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Belumosudil + Azithromycin for Lung Transplant Rejection (ROCKaspire Trial)

Phase 3

Recruiting

Research Sponsored by Sanofi

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants presenting with CLAD

Participants who have received at least 8 weeks of azithromycin

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to week 26

Awards & highlights

ROCKaspire Trial Summary

This trial is a large international study that aims to test the effectiveness and safety of a medication called belumosudil compared to a placebo. The medication will be given to participants who have undergone a lung

Who is the study for?

Adults over 18 who've had a bilateral lung transplant at least a year ago and are experiencing chronic rejection despite taking azithromycin can join. They should have been on azithromycin for at least 8 weeks.Check my eligibility

What is being tested?

The trial is testing the effectiveness of Belumosudil tablets against a placebo, in addition to standard immunosuppression and azithromycin therapy, for treating lung transplant rejection. It's randomized and double-blind, meaning neither participants nor researchers know who gets the real drug or placebo.See study design

What are the potential side effects?

While specific side effects of Belumosudil aren't listed here, common ones may include gastrointestinal issues, headaches, potential liver enzyme changes, and possible impact on blood cell counts.

ROCKaspire Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with chronic lung allograft dysfunction.

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I have been taking azithromycin for at least 8 weeks.

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I had a lung transplant more than a year ago.

ROCKaspire Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to week 26

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to week 26

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 26 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percent change from baseline to Week 26 in forced expiratory volume in 1 second (FEV1)

Secondary outcome measures

Absolute change from baseline to Week 26 in 6-minute walk distance

Absolute change from baseline to Week 26 in 6-minute walk nadir oxygen saturation

Absolute change from baseline to Week 26 in FEV1

+13 more

ROCKaspire Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Belumosudil + AzithromycinExperimental Treatment2 Interventions

Participants will receive 200 mg belumosudil orally once daily

Group II: Placebo + AzithromycinPlacebo Group2 Interventions

Participants will receive placebo orally once daily

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Azithromycin

2018

Completed Phase 4

~274950

Belumosudil

2018

Completed Phase 2

~320

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor

2,164 Previous Clinical Trials

3,514,800 Total Patients Enrolled

Clinical Sciences & OperationsStudy DirectorSanofi

862 Previous Clinical Trials

2,019,658 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

At how many different venues can this clinical trial be accessed?

"This clinical trial is currently being conducted at 14 different sites, including locations such as Leuven, Godinne, La Coruña, and various other cities. To minimize travel requirements for participants, it is advisable to choose the site that is geographically closest to you when enrolling in the study."

Answered by AI

Are there any vacancies available for patients to participate in this trial?

"Indeed, the information available on clinicaltrials.gov confirms that this specific clinical trial is actively seeking eligible participants. The trial was initially posted on October 10th, 2023, and recently updated on January 11th, 2024. Recruitment aims to enroll a total of 180 patients distributed among 14 different sites."

Answered by AI

What is the total number of participants enrolled in this clinical investigation?

"A total of 180 eligible participants are needed to enroll in this clinical trial. Patients can choose to participate at various locations, including Investigational Site Number: 0560001 located in Leuven, Florida and Investigational Site Number: 0560002 situated in Godinne, Cantabria."

Answered by AI

What is the level of safety associated with the combination therapy involving Belumosudil and Azithromycin for individuals?

"Our team at Power rates the safety of Belumosudil + Azithromycin as a 3 on a scale from 1 to 3. This rating is based on it being a Phase 3 trial, which indicates that there is existing evidence supporting its efficacy and multiple rounds of data demonstrating its safety."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "A Study to Test How Effective Belumosudil Tablets Are for Treating Adult Participants With Chronic Lung Allograft Dysfunction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06082037.