Overview
Sponsor-declared trial summary
Phase
Phase II and Phase III (Integrated)
Status
Ended
Participants planned
465
Countries
14
Sites
68
Hidradenitis Suppurativa (HS)
The primary objective of this trial is to assess the long-term safety of spesolimab in participants with HS who have completed approximately 8 to 12 months of spesolimab treatment in Part 1 or Part 2 of trial 1368-0098.
Key facts
- Sponsor
- Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Trial duration
- 27 Jun 2024 → 11 Apr 2025
- Decision date (initial)
- 2024-06-04
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-508377-82-00
- WHO UTN
- U1111-1300-2310
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety
The primary objective of this trial is to assess the long-term safety of spesolimab in participants with HS who have completed approximately 8 to 12 months of spesolimab treatment in Part 1 or Part 2 of trial 1368-0098.
Conditions and MedDRA coding
Hidradenitis Suppurativa (HS)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10020041 | Hidradenitis suppurativa | 10040785 |
Study design 3 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Screening period Screening period
|
2 | Double | [{"id":107828,"code":4,"name":"Analyst"},{"id":107829,"code":1,"name":"Subject"},{"id":107826,"code":5,"name":"Carer"},{"id":107825,"code":3,"name":"Monitor"},{"id":107827,"code":2,"name":"Investigator"}] | All participants: All participants |
| 2 | Treatment period Treatment period
|
2 | Double | [{"id":107831,"code":5,"name":"Carer"},{"id":107834,"code":2,"name":"Investigator"},{"id":107833,"code":3,"name":"Monitor"},{"id":107832,"code":4,"name":"Analyst"},{"id":107835,"code":1,"name":"Subject"}] | Patients treated in Part I of parent trial 1368-0098: Patients treated in Part I of parent trial 1368-0098 Patients treated in Part II of parent trial 1368-0098: Patients treated in Part II of parent trial 1368-0098 |
| 3 | Follow-up period up to 16 weeks from the last administration of spesolimab
|
2 | Double | [{"id":107838,"code":2,"name":"Investigator"},{"id":107841,"code":5,"name":"Carer"},{"id":107839,"code":1,"name":"Subject"},{"id":107837,"code":3,"name":"Monitor"},{"id":107840,"code":4,"name":"Analyst"}] | Patients treated in Part I of parent trial 1368-0098: Patients treated in Part I of parent trial 1368-0098 Patients treated in Part II of parent trial 1368-0098: Patients treated in Part II of parent trial 1368-0098 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Signed and dated written informed consent in accordance with ICH Harmonized Guideline for Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.
- Participants must be within the defined Residual Effect Period corresponding to 16 weeks since last spesolimab administration.
- Participants who have completed treatment in the parent HS spesolimab trial (1368-0098) without premature discontinuation and are willing and able to continue treatment in this trial.
- Woman of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly.
Exclusion criteria 6
- Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
- Use of any drug considered by the investigator likely to interfere with the safe conduct of the trial since the last visit of the parent trials.
- Use of immunomodulatory biologics or investigational agents since the last visit of the parent trials.
- Participants who require / intend to use certain restricted medications such as immunomodulatory biologics or other investigational drugs/devices during the course of the trial.
- Relevant chronic or acute infections including human immunodeficiency virus (HIV) and viral hepatitis. The corresponding laboratory tests will be performed at Visit 1. A participant can be re-screened if the participant was treated and is cured from the acute infection.
- Further exclusion criteria apply.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Occurrence of treatment emergent adverse events (TEAE)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
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
- SUBCUTANEOUS USE
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 76 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- BOEHRINGER INGELHEIM INTERNATIONAL
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
Placebo matching to Spesolimab
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 2
| Organisation | City, country | Duties |
|---|---|---|
| IQVIA RDS Hellas Single Member S.A. ORG-100048380
|
Chalandri, Greece | On site monitoring |
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | On site monitoring |
Boehringer Ingelheim Espana S.A.
- Sponsor organisation
- Boehringer Ingelheim Espana S.A.
- Address
- Carrer Prat De La Riba 50, Sant Cugat Del Valles Sant Cugat Del Valles
- City
- Barcelona
- Postcode
- 08174
- Country
- Spain
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
Sponsor responsibilities
- Article 77 compliance
- Boehringer Ingelheim International GmbH
- Contact point sponsor
- Boehringer Ingelheim International GmbH
- Article 77 implementation
- Boehringer Ingelheim International GmbH
Locations
14 EU/EEA countries · 68 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 | 7 | 4 |
| Greece | Ended | 5 | 4 |
| Italy | Ended | 13 | 13 |
| Lithuania | Ended | 10 | 2 |
| Poland | Ended | 12 | 8 |
| Slovakia | Ended | 3 | 2 |
| Spain | Ended | 12 | 10 |
| Rest of world
Australia, Malaysia, Japan, Chile, Turkey, Vietnam, China, New Zealand, Philippines, United Kingdom, Switzerland, Singapore, United States, Mexico, South Africa, Taiwan, Canada, Argentina, Korea, Republic of, Israel
|
— | 366 | — |
Investigational sites
Klinik Hietzing
Department of Dermatology, Wolkersbergenstrasse 1, Hietzing, Vienna
Medical University Of Vienna
Department of Dermatology, Waehringer Guertel 18-20, Alsergrund, Vienna
Cliniques Universitaires Saint-Luc
Service de Dermatologie, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Centre hospitalier universitaire de Liege
Dermatologie, Avenue De L'hopital 1, 4000, Liege
ASMC IPSMC Skin And Venereal Diseases
Private practice, Ulitsa Persenk 19, Enter B Floor 1 App 13, Sofiya
Dkc Fokus-5 Lzip OOD
NA, Ulitsa Hristo Stanchev 15, 1463, Sofiya
Diagnostic-Consultative Center Alexandrovska EOOD
clinical trial rooms, Triaditsa, Ulitsa Sveti Georgi Sofiyski 1, Sofiya
Military Medical Academy
Department of Skin and Venereal Diseases, Ulitsa Sveti Georgi Sofiyski 3, 1606, Sofiya
Umbal - Prof. D-R Stoyan Kirkovich AD
Clinic of Skin and Venereal Diseases, Ulitsa General Stoletov 2, 6003, Stara Zagora
Medical Center Kordis OOD
Private Practice, Ulitsa Sveti Sveti Kiril I Metodiy 18, 5800, Pleven
Fakultni Nemocnice Kralovske Vinohrady
Department of Dermatovenerology, Srobarova 1150/50, Vinohrady, Prague 10
Fakultni Nemocnice Ostrava
Department of Dermatovenerology, 17. Listopadu 1790/5, Poruba, Ostrava
Fakultni Nemocnice Bulovka
Department of Dermatovenerology, Budinova 67/2, Liben, Prague
Fakultni Nemocnice Plzen
Dermatovenereology Department, Edvarda Benese 1128/13, Jizni Predmesti, Plzen 3
Region Sjaelland
Dermatologisk afdeling, Sygehusvej 10, 4000, Roskilde
Region Midtjylland
Afd. for Hud-og kønssygdomme, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
Region Hovedstaden
Dermato-Venerologisk Afdeling, Bispebjerg Bakke 23, 2400, Copenhagen Nv
Assistance Publique Hopitaux De Marseille
Service Dermatologie, 264 Rue Saint Pierre, 13005, Marseille
Centre Hospitalier Universitaire De Nice
Service de Dermatologie, 151 Route De Saint Antoine, 06200, Nice
Centre Hospitalier Universitaire De Poitiers
Dermatologie, 2 Rue De La Miletrie, 86000, Poitiers
Assistance Publique Hopitaux De Paris
Service de Dermatologie, 1 Avenue Claude Vellefaux, 75010, Paris
Centre Hospitalier Universitaire De Rennes
Service de Dermatologie, 2 Rue Henri Le Guilloux, 35000, Rennes
Hospices Civils De Lyon
Service de Dermatologie, Vénéréologie, 5 Place D Arsonval, 69437, Lyon Cedex 03
Hopital Prive D Antony
Service de Dermatologie, 1 Rue Velpeau, 92160, Antony
Klinikum Oldenburg AöR
Universitätsklinik für Dermatologie und Allergologie, Rahel-Straus-Strasse 10, Kreyenbrueck, Oldenburg
Thermalsole und Schwefelbad Bentheim GmbH
Fachklinik Bad Bentheim, Am Bade 1, 48455, Bad Bentheim
Katholisches Klinikum Bochum gGmbH
St. Josef-Hospital, Gudrunstrasse 56, Grumme, Bochum
Hms GmbH
Ärztehaus Gesundheitscampus, Trierer Strasse 215-217, 66663, Merzig
University General Hospital Attikon
2nd Clinic of Venereal & Dermatological Diseases, Rimini Street 1, 124 62, Athens
Ippokratio General Hospital Of Thessaloniki
Hospital of Skin and Venereal Diseases - 1st Department of Dermatology-Venereology, Delfon 124, 546 43, Thessaloniki
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
Universita' Degli Studi Di Napoli Federico II
Dipartimento di Medicina clinica e Chirurgia, Via Sergio Pansini 5, 80131, Naples
Humanitas Research Hospital
U.O. Dermatologia, Via Alessandro Manzoni 56, 20089, Rozzano
I.F.O. Istituti Fisioterapici Ospitalieri
S.O.C. Dermatologia Clinica, Via Elio Chianesi N 53, 00144, Rome
Fondazione Luigi Maria Monti
DERMATOLOGIA, Roma, Via Dei Monti Di Creta 104, Rome
Azienda Ospedaliero Universitaria Di Modena
Dermatologia, Largo Del Pozzo 71, 41124, Modena
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Dermatologia U, Via Cherasco 15, 10126, Turin
Azienda Ospedaliero Universitaria Pisana
U.O. di Dermatologia, Via Roma 67, 56126, Pisa
Universita' Degli Studi Di Roma La Sapienza
UOC Dermatologia Universitaria, Via Firenze, 04019, Terracina
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
UO Dermatologia, Via Francesco Sforza 28, 20122, Milan
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
UOSD Dermatologia, Via Sergio Pansini 5, 80131, Naples
Azienda Ospedaliera Policlinico Universitario Tor Vergata
U.O.S.D. Dermatologia, Viale Oxford 81, 00133, Rome
Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco Di Catania
DERMATOLOGIA, Via Santa Sofia 78, 95123, Catania
Azienda Ospedaliero Universitaria Delle Marche
NA, Via Conca 71, 60126, Ancona
Vilniaus universiteto ligonine Santaros klinikos VšĮ
Centre of Dermatovenereology, Santariskiu G. 2, Vilniaus M. Sav., Vilnius
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos
Department of Skin and Venereal Diseases, Eiveniu G. 2, Kauno M. Sav., Kaunas
Wromedica I Bielicka A Strzalkowska s.c.
Private practice, Ul. Adama Mickiewicza 91, 51-685, Wroclaw
Provita Poliklinika Sp. z o.o.
Private practice, Baboszewska 1 Lok 2u4, 02-674, Warsaw
Royalderm Agnieszka Nawrocka
Private Practice, Ul. Krzysztofa Kieslowskiego 3b/3, 02-962, Warsaw
Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie
Department of Dermatology, Ul. Fryderyka Szopena 2, 35-055, Rzeszow
Dorota Bystrzanowska High Med Przychodnia Specjalistyczna
Private Practice, Jana Kasprowicza 27/2, 01-817, Warsaw
Termedia Sp. z o.o.
n/a, Ul. Boleslawa Chrobrego 101, 60-681, Poznan
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
Department of Dermatology, Ul. Woloska 137, 02-507, Warsaw
Non-Public Health Care Facility LABDERM
Private Practice, Lesna 2a Str, 42624, Ossy
Sanare spol. s r.o.
Dermatovenerology Department, Mudr. Pribulu 2, 089 01, Svidnik
Fakultna Nemocnica Trnava
Department of Dermatology, Andreja Zarnova 11, 917 02, Trnava
Hospital General Universitario Reina Sofia
Servicio de Dermatología, Avenida Menendez Pidal S/n, 14004, Cordoba
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
Complexo Hospitalario Universitario De Santiago
Servicio de Dermatología, Calle Choupana Da S/n, 15706, Santiago De Compostela
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
Hospital General Universitario Gregorio Maranon
Servicio de Dermatología, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital De Manises
Servicio de Dermatología, Avinguda De La Generalitat Valenciana 50, 46940, Manises
Hospital Universitario 12 De Octubre
Servicio de Dermatología, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital Universitario De Salamanca
Servicio de Dermatología, Paseo De San Vicente 58-182, 37007, Salamanca
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 | 2024-06-27 | 2024-06-27 | |||
| Bulgaria | 2024-08-07 | 2025-03-24 | 2024-08-12 | 2024-11-14 | |
| France | 2024-07-02 | 2025-03-31 | 2024-08-28 | 2024-11-14 | |
| Germany | 2024-06-28 | 2025-03-11 | 2024-08-06 | 2024-11-14 | |
| Lithuania | 2024-07-12 | 2025-03-14 | 2024-08-26 | 2024-11-14 | |
| Poland | 2024-07-22 | 2025-03-23 | 2024-08-25 | 2024-11-14 | |
| Spain | 2024-07-23 | 2025-03-19 | 2024-10-01 | 2024-11-14 |
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 |
|---|---|---|---|
| 1368-0130_EU structured results SUM-125721
|
2026-03-26T13:42:42 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| lay-summary-1368-0130 | 2026-03-26T13:42:51 | Submitted | Laypersons Summary of Results |
Documents 347 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-1368-0130-bulgaria-bulgarian | 1 |
| Laypersons summary of results (for publication) | lay-summary-1368-0130-english | 1 |
| Laypersons summary of results (for publication) | lay-summary-1368-0130-france-french | 1 |
| Laypersons summary of results (for publication) | lay-summary-1368-0130-germany-german | 1 |
| Laypersons summary of results (for publication) | lay-summary-1368-0130-lithuania-lithuanian | 1 |
| Laypersons summary of results (for publication) | lay-summary-1368-0130-poland-polish | 1 |
| Laypersons summary of results (for publication) | lay-summary-1368-0130-spain-spanish | 1 |
| Protocol (for publication) | D1_ Protocol Local Amendment-2023-508377-82-00-public | 2 |
| Protocol (for publication) | D1_ Protocol Local Amendment-CZ-2023-508377-82-00 | 2 |
| Protocol (for publication) | D1_ Protocol Local Amendment-GR-2023-508377-82-00-public | 2 |
| Protocol (for publication) | D1_Protocol 2023-508377-82-00-GR-public | 1 |
| Protocol (for publication) | D1_Protocol 2023-508377-82-00-public | 1 |
| Protocol (for publication) | D4_ Patient facing doc-AT-c-ssrs-baseline-screening | 1 |
| Protocol (for publication) | D4_ Patient facing doc-AT-c-ssrs-since-last-visit | 1 |
| Protocol (for publication) | D4_ Patient facing doc-AT-diary-patient-self-administration-sc-public | 2 |
| Protocol (for publication) | D4_ Patient facing doc-AT-dlqi | 1 |
| Protocol (for publication) | D4_ Patient facing doc-AT-ecoa-handheld-pain-diary | 1 |
| Protocol (for publication) | D4_ Patient facing doc-AT-ecoa-handheld-patient-instructions | 1 |
| Protocol (for publication) | D4_ Patient facing doc-AT-ecoa-handheld-privacy-statement | 1 |
| Protocol (for publication) | D4_ Patient facing doc-AT-ecoa-handheld-training-module | 2 |
| Protocol (for publication) | D4_ Patient facing doc-AT-ecoa-handheld-training-module-opt | 2 |
| Protocol (for publication) | D4_ Patient facing doc-AT-ecoa-tablet-dlqi | 1 |
| Protocol (for publication) | D4_ Patient facing doc-AT-ecoa-tablet-hisqol | 1 |
| Protocol (for publication) | D4_ Patient facing doc-AT-ecoa-tablet-training-module | 2 |
| Protocol (for publication) | D4_ Patient facing doc-AT-ecoa-tablet-training-module-optional | 2 |
| Protocol (for publication) | D4_ Patient facing doc-AT-ecoa-tablet-wpaishp | 1 |
| Protocol (for publication) | D4_ Patient facing doc-AT-hisqol | 1 |
| Protocol (for publication) | D4_ Patient facing doc-AT-pain-diary-daily-hs | 2 |
| Protocol (for publication) | D4_ Patient facing doc-AT-wpaihs | 2 |
| Protocol (for publication) | D4_ Patient facing doc-BE-dut-c-ssrs-baseline-screening | 1 |
| Protocol (for publication) | D4_ Patient facing doc-BE-dut-c-ssrs-since-last-visit | 1 |
| Protocol (for publication) | D4_ Patient facing doc-BE-dut-dlqi | 1 |
| Protocol (for publication) | D4_ Patient facing doc-BE-dut-hisqol | 1 |
| Protocol (for publication) | D4_ Patient facing doc-BE-dut-pain-diary-daily-hs | 2 |
| Protocol (for publication) | D4_ Patient facing doc-BE-dut-pain-patient-diary | 1 |
| Protocol (for publication) | D4_ Patient facing doc-BE-dut-self-administration-questionnaire-public | 2 |
| Protocol (for publication) | D4_ Patient facing doc-BE-dut-wpaihs | 2 |
| Protocol (for publication) | D4_ Patient facing doc-BE-fre-c-ssrs-baseline-screening | 1 |
| Protocol (for publication) | D4_ Patient facing doc-BE-fre-c-ssrs-since-last-visit | 1 |
| Protocol (for publication) | D4_ Patient facing doc-BE-fre-dlqi | 1 |
| Protocol (for publication) | D4_ Patient facing doc-BE-fre-hisqol | 1 |
| Protocol (for publication) | D4_ Patient facing doc-BE-fre-pain-diary-daily-hs | 2 |
| Protocol (for publication) | D4_ Patient facing doc-BE-fre-pain-patient-diary | 1 |
| Protocol (for publication) | D4_ Patient facing doc-BE-fre-self-administration-questionnaire-public | 2 |
| Protocol (for publication) | D4_ Patient facing doc-BE-fre-wpaihs | 2 |
| Protocol (for publication) | D4_ Patient facing doc-BG-c-ssrs-baseline-screening | 1 |
| Protocol (for publication) | D4_ Patient facing doc-BG-c-ssrs-since-last-visit | 1 |
| Protocol (for publication) | D4_ Patient facing doc-BG-diary-patient-self-administration-sc-public | 2 |
| Protocol (for publication) | D4_ Patient facing doc-BG-dlqi | 1 |
| Protocol (for publication) | D4_ Patient facing doc-BG-ecoa-dlqi-tablet | 1 |
| Protocol (for publication) | D4_ Patient facing doc-BG-ecoa-handheld-pain-diary | 1 |
| Protocol (for publication) | D4_ Patient facing doc-BG-ecoa-handheld-patient-instructions | 2 |
| Protocol (for publication) | D4_ Patient facing doc-BG-ecoa-handheld-privacy-statement | 1 |
| Protocol (for publication) | D4_ Patient facing doc-BG-ecoa-handheld-training-module | 2 |
| Protocol (for publication) | D4_ Patient facing doc-BG-ecoa-handheld-training-module-opt | 2 |
| Protocol (for publication) | D4_ Patient facing doc-BG-ecoa-hisqol-tablet | 1 |
| Protocol (for publication) | D4_ Patient facing doc-BG-ecoa-tablet-training-module | 2 |
| Protocol (for publication) | D4_ Patient facing doc-BG-ecoa-tablet-training-optional-module | 2 |
| Protocol (for publication) | D4_ Patient facing doc-BG-hisqol | 1 |
| Protocol (for publication) | D4_ Patient facing doc-BG-pain-diary-daily-hs | 2 |
| Protocol (for publication) | D4_ Patient facing doc-BG-pain-patient-diary | 1 |
| Protocol (for publication) | D4_ Patient facing doc-BG-self-administration-questionnaire-public | 2 |
| Protocol (for publication) | D4_ Patient facing doc-BG-wpaihs | 2 |
| Protocol (for publication) | D4_ Patient facing doc-c-ssrs-baseline-screening | 1 |
| Protocol (for publication) | D4_ Patient facing doc-c-ssrs-since-last-visit | 1 |
| Protocol (for publication) | D4_ Patient facing doc-CZ-c-ssrs-baseline-screening | 1 |
| Protocol (for publication) | D4_ Patient facing doc-CZ-c-ssrs-since-last-visit | 1 |
| Protocol (for publication) | D4_ Patient facing doc-CZ-dlqi | 1 |
| Protocol (for publication) | D4_ Patient facing doc-CZ-ecoa-dlqi | 1 |
| Protocol (for publication) | D4_ Patient facing doc-CZ-ecoa-handheld-pain-diary | 1 |
| Protocol (for publication) | D4_ Patient facing doc-CZ-ecoa-handheld-patient-instructions | 2 |
| Protocol (for publication) | D4_ Patient facing doc-CZ-ecoa-handheld-privacy-statement | 1 |
| Protocol (for publication) | D4_ Patient facing doc-CZ-ecoa-handheld-training-module | 2 |
| Protocol (for publication) | D4_ Patient facing doc-CZ-ecoa-handheld-training-module-opt | 2 |
| Protocol (for publication) | D4_ Patient facing doc-CZ-ecoa-hisqol | 1 |
| Protocol (for publication) | D4_ Patient facing doc-CZ-ecoa-tablet-training-module | 2 |
| Protocol (for publication) | D4_ Patient facing doc-CZ-ecoa-tablet-training-module-opt | 2 |
| Protocol (for publication) | D4_ Patient facing doc-CZ-hisqol | 1 |
| Protocol (for publication) | D4_ Patient facing doc-CZ-pain-diary-daily-hs | 2 |
| Protocol (for publication) | D4_ Patient facing doc-CZ-pain-patient-diary | 1 |
| Protocol (for publication) | D4_ Patient facing doc-CZ-self-administration-questionnaire-public | 2 |
| Protocol (for publication) | D4_ Patient facing doc-CZ-wpaihs | 1 |
| Protocol (for publication) | D4_ Patient facing doc-DE-c-ssrs-baseline-screening | 1 |
| Protocol (for publication) | D4_ Patient facing doc-DE-c-ssrs-since-last-visit | 1 |
| Protocol (for publication) | D4_ Patient facing doc-DE-diary-patient | 1 |
| Protocol (for publication) | D4_ Patient facing doc-DE-dlqi | 1 |
| Protocol (for publication) | D4_ Patient facing doc-DE-ecoa-dlqi | 1 |
| Protocol (for publication) | D4_ Patient facing doc-DE-ecoa-handheld-pain-diary | 1 |
| Protocol (for publication) | D4_ Patient facing doc-DE-ecoa-handheld-privacy-instr | 1 |
| Protocol (for publication) | D4_ Patient facing doc-DE-ecoa-handheld-privacy-statement | 1 |
| Protocol (for publication) | D4_ Patient facing doc-DE-ecoa-handheld-training-module | 2 |
| Protocol (for publication) | D4_ Patient facing doc-DE-ecoa-handheld-training-module-opt | 2 |
| Protocol (for publication) | D4_ Patient facing doc-DE-ecoa-hisqol | 1 |
| Protocol (for publication) | D4_ Patient facing doc-DE-ecoa-tablet-training-module-opt-screenshots | 2 |
| Protocol (for publication) | D4_ Patient facing doc-DE-ecoa-tablet-training-module-screenshots | 2 |
| Protocol (for publication) | D4_ Patient facing doc-DE-hisqol | 1 |
| Protocol (for publication) | D4_ Patient facing doc-DE-self-administration-questionnaire-public | 2 |
| Protocol (for publication) | D4_ Patient facing doc-DE-wpaihs | 2 |
| Protocol (for publication) | D4_ Patient facing doc-DK-c-ssrs-baseline-screening | 1 |
| Protocol (for publication) | D4_ Patient facing doc-DK-c-ssrs-since-last-visit | 1 |
| Protocol (for publication) | D4_ Patient facing doc-DK-diary-danish-patient-epro | 1 |
| Protocol (for publication) | D4_ Patient facing doc-DK-dlqi | 1 |
| Protocol (for publication) | D4_ Patient facing doc-DK-hisqol | 1 |
| Protocol (for publication) | D4_ Patient facing doc-DK-pain-patient-diary | 1 |
| Protocol (for publication) | D4_ Patient facing doc-DK-self-administration-questionnaire-public | 2 |
| Protocol (for publication) | D4_ Patient facing doc-DK-wpaihs | 2 |
| Protocol (for publication) | D4_ Patient facing doc-dlqi | 1 |
| Protocol (for publication) | D4_ Patient facing doc-ecoa-handheld-pain-diary | 1 |
| Protocol (for publication) | D4_ Patient facing doc-ecoa-handheld-patient-instructions | 1 |
| Protocol (for publication) | D4_ Patient facing doc-ecoa-handheld-privacy-statement | 1 |
| Protocol (for publication) | D4_ Patient facing doc-ecoa-handheld-training-module | 1 |
| Protocol (for publication) | D4_ Patient facing doc-ecoa-handheld-training-module-opt | 2 |
| Protocol (for publication) | D4_ Patient facing doc-ecoa-tablet-dlqi | 1 |
| Protocol (for publication) | D4_ Patient facing doc-ecoa-tablet-hisqol | 1 |
| Protocol (for publication) | D4_ Patient facing doc-ecoa-tablet-training-module | 1 |
| Protocol (for publication) | D4_ Patient facing doc-ecoa-tablet-training-module-opt | 2 |
| Protocol (for publication) | D4_ Patient facing doc-ecoa-tablet-wpaishp | 1 |
| Protocol (for publication) | D4_ Patient facing doc-ES-c-ssrs-baseline-screening | 1 |
| Protocol (for publication) | D4_ Patient facing doc-ES-c-ssrs-since-last-visit | 1 |
| Protocol (for publication) | D4_ Patient facing doc-ES-diary-patient-for-epro | 1 |
| Protocol (for publication) | D4_ Patient facing doc-ES-diary-patient-for-self-administration-public | 2 |
| Protocol (for publication) | D4_ Patient facing doc-ES-dlqi | 1 |
| Protocol (for publication) | D4_ Patient facing doc-ES-ecoa-dlqi-public | 1 |
| Protocol (for publication) | D4_ Patient facing doc-ES-ecoa-handheld-patient-instructions-public | 2 |
| Protocol (for publication) | D4_ Patient facing doc-ES-ecoa-handheld-privacy-statement-public | 1 |
| Protocol (for publication) | D4_ Patient facing doc-ES-ecoa-handheld-training-module-opt-public | 2 |
| Protocol (for publication) | D4_ Patient facing doc-ES-ecoa-handheld-training-module-public | 2 |
| Protocol (for publication) | D4_ Patient facing doc-ES-ecoa-tablet-training-module-opt-public | 2 |
| Protocol (for publication) | D4_ Patient facing doc-ES-ecoa-tablet-training-module-public | 1 |
| Protocol (for publication) | D4_ Patient facing doc-ES-hisqol | 1 |
| Protocol (for publication) | D4_ Patient facing doc-ES-hisqol-ecoa-tablet-public | 1 |
| Protocol (for publication) | D4_ Patient facing doc-ES-pain-diary-daily-hs | 2 |
| Protocol (for publication) | D4_ Patient facing doc-ES-paindiary-ecoa-handheld-public | 1 |
| Protocol (for publication) | D4_ Patient facing doc-ES-wpaihs | 2 |
| Protocol (for publication) | D4_ Patient facing doc-FI-c-ssrs-baseline-screening | 1 |
| Protocol (for publication) | D4_ Patient facing doc-FI-c-ssrs-since-last-visit | 1 |
| Protocol (for publication) | D4_ Patient facing doc-FI-diary-patient-for-epro | 1 |
| Protocol (for publication) | D4_ Patient facing doc-FI-dlqi | 1 |
| Protocol (for publication) | D4_ Patient facing doc-FI-hisqol | 1 |
| Protocol (for publication) | D4_ Patient facing doc-FI-pain-diary-daily-hs | 2 |
| Protocol (for publication) | D4_ Patient facing doc-FI-self-administration-questionnaire-public | 2 |
| Protocol (for publication) | D4_ Patient facing doc-FI-wpaihs | 2 |
| Protocol (for publication) | D4_ Patient facing doc-FR-c-ssrs-baseline-screening | 1 |
| Protocol (for publication) | D4_ Patient facing doc-FR-c-ssrs-since-last-visit | 1 |
| Protocol (for publication) | D4_ Patient facing doc-FR-dlqi | 1 |
| Protocol (for publication) | D4_ Patient facing doc-FR-hisqol | 1 |
| Protocol (for publication) | D4_ Patient facing doc-FR-pain-patient-diary | 1 |
| Protocol (for publication) | D4_ Patient facing doc-FR-self-administration-questionnaire-public | 2 |
| Protocol (for publication) | D4_ Patient facing doc-FR-wpaihs | 2 |
| Protocol (for publication) | D4_ Patient facing doc-GR-c-ssrs-baseline-screening | 1 |
| Protocol (for publication) | D4_ Patient facing doc-GR-c-ssrs-since-last-visit | 1 |
| Protocol (for publication) | D4_ Patient facing doc-GR-diary-greek-patient-for-epro | 1 |
| Protocol (for publication) | D4_ Patient facing doc-GR-dlqi | 1 |
| Protocol (for publication) | D4_ Patient facing doc-GR-hisqol | 1 |
| Protocol (for publication) | D4_ Patient facing doc-GR-pain-patient-diary | 1 |
| Protocol (for publication) | D4_ Patient facing doc-GR-self-administration-questionnaire-public | 2 |
| Protocol (for publication) | D4_ Patient facing doc-GR-wpaihs | 2 |
| Protocol (for publication) | D4_ Patient facing doc-hisqol | 1 |
| Protocol (for publication) | D4_ Patient facing doc-IT-c-ssrs-baseline-screening | 1 |
| Protocol (for publication) | D4_ Patient facing doc-IT-c-ssrs-since-last-visit | 1 |
| Protocol (for publication) | D4_ Patient facing doc-IT-dlqi | 1 |
| Protocol (for publication) | D4_ Patient facing doc-IT-ecoa-dlqi | 1 |
| Protocol (for publication) | D4_ Patient facing doc-IT-ecoa-handheld-pain-diary | 1 |
| Protocol (for publication) | D4_ Patient facing doc-IT-ecoa-handheld-privacy-statement | 1 |
| Protocol (for publication) | D4_ Patient facing doc-IT-ecoa-handheld-training-module | 2 |
| Protocol (for publication) | D4_ Patient facing doc-IT-ecoa-handheld-training-module-opt | 2 |
| Protocol (for publication) | D4_ Patient facing doc-IT-ecoa-hisqol | 1 |
| Protocol (for publication) | D4_ Patient facing doc-IT-ecoa-tablet-training-module-opt-screenshots | 2 |
| Protocol (for publication) | D4_ Patient facing doc-IT-ecoa-tablet-training-module-screenshots | 2 |
| Protocol (for publication) | D4_ Patient facing doc-IT-hisqol | 1 |
| Protocol (for publication) | D4_ Patient facing doc-IT-pain-diary-daily | 2 |
| Protocol (for publication) | D4_ Patient facing doc-IT-self-administration-questionnaire-public | 2 |
| Protocol (for publication) | D4_ Patient facing doc-IT-wpaihs | 1 |
| Protocol (for publication) | D4_ Patient facing doc-LT-c-ssrs-baseline-screening | 1 |
| Protocol (for publication) | D4_ Patient facing doc-LT-c-ssrs-since-last-visit | 1 |
| Protocol (for publication) | D4_ Patient facing doc-LT-dlqi | 1 |
| Protocol (for publication) | D4_ Patient facing doc-LT-ecoa-dlqi | 1 |
| Protocol (for publication) | D4_ Patient facing doc-LT-ecoa-handheld-pain-diary | 1 |
| Protocol (for publication) | D4_ Patient facing doc-LT-ecoa-handheld-patient-instructions | 3 |
| Protocol (for publication) | D4_ Patient facing doc-LT-ecoa-handheld-privacy-statement | 1 |
| Protocol (for publication) | D4_ Patient facing doc-LT-ecoa-handheld-training-module | 2 |
| Protocol (for publication) | D4_ Patient facing doc-LT-ecoa-handheld-training-module-opt | 2 |
| Protocol (for publication) | D4_ Patient facing doc-LT-ecoa-hisqol | 1 |
| Protocol (for publication) | D4_ Patient facing doc-LT-ecoa-tablet-training-module | 2 |
| Protocol (for publication) | D4_ Patient facing doc-LT-ecoa-tablet-training-module-opt | 2 |
| Protocol (for publication) | D4_ Patient facing doc-LT-hisqol | 1 |
| Protocol (for publication) | D4_ Patient facing doc-LT-pain-diary-daily-hs | 2 |
| Protocol (for publication) | D4_ Patient facing doc-LT-patient-diary | 1 |
| Protocol (for publication) | D4_ Patient facing doc-LT-self-administration-questionnaire-public | 2 |
| Protocol (for publication) | D4_ Patient facing doc-LT-wpaihs | 1 |
| Protocol (for publication) | D4_ Patient facing doc-memo-for-re-use-of-screenshots | 1 |
| Protocol (for publication) | D4_ Patient facing doc-pain-diary-daily-hs | 2 |
| Protocol (for publication) | D4_ Patient facing doc-pain-patient-diary | 1 |
| Protocol (for publication) | D4_ Patient facing doc-PL-self-administration-questionnaire-public | 2 |
| Protocol (for publication) | D4_ Patient facing doc-self-administration-questionnaire-public | 2 |
| Protocol (for publication) | D4_ Patient facing doc-SK-c-ssrs-baseline-screening | 1 |
| Protocol (for publication) | D4_ Patient facing doc-SK-c-ssrs-since-last-visit | 1 |
| Protocol (for publication) | D4_ Patient facing doc-SK-diary-self-admin | 2 |
| Protocol (for publication) | D4_ Patient facing doc-SK-dlqi | 1 |
| Protocol (for publication) | D4_ Patient facing doc-SK-ecoa-dlqi | 1 |
| Protocol (for publication) | D4_ Patient facing doc-SK-ecoa-handheld-optional-training-module | 2 |
| Protocol (for publication) | D4_ Patient facing doc-SK-ecoa-handheld-patient-instructions | 2 |
| Protocol (for publication) | D4_ Patient facing doc-SK-ecoa-handheld-privacy-statement | 1 |
| Protocol (for publication) | D4_ Patient facing doc-SK-ecoa-handheld-training-module | 2 |
| Protocol (for publication) | D4_ Patient facing doc-SK-ecoa-hisqol | 1 |
| Protocol (for publication) | D4_ Patient facing doc-SK-ecoa-tablet-training-module | 2 |
| Protocol (for publication) | D4_ Patient facing doc-SK-ecoa-tablet-training-module-opt | 2 |
| Protocol (for publication) | D4_ Patient facing doc-SK-hisqol | 1 |
| Protocol (for publication) | D4_ Patient facing doc-SK-pain-diary-daily-hs | 2 |
| Protocol (for publication) | D4_ Patient facing doc-SK-pain-patient-diary | 1 |
| Protocol (for publication) | D4_ Patient facing doc-SK-wpaihs | 2 |
| Protocol (for publication) | D4_ Patient facing doc-wpaihs | 2 |
| Protocol (for publication) | D4_ Patient facing document-BG-wpaishp-ecoa-tablet | 1 |
| Protocol (for publication) | D4_ Patient facing document-CZ-wpaishp-ecoa-tablet | 1 |
| Protocol (for publication) | D4_ Patient facing document-ES-wpaishp-ecoa-tablet-public | 1 |
| Protocol (for publication) | D4_ Patient facing document-FR-ecoa-handheld-patient-instructions | 2 |
| Protocol (for publication) | D4_ Patient facing document-IT-instructions-handheld-ecoa-screenshots | 2 |
| Protocol (for publication) | D4_ Patient facing document-IT-wpaishh-ecoa-tablet-screenshots | 1 |
| Protocol (for publication) | D4_ Patient facing document-LT-wpaishp-ecoa-tablet-screenshots | 1 |
| Protocol (for publication) | D4_ Patient facing document-SK-wpaishp-ecoa-tablet | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements-additional-document-FR-public | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements-AT-placeholder | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements-BE-placeholder | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements-BG-placeholder | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements-CZ-placeholder | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements-DE-placeholder | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements-DK-placeholder | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements-FR-placeholder | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements-GR-placeholder | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements-IT-placeholder | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements-LT-placeholder | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements-PL-placeholder | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements-SK-placeholder | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF-AT-public | 3 |
| Subject information and informed consent form (for publication) | L1_ ICF-BE-dut-public | 2 |
| Subject information and informed consent form (for publication) | L1_ ICF-BE-eng-public | 2 |
| Subject information and informed consent form (for publication) | L1_ ICF-BE-fre-public | 2 |
| Subject information and informed consent form (for publication) | L1_ ICF-BG-bulg-public | 2 |
| Subject information and informed consent form (for publication) | L1_ ICF-BG-eng-global-public | 2 |
| Subject information and informed consent form (for publication) | L1_ ICF-BG-eng-public | 2 |
| Subject information and informed consent form (for publication) | L1_ ICF-CZ-czech-public | 3 |
| Subject information and informed consent form (for publication) | L1_ ICF-CZ-english-main | 2 |
| Subject information and informed consent form (for publication) | L1_ ICF-CZ-main-highlighted-for-already-enrolled-patients | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF-DE-newborn-public | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF-DE-public | 3 |
| Subject information and informed consent form (for publication) | L1_ ICF-DK-public | 3 |
| Subject information and informed consent form (for publication) | L1_ ICF-FR-public | 3 |
| Subject information and informed consent form (for publication) | L1_ ICF-gdrp-SK | 2 |
| Subject information and informed consent form (for publication) | L1_ ICF-GR-public | 2 |
| Subject information and informed consent form (for publication) | L1_ ICF-IT-public | 3 |
| Subject information and informed consent form (for publication) | L1_ ICF-LT-public | 3 |
| Subject information and informed consent form (for publication) | L1_ ICF-main-gdpr-CZ-czech | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF-PL-public | 3 |
| Subject information and informed consent form (for publication) | L1_ ICF-SK-pregnant-participant | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF-SK-public | 2 |
| Subject information and informed consent form (for publication) | L2_ EU-ctr-investigator-list-AT | 4 |
| Subject information and informed consent form (for publication) | L2_ Other SK-birthday-card | 1 |
| Subject information and informed consent form (for publication) | L2_ Other SK-patient-leaflet | 2 |
| Subject information and informed consent form (for publication) | L2_ Other SK-remind-card | 1 |
| Subject information and informed consent form (for publication) | L2_ Other SK-storage-and-dispensing | 1 |
| Subject information and informed consent form (for publication) | L2_ Other SK-thanks-postcard | 1 |
| Subject information and informed consent form (for publication) | L2_ Other SK-trial-id-card | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject info-AT-diary-english-lionbridge-memo-for-signant | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject info-AT-diary-german-participant-training-guide | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject info-AT-diary-german-vtl-patient-facing-mobile | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject info-AT-diary-german-vtl-patient-facing-screenshots-web-platform | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject info-AT-diary-german-vtl-patient-facing-sms-messaging | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject info-birthday-card-IT | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject info-CZ-participant-training-guide | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject info-CZ-vtl-patient-facing-mobile | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject info-CZ-vtl-patient-facing-web | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject info-CZ-vtl-sms-messaging-patient-facing | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject info-instruccions-for-use-pfs-FR-public | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject info-instruccions-for-use-pfs-GR | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject info-instructions-for-use-pfs-IT | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject info-LT-participant-training-guide | 2 |
| Subject information and informed consent form (for publication) | L2_ Other subject info-LT-vtl-patient-facing-mobile | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject info-LT-vtl-patient-facing-web | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject info-LT-vtl-sms-messaging-patient-facing | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject info-patient-leaflet-for-self-administration-GR | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject info-patient-leaflet-for-self-administration-IT | 2 |
| Subject information and informed consent form (for publication) | L2_ Other subject info-reminder-card | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject info-study-remind-card-FR | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material-birthday-card-AT | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material-birthday-card-CZ | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material-leaflet-CZ-public | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material-patient-leaflet-AT-public | 2 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material-patient-leaflet-DK | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material-remind-card-AT | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material-remind-card-CZ | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material-storage-and-dispensing-AT-public | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material-storage-and-dispensing-DK | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material-thanks-postcard-AT | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material-thanks-postcard-CZ | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material-trial-id-local-AT-public | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material-use-instructions-CZ-public | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information-BE-dut-patient-leaflet-for-self-administration | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information-BE-fre-patient-leaflet-for-self-administration | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information-gp-letter-IT-public | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information-instr-for-use-pfs-BE-dut | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information-instr-for-use-pfs-BE-fre | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information-patient-leaflet-BG-public | 2 |
| Subject information and informed consent form (for publication) | L2_ Other subject information-patient-leaflet-for-self-administration-DK | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information-patient-leaflet-PL-public | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information-trial-id-card-BG-public | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information-trial-id-card-PL-public | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information-trialidcard-IT-public | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information-use-instructions-BG-public | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information-use-instructions-PL-public | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject-info-patient-leaflet-for-self-administration-FR-public | 2 |
| Subject information and informed consent form (for publication) | L2_ Other-DE-instructions-for-use-sc-pfs-for-patients-public | 1 |
| Subject information and informed consent form (for publication) | L2_ Other-DE-patient-birthday-card | 1 |
| Subject information and informed consent form (for publication) | L2_ Other-DE-patient-leaflet-for-self-administration-public | 2 |
| Subject information and informed consent form (for publication) | L2_ Other-DE-patient-thank-you-postcard | 1 |
| Subject information and informed consent form (for publication) | L2_ Other-DE-prr-mock-up-design-layout-for-id-card | 1 |
| Subject information and informed consent form (for publication) | L2_ Other-DE-prr-mock-up-design-layout-for-informed-consent-forms-grey | 1 |
| Subject information and informed consent form (for publication) | L2_ Other-DE-prr-mock-up-design-layout-informed-consent-forms | 1 |
| Subject information and informed consent form (for publication) | L2_ Other-DE-submission-process-description | 2 |
| Subject information and informed consent form (for publication) | L2_ Other-DE-trial-id-card-local-public | 1 |
| Subject information and informed consent form (for publication) | L2_ Other-DE-visit-reminder-card | 1 |
| Subject information and informed consent form (for publication) | L2_ Other-LT-birthday-card | 1 |
| Subject information and informed consent form (for publication) | L2_ Other-LT-instructions-for-use-spesolimab-pfs-public | 1 |
| Subject information and informed consent form (for publication) | L2_ Other-LT-patient-leaflet-for-self-administration-public | 2 |
| Subject information and informed consent form (for publication) | L2_ Other-LT-remind-card | 1 |
| Subject information and informed consent form (for publication) | L2_ Other-LT-thanks-postcard | 1 |
| Subject information and informed consent form (for publication) | L2_ Other-LT-trial-id-card-local | 1 |
| Summary of results (for publication) | 1368-0130_EU structured results | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol summary_AT-2023-508377-82-00-public | 3 |
| Synopsis of the protocol (for publication) | D1_ Protocol summary_CZ-2023-508377-82-00-public | 2 |
| Synopsis of the protocol (for publication) | D1_ Protocol summary_IT-2023-508377-82-00-public | 3 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_2023-508377-82-00-public | 2 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_AT-2023-508377-82-00-public | 2 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_BE-dut-2023-508377-82-00-public | 2 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_BE-fre-2023-508377-82-00-public | 2 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_BE-ger-2023-508377-82-00-public | 2 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_BG-2023-508377-82-00-public | 2 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_CZ-2023-508377-82-00-public | 2 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_DE-2023-508377-82-00-public | 2 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_DK-2023-508377-82-00-public | 2 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_ES-2023-508377-82-00-public | 2 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_FI-2023-508377-82-00-public | 2 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_FR-2023-508377-82-00-public | 2 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_GR-2023-508377-82-00-public | 2 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_IT-2023-508377-82-00-public | 2 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_LT-2023-508377-82-00-public | 2 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_PL-2023-508377-82-00-public | 2 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_SK-2023-508377-82-00-public | 2 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-15 | Finland | Acceptable 2024-06-03
|
2024-06-03 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-06-28 | Acceptable 2024-06-03
|
2024-06-28 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-07-17 | Finland | Acceptable 2024-09-10
|
2024-09-10 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-02-11 | Finland | Acceptable 2024-09-10
|
2025-02-11 |