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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06082037




Registration number
NCT06082037
Ethics application status
Date submitted
7/10/2023
Date registered
13/10/2023

Titles & IDs
Public title
A Study to Test How Effective Belumosudil Tablets Are for Treating Adult Participants With Chronic Lung Allograft Dysfunction
Scientific 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
Secondary ID [1] 0 0
U1111-1280-6777
Secondary ID [2] 0 0
EFC17801
Universal Trial Number (UTN)
Trial acronym
ROCKaspire
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung Transplant Rejection 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Belumosudil
Treatment: Drugs - Azithromycin
Treatment: Drugs - Placebo

Experimental: Belumosudil + Azithromycin - Participants will receive 200 mg belumosudil orally once daily

Placebo comparator: Placebo + Azithromycin - Participants will receive placebo orally once daily


Treatment: Drugs: Belumosudil
Tablet, Oral

Treatment: Drugs: Azithromycin
Depends on pharmaceutical presentation, Oral

Treatment: Drugs: Placebo
Tablet, Oral
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percent change from baseline to Week 26 in forced expiratory volume in 1 second (FEV1)
Timepoint [1] 0 0
Baseline to Week 26
Secondary outcome [1] 0 0
Response rate at Week 26
Timepoint [1] 0 0
Baseline to Week 26
Secondary outcome [2] 0 0
Absolute change from baseline to Week 26 in FEV1
Timepoint [2] 0 0
Baseline to Week 26
Secondary outcome [3] 0 0
Absolute change from baseline to Week 26 in percent predicted FEV1
Timepoint [3] 0 0
Baseline to Week 26
Secondary outcome [4] 0 0
Percent change from baseline to Week 26 in forced vital capacity (FVC)
Timepoint [4] 0 0
Baseline to Week 26
Secondary outcome [5] 0 0
Absolute change from baseline to Week 26 in FVC
Timepoint [5] 0 0
Baseline to Week 26
Secondary outcome [6] 0 0
Absolute change from baseline to Week 26 in percent predicted FVC
Timepoint [6] 0 0
Baseline to Week 26
Secondary outcome [7] 0 0
Percent change from baseline to Week 26 in total lung capacity (TLC)
Timepoint [7] 0 0
Baseline to Week 26
Secondary outcome [8] 0 0
Time to CLAD progression during the double-blind treatment period
Timepoint [8] 0 0
Baseline to Week 26
Secondary outcome [9] 0 0
Time to re-transplantation or death
Timepoint [9] 0 0
Up to 7 days after the administration of last dose of study drug
Secondary outcome [10] 0 0
Percent change from baseline to Week 26 in 6-minute walk distance
Timepoint [10] 0 0
Baseline to Week 26
Secondary outcome [11] 0 0
Absolute change from baseline to Week 26 in 6-minute walk distance
Timepoint [11] 0 0
Baseline to Week 26
Secondary outcome [12] 0 0
Absolute change from baseline to Week 26 in 6-minute walk nadir oxygen saturation
Timepoint [12] 0 0
Baseline to Week 26
Secondary outcome [13] 0 0
Change from baseline to Week 26 in Saint George Respiratory Questionnaire (SGRQ)
Timepoint [13] 0 0
Baseline to Week 26
Secondary outcome [14] 0 0
Change from baseline to Week 26 in EQ-5D-5L
Timepoint [14] 0 0
Baseline to Week 26
Secondary outcome [15] 0 0
Change from baseline to Week 26 in Patient-Reported Outcomes Measurement Information System-29 profile version 2.1
Timepoint [15] 0 0
Baseline to Week 26
Secondary outcome [16] 0 0
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Timepoint [16] 0 0
Up to 7 days after the administration of last dose of study drug

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/10/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
2/06/2028
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA
Recruitment hospital [1] 0 0
Investigational Site Number : 0360003 - Darlinghurst
Recruitment hospital [2] 0 0
Investigational Site Number : 0360001 - Chermside
Recruitment hospital [3] 0 0
Investigational Site Number : 0360002 - Murdoch
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
4032 - Chermside
Recruitment postcode(s) [3] 0 0
6961 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
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United States of America
State/province [5] 0 0
Georgia
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United States of America
State/province [6] 0 0
Illinois
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United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
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New York
Country [11] 0 0
United States of America
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North Carolina
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United States of America
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Ohio
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United States of America
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Pennsylvania
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United States of America
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Texas
Country [15] 0 0
United States of America
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Virginia
Country [16] 0 0
Austria
State/province [16] 0 0
Wien
Country [17] 0 0
Belgium
State/province [17] 0 0
Godinne
Country [18] 0 0
Belgium
State/province [18] 0 0
Leuven
Country [19] 0 0
Canada
State/province [19] 0 0
British Columbia
Country [20] 0 0
Czechia
State/province [20] 0 0
Olomouc
Country [21] 0 0
Czechia
State/province [21] 0 0
Praha 5 - Motol
Country [22] 0 0
Denmark
State/province [22] 0 0
Copenhagen
Country [23] 0 0
Finland
State/province [23] 0 0
Helsinki
Country [24] 0 0
France
State/province [24] 0 0
La Plessis Robinson
Country [25] 0 0
France
State/province [25] 0 0
Marseille
Country [26] 0 0
France
State/province [26] 0 0
Paris
Country [27] 0 0
France
State/province [27] 0 0
Pessac
Country [28] 0 0
France
State/province [28] 0 0
Saint Herblain
Country [29] 0 0
France
State/province [29] 0 0
Suresnes
Country [30] 0 0
Germany
State/province [30] 0 0
München
Country [31] 0 0
Hungary
State/province [31] 0 0
Budapest
Country [32] 0 0
Israel
State/province [32] 0 0
Petah-Tikva
Country [33] 0 0
Italy
State/province [33] 0 0
Milano
Country [34] 0 0
Italy
State/province [34] 0 0
Palermo
Country [35] 0 0
Italy
State/province [35] 0 0
Pavia
Country [36] 0 0
Italy
State/province [36] 0 0
Siena
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Netherlands
State/province [37] 0 0
Groningen
Country [38] 0 0
Norway
State/province [38] 0 0
Oslo
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Spain
State/province [39] 0 0
A Coruña [La Coruña]
Country [40] 0 0
Spain
State/province [40] 0 0
Barcelona [Barcelona]
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Spain
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Cantabria
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Spain
State/province [42] 0 0
Valencia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Sciences & Operations
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Trial Transparency email recommended (Toll free number for US & Canada)
Address 0 0
Country 0 0
Phone 0 0
800-633-1610
Fax 0 0
Email 0 0
contact-us@sanofi.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06082037