Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
16
Countries
1
Sites
2
Mild to Moderate Asthma
Key facts
- Sponsor
- Aclaris Therapeutics Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08]
- Trial duration
- 4 May 2026 → ongoing
- Decision date (initial)
- 2026-04-16
- 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
Mild to Moderate Asthma
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Aclaris Therapeutics Inc.
- Sponsor organisation
- Aclaris Therapeutics Inc.
- Address
- 701 Lee Road Suite 103
- City
- Chesterbrook
- Postcode
- 19087-5612
- Country
- United States
Scientific contact point
- Organisation
- Aclaris Therapeutics Inc.
- Contact name
- Aclaris Lead Clinical Development Physician
Public contact point
- Organisation
- Aclaris Therapeutics Inc.
- Contact name
- Aclaris Clinical Trial Information Desk
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruiting | 10 | 2 |
| Rest of world
United States
|
— | 6 | — |
Investigational sites
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 | 2026-05-04 | 2026-05-04 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-01-23 | Germany | Acceptable 2026-04-14
|
2026-04-16 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-05-29 | Germany | Acceptable | 2026-06-03 |