Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
143
Countries
3
Sites
9
Eosinophilic esophagitis (EoE)
Key facts
- Sponsor
- Anaptysbio Inc.
- Participant type
- Patients, Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 14 Nov 2025 → ongoing
- Decision date (initial)
- 2025-12-18
- 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
Eosinophilic esophagitis (EoE)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | PT | 10064212 | Eosinophilic oesophagitis | 100000004856 |
| 28.0 | LLT | 10007864 | Celiac disease | 10017947 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Anaptysbio Inc.
- Sponsor organisation
- Anaptysbio Inc.
- Address
- 10770 Wateridge Circle Suite 210
- City
- San Diego
- Postcode
- 92121-5801
- Country
- United States
Scientific contact point
- Organisation
- Anaptysbio Inc.
- Contact name
- Mark Rigby, M.D.
Public contact point
- Organisation
- Anaptysbio Inc.
- Contact name
- Anne Severtson
Locations
3 EU/EEA countries · 9 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Finland | Ongoing, recruiting | 3 | 1 |
| Germany | Ongoing, recruiting | 10 | 5 |
| Netherlands | Ongoing, recruiting | 12 | 3 |
| Rest of world
New Zealand, Australia, Canada, United Kingdom, United States
|
— | 118 | — |
Investigational sites
Pirkanmaan hyvinvointialue
Tutkimusvastaanotto, Biokatu 10, FM 3, 2. krs., Elamanaukio 2, 33520, Tampere
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
N/A, Langenbeckstrasse 1, Oberstadt, Mainz
Universitaetsklinikum Erlangen AöR
N/A, Ulmenweg 18, Innenstadt, Erlangen
University Medical Center Hamburg-Eppendorf
N/A, Martinistrasse 52, Eppendorf, Hamburg
Universitaet Leipzig
Bereich Gastroenterologie, Liebigstrasse 20, Zentrum-Suedost, Leipzig
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
N/A, Ismaninger Strasse 22, Au-Haidhausen, Munich
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 |
|---|---|---|---|---|---|
| Finland | 2026-01-29 | 2026-03-18 | |||
| Germany | 2026-03-04 | 2026-03-18 | |||
| Netherlands | 2025-11-14 | 2026-02-10 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-05-26 | Netherlands | Acceptable 2025-07-23
|
2025-07-24 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-08-13 | Netherlands | Acceptable 2025-08-15
|
2025-08-18 |
| 3 | SUBSEQUENT ADDITION OF MSC | APP-3 | 2025-10-07 | Acceptable 2025-08-15
|
2025-12-18 | |
| 4 | SUBSEQUENT ADDITION OF MSC | APP-4 | 2025-10-07 | 2026-01-13 | ||
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-12-19 | Netherlands | Acceptable | 2026-01-08 |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-02-27 | Netherlands | Acceptable 2026-05-06
|
2026-05-15 |