-hydroxy-4-cholesten-3-one (C4) and bile acids
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 4
PRD8920757 · Product
- Active substance
- Bezafibrate
- Substance synonyms
- BENZOFIBRATE
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 718000 mg milligram(s)
- Max treatment duration
- 59 Month(s)
- Authorisation status
- Authorised
- ATC code
- C10AB02 — BEZAFIBRATE
- Marketing authorisation
- PL 00289/2482
- MA holder
- TEVA UK LIMITED
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Purchased, repackaged and relabeled for clinical trial use.
PRD8910703 · Product
- Active substance
- Bezafibrate
- Substance synonyms
- BENZOFIBRATE
- Pharmaceutical form
- PROLONGED-RELEASE TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 718000 mg milligram(s)
- Max treatment duration
- 59 Month(s)
- Authorisation status
- Authorised
- ATC code
- C10AB02 — BEZAFIBRATE
- Marketing authorisation
- PL 00289/2483
- MA holder
- TEVA UK LIMITED
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Purchased, repackaged and relabeled for clinical trial use.
PRD12027341 · Product
- Active substance
- Obeticholic Acid
- Substance synonyms
- DSP-1747, INT-747, 6-ALPHA-ETHYLCHENODEOXYCHOLIC ACID
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 14605 mg milligram(s)
- Max treatment duration
- 59 Month(s)
- Authorisation status
- Not Authorised
- ATC code
- A05AA04 — -
- MA holder
- INTERCEPT PHARMACEUTICALS INC.
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/10/753
PRD12027333 · Product
- Active substance
- Obeticholic Acid
- Substance synonyms
- DSP-1747, INT-747, 6-ALPHA-ETHYLCHENODEOXYCHOLIC ACID
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 14605 mg milligram(s)
- Max treatment duration
- 59 Month(s)
- Authorisation status
- Not Authorised
- ATC code
- A05AA04 — -
- MA holder
- INTERCEPT PHARMACEUTICALS INC.
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/10/753
Placebo 2
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
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
Intercept Pharmaceuticals Inc.
- Sponsor organisation
- Intercept Pharmaceuticals Inc.
- Address
- 305 Madison Avenue
- City
- Morristown
- Postcode
- 07960-6117
- Country
- United States
Scientific contact point
- Organisation
- Intercept Pharmaceuticals Inc.
- Contact name
- Clinical Research
Public contact point
- Organisation
- Intercept Pharmaceuticals Inc.
- Contact name
- Clinical Operations
Third parties 9
| Organisation | City, country | Duties |
|---|---|---|
| Nordic Bioscience A/S ORG-100009315
|
Herlev, Denmark | Other |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | Interactive response technologies (IRT), Data management |
| PPD Global Central Labs ORG-100046496
|
Zaventem, Belgium | Laboratory analysis |
| Q Squared Solutions Limited ORG-100042527
|
Livingston, United Kingdom | Laboratory analysis |
| Syneos Health Hellas Single Member S.A. ORG-100043210
|
Vrilissia, Greece | On site monitoring, Code 12, E-data capture, Code 8 |
| Q Squared Solutions Holdings LLC ORG-100043288
|
Valencia, United States | Laboratory analysis |
| Syneos Health Inc. ORG-100008382
|
Morrisville, United States | On site monitoring, Code 12, Code 2, E-data capture, Code 8, Code 9 |
| Manufacturing Packaging Farmaca (MPF) B.V. ORG-100011536
|
Heerenveen, Netherlands | Code 14 |
| Pyxant Labs Inc. ORG-100044673
|
Colorado Springs, United States | Laboratory analysis |
Locations
12 EU/EEA countries · 21 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 10 | 2 |
| Croatia | Ended | 5 | 2 |
| Czechia | Ended | 18 | 3 |
| Estonia | Ended | 2 | 1 |
| France | Ended | 10 | 4 |
| Germany | Ended | 2 | 2 |
| Greece | Ended | 1 | 1 |
| Hungary | Ended | 5 | 1 |
| Lithuania | Ended | 2 | 1 |
| Netherlands | Ended | 3 | 1 |
| Norway | Ended | 3 | 1 |
| Spain | Ended | 4 | 2 |
| Rest of world
Israel, United Kingdom, Australia, Korea, Republic of
|
— | 7 | — |
Investigational sites
UZ Leuven
Gastroenterology and Hepatology, Herestraat 49, 3000, Leuven
Hopital Erasme
Gastroenterology, Lennikse Baan 808, 1070, Anderlecht
Clinical Hospital Dubrava
Internal medicine, Avenija Gojka Suska 6, Zagreb, Grad Zagreb
University Hospital Centre Zagreb
Gastroenterology and Hepatology, Ulica Mije Kispatica 12, 10000, Zagreb
Research Site s.r.o.
Gastroenterology, Sumavska 163/2, Vychodni Predmesti, Plzen 3
Artroscan s.r.o.
Gastroenterology, Trebovicka 5114/106, 722 00, Trebovice
Hepato-Gastroenterologie HK s.r.o.
Gastroenterology, Trida Edvarda Benese 1549/34, 500 12, Hradec Kralove
Tartu University Hospital
N/A, A006, L. Puusepa Tn 8, Tartu Linn
Assistance Publique Hopitaux De Paris
Service d'hepatologie, 184 Rue Du Faubourg Saint Antoine, 75012, Paris
Assistance Publique Hopitaux De Paris
Service Hepato Gastro Enterologie, Num Voie 47 A 83, 47 Boulevard De L Hopital, Paris
Centre Hospitalier Universitaire De Lille
Service des Maladies de l'appareil digestif et de la nutrition, Rue Michel Polonovski, 59037, Lille Cedex
Assistance Publique Hopitaux De Paris
Departemernt d'hepatologie, 51 Avenue Du Mal De Lattre De Tassigny, 94010, Creteil Cedex
University Medical Center Hamburg-Eppendorf
Zentrum fuer Innere Medizin I, Martinistrasse 52, Eppendorf, Hamburg
Medizinische Hochschule Hannover
Klinik für Gastroenterologie, Hepatologie und Endokrinologie, Carl-Neuberg-Strasse 1, Gross Buchholz, Hanover
General University Hospital Of Larissa
Department of Medicine & Research Laboratory of Internal Medicine, P. O. Box 1425, 411 10, Larissa
Vilniaus Universiteto Ligonine Santaros Klinikos Vsi
N/A, Santariskiu G 2, Vilniaus M. Sav., Vilnius
VUmc Stichting
Gastroenterology and hepatology, De Boelelaan 1117, 1081 HV, Amsterdam
Akershus University Hospital
Gastroenterology, Sykehusveien 25, 1474, Loerenskog
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 |
|---|---|---|---|---|---|
| Belgium | 2020-10-15 | 2020-10-21 | 2022-12-15 | ||
| Croatia | 2020-10-15 | 2021-09-23 | 2022-03-31 | ||
| Czechia | 2020-12-17 | 2021-04-13 | 2023-01-10 | ||
| Estonia | 2021-08-26 | 2025-09-10 | 2022-01-14 | 2022-10-05 | |
| France | 2021-04-30 | 2021-07-21 | 2023-02-09 | ||
| Germany | 2021-03-31 | 2021-12-14 | 2022-11-28 | ||
| Greece | 2021-10-28 | 2021-12-01 | 2022-02-09 | ||
| Hungary | 2019-09-20 | 2019-10-02 | 2022-04-09 | ||
| Lithuania | 2021-03-31 | 2025-09-08 | 2022-03-30 | 2022-05-19 | |
| Netherlands | 2021-06-17 | 2022-02-03 | 2022-05-12 | ||
| Norway | 2020-11-13 | 2021-01-05 | 2022-12-17 | ||
| Spain | 2020-02-19 | 2020-02-25 | 2022-11-29 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 121 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-513762-18_EL_Redacted | 7 |
| Protocol (for publication) | D1_Protocol_2024-513762-18_EN_Redacted | 7 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements_Placeholder document | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements_Placeholder document | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangement_Blank_ES | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_BLANK | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_BLANK | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_BLANK | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_BLANK | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_BLANK | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_BLANK | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_BLANK | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_BLANK | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_BLANK | N/A |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Blank_ES | N/A |
| Subject information and informed consent form (for publication) | L1_ICF_Optional Genetic | 4.1.0 |
| Subject information and informed consent form (for publication) | L1_PIS-ICF_COVID-19 Addendum | 4.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF COVID Addendum_ongoing | 3.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF COVID_HR | 4.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Genetics _HR | 4.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Addendum | 2.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main__ongoing_Redacted | 8.1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_ES | 8.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_HR_Redacted | 8.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_ongoing__Redacted | 8.1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_ongoing_Redacted | 8.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Redacted | 8.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Redacted | 8.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnancy | 2.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnancy _HR | 3.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Privacy Notice_ongoing | 4.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Restart_HR | 5.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ Optional Genetics | 1.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Additional Sources | 3.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Additional Sources ICF | 3.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_COVID-19 | 4.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_COVID-19 Addendum | 3.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_COVID-19 Addendum ICF_EST_EE | 2.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_COVID-19 Addendum ICF_LIT | 2.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_COVID-19 Addendum ICF_RUS_EE | 2.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_COVID-19 Addendum ICF_RUS_Redacted | 2.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_COVID-19 Addendum_ES | 2.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_COVID-19 Addendum_FR | 2.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_COVID-19 ICF | 4.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Genetic_BE-EN_Redacted | 4.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Genetic_BE-FR_Redacted | 4.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Genetic_BE-NL_Redacted | 4.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ICF to restart IMP_LIT | 5.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ICF to restart IMP_RUS_Redacted | 5.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_EST_EE | 8.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_LIT | 8.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_Redacted | 8.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_RUS_EE | 8.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_RUS_Redacted | 8.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_BE-EN_Redacted | 8.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_BE-FR_Redacted | 8.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_BE-NL_Redacted | 8.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_FR_Redacted | 8.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_ICF__Redacted | 8.1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_ICF_Redacted | 8.1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Redacted | 8.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Genetics | 4.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Genetics ICF_EST_EE | 4.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Genetics ICF_LIT | 4.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Genetics ICF_RUS_EE | 4.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Genetics ICF_RUS_Redacted | 4.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Genetics Reasearch ICF | 4.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Genetics Research_FR | 4.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Genetics_ES | 4.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy and Birth_Redacted | 3.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy_BE-EN_Redacted | 2.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy_BE-FR_Redacted | 2.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy_BE-NL_Redacted | 2.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Patient_FR | 2.3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Privacy Notice | 4.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Restart of IP | 3.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Restarting IP ICF | 7.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS_Optional Genetic | 4.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Main_Redacted | 8.1.0 |
| Subject information and informed consent form (for publication) | L1_Subject information and informed consent form COVID_Redacted | 4.2.0 |
| Subject information and informed consent form (for publication) | L1_Subject information and informed consent form optional Genetics_Redacted | 4.2.0 |
| Subject information and informed consent form (for publication) | L1_Subject information and informed consent form_Redacted | 8.2.0 |
| Subject information and informed consent form (for publication) | L2_Other information given to subjects_Dosing Card_BE-EN | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other information given to subjects_Dosing Card_BE-FR | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other information given to subjects_Dosing Card_BE-NL | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other information given to subjects_Dosing Diary_BE-EN | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other information given to subjects_Dosing Diary_BE-FR | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other information given to subjects_Dosing Diary_BE-NL | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Dosing Card_HR | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_OCA and BZF Dosing Diary_HR | 2.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Patient Alert Card_BE-FR | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Patient Alert Card_BE-NL | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Patient Alert Card_CZ | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Patient Alert Card_DE | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Patient Alert Card_EE-EST | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Patient Alert Card_EE-RUS | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Patient Alert Card_EL | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Patient Alert Card_ES | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Patient Alert Card_FR | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Patient Alert Card_HR | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Patient Alert Card_LT-LIT | 3.1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Patient Alert Card_LT-RUS_Redacted | 3.1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Patient Alert Card_NL-DUT | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Patient Alert Card_NL-ENG | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Patient Alert Card_NO | 3.0 |
| Subject information and informed consent form (for publication) | L2_Subject ID Card | 3.1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_Placeholder_for publication | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_CZ_2024-513762-18_Redacted | 7 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_Lay person_BE-DE_2024-513762-18 | 7 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_Lay person_BE-FR_2024-513762-18 | 7 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_Lay person_BE-NL_2024-513762-18 | 7 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_Lay person_CZ_2024-513762-18 | 7 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_Lay person_EL_2024-513762-18 | 7 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_Lay person_EN_2024-513762-18 | 7 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_Lay person_ES_2024-513762-18 | 7 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_Lay person_FR_2024-513762-18 | 7 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_Lay person_HR_2024-513762-18 | 7 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_Lay person_HU_2024-513762-18 | 7 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_Lay person_LT_2024-513762-18 | 7 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_Lay person_NL_2024-513762-18 | 7 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_Lay person_NO_2024-513762-18 | 7 |
Application history
12 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-02 | Netherlands | Acceptable 2024-06-14
|
2024-06-14 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-12-12 | Netherlands | Acceptable 2025-04-02
|
2025-04-02 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-04-25 | Acceptable 2025-04-02
|
2025-04-25 | |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-04-30 | Netherlands | Acceptable 2025-04-02
|
2025-04-30 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-04-30 | Acceptable 2025-04-02
|
2025-04-30 | |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-04-30 | Acceptable 2025-04-02
|
2025-04-30 | |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2025-05-02 | Acceptable 2025-04-02
|
2025-05-02 | |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2025-05-06 | Netherlands | Acceptable 2025-04-02
|
2025-05-06 |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-7 | 2025-05-07 | Acceptable 2025-04-02
|
2025-05-07 | |
| 10 | NON SUBSTANTIAL MODIFICATION | NSM-8 | 2025-05-07 | Acceptable 2025-04-02
|
2025-05-07 | |
| 11 | NON SUBSTANTIAL MODIFICATION | NSM-9 | 2025-05-07 | Acceptable 2025-04-02
|
2025-05-07 | |
| 12 | NON SUBSTANTIAL MODIFICATION | NSM-10 | 2025-07-18 | Netherlands | Acceptable 2025-04-02
|
2025-07-18 |