Overview
Sponsor-declared trial summary
Phase
Phase II and Phase III (Integrated)
Status
Ended
Participants planned
193
Countries
17
Sites
78
Hidradenitis suppurativa
Study 1368-0098 consists of 2 parts: dose finding Phase IIb (Part 1), designed to find the optimal dose in patients with moderate to severe HS for Phase III development; confirmatory Phase III (Part 2), designed to assess the efficacy and safety of spesolimab in patients with moderate to severe HS.
Key facts
- Sponsor
- Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A., Boehringer Ingelheim RCV GmbH & Co. KG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Bacterial Infections and Mycoses [C01], Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Trial duration
- 13 Oct 2023 → 1 Apr 2025
- Decision date (initial)
- 2023-05-30
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Dose response, Efficacy, Safety
Study 1368-0098 consists of 2 parts: dose finding Phase IIb (Part 1), designed to find the optimal dose in patients with moderate to severe HS for Phase III development; confirmatory Phase III (Part 2), designed to assess the efficacy and safety of spesolimab in patients with moderate to severe HS.
Conditions and MedDRA coding
Hidradenitis suppurativa
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10020041 | Hidradenitis suppurativa | 10040785 |
| 20.0 | LLT | 10020041 | Hidradenitis suppurativa | 10040785 |
Study design 6 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Part 1 - Screening and randomisation 28 days
|
Not Applicable | None | All participants: All participants | |
| 2 | Part 1 - Treatment phase 48 weeks
|
Randomised Controlled | Double | [{"id":115318,"code":2,"name":"Investigator"},{"id":115321,"code":5,"name":"Carer"},{"id":115322,"code":1,"name":"Subject"},{"id":115320,"code":3,"name":"Monitor"},{"id":115319,"code":4,"name":"Analyst"}] | BI 655130: High dose level BI 655130: Medium dose level BI 655130: Low dose level Placebo: Placebo |
| 3 | Part 1 - Follow-up phase 16 weeks
|
Not Applicable | Double | [{"id":115324,"code":1,"name":"Subject"},{"id":115327,"code":2,"name":"Investigator"},{"id":115325,"code":4,"name":"Analyst"},{"id":115326,"code":5,"name":"Carer"},{"id":115328,"code":3,"name":"Monitor"}] | All participants: All participants |
| 4 | Part 2 - Screening and randomisation 28 days
|
Not Applicable | None | All participants: All participants | |
| 5 | Part 2 - Treatment phase 50 weeks
|
Randomised Controlled | Double | [{"id":115332,"code":5,"name":"Carer"},{"id":115331,"code":3,"name":"Monitor"},{"id":115335,"code":4,"name":"Analyst"},{"id":115334,"code":1,"name":"Subject"},{"id":115333,"code":2,"name":"Investigator"}] | BI 655130: BI 655130 Placebo: Placebo |
| 6 | Part 2 - Follow-up phase 16 weeks
|
Not Applicable | Double | [{"id":115338,"code":1,"name":"Subject"},{"id":115339,"code":5,"name":"Carer"},{"id":115341,"code":3,"name":"Monitor"},{"id":115340,"code":2,"name":"Investigator"},{"id":115337,"code":4,"name":"Analyst"}] | All participants: All participants |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- Plan to share IPD
- Yes
- IPD plan description
- Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed “Document Sharing Agreement”. Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined on the website. Time Frame: One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program. Access Criteria: For study documents – upon signing of a ‚Document Sharing Agreement‘. For study data – 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 9
- Of full age of consent at screening.
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
- Moderate to severe HS.
- HS lesions in at least 2 distinct anatomic areas.
- Biologic naive or TNFi-exposed for HS.
- For biologic naïve, inadequate response to an adequate course of appropriate oral antibiotics for treatment of HS. All participants must have previous exposure to antibiotics for HS.
- Total AN count of greater than or equal to 5.
- Total dT count of at least 1 at Baseline visit.
- Further criteria apply.
Exclusion criteria 8
- Participants who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial.
- Prior exposure to any immunosuppressive/ immunomodulatory biologic other than TNFi for HS.
- Prior exposure to IL-36R inhibitors including spesolimab.
- Treated with any investigational device or investigational drug of chemical or biologic nature within a minimum of 30 days or 5 half-lives of the drug, whichever is longer.
- Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
- Participants with history of allergy/hypersensitivity to the systemically administered trial medication agent or its excipients.
- Participants with a transplanted organ (with exception of a corneal transplant >12 weeks prior to screening) or who has ever received stem cell therapy (e.g., Remestemcel-L)
- Participants with any documented active or suspected malignancy or history of malignancy within 5 years prior to the screening visit, except appropriately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ carcinoma of uterine cervix.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Percent change from baseline in dT count.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PRD9853966 · Product
- Active substance
- Spesolimab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- SOLUTION FOR INFUSION
- Max daily dose
- 1800 mg milligram(s)
- Max total dose
- 7200 mg milligram(s)
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- BOEHRINGER INGELHEIM INTERNATIONAL
- Paediatric formulation
- No
- Orphan designation
- No
PRD9854934 · Product
- Active substance
- Spesolimab
- Substance synonyms
- IMMUNOGLOBULIN G1-KAPPA, ANTI-(HOMO SAPIENS IL1RL2), HUMANIZED MONOCLONAL ANTIBODY, BI655130, BI-655130
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Max daily dose
- 1200 mg milligram(s)
- Max total dose
- 30000 mg milligram(s)
- Max treatment duration
- 48 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- BOEHRINGER INGELHEIM INTERNATIONAL
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 2
Placebo for BI 655130 (solution for infusion)
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
Placebo for BI 655130 (solution for injection)
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
Boehringer Ingelheim International GmbH
- Sponsor organisation
- Boehringer Ingelheim International GmbH
- Address
- Binger Strasse 173
- City
- Ingelheim Am Rhein
- Postcode
- 55216
- Country
- Germany
Scientific contact point
- Organisation
- Boehringer Ingelheim International GmbH
- Contact name
- CT Disclosure & Data Transparency
Public contact point
- Organisation
- Boehringer Ingelheim International GmbH
- Contact name
- CT Disclosure & Data Transparency
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Iqvia Limited ORG-100008655
|
Reading, United Kingdom | On site monitoring, Code 12, Other |
Boehringer Ingelheim Espana S.A.
- Sponsor organisation
- Boehringer Ingelheim Espana S.A.
- Address
- Carrer Prat De La Riba 50
- City
- Sant Cugat Del Valles
- Postcode
- 08174
- Country
- Spain
Boehringer Ingelheim RCV GmbH & Co. KG
- Sponsor organisation
- Boehringer Ingelheim RCV GmbH & Co. KG
- Address
- Dr.-Boehringer-Gasse 5-11, Meidling Meidling
- City
- Vienna
- Postcode
- 1121
- Country
- Austria
Sponsor responsibilities
- Article 77 compliance
- Boehringer Ingelheim International GmbH
- Contact point sponsor
- Boehringer Ingelheim International GmbH
- Article 77 implementation
- Boehringer Ingelheim International GmbH
Locations
17 EU/EEA countries · 78 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ended | 6 | 2 |
| Belgium | Ended | 6 | 2 |
| Bulgaria | Ended | 6 | 6 |
| Czechia | Ended | 4 | 4 |
| Denmark | Ended | 4 | 3 |
| Finland | Ended | 2 | 1 |
| France | Ended | 9 | 7 |
| Germany | Ended | 6 | 6 |
| Greece | Ended | 5 | 5 |
| Italy | Ended | 13 | 13 |
| Lithuania | Ended | 2 | 2 |
| Netherlands | Ended | 1 | 1 |
| Norway | Ended | 1 | 2 |
| Poland | Ended | 8 | 8 |
| Portugal | Ended | 1 | 4 |
| Slovakia | Ended | 3 | 2 |
| Spain | Ended | 12 | 10 |
| Rest of world
Colombia, China, Japan, South Africa, Switzerland, Mexico, Korea, Republic of, United Kingdom, Argentina, New Zealand, Israel, Turkey, Malaysia, Chile, Philippines, Taiwan, Singapore, United States, Canada, Vietnam, Australia
|
— | 104 | — |
Investigational sites
Allgemeines Krankenhaus Der Stadt Wien Universitatskliniken
Department of Dermatology, Währinger Gürtel 18-20, Alsergrund, Vienna
Klinik Hietzing
Department of Dermatology, Wolkersbergenstrasse 1, Hietzing, Vienna
CHU De Liège
Dermatologie, Avenue De L'hopital 1, 4000, Liege
Cliniques Universitaires Saint-Luc
Service de Dermatologie, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Dkc Fokus-5 Lzip OOD
NA, Ulitsa Hristo Stanchev 15, 1463, Sofiya
Military Medical Academy
Department of Skin and Venereal Diseases, Ulitsa Sveti Georgi Sofiyski 3, 1606, Sofiya
ASMC – IPSMC - Skin And Venereal Diseases
Private practice, Ulitsa Persenk 19, Enter B Floor 1 App 13, Sofiya
Umbal - Prof. D-R Stoyan Kirkovich AD
Clinic of Skin and Venereal Diseases, Ulitsa General Stoletov 2, 6003, Stara Zagora
Diagnostic-Consultative Center Alexandrovska EOOD
Clinical trial cabinet, Triaditsa, Ulitsa Sveti Georgi Sofiyski 1, Sofiya
Medical Center Kordis OOD
Private Practice, Ulitsa Sveti Sveti Kiril I Metodiy 18, 5800, Pleven
Fakultni Nemocnice Bulovka
Department of Dermatovenerology, Budinova 67/2, Liben, Prague
Fakultni Nemocnice Kralovske Vinohrady
Department of Dermatovenerology, Srobarova 1150/50, Vinohrady, Prague 10
University Hospital Ostrava
Department of Dermatovenerology, 17 Listopadu 1790 5, 708 00, Ostrava Poruba
Fakultni Nemocnice Plzen
Dermatovenereology Department, Edvarda Benese 1128/13, 301 00, Plzen 1
Bispebjerg Hospital
Dermato-Venerologisk Afdeling, Bispebjerg Bakke 23, 2400, Copenhagen Nv
Zealand University Hospital
Dermatologisk afdeling, Sygehusvej 10, 4000, Roskilde
Aarhus University Hospital
Afd. for Hud-og kønssygdomme, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
Assistance Publique Hopitaux De Paris
Service de Dermatologie, 1 Avenue Claude Vellefaux, 75010, Paris
Hospices Civils De Lyon
Service de Dermatologie, Vénéréologie, 5 Place D Arsonval, 69437, Lyon Cedex 03
Assistance Publique Hopitaux De Marseille
Service Dermatologie, 264 Rue Saint Pierre, 13005, Marseille
Centre Hospitalier Universitaire De Poitiers
Dermatologie, 2 Rue De La Miletrie, 86000, Poitiers
Hopital Prive D Antony
Service de Dermatologie, 1 Rue Velpeau, 92160, Antony
Centre Hospitalier Universitaire De Rennes
Service de Dermatologie, 2 Rue Henri Le Guilloux, 35000, Rennes
Centre Hospitalier Universitaire De Nice
Service de Dermatologie, 151 Route De Saint Antoine, 06200, Nice
Hms GmbH
Ärztehaus Gesundheitscampus, Trierer Strasse 215-217, 66663, Merzig
Katholisches Klinikum Bochum gGmbH
Klinik für Dermatologie, Venerologie und Allergologie, Gudrunstrasse 56, Grumme, Bochum
Universitaetsmedizin Goettingen
Klinik für Dermatologie, Venerologie und Allergologie, Robert-Koch-Strasse 40, Weende, Goettingen
Thermalsole- Und Schwefelbad Bentheim GmbH
Thermalsole- und Schwefelbad Bentheim GmbH, Am Bade 1, 48455, Bad Bentheim
Klinikum Oldenburg AöR
Universitätsklinik für Dermatologie und Allergologie, Rahel-Straus-Strasse 10, Kreyenbrueck, Oldenburg
Charite Universitaetsmedizin Berlin KöR
Klinik für Dermatologie, Venerologie und Allergologie, Charitéplatz 1, Mitte, Berlin
Ippokratio General Hospital Of Thessaloniki
1st Department of Dermatology-Venereology, Konstadinoupoleos 49, 546 42, Thessaloniki
University General Hospital Attikon
2nd Clinic of Venereal & Dermatological Diseases, Rimini Street 1, 124 62, Athens
Andreas Syngros Hospital Of Venereal And Dermatological Diseases
Dpt. of Infectious Diseases, Dragoumi Ionos 5 I, 161 21, Athens
General Hospital Of Thessaloniki Papageorgiou
2nd Department of Dermatology-Venereology of Aristotle University of Thessaloniki, Ring Road Of Thessaloniki, Ministry Of Pavlos Melas, Efkarpia
University General Hospital Attikon
4th Department of Internal Medicine, Rimini Street 1, 124 62, Athens
Azienda Ospedaliera Universitaria - Universita' Degli Studi Della Campania Luigi Vanvitelli
UOSD Dermatologia, Piazza Luigi Miraglia 2, 80138, Naples
Humanitas Research Hospital
U.O. Dermatologia, Via Alessandro Manzoni 56, 20089, Rozzano
Sapienza University Of Rome
UOC Dermatologia Universitaria, Via Firenze, 04019, Terracina
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
DERMATOLOGIA, Via Santa Sofia 78, 95123, Catania
Azienda Ospedaliera Policlinico Universitario Tor Vergata
U.O.S.D. Dermatologia, Viale Oxford 81, 00133, Rome
Azienda Ospedaliero Universitaria Pisana
U.O. di Dermatologia, Via Roma 67, 56126, Pisa
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
UO Dermatologia, Via Francesco Sforza 28, 20122, Milan
Fondazione Luigi Maria Monti
DERMATOLOGIA, Roma, Via Dei Monti Di Creta 104, Rome
Medicina E Chirurgia Universita Degli Studi Di Napoli Federico II
Dipartimento di Medicina clinica e Chirurgia, Via Sergio Pansini 5, 80131, Naples
Azienda Ospedaliero Universitaria Citta Della Salute E Della Scienza Di Torino
Dermatologia U, Corso Bramante 88, 10126, Turin
Azienda Ospedaliero Universitaria Ospedali Riuniti Ancona
N/A, Via Conca 71, 60126, Ancona
Azienda Ospedaliero Universitaria Di Modena
Dermatologia, Largo Del Pozzo 71, 41124, Modena
Istituti Fisioterapici Ospitalieri
S.O.C. Dermatologia Clinica, Via Elio Chianesi N 53, 00144, Rome
Lietuvos Sveikatos Mokslu Universiteto Ligonine Kauno Klinikos
Department of Skin and Venereal Diseases, Eiveniu G. 2, Kauno M. Sav., Kaunas
Vilnius University Hospital
Centre of Dermatovenereology, Santariskiu G. 2, Vilniaus M. Sav., Vilnius
University Medical Center Groningen
Department of Dermatology, Hanzeplein 1, 9713 GZ, Groningen
Helse Stavanger HF
Forskningsposten, Gerd-Ragna Bloch Thorsens Gate 8, 4011, Stavanger
Oslo University Hospital HF
Klinisk Forskningspost, Sognsvannsveien 20, 0372, Oslo
Dorota Bystrzanowska High Med Przychodnia Specjalistyczna
private practice, Ul. Ulica Jana Kasprowicza 27/2, 01-817, Warsaw
Non-Public Health Care Facility LABDERM
Private Practice, Lesna 2a Str, 42624, Ossy
Uniwersytecki Szpital Kliniczny Im. Fryderyka Chopina W Rzeszowie
Department of Dermatology, Ul. Fryderyka Szopena 2, 35-055, Rzeszow
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
Department of Dermatology, Ul. Woloska 137, 02-507, Warsaw
Niepubliczny Zaklad Opieki Zdrowotnej Zespol Poradni Specjalistycznych "Termedica"
Private practice, Os. Boleslawa Chrobrego 101, 60-681, Poznan
Provita Poliklinika
Private practice, ul. Baboszewska 1 2U4, 02-647, Warsaw
Wromedica I Bielicka A Strzalkowska s.c.
Private Practice, Ul. Adama Mickiewicza 91, 51-685, Wroclaw
Royalderm Agnieszka Nawrocka
Private practice, Ul. Krzysztofa Kieslowskiego 3b/3, 02-962, Warsaw
Unidade Local De Saude De Santa Maria E.P.E.
Serviço Dermatologia, Avenida Professor Egas Moniz, 1649-035, Lisbon
CCAB Centro Clinico Academico Braga Associacao
Serviço Dermatologia, Lugar De Sete Fontes S Victor, 4710-243, Braga
Unidade Local De Saude De Santo Antonio E.P.E.
Serviço Dermatologia, Rua Dom Manuel II 57, 1508, Porto
Hospital Cuf Descobertas S.A.
Dermatologia, Rua Mario Botas 1, 1998-018, Lisbon
Fakultna Nemocnica Trnava
Department of Dermatology, Andreja Zarnova 11, 917 02, Trnava
DOST (dermatovenerologicke oddelenie sanatorneho typu)
Dermatovenerology department, MUDr. Pribulu 2, 08901, Svidnik
Hospital De Manises
Servicio de Dermatología, Avinguda De La Generalitat Valenciana 50, 46940, Manises
Hospital Unviersitario Miguel Servet
Servicio de Dermatología, Paseo De Isabel La Catolica 1-3, 50009, Zaragoza
Hospital De La Santa Creu I Sant Pau
Servicio de Dermatología, Calle De San Antonio Maria Claret 167, 08025, Barcelona
Hospital Universitario 12 De Octubre
Servicio de Dermatología, Bloque D, Avenida De Cordoba S/n, Madrid
Hospital Universitario De Salamanca
Servicio de Dermatología, Paseo De San Vicente 58-182, 37007, Salamanca
Hospital Universitario Reina Sofia
Servicio de Dermatología, Avenida Menendez Pidal S/n, 14004, Cordoba
Hospital Universitario Clinico San Cecilio
Servicio de Dermatología, Avenida Del Conocimiento S/n, Poligono Industrial De Ciencias De La Salud, Granada
Hospital General De Granollers
Servicio de Dermatología, Calle De Francesc Ribas 1, 08402, Granollers
Complexo Hospitalario Universitario De Santiago
Servicio de Dermatología, Calle Choupana Da S/n, 15706, Santiago De Compostela
Hospital General Universitario Gregorio Maranon
Servicio de Dermatología, Calle Del Doctor Esquerdo 46, 28009, Madrid
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 | 2024-01-15 | ||||
| Belgium | 2023-06-28 | ||||
| Bulgaria | 2023-06-28 | 2025-03-28 | 2023-08-09 | 2024-06-05 | |
| Czechia | 2024-01-10 | 2025-02-28 | 2024-05-06 | 2024-06-05 | |
| Denmark | 2023-06-21 | 2023-11-22 | |||
| Finland | 2023-08-17 | 2025-03-06 | 2023-11-21 | 2024-06-05 | |
| France | 2023-06-15 | 2025-03-04 | 2023-07-06 | 2024-06-05 | |
| Germany | 2023-06-20 | 2025-03-14 | 2023-07-19 | 2024-06-05 | |
| Greece | 2023-10-18 | 2025-02-25 | 2024-04-10 | 2024-06-05 | |
| Italy | 2023-09-01 | 2025-03-11 | 2024-03-14 | 2024-06-05 | |
| Lithuania | 2023-07-11 | 2025-03-14 | 2023-08-17 | 2024-06-05 | |
| Netherlands | 2023-06-26 | ||||
| Poland | 2023-06-21 | 2025-03-27 | 2023-07-18 | 2024-06-05 | |
| Slovakia | 2023-08-09 | 2025-03-25 | 2023-11-14 | 2024-06-05 | |
| Spain | 2023-06-22 | 2025-03-31 | 2023-07-27 | 2024-06-05 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 12 · Art. 38 CTR
Temporary halt TH-7181
- Halt date
- 2023-10-05
- Member states concerned
- Denmark
- Publication date
- 2023-11-03
- Reason
- Feasibility (recruitment issues etc.)
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-7161
- Halt date
- 2023-10-05
- Member states concerned
- Lithuania
- Publication date
- 2023-11-03
- Reason
- Feasibility (recruitment issues etc.)
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-7183
- Halt date
- 2023-10-05
- Member states concerned
- Bulgaria
- Publication date
- 2023-11-03
- Reason
- Feasibility (recruitment issues etc.)
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-7172
- Halt date
- 2023-10-05
- Member states concerned
- France
- Publication date
- 2023-11-03
- Reason
- Feasibility (recruitment issues etc.)
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-7190
- Halt date
- 2023-10-05
- Member states concerned
- Slovakia
- Publication date
- 2023-11-03
- Reason
- Feasibility (recruitment issues etc.)
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-6427
- Halt date
- 2023-10-05
- Member states concerned
- Poland
- Publication date
- 2023-11-03
- Reason
- Feasibility (recruitment issues etc.)
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-7156
- Halt date
- 2023-10-05
- Member states concerned
- Spain
- Publication date
- 2023-11-03
- Reason
- Feasibility (recruitment issues etc.)
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-7178
- Halt date
- 2023-10-05
- Member states concerned
- Finland
- Publication date
- 2023-11-03
- Reason
- Feasibility (recruitment issues etc.)
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-7168
- Halt date
- 2023-10-05
- Member states concerned
- Germany
- Publication date
- 2023-11-03
- Reason
- Feasibility (recruitment issues etc.)
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-7147
- Halt date
- 2023-10-05
- Member states concerned
- Netherlands
- Publication date
- 2023-11-03
- Reason
- Feasibility (recruitment issues etc.)
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-7165
- Halt date
- 2023-10-05
- Member states concerned
- Italy
- Publication date
- 2023-11-03
- Reason
- Feasibility (recruitment issues etc.)
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-7188
- Halt date
- 2023-10-05
- Member states concerned
- Belgium
- Publication date
- 2023-11-03
- Reason
- Feasibility (recruitment issues etc.)
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| 1368-0098_EU structured results SUM-125330
|
2026-03-25T13:33:57 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| lay-summary-1368-0098 | 2026-03-25T13:33:32 | Submitted | Laypersons Summary of Results |
Documents 355 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | lay-summary-1368-0098-bulgaria-bulgarian | 1 |
| Laypersons summary of results (for publication) | lay-summary-1368-0098-czech-republic-czech | 1 |
| Laypersons summary of results (for publication) | lay-summary-1368-0098-english | 1 |
| Laypersons summary of results (for publication) | lay-summary-1368-0098-finland-finnish | 1 |
| Laypersons summary of results (for publication) | lay-summary-1368-0098-france-french | 1 |
| Laypersons summary of results (for publication) | lay-summary-1368-0098-germany-german | 1 |
| Laypersons summary of results (for publication) | lay-summary-1368-0098-greece-greek | 1 |
| Laypersons summary of results (for publication) | lay-summary-1368-0098-italy-italian | 1 |
| Laypersons summary of results (for publication) | lay-summary-1368-0098-lithuania-lithuanian | 1 |
| Laypersons summary of results (for publication) | lay-summary-1368-0098-poland-polish | 1 |
| Laypersons summary of results (for publication) | lay-summary-1368-0098-slovakia-slovak | 1 |
| Laypersons summary of results (for publication) | lay-summary-1368-0098-spain-spanish | 1 |
| Protocol (for publication) | D1_EU Amendment- Signature Protocol 2022-501074-19-00-public | 2 |
| Protocol (for publication) | D1_EU Amendment- Signature Protocol AT AKH - Med Univ Vienna-public | 2 |
| Protocol (for publication) | D1_EU Amendment- Signature Protocol-AT Hospital Hietzing-public | 2 |
| Protocol (for publication) | D1_EU Amendment- Signature Protocol-IT Camania Luigi Vanvitelli public | 2 |
| Protocol (for publication) | D1_EU Amendment- Signature Protocol-IT Citta della Salute e Scienza public | 2 |
| Protocol (for publication) | D1_EU Amendment- Signature Protocol-IT IDI - IRCCS -public | 2 |
| Protocol (for publication) | D1_EU Amendment- Signature Protocol-IT Istituto Clinico Humanitas-public | 2 |
| Protocol (for publication) | D1_EU Amendment- Signature Protocol-IT Maggiore Policlinico public | 2 |
| Protocol (for publication) | D1_EU Amendment- Signature Protocol-IT Ospedale Fiorini public | 2 |
| Protocol (for publication) | D1_EU Amendment- Signature Protocol-IT Ospedali Riuniti di Ancona public | 2 |
| Protocol (for publication) | D1_EU Amendment- Signature Protocol-IT Ospedaliera Universitaria Pisana public | 2 |
| Protocol (for publication) | D1_EU Amendment- Signature Protocol-IT Policlinico di Modena public | 2 |
| Protocol (for publication) | D1_EU Amendment- Signature Protocol-IT Policlinico Gaspare Rodolico -public | 2 |
| Protocol (for publication) | D1_EU Amendment- Signature Protocol-IT Universitario Tor Vergata public | 2 |
| Protocol (for publication) | D1_EU Amendment-Protocol 2022-501074-19-00-public | 3 |
| Protocol (for publication) | D1_Protocol 2022-501074-19-00-GREECE-public | 2 |
| Protocol (for publication) | D1_Protocol 2022-501074-19-00-public | 2 |
| Protocol (for publication) | D1_Protocol signature page-AT-hosp-Hietzing-public | 1 |
| Protocol (for publication) | D1_Protocol signature page-AT-med-univ-of-graz-st-hos-uni-hos-graz-public | 1 |
| Protocol (for publication) | D1_Protocol signature page-AT-med-univ-of-vienna-public | 1 |
| Protocol (for publication) | D1_Protocol signature page-IT-AO-cit-del-sal-e-sci-public | 1 |
| Protocol (for publication) | D1_Protocol signature page-IT-AOU-uni-de-St-del-Cam-Lui-Van-public | 1 |
| Protocol (for publication) | D1_Protocol signature page-IT-azi-osp-poli-di-mod-public | 1 |
| Protocol (for publication) | D1_Protocol signature page-IT-azi-osp-univ-pis-public | 1 |
| Protocol (for publication) | D1_Protocol signature page-IT-Ist-clin-hum-public | 1 |
| Protocol (for publication) | D1_Protocol signature page-IT-ist-dermo-del-immac-public | 1 |
| Protocol (for publication) | D1_Protocol signature page-IT-Milano-fond-IRCCS-ca-os-mag-pol-public | 1 |
| Protocol (for publication) | D1_Protocol signature page-IT-osp-fiorini-public | 1 |
| Protocol (for publication) | D1_Protocol signature page-IT-osp-riun-di-ancona-public | 1 |
| Protocol (for publication) | D1_Protocol signature page-IT-osp-univ-polic-gasp-rod-public | 1 |
| Protocol (for publication) | D1_Protocol signature page-IT-pol-univ-tor-vergata-public | 1 |
| Protocol (for publication) | D1_Protocol signature page-IT-sti-fisio-ospi-public | 1 |
| Protocol (for publication) | D1_Protocol signature page-IT-univ-fede-II-public | 1 |
| Protocol (for publication) | D4_ Patient facing document-AT-diary | 2 |
| Protocol (for publication) | D4_ Patient facing document-AT-diary-electronic | 1 |
| Protocol (for publication) | D4_ Patient facing document-AT-diary-paper | 1 |
| Protocol (for publication) | D4_ Patient facing document-AT-DLQI | 1 |
| Protocol (for publication) | D4_ Patient facing document-AT-Facit Fatigue | 4 |
| Protocol (for publication) | D4_ Patient facing document-AT-Facit Fatigue-ePRO | 4 |
| Protocol (for publication) | D4_ Patient facing document-AT-HADS | 1 |
| Protocol (for publication) | D4_ Patient facing document-AT-HisQoL | 1 |
| Protocol (for publication) | D4_ Patient facing document-AT-HODS | 1 |
| Protocol (for publication) | D4_ Patient facing document-AT-PGI-C | 1 |
| Protocol (for publication) | D4_ Patient facing document-AT-PGI-S | 1 |
| Protocol (for publication) | D4_ Patient facing document-AT-PP-NRS | 1 |
| Protocol (for publication) | D4_ Patient facing document-BE-DUTCH-diary | 2 |
| Protocol (for publication) | D4_ Patient facing document-BE-DUTCH-diary-electronic | 1 |
| Protocol (for publication) | D4_ Patient facing document-BE-DUTCH-diary-paper | 1 |
| Protocol (for publication) | D4_ Patient facing document-BE-DUTCH-DLQI | 1 |
| Protocol (for publication) | D4_ Patient facing document-BE-DUTCH-Facit Fatigue | 4 |
| Protocol (for publication) | D4_ Patient facing document-BE-DUTCH-Facit Fatigue-ePRO | 4 |
| Protocol (for publication) | D4_ Patient facing document-BE-DUTCH-HADS | 1 |
| Protocol (for publication) | D4_ Patient facing document-BE-DUTCH-HisQoL | 1 |
| Protocol (for publication) | D4_ Patient facing document-BE-DUTCH-HODS | 1 |
| Protocol (for publication) | D4_ Patient facing document-BE-DUTCH-PGI-C | 1 |
| Protocol (for publication) | D4_ Patient facing document-BE-DUTCH-PGI-S | 1 |
| Protocol (for publication) | D4_ Patient facing document-BE-DUTCH-PP-NRS | 1 |
| Protocol (for publication) | D4_ Patient facing document-BE-FRENCH-diary | 2 |
| Protocol (for publication) | D4_ Patient facing document-BE-FRENCH-diary-electronic | 1 |
| Protocol (for publication) | D4_ Patient facing document-BE-FRENCH-diary-paper | 1 |
| Protocol (for publication) | D4_ Patient facing document-BE-FRENCH-DLQI | 1 |
| Protocol (for publication) | D4_ Patient facing document-BE-FRENCH-Facit Fatigue | 4 |
| Protocol (for publication) | D4_ Patient facing document-BE-FRENCH-Facit Fatigue-ePRO | 4 |
| Protocol (for publication) | D4_ Patient facing document-BE-FRENCH-HADS | 1 |
| Protocol (for publication) | D4_ Patient facing document-BE-FRENCH-HisQoL | 1 |
| Protocol (for publication) | D4_ Patient facing document-BE-FRENCH-HODS | 1 |
| Protocol (for publication) | D4_ Patient facing document-BE-FRENCH-PGI-C | 1 |
| Protocol (for publication) | D4_ Patient facing document-BE-FRENCH-PGI-S | 1 |
| Protocol (for publication) | D4_ Patient facing document-BE-FRENCH-PP-NRS | 1 |
| Protocol (for publication) | D4_ Patient facing document-BG-diary | 2 |
| Protocol (for publication) | D4_ Patient facing document-BG-diary-ELECTRONIC | 1 |
| Protocol (for publication) | D4_ Patient facing document-BG-diary-PAPER | 1 |
| Protocol (for publication) | D4_ Patient facing document-BG-DLQI | 1 |
| Protocol (for publication) | D4_ Patient facing document-BG-Facit Fatigue | 4 |
| Protocol (for publication) | D4_ Patient facing document-BG-Facit Fatigue-ePRO | 4 |
| Protocol (for publication) | D4_ Patient facing document-BG-HADS | 1 |
| Protocol (for publication) | D4_ Patient facing document-BG-HisQoL | 1 |
| Protocol (for publication) | D4_ Patient facing document-BG-HODS | 1 |
| Protocol (for publication) | D4_ Patient facing document-BG-PGI-C | 1 |
| Protocol (for publication) | D4_ Patient facing document-BG-PGI-S | 1 |
| Protocol (for publication) | D4_ Patient facing document-BG-PP-NRS | 1 |
| Protocol (for publication) | D4_ Patient facing document-DE-diary | 2 |
| Protocol (for publication) | D4_ Patient facing document-DE-DLQI | 1 |
| Protocol (for publication) | D4_ Patient facing document-DE-Facit Fatigue | 4 |
| Protocol (for publication) | D4_ Patient facing document-DE-HADS | 1 |
| Protocol (for publication) | D4_ Patient facing document-DE-HisQoL | 1 |
| Protocol (for publication) | D4_ Patient facing document-DE-HODS | 1 |
| Protocol (for publication) | D4_ Patient facing document-DE-PGI-C | 1 |
| Protocol (for publication) | D4_ Patient facing document-DE-PGI-S | 1 |
| Protocol (for publication) | D4_ Patient facing document-DE-PP-NRS | 1 |
| Protocol (for publication) | D4_ Patient facing document-DLQI | 1 |
| Protocol (for publication) | D4_ Patient facing document-ecoa-handheld-pain-diary | 1 |
| Protocol (for publication) | D4_ Patient facing document-ecoa-handheld-patient-instructions | 1 |
| Protocol (for publication) | D4_ Patient facing document-ecoa-handheld-peak-pruritus-nrs | 1 |
| Protocol (for publication) | D4_ Patient facing document-ecoa-handheld-privacy-statement | 1 |
| Protocol (for publication) | D4_ Patient facing document-ecoa-handheld-reminder-icon | 1 |
| Protocol (for publication) | D4_ Patient facing document-ecoa-handheld-training-module | 1 |
| Protocol (for publication) | D4_ Patient facing document-ecoa-handheld-training-module-opt | 1 |
| Protocol (for publication) | D4_ Patient facing document-ecoa-tablet-dlqi | 1 |
| Protocol (for publication) | D4_ Patient facing document-ecoa-tablet-facit-fatigue | 1 |
| Protocol (for publication) | D4_ Patient facing document-ecoa-tablet-hads-ecoa | 1 |
| Protocol (for publication) | D4_ Patient facing document-ecoa-tablet-hisqol | 1 |
| Protocol (for publication) | D4_ Patient facing document-ecoa-tablet-hods | 1 |
| Protocol (for publication) | D4_ Patient facing document-ecoa-tablet-pgi-c | 1 |
| Protocol (for publication) | D4_ Patient facing document-ecoa-tablet-pgi-s | 1 |
| Protocol (for publication) | D4_ Patient facing document-ecoa-tablet-training-module | 1 |
| Protocol (for publication) | D4_ Patient facing document-ecoa-tablet-training-module-opt | 1 |
| Protocol (for publication) | D4_ Patient facing document-ES-diary | 2 |
| Protocol (for publication) | D4_ Patient facing document-ES-diary-electronic | 1 |
| Protocol (for publication) | D4_ Patient facing document-ES-diary-paper | 1 |
| Protocol (for publication) | D4_ Patient facing document-ES-DLQI | 1 |
| Protocol (for publication) | D4_ Patient facing document-ES-Facit Fatigue | 4 |
| Protocol (for publication) | D4_ Patient facing document-ES-Facit Fatigue-ePRO | 4 |
| Protocol (for publication) | D4_ Patient facing document-ES-HADS | 1 |
| Protocol (for publication) | D4_ Patient facing document-ES-HisQoL | 1 |
| Protocol (for publication) | D4_ Patient facing document-ES-HODS | 1 |
| Protocol (for publication) | D4_ Patient facing document-ES-PGI-C | 1 |
| Protocol (for publication) | D4_ Patient facing document-ES-PGI-S | 1 |
| Protocol (for publication) | D4_ Patient facing document-ES-PP-NRS | 1 |
| Protocol (for publication) | D4_ Patient facing document-Facit Fatigue | 1 |
| Protocol (for publication) | D4_ Patient facing document-Facit Fatigue-ePRO | 1 |
| Protocol (for publication) | D4_ Patient facing document-FR-diary | 2 |
| Protocol (for publication) | D4_ Patient facing document-FR-diary-electronic | 1 |
| Protocol (for publication) | D4_ Patient facing document-FR-diary-paper | 1 |
| Protocol (for publication) | D4_ Patient facing document-FR-DLQI | 1 |
| Protocol (for publication) | D4_ Patient facing document-FR-Facit Fatigue | 4 |
| Protocol (for publication) | D4_ Patient facing document-FR-Facit Fatigue-ePRO | 4 |
| Protocol (for publication) | D4_ Patient facing document-FR-HADS | 1 |
| Protocol (for publication) | D4_ Patient facing document-FR-HisQoL | 1 |
| Protocol (for publication) | D4_ Patient facing document-FR-HODS | 1 |
| Protocol (for publication) | D4_ Patient facing document-FR-PGI-C | 1 |
| Protocol (for publication) | D4_ Patient facing document-FR-PGI-S | 1 |
| Protocol (for publication) | D4_ Patient facing document-FR-PP-NRS | 1 |
| Protocol (for publication) | D4_ Patient facing document-GR-diary | 2 |
| Protocol (for publication) | D4_ Patient facing document-GR-diary-electronic | 1 |
| Protocol (for publication) | D4_ Patient facing document-GR-diary-paper | 1 |
| Protocol (for publication) | D4_ Patient facing document-GR-DLQI | 1 |
| Protocol (for publication) | D4_ Patient facing document-GR-Facit Fatigue | 4 |
| Protocol (for publication) | D4_ Patient facing document-GR-Facit Fatigue-ePRO | 4 |
| Protocol (for publication) | D4_ Patient facing document-GR-HADS | 1 |
| Protocol (for publication) | D4_ Patient facing document-GR-HisQoL | 1 |
| Protocol (for publication) | D4_ Patient facing document-GR-HODS | 1 |
| Protocol (for publication) | D4_ Patient facing document-GR-PGI-C | 1 |
| Protocol (for publication) | D4_ Patient facing document-GR-PGI-S | 1 |
| Protocol (for publication) | D4_ Patient facing document-GR-PP-NRS | 1 |
| Protocol (for publication) | D4_ Patient facing document-HADS | 1 |
| Protocol (for publication) | D4_ Patient facing document-HisQoL | 1 |
| Protocol (for publication) | D4_ Patient facing document-HODS | 1 |
| Protocol (for publication) | D4_ Patient facing document-IT-diary | 2 |
| Protocol (for publication) | D4_ Patient facing document-IT-diary-electronic | 1 |
| Protocol (for publication) | D4_ Patient facing document-IT-diary-paper | 1 |
| Protocol (for publication) | D4_ Patient facing document-IT-DLQI | 1 |
| Protocol (for publication) | D4_ Patient facing document-IT-Facit Fatigue | 4 |
| Protocol (for publication) | D4_ Patient facing document-IT-Facit Fatigue-ePRO | 4 |
| Protocol (for publication) | D4_ Patient facing document-IT-HADS | 1 |
| Protocol (for publication) | D4_ Patient facing document-IT-HisQoL | 1 |
| Protocol (for publication) | D4_ Patient facing document-IT-HODS | 1 |
| Protocol (for publication) | D4_ Patient facing document-IT-PGI-C | 1 |
| Protocol (for publication) | D4_ Patient facing document-IT-PGI-S | 1 |
| Protocol (for publication) | D4_ Patient facing document-IT-PP-NRS | 1 |
| Protocol (for publication) | D4_ Patient facing document-LT-diary | 2 |
| Protocol (for publication) | D4_ Patient facing document-LT-diary-electronic | 1 |
| Protocol (for publication) | D4_ Patient facing document-LT-diary-paper | 1 |
| Protocol (for publication) | D4_ Patient facing document-LT-DLQI | 1 |
| Protocol (for publication) | D4_ Patient facing document-LT-Facit Fatigue | 4 |
| Protocol (for publication) | D4_ Patient facing document-LT-Facit Fatigue-ePRO | 4 |
| Protocol (for publication) | D4_ Patient facing document-LT-HADS | 1 |
| Protocol (for publication) | D4_ Patient facing document-LT-HisQoL | 1 |
| Protocol (for publication) | D4_ Patient facing document-LT-HODS | 1 |
| Protocol (for publication) | D4_ Patient facing document-LT-PGI-C | 1 |
| Protocol (for publication) | D4_ Patient facing document-LT-PGI-S | 1 |
| Protocol (for publication) | D4_ Patient facing document-LT-PP-NRS | 1 |
| Protocol (for publication) | D4_ Patient facing document-Pain NRS Patient diary | 1 |
| Protocol (for publication) | D4_ Patient facing document-Pain NRS Patient diary ePRO electr | 1 |
| Protocol (for publication) | D4_ Patient facing document-Pain NRS Patient diary ePRO paper | 1 |
| Protocol (for publication) | D4_ Patient facing document-PGI-C | 1 |
| Protocol (for publication) | D4_ Patient facing document-PGI-S | 1 |
| Protocol (for publication) | D4_ Patient facing document-PP-NRS | 1 |
| Protocol (for publication) | D4_ Patient facing document-SK-diary | 2 |
| Protocol (for publication) | D4_ Patient facing document-SK-diary-electronic | 1 |
| Protocol (for publication) | D4_ Patient facing document-SK-diary-paper | 1 |
| Protocol (for publication) | D4_ Patient facing document-SK-DLQI | 1 |
| Protocol (for publication) | D4_ Patient facing document-SK-Facit Fatigue | 4 |
| Protocol (for publication) | D4_ Patient facing document-SK-Facit Fatigue-ePRO | 4 |
| Protocol (for publication) | D4_ Patient facing document-SK-HADS | 1 |
| Protocol (for publication) | D4_ Patient facing document-SK-HisQoL | 1 |
| Protocol (for publication) | D4_ Patient facing document-SK-HODS | 1 |
| Protocol (for publication) | D4_ Patient facing document-SK-PGI-C | 1 |
| Protocol (for publication) | D4_ Patient facing document-SK-PGI-S | 1 |
| Protocol (for publication) | D4_ Patient facing document-SK-PP-NRS | 1 |
| Protocol (for publication) | D4_ Patient facing-DE-diary-german-daily-patient | 1 |
| Protocol (for publication) | D4_ Patient facing-DE-diary-german-daily-patient-part-02 | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-bulg-BG-dlqi-ecoa-tablet | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-bulg-BG-ecoa-handheld-privacy-statement | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-bulg-BG-ecoa-handheld-reminder-icon | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-bulg-BG-ecoa-handheld-training-module | 2 |
| Protocol (for publication) | D4_ Patient facing-worksheet-bulg-BG-ecoa-handheld-training-module-optional | 2 |
| Protocol (for publication) | D4_ Patient facing-worksheet-bulg-BG-ecoa-patient-instr | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-bulg-BG-ecoa-tablet-training-module-optional | 2 |
| Protocol (for publication) | D4_ Patient facing-worksheet-bulg-BG-ecoa-tablet-training-module-png | 2 |
| Protocol (for publication) | D4_ Patient facing-worksheet-bulg-BG-facit-fatigue-ecoa-tablet | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-bulg-BG-hads-ecoa-tablet | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-bulg-BG-hisqol-ecoa-tablet | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-bulg-BG-hods-ecoa-tablet | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-bulg-BG-pain-diary-ecoa-handheld | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-bulg-BG-peak-pruritus-nrs-ecoa-handheld | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-bulg-BG-pgi-c-ecoa-tablet | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-bulg-BG-pgi-s-ecoa-tablet | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-cat-ES-ecoa-handheld-patient-instr-screenshot-public | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-cat-ES-ecoa-handheld-training-mod-screenshots-public | 2 |
| Protocol (for publication) | D4_ Patient facing-worksheet-catalan-ES-dlqi-ecoa-tablet-screenshot-public | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-catalan-ES-ecoa-handheld-privacy-st-public | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-catalan-ES-ecoa-handheld-reminder-public | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-catalan-ES-ecoa-handheld-training-screenshots-public | 2 |
| Protocol (for publication) | D4_ Patient facing-worksheet-catalan-ES-ecoa-tablet-training-module-opt-public | 2 |
| Protocol (for publication) | D4_ Patient facing-worksheet-catalan-ES-ecoa-tablet-training-module-public | 2 |
| Protocol (for publication) | D4_ Patient facing-worksheet-catalan-ES-facit-fatigue-ecoa-tablet-public | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-catalan-ES-hads-ecoa-tablet-public | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-catalan-ES-hisqol-ecoa-tablet-public | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-catalan-ES-hods-ecoa-tablet-public | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-catalan-ES-pain-diary-ecoa-handheld-public | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-catalan-ES-peak-pruritus-nrs-ecoa-handheld-public | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-catalan-ES-pgi-c-ecoa-tablet-public | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-catalan-ES-pgi-s-ecoa-tablet-public | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-english-LT-ecoa-patient-instr | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-english-LT-ecoa-training-module | 2 |
| Protocol (for publication) | D4_ Patient facing-worksheet-english-LT-hads-ecoa-tablet | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-gal-ES-ecoa-handheld-patient-instr-screenshots-public | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-gal-ES-ecoa-handheld-privacy-statm-screenshots-public | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-gal-ES-ecoa-handheld-reminder-icon-screenshots-public | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-gal-ES-ecoa-handheld-train-mod-opt-screenshots-public | 2 |
| Protocol (for publication) | D4_ Patient facing-worksheet-gal-ES-ecoa-handheld-training-mod-screenshots-public | 2 |
| Protocol (for publication) | D4_ Patient facing-worksheet-galician-ES-dlqi-ecoa-tablet-screenshots-public | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-galician-ES-dlqi-public | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-galician-ES-ecoa-tablet-training-module-opt-public | 2 |
| Protocol (for publication) | D4_ Patient facing-worksheet-galician-ES-ecoa-tablet-training-module-public | 2 |
| Protocol (for publication) | D4_ Patient facing-worksheet-galician-ES-facit-ecoa tablet-screenshots-public | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-galician-ES-hads-ecoa-tablet-public | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-galician-ES-hisqol-ecoa-tablet-public | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-galician-ES-hods-ecoa-tablet-public | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-galician-ES-pain-diary-ecoa-public | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-galician-ES-peak-pruritis-nrs-ecoa-public | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-galician-ES-pgi-c-ecoa-tablet-public | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-galician-ES-pgi-s-ecoa-tablet-public | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-german-AT-ecoa-dlqi-tablet | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-german-AT-ecoa-facit-tablet | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-german-AT-ecoa-hads-tablet | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-german-AT-ecoa-handheld-patient-instr | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-german-AT-ecoa-handheld-privacy-statement | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-german-AT-ecoa-handheld-reminder | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-german-AT-ecoa-handheld-training-module | 2 |
| Protocol (for publication) | D4_ Patient facing-worksheet-german-AT-ecoa-handheld-training-module-opt | 2 |
| Protocol (for publication) | D4_ Patient facing-worksheet-german-AT-ecoa-hisqol-tablet | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-german-AT-ecoa-hods-tablet | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-german-AT-ecoa-pain-diary-handheld | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-german-AT-ecoa-peak-pruritus-nrs-handheld | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-german-AT-ecoa-pgi-c-tablet | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-german-AT-ecoa-tablet-training-module | 2 |
| Protocol (for publication) | D4_ Patient facing-worksheet-german-AT-ecoa-tablet-training-module-optional | 2 |
| Protocol (for publication) | D4_ Patient facing-worksheet-german-AT-pgi-s-ecoa-tablet | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-german-DE-dlqi-ecoa-tablet-screenshot | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-german-DE-facit-fatigue-ecoa-tablet-screenshots | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-german-DE-facit-fatigue-scale-for-epro | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-german-DE-hads-ecoa-tablet-screenshots | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-german-DE-hisqol-ecoa-tablet-screenshots | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-german-DE-hods-ecoa-tablet-screenshots | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-german-DE-pain-diary-ecoa-handheld-screenshots | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-german-DE-peak-pruritus-ecoa-handheld-screenshots | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-german-DE-pgic-ecoa-tablet-screenshots | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-german-DE-pgis-ecoa-tablet-screenshots | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-lithuanian-LT-dlqi-ecoa-tablet | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-lithuanian-LT-ecoa-handheld-reminder | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-lithuanian-LT-ecoa-privacy-statement | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-lithuanian-LT-ecoa-tablet-training-mod-optional | 2 |
| Protocol (for publication) | D4_ Patient facing-worksheet-lithuanian-LT-ecoa-tablet-training-module | 2 |
| Protocol (for publication) | D4_ Patient facing-worksheet-lithuanian-LT-ecoa-training-module-optional | 2 |
| Protocol (for publication) | D4_ Patient facing-worksheet-lithuanian-LT-facit-fatigue-ecoa-tablet | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-lithuanian-LT-hisqol-ecoa-tablet | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-lithuanian-LT-hods-ecoa-tablet | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-lithuanian-LT-pain-diary-ecoa-handheld | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-lithuanian-LT-peak-pruritus-nrs-ecoa-handheld | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-lithuanian-LT-pgi-c-ecoa-tablet | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-lithuanian-LT-pgi-s-ecoa-tablet | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-slovak-SK-ecoa-handheld-patient-instructions | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-slovak-SK-ecoa-handheld-privacy-statement | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-slovak-SK-ecoa-handheld-reminder-icon | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-slovak-SK-ecoa-handheld-training-mod-optional | 2 |
| Protocol (for publication) | D4_ Patient facing-worksheet-slovak-SK-ecoa-handheld-training-module | 2 |
| Protocol (for publication) | D4_ Patient facing-worksheet-slovak-SK-ecoa-pain-diary-handheld | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-slovak-SK-ecoa-peak-pruritus-nrs-handheld | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-slovak-SK-ecoa-tablet-dlqi | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-slovak-SK-ecoa-tablet-facit-fatigue | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-slovak-SK-ecoa-tablet-hads-ecoa | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-slovak-SK-ecoa-tablet-hisqol | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-slovak-SK-ecoa-tablet-hods | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-slovak-SK-ecoa-tablet-pgi-c | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-slovak-SK-ecoa-tablet-pgi-s | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-slovak-SK-ecoa-tablet-training-module | 2 |
| Protocol (for publication) | D4_ Patient facing-worksheet-slovak-SK-ecoa-tablet-training-optional-mod | 2 |
| Protocol (for publication) | D4_ Patient facing-worksheet-spanish-ES-dlqi-ecoa-tablet-screenshots-public | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-spanish-ES-ecoa-handheld-patient-instructions-public | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-spanish-ES-ecoa-handheld-privacy-statement-public | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-spanish-ES-ecoa-handheld-reminder-public | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-spanish-ES-ecoa-handheld-training-mod-public | 2 |
| Protocol (for publication) | D4_ Patient facing-worksheet-spanish-ES-ecoa-handheld-training-module-opt-1 | 2 |
| Protocol (for publication) | D4_ Patient facing-worksheet-spanish-ES-ecoa-handheld-training-module-opt-2 | 2 |
| Protocol (for publication) | D4_ Patient facing-worksheet-spanish-ES-ecoa-tablet-training-module-opt-public | 2 |
| Protocol (for publication) | D4_ Patient facing-worksheet-spanish-ES-ecoa-tablet-training-module-public | 2 |
| Protocol (for publication) | D4_ Patient facing-worksheet-spanish-ES-facit-fatigue-ecoa-table-public | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-spanish-ES-hads-ecoa-table-public | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-spanish-ES-hisqol-ecoa-table-public | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-spanish-ES-hods-ecoa-tablet-public | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-spanish-ES-pain-diary-ecoa-public | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-spanish-ES-peak-pruritus-nrs-ecoa-public | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-spanish-ES-pgi-c-ecoa-tablet-public | 1 |
| Protocol (for publication) | D4_ Patient facing-worksheet-spanish-ES-pgi-s-ecoa-tablet-public | 1 |
| Protocol (for publication) | D4_Patient facing document-FR-cssrs-baseline-screening | 1 |
| Protocol (for publication) | D4_Patient facing document-FR-cssrs-since-last-visit | 1 |
| Summary of results (for publication) | 1368-0098_EU structured results | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_PT-2022-501074-19-00-public | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis-AT-2022-501074-19-00-ger-public | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis-BE-2022-501074-19-00-dut-public | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis-BE-2022-501074-19-00-fre-public | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis-BE-2022-501074-19-00-ger-public | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis-BG-2022-501074-19-00-bul-public | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis-CZ-2022-501074-19-00-cze-public | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis-DE-2022-501074-19-00-ger-public | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis-DK-2022-501074-19-00-eng-public | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis-ES-2022-501074-19-00-spa-public | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis-FI-2022-501074-19-00-eng-public | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis-FR-2022-501074-19-00-fr-public | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis-FR-2022-501074-19-00-fre-public | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis-GR-2022-501074-19-00-gre-public | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis-IT-2022-501074-19-00-ita-public | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis-LT-2022-501074-19-00-lit-public | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis-NL-2022-501074-19-00-dut-public | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis-NO-2022-501074-19-00-nor-public | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis-PL-2022-501074-19-00-pol-public | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis-PT-2022-501074-19-00-eng-public | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis-SK-2022-501074-19-00-slo-public | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol summary IT 2022-501074-19-00-public | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol summary_AT-2022-501074-19-00-ger-public | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol summary_FR-2022-501074-19-00-fr-public | 1 |
Application history
14 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-01-30 | Finland | Acceptable 2023-05-22
|
2023-05-22 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-07-05 | Acceptable | 2023-08-18 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-07-05 | Acceptable | 2023-07-26 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2023-07-05 | Acceptable | 2023-10-09 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-5 | 2023-07-05 | Acceptable | 2023-08-18 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2023-07-21 | Acceptable | 2023-09-08 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2023-07-21 | 2023-09-25 | ||
| 8 | SUBSTANTIAL MODIFICATION | SM-7 | 2023-07-21 | Acceptable | 2023-09-22 | |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2023-10-20 | Acceptable | 2023-10-20 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-8 | 2024-01-25 | Finland | Acceptable 2024-04-26
|
2024-04-26 |
| 11 | SUBSEQUENT ADDITION OF MSC | APP-11 | 2024-05-29 | Acceptable 2024-04-26
|
2024-08-13 | |
| 12 | SUBSEQUENT ADDITION OF MSC | APP-12 | 2024-05-29 | Acceptable 2024-04-26
|
2024-08-07 | |
| 13 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-02-12 | Finland | Acceptable 2024-04-26
|
2025-02-12 |
| 14 | SUBSTANTIAL MODIFICATION | SM-10 | 2025-03-06 | Finland | Acceptable 2025-05-05
|
2025-05-05 |