Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruitment ended
Participants planned
9
Countries
6
Sites
14
Type 1 interferonopathies
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] - Immune System Diseases [C20]
- Trial duration
- 11 Apr 2025 → ongoing
- Decision date (initial)
- 2025-11-20
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-514942-35-00
- WHO UTN
- U1111-1309-4909
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Type 1 interferonopathies
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
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
Locations
6 EU/EEA countries · 14 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruitment ended | 1 | 1 |
| France | Ongoing, recruitment ended | 2 | 3 |
| Germany | Ongoing, recruitment ended | 2 | 3 |
| Italy | Ongoing, recruitment ended | 1 | 2 |
| Portugal | Ongoing, recruitment ended | 1 | 2 |
| Spain | Ongoing, recruitment ended | 2 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
Hopital Necker Enfants Malades
Centre d'Investigation Clinique, 149 Rue De Sevres, 75015, Paris
Assistance Publique Hopitaux De Paris
Service Médecine Interne, 4 Rue De La Chine, 75020, Paris
Centre Hospitalier Universitaire De Montpellier
Centre d’Investigation Clinique, 80 Avenue Augustin Fliche, 34295, Montpellier Cedex 5
Technische Universitaet Dresden
Klinik und Poliklinik für Dermatologie, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Universitaetsklinikum Tuebingen AöR
Universitäts-Hautklinik, Liebermeisterstrasse 25, Innenstadt, Tuebingen
Medizinische Hochschule Hannover
Klinik für Pädiatrische Pneumologie, Allergologie und Neonatologie, Carl-Neuberg-Strasse 1, Gross Buchholz, Hanover
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
DSCS UO Neuropsichiatria Infantile, Piazzale Spedali Civili 1, 25123, Brescia
Istituto Di Ricovero E Cura A Carattere Scientifico Materno Infantile Burlo Garofolo
SC (UCO) Medicina Clinica, Via Dell' Istria 65/1, 34137, Trieste
Unidade Local De Saude De Santo Antonio E.P.E.
Neurology department, Rua Dom Manuel II 57, 1508, Porto
Unidade Local De Saude De Santa Maria E.P.E.
Serviço Reumatologia, Avenida Professor Egas Moniz, 1649-035, Lisbon
Hospital Universitario La Paz
Reumatología Pediátrica, Paseo De La Castellana 261, 28046, Madrid
University Hospital Virgen Del Rocio S.L.
Pediatría, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Universitari Vall D Hebron
Unidad de enfermedades infecciosas e inmunodeficiencias, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Belgium | 2026-01-09 | 2026-01-26 | 2026-03-05 | ||
| France | 2025-06-10 | 2025-10-21 | 2026-03-05 | ||
| Germany | 2025-06-16 | 2025-08-28 | 2026-03-05 | ||
| Italy | 2025-06-27 | 2026-02-24 | 2026-03-05 | ||
| Portugal | 2025-11-17 | 2025-11-18 | 2026-03-05 | ||
| Spain | 2025-04-11 | 2025-07-29 | 2026-03-05 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-06 | Germany | Acceptable 2025-03-07
|
2025-03-07 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-07-01 | Germany | Acceptable 2025-08-27
|
2025-08-27 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-09-25 | Germany | Acceptable | 2025-10-17 |
| 4 | SUBSEQUENT ADDITION OF MSC | APP-4 | 2025-10-09 | Acceptable 2025-08-27
|
2025-11-20 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-12-10 | Germany | Acceptable | 2025-12-23 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-01-07 | Germany | Acceptable | 2026-01-07 |