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Immunomodulatory Treatment of Interstitial Lung Disease Associated With Surfactant Related Gene Variants
NCT07443436Phase 2
Key facts
- Status
- Not yet recruiting
- Start
- Nov 2026
- Primary completion
- Nov 2027
- Countries
- 1
- Sponsor
- Assistance publique - Hôpitaux de Paris
- Modality
- Orthosteric Ligands
- Conditions
- interstitial lung disease (ILD)
01
Overview
Phase 2, randomised, open-label trial in interstitial lung disease (ILD) comparing Prednisone + Hydroxychloroquine + Azithromycin with Standard of care (2 arms). Primary endpoint: Difference in forced vital capacity decline at 12 months. Planned start Nov 2026; status: not yet recruiting.
02
Design
2 arms- Study design
- RandomizedOpen-label
Prednisone + Hydroxychloroquine + Azithromycin
Prednisone 10 mg/day, Hydroxychloroquine 400 mg/day, Azithromycin 250 mg x3/week for 12 months.
Standard of care
Any symptomatic treatment to interstitial lung disease.
03
Who it enrols
Adult patients with interstitial lung disease and a pathogenic variant in surfactant-related genes (SFTPA1, SFTPA2, SFTPC, NKX2-1, SFTPB, or ABCA3) with ILD volume >10% on CT scan.
04
Endpoints
Primary
Difference in forced vital capacity decline
Secondary
Clinical and biological tolerance
Correlation between the respiratory, radiological and clinical functional response
Quality of life questionnaire (EORTC QLQ-C30, v3.0)
Overall survival
Transplant-free survival
Exacerbation-free survival
Hospitalization-free survival
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