Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
156
Countries
2
Sites
9
Atopic Dermatitis
Key facts
- Sponsor
- Yellow Jersey Therapeutics AG
- Participant type
- Patients, Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Trial duration
- 7 Dec 2023 → 2 Oct 2024
- Decision date (initial)
- 2023-09-15
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-503577-38-00
- ClinicalTrials.gov
- NCT05859724
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Atopic Dermatitis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10003639 | Atopic dermatitis | 10040785 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Yellow Jersey Therapeutics AG
- Sponsor organisation
- Yellow Jersey Therapeutics AG
- Address
- Gubelstrasse 34
- City
- Zug
- Postcode
- 6300
- Country
- Switzerland
Scientific contact point
- Organisation
- Yellow Jersey Therapeutics AG
- Contact name
- Yellow Jersey Therapeutics Clinical Trials
Public contact point
- Organisation
- Yellow Jersey Therapeutics AG
- Contact name
- Yellow Jersey Therapeutics Clinical Trials
Locations
2 EU/EEA countries · 9 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 6 | 5 |
| Poland | Ended | 8 | 4 |
| Rest of world
Canada, United States
|
— | 142 | — |
Investigational sites
Universitaetsklinikum Bonn AöR
#4905:Klinik und Poliklinik für Dermatologie und Allergologie Klinisches Studienzentrum Dermatologie, Venusberg-Campus 1, Venusberg, Bonn
Technische Universitat Dresden
#4901:Dermatology, Venereology & Allergologie, Fetscherstrasse 74, Johannstadt-Nord, Dresden
University Medical Centre Schleswig-Holstein
#4904:Institut für Entzündungsmedizin, Ratzeburger Allee 160, 23538, Lübeck
Universitaetsmedizin Der Johannes Gutenberg-Universitaet Mainz
#4903:Dermatology, Langenbeckstrasse 1, Oberstadt, Mainz
Universitaetsklinikum Frankfurt AöR
#4902:Dermatology, Venereology & Allergologie, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
Klinika Ambroziak Sp. z o.o.
#4801: NA, Ul. Ulica Kosiarzy 9a, 02-953, Warsaw
Copernicus Podmiot Leczniczy Sp. z o.o.
#4804:Oddzial Dermatologii, Al. Jana Pawla II 50, 80-462, Gdansk
Uniwersytecki Szpital Kliniczny Im. Fryderyka Chopina W Rzeszowie
#4802:Klinika Dermatologii, Ul. Fryderyka Szopena 2, 35-055, Rzeszow
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
#4803:Klinika Dermatologii, Ul. Woloska 137, 02-507, Warsaw
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 | 2023-12-07 | 2024-06-04 | 2024-07-15 | ||
| Poland | 2023-12-12 | 2024-01-29 | 2024-05-14 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-05-22 | Germany | Acceptable 2023-09-11
|
2023-09-15 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-09-27 | Germany | Acceptable 2023-11-13
|
2023-11-15 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-02-02 | Germany | Acceptable 2024-03-18
|
2024-03-22 |
| 4 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-10-11 | Germany | Acceptable 2024-11-25
|
2024-11-29 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-12-05 | Germany | Acceptable 2024-11-25
|
2024-12-05 |