Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
30
Countries
3
Sites
7
Chronic Inducible Urticaria
Key facts
- Sponsor
- Escient Pharmaceuticals Inc.
- 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
- 23 Feb 2024 → 23 Oct 2024
- Decision date (initial)
- 2023-12-04
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Chronic Inducible Urticaria
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10009870 | Cold-induced urticaria | 10040785 |
| 23.0 | LLT | 10012499 | Dermatographic urticaria | 10040785 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Escient Pharmaceuticals Inc.
- Sponsor organisation
- Escient Pharmaceuticals Inc.
- Address
- 10578 Science Center Drive Suite 250
- City
- San Diego
- Postcode
- 92121-1147
- Country
- United States
Scientific contact point
- Organisation
- Escient Pharmaceuticals Inc.
- Contact name
- Clinical Trial Information
Public contact point
- Organisation
- Escient Pharmaceuticals Inc.
- Contact name
- Clinical Trial Information
Locations
3 EU/EEA countries · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 8 | 4 |
| Netherlands | Ended | 2 | 1 |
| Spain | Ended | 4 | 2 |
| Rest of world
Canada, United States
|
— | 16 | — |
Investigational sites
Universitaetsmedizin Der Johannes Gutenberg-Universitaet Mainz Koerperschaft Des Offentlichen Rechts
Dermatology, Langenbeckstrasse 1, Oberstadt, Mainz
Medizinische Hochschule Hannover
Dermatology, Carl-Neuberg-Strasse 1, Gross Buchholz, Hanover
Technische Universitat Dresden
Dermatology, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Charite Universitaetsmedizin Berlin KöR
Dermatology, Hindenburgdamm 30, Lichterfelde, Berlin
Centre for Human Drug Research
Dermatology, Zernikedreef 8, 2333 CL, Leiden
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 | 2024-02-23 | 2024-10-22 | 2024-02-23 | 2024-07-30 | |
| Netherlands | 2024-02-29 | 2024-08-01 | 2024-02-29 | 2024-07-30 | |
| Spain | 2024-03-12 | 2024-09-09 | 2024-03-12 | 2024-07-30 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-09-05 | Germany | Acceptable 2023-11-22
|
2023-12-04 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-12-19 | Acceptable | 2024-01-24 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-02-15 | Germany | Acceptable 2024-03-25
|
2024-03-26 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-04-18 | Germany | Acceptable 2024-07-15
|
2024-07-16 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-08-22 | Germany | Acceptable 2024-07-15
|
2024-08-22 |