A Study to Test How Effective Belumosudil Tablets Are for Treating Adult Participants With Chronic Lung Allograft Dysfunction

Lung Transplant Rejection Clinical Trial

— ROCKaspire  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06082037
• Other study ID #: EFC17801
• Secondary ID: U1111-1280-67772
• Status: Recruiting
• Phase: Phase 3
• Start date: October 10, 2023
• Est. completion date: June 2, 2028

Study information

• Verified date: May 2024
• Source: Sanofi
• Contact: Trial Transparency email recommended (Toll free number for US &
• Phone: 800-633-1610
• Email: Contact-US[@]sanofi.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This double-blind, randomized, placebo-controlled, multinational, multicenter, parallel-group, Phase 3, 2-arm, study will investigate the efficacy and safety of belumosudil compared with placebo, both administered on top of azithromycin and standard-of-care regimen of immunosuppression in male or female participants at least 1 year after bilateral lung transplant, who are at least 18 years of age and who have evidence of progressive CLAD despite azithromycin therapy. Study details include: The study duration will be up to 31 weeks for participants not entering the open-label extension (OLE) period and up to 57 weeks for participants entering the OLE period but not the long-term OLE. The treatment duration will be up to 26 weeks for participants not entering the OLE period and up to 52 weeks for participants entering the OLE period but not the long-term OLE. The number of visits will be up to 10 visits for participants not entering the OLE period and up to 16 visits for participants entering the OLE period but not the long-term OLE. For participants who enter the long-term OLE, treatment and study participation will continue with visits every 12 weeks per protocol specifications.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: June 2, 2028
• Est. primary completion date: September 17, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participant =1 year post bilateral lung transplantation at the time of screening
• Participants presenting with CLAD
• Participants who have received at least 8 weeks of azithromycin

Exclusion Criteria:

• Lung function decline that can be explained by non-CLAD causes including but not limited to acute lung allograft rejection (>A1), antibody-mediated rejection within 4 weeks of screening, airway stenosis, or tracheobronchomalacia
• Participants who have received other treatments for CLAD

Related Conditions & MeSH terms

• Lung Transplant Rejection

Intervention

Drug:
• Belumosudil
Tablet, Oral
• Azithromycin
Depends on pharmaceutical presentation, Oral
• Placebo
Tablet, Oral

Locations

Country	Name	City	State
Belgium	Investigational Site Number : 0560002	Godinne
Belgium	Investigational Site Number : 0560001	Leuven
Czechia	Investigational Site Number : 2030002	Olomouc
Czechia	Investigational Site Number : 2030001	Praha 5
Finland	Investigational Site Number : 2460001	Helsinki
France	Investigational Site Number : 2500006	Marseille
France	Investigational Site Number : 2500002	Pessac
Hungary	Investigational Site Number : 3480001	Budapest
Israel	Investigational Site Number : 3760001	Petah-Tikva
Italy	Investigational Site Number : 3800001	Milano
Italy	Investigational Site Number : 3800004	Palermo
Italy	Investigational Site Number : 3800003	Pavia
Italy	Investigational Site Number : 3800002	Siena
Netherlands	Investigational Site Number : 5280001	Groningen
Spain	Investigational Site Number : 7240003	Barcelona	Barcelona [Barcelona]
Spain	Investigational Site Number : 7240002	La Coruña	A Coruña [La Coruña]
Spain	Investigational Site Number : 7240001	Santander	Cantabria
Spain	Investigational Site Number : 7240004	Valencia
United States	University of Michigan Hospital - 1500 E Medical Center Dr Site Number : 8400014	Ann Arbor	Michigan
United States	University of Maryland School of Medicine Site Number : 8400009	Baltimore	Maryland
United States	UAB Lung Health Center Site Number : 8400026	Birmingham	Alabama
United States	Baylor University Medical Center - Dallas Site Number : 8400011	Dallas	Texas
United States	Duke Lung Transplant Program Site Number : 8400017	Durham	North Carolina
United States	Houston Methodist Research Institute Site Number : 8400021	Houston	Texas
United States	New York Presbyterian/Columbia University Medical Center Site Number : 8400002	New York	New York
United States	Advent Health Transplant Institute Site Number : 8400023	Orlando	Florida
United States	Temple University Hospital Site Number : 8400007	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Belgium,  Czechia,  Finland,  France,  Hungary,  Israel,  Italy,  Netherlands,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change from baseline to Week 26 in forced expiratory volume in 1 second (FEV1)		Baseline to Week 26
Secondary	Response rate at Week 26	Defined as the proportion of participants with =10% decline in FEV1 at Week 26 compared with baseline	Baseline to Week 26
Secondary	Absolute change from baseline to Week 26 in FEV1		Baseline to Week 26
Secondary	Absolute change from baseline to Week 26 in percent predicted FEV1		Baseline to Week 26
Secondary	Percent change from baseline to Week 26 in forced vital capacity (FVC)		Baseline to Week 26
Secondary	Absolute change from baseline to Week 26 in FVC		Baseline to Week 26
Secondary	Absolute change from baseline to Week 26 in percent predicted FVC		Baseline to Week 26
Secondary	Percent change from baseline to Week 26 in total lung capacity (TLC)		Baseline to Week 26
Secondary	Time to CLAD progression during the double-blind 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	Baseline to Week 26
Secondary	Time to re-transplantation or death		Up to 7 days after the administration of last dose of study drug
Secondary	Percent change from baseline to Week 26 in 6-minute walk distance		Baseline to Week 26
Secondary	Absolute change from baseline to Week 26 in 6-minute walk distance		Baseline to Week 26
Secondary	Absolute change from baseline to Week 26 in 6-minute walk nadir oxygen saturation		Baseline to Week 26
Secondary	Change from baseline to Week 26 in Saint George Respiratory Questionnaire (SGRQ)	Total score and scores by domain	Baseline to Week 26
Secondary	Change from baseline to Week 26 in EQ-5D-5L	Visual analogue scale and individual dimensions	Baseline to Week 26
Secondary	Change from baseline to Week 26 in Patient-Reported Outcomes Measurement Information System-29 profile version 2.1	Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29) profile V2.1 (domain scores)	Baseline to Week 26
Secondary	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	Up to 7 days after the administration of last dose of study drug