Lung Transplant RejectionPhase 3ROCKaspireNCT06082037
A Study to Test How Effective Belumosudil Tablets Are for Treating Adult Participants With Chronic Lung Allograft Dysfunction
A Phase 3 study testing Belumosudil and Azithromycin in people with Lung Transplant Rejection, run by Sanofi at 82 sites in 19 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Transplant Rejection
- What is being tested?
- Belumosudil and Azithromycin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 82 sitesin 19 countries
- Study dates
- 10 Oct 2023to 1 Oct 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
82 sites in 19 countries. Contact the study team or a site near you to ask about taking part.
Trial Transparency email recommended (Toll free number for US & Canada) contact
82 sites in 19 countries
United States33 sites, 32 recruiting
- Recruiting
University of Michigan Health System - Ann Arbor- Site Number : 8400014
Ann Arbor, Michigan, 48109
- Recruiting
Emory University Hospital- Site Number : 8400027
Atlanta, Georgia, 30324
- Recruiting
University of Maryland School of Medicine - Baltimore- Site Number : 8400009
Baltimore, Maryland, 21201
- Recruiting
Johns Hopkins Hospital- Site Number : 8400034
Baltimore, Maryland, 21287
- Recruiting
University of Alabama at Birmingham- Site Number : 8400026
Birmingham, Alabama, 35233
- Completed
Brigham & Women's Hospital- Site Number : 8400016
Boston, Massachusetts, 02115
- Recruiting
Northwestern University- Site Number : 8400003
Chicago, Illinois, 60611
- Recruiting
Cleveland Clinic - Cleveland- Site Number : 8400005
Cleveland, Ohio, 44195
- Recruiting
The Ohio State University- Site Number : 8400028
Columbus, Ohio, 43210
- Recruiting
University of Texas - Southwestern Medical Center- Site Number : 8400013
Dallas, Texas, 75390
- Recruiting
Duke University Medical Center- Site Number : 8400017
Durham, North Carolina, 27705
- Recruiting
Inova Fairfax Hospital- Site Number : 8400004
Falls Church, Virginia, 22042
- Recruiting
Corewell Health - Grand Rapids - Michigan Street Northeast- Site Number : 8400010
Grand Rapids, Michigan, 49503
- Recruiting
Baylor College of Medicine- Site Number : 8400024
Houston, Texas, 77030
- Recruiting
Houston Methodist Hospital- Site Number : 8400021
Houston, Texas, 77030
- Recruiting
University of Iowa- Site Number : 8400032
Iowa City, Iowa, 52242
- Recruiting
Mayo Clinic in Florida- Site Number : 8400031
Jacksonville, Florida, 32224
- Recruiting
University of California Los Angeles Medical Center- Site Number : 8400020
Los Angeles, California, 90095
- Recruiting
Loyola University Medical Center- Site Number : 8400025
Maywood, Illinois, 60153
- Recruiting
Jackson Memorial Hospital- Site Number : 8400030
Miami, Florida, 33136
- Recruiting
Vanderbilt University Medical Center- Site Number : 8400018
Nashville, Tennessee, 37232
- Recruiting
NYU Perlmutter Cancer Center - Energy Building- Site Number : 8400001
New York, New York, 10016
- Recruiting
Icahn School of Medicine at Mount Sinai- Site Number : 8400037
New York, New York, 10029
- Recruiting
Columbia University Irving Medical Center- Site Number : 8400002
New York, New York, 10032
- Recruiting
AdventHealth Orlando- Site Number : 8400023
Orlando, Florida, 32803
- Recruiting
Penn Medicine: University of Pennsylvania Health System- Site Number : 8400006
Philadelphia, Pennsylvania, 19104
- Recruiting
Temple University Hospital- Site Number : 8400007
Philadelphia, Pennsylvania, 19140
- Recruiting
St. Joseph's Hospital and Medical Center- Site Number : 8400019
Phoenix, Arizona, 85013
- Recruiting
University of Utah Medical Group- Site Number : 8400039
Salt Lake City, Utah, 84102
- Recruiting
University Health System - San Antonio- Site Number : 8400035
San Antonio, Texas, 78229
- Recruiting
Stanford University Medical Center- Site Number : 8400008
Stanford, California, 94305
- Recruiting
Tampa General Hospital - Tampa - General Circle- Site Number : 8400015
Tampa, Florida, 33606
- Recruiting
Montefiore Medical Center - Moses Campus- Site Number : 8400036
The Bronx, New York, 10467
China9 sites, 9 recruiting
- Recruiting
Investigational Site Number : 1560004
Beijing, 100029
- Recruiting
Investigational Site Number : 1560002
Chengdu, 610072
- Recruiting
Investigational Site Number : 1560008
Fuzhou, 350001
- Recruiting
Investigational Site Number : 1560007
Guangzhou, 510163
- Recruiting
Investigational Site Number : 1560001
Hangzhou, 310009
- Recruiting
Investigational Site Number : 1560005
Hefei, 230001
- Recruiting
Investigational Site Number : 1560009
Shanghai, 200433
- Recruiting
Investigational Site Number : 1560003
Wuxi, 214023
- Recruiting
Investigational Site Number : 1560006
Zhengzhou, 450052
France7 sites, 7 recruiting
- Recruiting
Investigational Site Number : 2500005
Le Plessis-Robinson, 92350
- Recruiting
Investigational Site Number : 2500006
Marseille, 13915
- Recruiting
Investigational Site Number : 2500004
Paris, 75018
- Recruiting
Investigational Site Number : 2500002
Pessac, 33604
- Recruiting
Investigational Site Number : 2500003
Saint-Herblain, 44800
- Recruiting
Investigational Site Number : 2500007
Strasbourg, 67000
- Recruiting
Investigational Site Number : 2500001
Suresnes, 92151
Italy5 sites, 5 recruiting
- Recruiting
Investigational Site Number : 3800001
Milan, Milano, 20122
- Recruiting
Investigational Site Number : 3800005
Padua, Padova, 35128
- Recruiting
Investigational Site Number : 3800004
Palermo, 90133
- Recruiting
Investigational Site Number : 3800003
Pavia, 27100
- Recruiting
Investigational Site Number : 3800002
Siena, 53100
Spain5 sites, 5 recruiting
- Recruiting
Investigational Site Number : 7240002
A Coruña, Galicia [Galicia], 15006
- Recruiting
Investigational Site Number : 7240003
Barcelona, Catalunya [Cataluña], 08035
- Recruiting
Investigational Site Number : 7240005
Majadahonda, Madrid, 28222
- Recruiting
Investigational Site Number : 7240001
Santander, Cantabria, 39008
- Recruiting
Investigational Site Number : 7240004
Valencia, 46026
South Korea4 sites, 4 recruiting
- Recruiting
Investigational Site Number : 4100002
Seoul, Seoul-teukbyeolsi, 03080
- Recruiting
Investigational Site Number : 4100001
Seoul, Seoul-teukbyeolsi, 03722
- Recruiting
Investigational Site Number : 4100003
Seoul, Seoul-teukbyeolsi, 06351
- Recruiting
Investigational Site Number : 4100004
Yangsan, Gyeongsangnam-do, 50612
Australia3 sites, 3 recruiting
- Recruiting
Investigational Site Number : 0360001
Brisbane, Queensland, 4032
- Recruiting
Investigational Site Number : 0360003
Darlinghurst, New South Wales, 2010
- Recruiting
Investigational Site Number : 0360002
Murdoch, Western Australia, 6150
Canada3 sites, 3 recruiting
- Recruiting
Investigational Site Number : 1240002
Edmonton, Alberta, T6G 2B7
- Recruiting
Investigational Site Number : 1240004
Toronto, Ontario, M5G 2C4
- Recruiting
Investigational Site Number : 1240001
Vancouver, British Columbia, V5Z 1M9
Belgium2 sites, 2 recruiting
- Recruiting
Investigational Site Number : 0560001
Leuven, 3000
- Recruiting
Investigational Site Number : 0560002
Yvoir, 5530
Czechia2 sites, 2 recruiting
- Recruiting
Investigational Site Number : 2030002
Olomouc, 779 00
- Recruiting
Investigational Site Number : 2030001
Prague, 150 06
Austria1 site, 1 recruiting
- Recruiting
Investigational Site Number : 0400001
Vienna, 1090
Denmark1 site, 1 recruiting
- Recruiting
Investigational Site Number : 2080001
Copenhagen, 2100
Finland1 site, 1 recruiting
- Recruiting
Investigational Site Number : 2460001
Helsinki, 00029
Germany1 site, 1 recruiting
- Recruiting
Investigational Site Number : 2760003
Munich, 81337
Hungary1 site, 1 recruiting
- Recruiting
Investigational Site Number : 3480001
Budapest, 1085
Israel1 site, 1 recruiting
- Recruiting
Investigational Site Number : 3760001
Petah Tikva, 4941492
Japan1 site, 1 recruiting
- Recruiting
Investigational Site Number : 3920001
Tokyo, 113-8654
Netherlands1 site, 1 recruiting
- Recruiting
Investigational Site Number : 5280001
Groningen, 9713 GR
Sweden1 site, 1 recruiting
- Recruiting
Investigational Site Number : 7520001
Gothenburg, 413 45
About this study
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
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:
Read more
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.
- Conditions
- Lung Transplant Rejection
- Being tested
- Belumosudil, Azithromycin, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BelumosudilDrug
Also called REZUROCK
Tablet, Oral
AzithromycinDrug
Depends on pharmaceutical presentation, Oral
PlaceboDrug
Tablet, Oral
| Study group | Role | What they receive |
|---|---|---|
| Belumosudil + Azithromycin | Experimental | Participants will receive 200 mg belumosudil orally once daily Receives: Drug: Belumosudil; Drug: Azithromycin |
| Placebo + Azithromycin | Placebo comparator | Participants will receive placebo orally once daily Receives: Drug: Azithromycin; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change from baseline to Week 26 in forced expiratory volume in 1 second (FEV1)
Measured: Baseline to Week 26
Secondary outcomes (14)
Response rate at Week 26
Defined as the proportion of participants with ≤10% decline in FEV1 at Week 26 compared with baseline
Measured: Baseline to Week 26
Absolute change from baseline to Week 26 in FEV1
Measured: Baseline to Week 26
Absolute change from baseline to Week 26 in percent predicted FEV1
Measured: Baseline to Week 26
Percent change from baseline to Week 26 in forced vital capacity (FVC)
Measured: Baseline to Week 26
Absolute change from baseline to Week 26 in FVC
Measured: Baseline to Week 26
Absolute change from baseline to Week 26 in percent predicted FVC
Measured: Baseline to Week 26
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
Measured: Baseline to Week 26
Time to re-transplantation or death
Measured: Up to 7 days after the administration of last dose of study drug
Percent change from baseline to Week 26 in 6-minute walk distance
Measured: Baseline to Week 26
Absolute change from baseline to Week 26 in 6-minute walk distance
Measured: Baseline to Week 26
Change from baseline to Week 26 in Saint George Respiratory Questionnaire (SGRQ)
Total score and scores by domain
Measured: Baseline to Week 26
Change from baseline to Week 26 in EQ-5D-5L
Visual analogue scale and individual dimensions
Measured: Baseline to Week 26
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)
Measured: Baseline to Week 26
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
Measured: Up to 7 days after the administration of last dose of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study start10 Oct 2023
- Primary completion29 Jan 2029 (estimated)
- Study completion1 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Transplant RejectionStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Meiji Seika Pharma Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06082037
- Sponsor's protocol ID
- EFC17801
- Other IDs
- U1111-1280-6777, 2023-503462-23, 2023
- Acronym
- ROCKaspire
- Status last verified
- Sep 2026
- First submitted
- 7 Oct 2023
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06082037
- Acronym / sponsor ID
- ROCKaspire / EFC17801
- Conditions
- Lung Transplant Rejection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- Meiji Seika Pharma Co., Ltd.
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- 29 Jan 2029 (estimated)
- Study completion
- 1 Oct 2030 (estimated)
- First posted
- 13 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Belumosudil + Azithromycin | Experimental | Drug: Belumosudil, Drug: AzithromycinParticipants will receive 200 mg belumosudil orally once daily |
| Placebo + Azithromycin | Placebo comparator | Drug: Azithromycin, Drug: PlaceboParticipants will receive placebo orally once daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BelumosudilAlso: REZUROCKTablet, Oral | Drug | Belumosudil + Azithromycin |
| AzithromycinDepends on pharmaceutical presentation, Oral | Drug | Belumosudil + Azithromycin, Placebo + Azithromycin |
| PlaceboTablet, Oral | Drug | Placebo + Azithromycin |
Primary outcome
Percent change from baseline to Week 26 in forced expiratory volume in 1 second (FEV1)
Time frame: Baseline to Week 26
14 secondary outcomes
Response rate at Week 26
Time frame: Baseline to Week 26
Absolute change from baseline to Week 26 in FEV1
Time frame: Baseline to Week 26
Absolute change from baseline to Week 26 in percent predicted FEV1
Time frame: Baseline to Week 26
Percent change from baseline to Week 26 in forced vital capacity (FVC)
Time frame: Baseline to Week 26
Absolute change from baseline to Week 26 in FVC
Time frame: Baseline to Week 26
Absolute change from baseline to Week 26 in percent predicted FVC
Time frame: Baseline to Week 26
Time to CLAD progression during the double-blind treatment period
Time frame: Baseline to Week 26
Time to re-transplantation or death
Time frame: Up to 7 days after the administration of last dose of study drug
Percent change from baseline to Week 26 in 6-minute walk distance
Time frame: Baseline to Week 26
Absolute change from baseline to Week 26 in 6-minute walk distance
Time frame: Baseline to Week 26
Change from baseline to Week 26 in Saint George Respiratory Questionnaire (SGRQ)
Time frame: Baseline to Week 26
Change from baseline to Week 26 in EQ-5D-5L
Time frame: Baseline to Week 26
Change from baseline to Week 26 in Patient-Reported Outcomes Measurement Information System-29 profile version 2.1
Time frame: Baseline to Week 26
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Time frame: Up to 7 days after the administration of last dose of study drug
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- EFC17801 Plain Language Results SummaryLink provided by the sponsor.
- For EU sites click here and navigate to 'Locations and contact points'Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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
Related trials for Lung Transplant Rejection
RecruitingPhase 1
Syk Inhibition in MItigating Lung Allograft Rejection (SIMILAR): A Trial to Evaluate the Safety and Tolerability of Fostamatinib in Lung Transplant Patients With Donor-Specific Antibodies
Lung Transplantation
RecruitingPhase 1
A Phase 1 Clinical Trial of Siltuximab for the Treatment of Antibody-Mediated Rejection After Lung Transplantation
Antibody Mediated Rejection of Lung Transplant
RecruitingPhase 2
Belumosudil to Block Chronic Lung Allograft Dysfunction (CLAD) in High Risk Lung Transplant Recipients
Lung Transplant
RecruitingObservational study
Prospective Multicenter Research on Donor and Recipient Management Strategies to Improve Lung Transplant Outcomes
Lung Transplant; Complications, Lung Transplant; Infection or Inflammation
RecruitingObservational study
GRAfT 2.0. A Multimodal Prospective Approach to Define the Mechanisms and Clinical Features of Acute and Chronic Rejection in Lung Transplantation
Lung Transplant, End Stage Lung Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Trial Transparency email recommended (Toll free number for US & Canada) contact
Clinical Sciences & Operations study director
Sanofi
82 sites in 19 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Belumosudil and Azithromycin in people with Lung Transplant Rejection, run by Sanofi at 82 sites in 19 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 82 sites in United States, China, France, Italy, Spain and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trial Transparency email recommended (Toll free number for US & Canada) (800-633-1610 ext. option 6, contact-us@sanofi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change from baseline to Week 26 in forced expiratory volume in 1 second (FEV1) (time frame: Baseline to Week 26). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.