Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
62
Countries
4
Sites
11
Polymyalgia rheumatica (PMR)
Key facts
- Sponsor
- Novartis Pharma AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Musculoskeletal Diseases [C05]
- Trial duration
- 6 Jun 2024 → 3 Apr 2025
- Decision date (initial)
- 2024-05-03
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-507667-19-00
- ClinicalTrials.gov
- NCT06130540
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Polymyalgia rheumatica (PMR)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | SOC | 10028395 | Musculoskeletal and connective tissue disorders | 17 |
| 23.1 | PT | 10018250 | Giant cell arteritis | 10047065 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Novartis Pharma AG
- Sponsor organisation
- Novartis Pharma AG
- Address
- Lichtstrasse 35
- City
- Basel Town
- Postcode
- 4056
- Country
- Switzerland
Scientific contact point
- Organisation
- Novartis Pharma AG
- Contact name
- Novartis Pharma Arzneimittel GmbH
Public contact point
- Organisation
- Novartis Pharma AG
- Contact name
- Novartis Pharma Arzneimittel GmbH
Locations
4 EU/EEA countries · 11 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Ended | 4 | 3 |
| Italy | Ended | 10 | 4 |
| Portugal | Ended | 4 | 1 |
| Spain | Ended | 6 | 3 |
| Rest of world
United States, Switzerland
|
— | 38 | — |
Investigational sites
Fakultni Nemocnice Brno
2001: Revmatologická ambulance, Jihlavska 340/20, Bohunice, Brno
Revmacentrum MUDr. Mostera s.r.o.
#2004 : Revmatologie, Mosnova 2476/8, Zidenice, Brno-Zidenice
Medical Plus s.r.o.
#2003: Revmatologie, Obchodni 1507, 686 01, Uherske Hradiste
Azienda USL IRCCS Di Reggio Emilia
2051:U. O. Reumatologia, Viale Risorgimento 80, 42123, Reggio Emilia
Centro Ricerche Cliniche Di Verona S.r.l.
2053: U.O.C. di Reumatologia, Piazzale Ludovico Antonio Scuro 10, 37134, Verona
Careggi University Hospital
2052:S. O.D. Reumatologia, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
2054:Unità di Fase I - FI/112, Piazzale Spedali Civili 1, 25123, Brescia
Unidade Local De Saude De Santa Maria E.P.E.
2101: Serviço de Reumatologia, Avenida Professor Egas Moniz, 1649-035, Lisbon
Hospital General Universitario Gregorio Maranon
2154: Rheumatology Department, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital Universitario La Paz
2151: Rheumatology Department, Paseo Castellana 261, 28046, Madrid
Complexo Hospitalario Universitario De Santiago
2152 : Rheumatology Department, Calle Choupana Da S/n, 15706, Santiago De Compostela
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 |
|---|---|---|---|---|---|
| Czechia | 2024-10-09 | 2025-02-11 | 2024-10-09 | 2024-12-18 | |
| Italy | 2024-09-11 | 2025-01-14 | 2024-09-11 | 2024-12-18 | |
| Portugal | 2024-07-01 | 2025-02-25 | 2024-07-01 | 2024-12-18 | |
| Spain | 2024-06-06 | 2025-04-02 | 2024-06-06 | 2024-12-18 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-01-15 | Czechia | Acceptable with conditions 2024-05-03
|
2024-05-03 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-06-14 | Czechia | Acceptable with conditions 2024-05-03
|
2024-06-14 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-06-21 | Acceptable with conditions 2024-05-03
|
2024-06-21 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-06-25 | Acceptable with conditions | 2024-08-09 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-06-27 | Czechia | Acceptable with conditions | 2024-08-30 |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-11-18 | Czechia | Acceptable 2025-01-30
|
2025-01-30 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-02-14 | Czechia | Acceptable 2025-01-30
|
2025-02-14 |