2026-08-31
notable
Study Status, Contacts/Locations v24
Enrollment closed, study ongoing
Final enrollment: 81 participants (planned 71)
Study sitesdetails revised at 24 of 46 sites
2026-07-26
minor
Study Status, Study Description, Outcome Measures, Eligibility, Contacts/Locations v23
Eligibility criteria+404 characters
[...] n prior to admission to the trial.
Male or female patients.
Male patients must not donate sperm while taking part in this study and for a specific period after the last dose of the IMP.
Male patients with Womanwoman of childbearing potential (WOCBP) sexual partners must use [...] without an alternative medical cause.
In questionable cases ofwherein postmenopausalthe menopausal status is uncertain and cannot be clearly determined, the following should be taken into consideration by the investigator:
Women not using sex hormone medication such as hormone rep [...] r cryobiopsy demonstrating a "UIP" or "Proba [...]
Secondary endpoints5 to 8 entries
Absolute change from baseline in FVC (mL) at 24 weeks
Absolute change from baseline in DLCO % predicted at 24 weeks
Absolute change from baseline in distance walked (m) during 6MWT at 24 weeks
Study sites46 entries, revised
Temple University Hospital
2026-06-22
minor
Study Status, Contacts/Locations v22
Primary completion moved earlier: 2027-04-28 → 2027-03-11
Study sites46 entries, revised
A.O.Azienda Ospedaliera dei Colli
2026-06-08
minor
Study Status, Contacts/Locations, References v21
Completion moved earlier: 2027-11-01 → 2027-06-22
2026-05-26
minor
Study Status, Contacts/Locations v20
Study sitesdetails revised at 6 of 47 sites
2026-05-12
minor
Study Status, Contacts/Locations v19
Study sitesdetails revised at 3 of 47 sites
2026-04-28
minor
Study Status, Contacts/Locations v18
Completion pushed: 2027-09-02 → 2027-11-01
2026-04-13
minor
Study Status, Contacts/Locations v17
2026-03-16
minor
Study Status, Contacts/Locations v16
Study sites50 entries, revised
Fondazione Policlinico Universitario A.Agostino Gemelli IRCCS
2026-03-03
minor
Study Status, Contacts/Locations v15
2026-02-22
minor
Study Status, References v14
Re-verified, no change to tracked fields
2026-02-09
minor
Study Status, Contacts/Locations, IPDSharing v13
Study sitesdetails revised at 1 of 49 sites
2026-02-03
minor
Study Status, Contacts/Locations v12
Study sites49 entries, revised
StFondazione Vincent'sPoliclinico HospitalUniversitario SydneyA. Gemelli IRCCS
2026-01-22
minor
Study Status, Contacts/Locations v11
2026-01-05
minor
Study Status, Contacts/Locations v10
Study sites50 entries, revised
Hospital Universitario De La Princesa
2025-12-20
minor
Study Status, Contacts/Locations v9
2025-12-10
minor
Study Status, Contacts/Locations v8
Study sitesdetails revised at 2 of 49 sites
2025-11-28
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v7
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-11-15→confirmed 2025-11-13
Study sitesdetails revised at 49 of 49 sites
2025-11-11
minor
Study Status v6
Start date2025-11-05→2025-11-15
2025-10-30
minor
Study Status, Study Design, Contacts/Locations v5
Start date2025-10-21→2025-11-05
Enrollment target70→71
Study sites48→49
2025-09-02
minor
Study Status, Contacts/Locations v4
Study sites48 entries, revised
BrusselsCliniques - UNIVUniversitaires Saint-Luc
2025-08-20
minor
Study Status, Contacts/Locations v3
Primary completion date2027-03-31→2027-04-28
Completion date2027-08-05→2027-09-02
Start date2025-09-26→2025-10-21
Study sites45→48
2025-08-05
minor
Study Status, Contacts/Locations v2
2025-07-21
minor
Study Status, Contacts/Locations v1
2025-06-17
minor
Original filing