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A randomized, double-blind, placebo-controlled, parallel group, Phase 3 study, followed by open-label extensions, to evaluate the efficacy of oral belumosudil in adult participants with chronic lung allograft dysfunction (CLAD) following bilateral lung transplantation

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-503462-23-00
Acronym
EFC17801
Enrollment
77
Registered
2023-10-09
Start date
2023-12-28
Completion date
Unknown
Last updated
2025-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung transplant rejection

Brief summary

Percent change from baseline to Week 26 in FEV1

Detailed description

Response rate at Week 26. Defined as the proportion of participants with ≤10% decline in FEV1 at Week 26 compared with baseline, Absolute change from baseline to Week 26 in FEV1, Absolute change from baseline to Week 26 in percent predicted FEV1, Percent change from baseline to Week 26 in FVC, Absolute change from baseline to Week 26 in FVC, Absolute change from baseline to Week 26 in percent predicted FVC, Time to CLAD progression during the doubleblind treatment period.Defined as the first of the following events: >10% decline in FEV1 compared with baseline, or change in CLAD stage, or re-transplantation, or death., Time to re-transplantation or death, Percent change from baseline to Week 26 in 6- minute walk distance, Absolute change from baseline to Week 26 in 6-minute walk distance, Change from baseline to Week 26 in Saint George Respiratory Questionnaire (SGRQ). Total score and scores by domain, Change from baseline to Week 26 in EQ-5D-5L.Visual analogue scale and individual dimensions, Change from baseline to Week 26 in Patient- Reported Outcomes Measurement Information System-29 profile version 2.1. PROMIS-29 profile V2.1 (domain scores), Number of participants with adverse events (AEs) and serious adverse events (SAEs). Treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs), as well as laboratory abnormalities during the double-blind treatment period and the open-label extensions

Interventions

Sponsors

Sanofi-Aventis Recherche & Developpement
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Percent change from baseline to Week 26 in FEV1

Secondary

MeasureTime frame
Response rate at Week 26. Defined as the proportion of participants with ≤10% decline in FEV1 at Week 26 compared with baseline, Absolute change from baseline to Week 26 in FEV1, Absolute change from baseline to Week 26 in percent predicted FEV1, Percent change from baseline to Week 26 in FVC, Absolute change from baseline to Week 26 in FVC, Absolute change from baseline to Week 26 in percent predicted FVC, Time to CLAD progression during the doubleblind treatment period.Defined as the first of the following events: >10% decline in FEV1 compared with baseline, or change in CLAD stage, or re-transplantation, or death., Time to re-transplantation or death, Percent change from baseline to Week 26 in 6- minute walk distance, Absolute change from baseline to Week 26 in 6-minute walk distance, Change from baseline to Week 26 in Saint George Respiratory Questionnaire (SGRQ). Total score and scores by domain, Change from baseline to Week 26 in EQ-5D-5L.Visual analogue scale and individual dime

Countries

Austria, Belgium, Czechia, Denmark, Finland, France, Germany, Hungary, Italy, Netherlands, Norway, Poland, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026