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

Conditions

• Lung Transplant Rejection

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Belumosudil — DRUG
  Tablet, Oral
• Azithromycin — DRUG
  Depends on pharmaceutical presentation, Oral
• Placebo — DRUG
  Tablet, Oral

Study Details

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.

Key Dates

Start date

Oct 10, 2023

Status verified

Jun 2026

Primary completion

Jan 29, 2029

Completion

Oct 1, 2030

Study Design

Enrollment

180 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Belumosudil + Azithromycin
  Participants will receive 200 mg belumosudil orally once daily
• Placebo Comparator: Placebo + Azithromycin
  Participants will receive placebo orally once daily

Primary Outcome Measure

Percent change from baseline to Week 26 in forced expiratory volume in 1 second (FEV1) [ Time Frame: Baseline to Week 26 ]

Central Contacts

• Trial Transparency email recommended (Toll free number for US & Canada)
  800-633-1610
  [email protected]

Locations (32)

Find similar trials in Birmingham, AL

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