Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
14
Countries
1
Sites
5
polymyalgia rheumatica
Key facts
- Sponsor
- Sparrow Pharmaceuticals Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Musculoskeletal Diseases [C05]
- Trial duration
- 11 Mar 2024 → 3 Dec 2024
- Decision date (initial)
- 2024-02-20
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-507721-41-00
- WHO UTN
- U1111-1296-6448
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
polymyalgia rheumatica
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | PT | 10036099 | Polymyalgia rheumatica | 100000004859 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Sparrow Pharmaceuticals Inc.
- Sponsor organisation
- Sparrow Pharmaceuticals Inc.
- Address
- 920 Southwest 6th Avenue
- City
- Portland
- Postcode
- 97204-1239
- Country
- United States
Scientific contact point
- Organisation
- Sparrow Pharmaceuticals Inc.
- Contact name
- Scientific contact point
Public contact point
- Organisation
- Sparrow Pharmaceuticals Inc.
- Contact name
- Scientific contact point
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 14 | 5 |
| Rest of world | — | 0 | — |
Investigational sites
Klinische Forschung Hannover-Mitte GmbH
n.a., Schillerstrasse 30, Mitte, Hanover
Klinische Forschung Schwerin GmbH
n.a., Friedrichstrasse 1, Altstadt, Schwerin
Emovis GmbH
n.a., Bezirk Charlottenburg Wilmersdorf, Wilmersdorfer Strasse 79, Berlin
Klinikum der Universitaet Muenchen AöR
Medizinische Klinik und Poliklinik IV, Pettenkoferstrasse 8a, Ludwigsvorstadt-Isarvorstadt, Munich
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
I. Medizinische Klinik und Poliklinik: Rheumatologie und klinische Immunologie, Langenbeckstrasse 1, Oberstadt, Mainz
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 |
|---|---|---|---|---|---|
| Germany | 2024-03-11 | 2024-04-02 | 2024-06-03 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-10-27 | Germany | Acceptable 2024-02-19
|
2024-02-20 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-02-29 | Germany | Acceptable | 2024-04-19 |