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

Sanofi

Status and phase: Enrolling; Phase 3

Conditions: Lung Transplant Rejection

Treatments: Drug: Placebo; Drug: Azithromycin; Drug: Belumosudil

Study type: Interventional

Funder types: Industry

Identifiers

NCT06082037

U1111-1280-6777 (Registry Identifier)

EFC17801

2023-503462-23 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participant ≥1 year post bilateral lung transplantation at the time of screening
• Participants presenting with CLAD Stage 1 or 2: FEV1 from >50% to 80% of post-transplant baseline at screening and at randomization
• Participants who have received at least 8 weeks of azithromycin (≥250 mg/day, at least 3 times a week) prior to randomization

Exclusion criteria

• FEV1 ≤50% of the post-transplant baseline value (CLAD 3 and 4)
• Lung function decline that can be explained by non-CLAD causes including but not limited to acute lung allograft rejection (>A1), antibody-mediated rejection, airway stenosis, or tracheobronchomalacia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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180 participants in 2 patient groups, including a placebo group

Belumosudil + Azithromycin

Experimental group

Description:

Participants will receive 200 mg belumosudil orally once daily

Treatment:

Drug: Belumosudil

Drug: Azithromycin

Placebo + Azithromycin

Placebo Comparator group

Description:

Participants will receive placebo orally once daily

Treatment:

Drug: Azithromycin

Drug: Placebo