Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - First administration to humans
Status
Ended
Participants planned
97
Countries
3
Sites
11
Idiopathic pulmonary fibrosis
Key facts
- Sponsor
- Arrowhead Pharmaceuticals Inc.
- Participant type
- Healthy volunteers, Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08]
- Trial duration
- 6 Nov 2024 → 6 Oct 2025
- Decision date (initial)
- 2023-10-09
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-504964-41-00
- WHO UTN
- U1111-1281-3043
- ClinicalTrials.gov
- NCT05537025
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Idiopathic pulmonary fibrosis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10021240 | Idiopathic pulmonary fibrosis | 100000004855 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Arrowhead Pharmaceuticals Inc.
- Sponsor organisation
- Arrowhead Pharmaceuticals Inc.
- Address
- 177 East Colorado Boulevard Suite 700
- City
- Pasadena
- Postcode
- 91105-1976
- Country
- United States
Scientific contact point
- Organisation
- Arrowhead Pharmaceuticals Inc.
- Contact name
- Medical Department
Public contact point
- Organisation
- Arrowhead Pharmaceuticals Inc.
- Contact name
- Regulatory Unit
Locations
3 EU/EEA countries · 11 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ended | 2 | 2 |
| Italy | Ended | 6 | 6 |
| Spain | Ended | 7 | 3 |
| Rest of world
New Zealand, United Kingdom
|
— | 82 | — |
Investigational sites
Odense University Hospital
Respiratory Medicine, Indgang 87-88, Kloevervaenget 2, Odense C
Rigshospitalet
Pneumology Service - Lung transplantation section, Blegdamsvej 9, 2100, Copenhagen Oe
Azienda Ospedaliera Dei Colli
Clinical Medecine and Surgery, Via Leonardo Bianchi, 80131, Naples
Careggi University Hospital
Interventional Pulmonology Unit, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
UOC of Bronchopneumology, Via Francesco Sforza 28, 20122, Milan
Ospedale Giovan Battista Morgagni-Luigi Pierantoni Di Forlì
Pneumology Unit, Via Carlo Forlanini 34, 47121, Forli'
Multimedica S.p.A.
Division of Internal Medicine and the Division of Pulmonary Disease Intensive Respiratory Care Unit, Via San Vittore 12, 20123, Milan
Azienda Ospedaliero Universitaria Delle Marche
Respiratory Medicine Unit, Via Conca 71, 60126, Ancona
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 |
|---|---|---|---|---|---|
| Denmark | 2024-04-18 | 2025-07-30 | 2024-06-03 | 2025-07-30 | |
| Italy | 2024-11-28 | 2025-07-30 | |||
| Spain | 2023-12-11 | 2025-07-30 | 2024-03-25 | 2025-07-30 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 2 · Art. 38 CTR
Temporary halt TH-55769
- Halt date
- 2024-11-01
- Member states concerned
- Spain
- Publication date
- 2024-11-05
- Reason
- Sponsor decision
- Explanation
- Temporarily pausing enrollment in limited countries until the investigational medicinal product dossier (IMPD), which is currently being evaluated by regulators, is approved.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-55767
- Halt date
- 2024-11-01
- Member states concerned
- Denmark
- Publication date
- 2024-11-05
- Reason
- Sponsor decision
- Explanation
- Temporarily pausing enrollment in limited countries until the investigational medicinal product dossier (IMPD), which is currently being evaluated by regulators, is approved.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-06-19 | Spain | Acceptable with conditions 2023-10-06
|
2023-10-06 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-12-22 | Spain | Acceptable 2024-04-01
|
2024-04-01 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-05-06 | Spain | Acceptable 2024-07-03
|
2024-07-03 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-09-04 | Acceptable 2024-07-03
|
2024-09-04 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-09-06 | Spain | Acceptable 2024-11-06
|
2024-11-06 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-11-19 | Acceptable | 2024-12-20 | |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-01-16 | Spain | 2025-01-16 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-01-31 | Spain | Acceptable 2025-04-12
|
2025-04-12 |