ClinicalTrials.gg
RecruitingNCT07116031schoolROCKUpdated Sep 22, 2026

A Study of Belumosudil in Children With Chronic Graft Versus Host Disease (schoolROCK)

A Phase 2 interventional study of Belumosudil and Belumosudil in Chronic Graft Versus Host Disease, sponsored by Sanofi. Recruiting at 35 sites in 13 countries. Open to participants aged 1 Year to 18 Years. Per ClinicalTrials.gov, last updated 2026-09-22.

Sponsored by Sanofi · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Dec 2025; still recruiting 11 months later.

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Phase
Phase 2
Study type
Interventional
Enrollment
37
Allocation
Not applicable
Ages
1 Year to 18 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 14 studies testing belumosudil in Bronchiolitis Obliterans Syndrome — 7 open to participants now, 8 under way, 2 of them phase 3. belumosudil · Bronchiolitis Obliterans Syndrome.

Planned enrollment
7th of 14
37 · median 34
Started
2025
with 1 other
Phase 2
8 of 14
3 open now
Registered
11th of 14
by date
Lead sponsor
6 of 14
Sanofi

Among the 14 studies testing belumosudil in Bronchiolitis Obliterans Syndrome, this one is the 7th largest by planned enrollment, is one of 2 that started in 2025, is one of 8 in phase 2, and was the 11th registered.

Bronchiolitis Obliterans Syndrome

714 studies on the registry are indexed under Bronchiolitis Obliterans Syndrome; 128 are open to participants now.

Browse Bronchiolitis Obliterans Syndrome studies →

Open to participants now

7 of the 14 studies testing belumosudil in Bronchiolitis Obliterans Syndrome are open now, in 12 countries. Recruiting first, the newest first:

1 more — sign in →

By country, each count listing its studies:

All 7 open studies →

About belumosudil

belumosudil: first FDA approval 2021 (REZUROCK), first EMA approval 2026. What it is approved for, and how studies give it, is on its page →

Who these studies take

Of the 100 Bronchiolitis Obliterans Syndrome studies recruiting now, 45 (45%) set no upper age limit and 45 (45%) stop at 75 or younger; 25 take children under 18; 12 take healthy volunteers.

This study: 1 Year to 18 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 14 studies testing belumosudil in Bronchiolitis Obliterans Syndrome, or all of them as a file.
02

Study summary

This is an open-label, single group, Phase 1/2, 1-arm study for treatment of children aged 1 to \<18 years with active moderate-to-severe cGVHD that is refractory to or recurred after at least 2 prior lines of systemic therapy for cGVHD.

The purpose of Phase 1 is to determine the PK profiles and to establish the Recommended Pediatric Equivalent Dose (RPED) of belumosudil in participants aged 1 to \<12 years with active moderate to severe cGVHD. Upon completion and evaluation of Phase 1, Phase 2 will commence with the purpose of determining safety and efficacy (ORR by 24 weeks) of belumosudil in participants aged 1 to \<18 years.

Study details include:

The end of study is defined as 3 years after the last participant is recruited or all participants have discontinued treatment, or have died, whichever comes first.

Minimum of 6 participants ages 1 to 6 years will be enrolled for each phase of study

Individual participant duration on study will consist of:

Up to 4 weeks for screening. Treatment until clinically significant progression of cGVHD, relapse/recurrence of the underlying disease, start of a new systemic treatment for cGVHD, experience of an unacceptable adverse event, request from participant or Investigator, or until the end of the study is reached, whichever comes first.

30 days of post treatment safety follow-up. Long-term follow-up until death or end of study, whichever occurs first.

03

Conditions studied

  • Chronic Graft Versus Host Disease
04

Who can participate

Ages eligible
1 Year to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participant must be 1 to \<18 years of age, at the time the consent/assent is signed. For Phase 1: participant must be 1 to \<12 years of age, at the time the consent/assent is signed. For Phase 2: participant must be 1 to \<18 years of age, at the time the consent/assent is signed.
  • Participant has undergone an HCT
  • Has active moderate to severe cGVHD, defined using the NIH Consensus diagnosis and staging criteria for which systemic therapy is required
  • cGVHD is to or has recurred after at least 2
  • Has received at least two lines of prior systemic therapy for cGVHD, but no more than 5 lines.
  • If participant receives therapy for cGVHD, the dose must be stable for at least 2 weeks prior to the first dose of the IMP
  • Has a Lansky-Play (if aged \<16 years) or (if aged ≥16 years) performance scale of ≥60
  • Body weight of 8 kg and above
  • use by sexually active male and female should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
  • The participant or their legally authorized representative (LAR) must be capable of giving signed
  • of >6 months
  • Participants can take the IMP orally or via a nasogastric tube

Exclusion criteria

Exclusion Criteria:

  • Progressive underlying disease or post-transplant lymphoproliferative disease within 4 weeks prior to the first dose of the IMP.
  • Diagnosed with another (other than malignancy for which transplant was performed) within 3 years prior to the first dose of the IMP
  • History or other evidence of severe illness or any other conditions that would make the participant, in the opinion of the Investigator, unsuitable for the study (such as malabsorption syndromes, active, uncontrolled infections, or poorly controlled psychiatric disease)
  • Has a forced expiratory volume (in the first second; ) ≤39% or has lung score of 3
  • Female participants who are pregnant or breastfeeding
  • Participants who meet any of the following criteria regarding systemic treatments:
  • Participants who newly initiated any systemic GVHD treatment within 14 days prior to the first dose of belumosudil.
  • Participants receiving systemic GVHD treatments ibrutinib, ruxolitinib, mycophenolate (MMF), methotrexate, rituximab, axatilimab, or imatinib who are unable to meet the following requirements:
  • No dose increases from 14 days prior to belumosudil initiation and continuing for the first 14 days of belumosudil treatment (dose reductions and discontinuations are permitted during this period)
  • Ability to discontinue these therapies within 14 days after initiating belumosudil (allowing for a maximum overlap period of up to 14 days with belumosudil treatment)
  • Participants receiving other systemic GVHD treatments (apart from and calcineurin inhibitors) including treatments who have not completed a of at least 28 days or 5 half-lives (whichever is shorter) prior to the first dose of belumosudil. No washout period is required for extracorporeal photopheresis (ECP) or sirolimus therapy, but these must be discontinued before study treatment initiation.

Note: Corticosteroids and calcineurin inhibitors may continue throughout the study.

  • The use of herbal and recreational drugs within 7 days before the start of study intervention
  • Participant has had previous exposure to belumosudil
  • Administration of live or is prohibited within 28 days or 5 elimination half-lives of the respective vaccine, whichever is longer, prior to IMP administration and until study intervention discontinuation
  • Treatment with any non-GVHD investigational agent, or any investigational device or procedure, within 28 days (or 5 half-lives, whichever is longer) of enrollment, prior to the first dose of the IMP
  • For Phase 1 only: Administration with strong inducers is not allowed within 14 days or 5 half-lives (whichever is longer) of the first dose of IMP until the study intervention discontinuation.
  • For Phase 1 only: PPIs are not allowed within 1 day or 5 half-lives (whichever is longer) of the first dose of IMP and Day 15 of Cycle 1. They can be restarted on Cycle 1 Day 16.
  • \<1.0 × 109/L. The use of granulocyte-colony stimulating factor (G-CSF) is not allowed within 7 days prior to the ANC test to reach this level during screening
  • count \<25 × 109/L. Platelet transfusions are not allowed within 72 hours before hematology screening test. Participants with platelet transfusion refractoriness will be excluded. (Participants who have suboptimal responses to at least 2 transfusions will be considered as platelet transfusion )
  • (ALT) and/or aspartate aminotransferase (AST) >3× (ULN) (> 5x ULN if abnormalities are due to cGVHD)
  • Total >1.5 × ULN (>3 x ULN if Gilbert's syndrome or if abnormalities are due to cGVHD)
  • (GFR) \<30 mL/min/1.73 m2 using the revised Bedside Schwartz calculator
  • Participants with an active viral disease including virus (HBV) and virus (HCV)
  • Active uncontrolled Cytomegalovirus (CMV) or Epstein-Barr virus (EBV) infection
  • Known history of (HIV)
  • Not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Terms in these criteria, in plain language(24)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Karnofsky performance status (KPS)

A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.

Studies often ask for 60 or 70 and above. Your doctor gives the score.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

FEV1

From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.

GVHD (graft-versus-host disease)

After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

CYP3A (CYP3A4) inhibitors and inducers

CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.

Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
37 participants (estimated)

Study arms

  • Experimental
    belumosudil

    Participant will take IMP with a meal approximately the same time each morning. IMP dose will be according to weight and will be increased to daily dose of twice a day (BID) in participants who concomitantly receive proton pump inhibitors (PPIs) or strong CYP3A4 inducers. No concomitant PPIs are allowed during Phase 1 up to and including Cycle 1 Day 15. From Day 16 onwards, PPIs will be permitted, resulting in an increased dose of Belumosudil to BID. No concomitant strong CYP3A4 inducers are allowed during Phase 1.

    Drug: Belumosudil

Interventions

  • Pharmaceutical form:Oral suspension -Route of administration:Oral or nasogastric tube

    Also known as: SAR445761, REZUROCK

  • Pharmaceutical form:Tablet formulation-Route of administration:Oral

    Also known as: SAR445761, REZUROCK

06

What researchers measure

Primary outcomes

  1. Phase 1: AUC

    PK parameter (AUC at steady state)

    Time frame: Cycle 1 Day 15 after the last participant dosed in the phase 1 part.

  2. Proportion of participants who achieve an overall response (partial response [PR] or complete response [CR]) by Week 25 or Cycle 7 Day 1 whichever is first

    Proportion of participants who achieve an overall response (partial response \[PR\] or complete response \[CR\]) with up to 24 weeks of therapy (i.e. by the Week 25 or Cycle 7 Day 1 visit whichever is first), as defined by the National Institute of Health (NIH) Consensus response criteria

    Time frame: Last participant completing 24 weeks (Week 25 visit or Cycle 7 Day 1 visit, whichever comes first) in the study

Secondary outcomes

  1. Phase 1: Number of participants with treatment-emergent adverse events [TEAEs], serious TEAEs, and adverse events of special interest (AESIs)

    Safety

    Time frame: Up to 3 years after the last participant enrolled

  2. Phase 1: Cmax

    Steady-state belumosudil PK parameters

    Time frame: Cycle 1 Day 15 after the last participant dosed in the phase 1 part

  3. Phase 1: AUC0-6h

    Steady-state belumosudil PK parameters

    Time frame: Cycle 1 Day 15 after the last participant dosed in the phase 1 part

  4. Phase 1: ORR

    Proportion of participants who achieve an overall response (complete response \[CR\] or partial response \[PR\]) by 24 weeks, as defined by the 2014 National Institute of Health (NIH) Consensus response criteria

    Time frame: last participant completing 24 weeks (Week 25 visit or Cycle 7 Day 1 visit, whichever comes first) in the study.

  5. Phase 1: DOR

    Time from the date of first response to the date of progression of cGVHD, initiation of a new systemic treatment for cGVHD, or death, whichever comes first. DOR is determined only for participants who achieved overall response (PR or CR) as per 2014 NIH Consensus response criteria

    Time frame: Up to 3 years after the last participant enrolled

  6. Phase 1: response by organ

    As defined by the 2014 NIH Consensus response criteria

    Time frame: Up to 3 years after the last participant enrolled

  7. Phase 1: failure-free survival (FFS)

    Time from the date of the first investigational medicinal product (IMP) administration to the date of initiation of a new systemic treatment for cGVHD, relapse or recurrence of the underlying disease, or death, whichever occurs first

    Time frame: Up to 3 years after the last participant enrolled

  8. Phase 1: overall survival (OS)

    Time from the date of first IMP administration to the date of death due to any cause

    Time frame: Up to 3 years after the last participant enrolled

  9. Phase 1: time to response (TTR)

    Time from the date of the first IMP administration to the first documented response (either CR or PR) according to the 2014 NIH Consensus Criteria for cGVHD

    Time frame: Up to 3 years after the last participant enrolled

  10. Phase 2: Number of participants with treatment-emergent adverse events [TEAEs], serious TEAEs, and adverse events of special interest (AESIs)

    Safety

    Time frame: Up to 3 years after the last participant enrolled

  11. Phase 2: Ctrough of belumosudil

    Time frame: Cycle 2 Day 1 and Cycle 4 Day 1 after the last participant enrolled

  12. Phase 2: DOR

    Time from first response to the date of progression of cGVHD, initiation of a new systemic treatment for cGVHD, or death, whichever comes first. DOR is determined only for participants who achieved overall response (PR or CR) as per NIH Consensus response criteria

    Time frame: Up to 3 years after the last participant enrolled

  13. Phase 2: response by organ

    response by organ as defined by the 2014 NIH Consensus response criteria

    Time frame: Up to 3 years after the last participant enrolled

  14. Phase 2: FFS

    Time from the date of the first IMP administration to the date of initiation of a new systemic treatment for cGVHD, relapse or recurrence of the underlying disease, or death, whichever occurs first

    Time frame: Up to 3 years after the last participant enrolled

  15. Phase 2: OS

    Time from the date of first IMP administration to the date of death due to any cause

    Time frame: Up to 3 years after the last participant enrolled

  16. Phase 2: time to response (TTR)

    Time from the date of the first IMP administration to the first documented response (either CR or PR) according to the 2014 NIH Consensus Criteria for cGVHD

    Time frame: Up to 3 years after the last participant enrolled

  17. Phase 1: time to next treatment (TTNT)

    Time from the date of the first IMP administration to initiating the next line of systemic therapy, or death whichever is first

    Time frame: Up to 3 years after the last participant enrolled

  18. Phase 2: time to next treatment (TTNT)

    Time from the date of the first IMP administration to initiating the next line of systemic therapy, or death whichever is first

    Time frame: Up to 3 years after the last participant enrolled

07

Study locations

35 of 35 sites recruiting
  • Children's Hospital Los Angeles- Site Number : 8400009
    Los Angeles, California 90027, United States
    Recruiting
  • Children's National Medical Center - Washington- Site Number : 8400005
    Washington D.C., District of Columbia 20010, United States
    Recruiting
  • Children's Healthcare of Atlanta - Egleston Hospital- Site Number : 8400003
    Atlanta, Georgia 30322, United States
    Recruiting
  • Dana-Farber Cancer Institute- Site Number : 8400007
    Boston, Massachusetts 02215, United States
    Recruiting
  • Memorial Sloan Kettering Cancer Center - New York - York Avenue- Site Number : 8400001
    New York, New York 10065, United States
    Recruiting
  • Texas Children's Hospital- Site Number : 8400008
    Houston, Texas 77030, United States
    Recruiting
  • Fred Hutchinson Cancer Research Center- Site Number : 8400002
    Seattle, Washington 98109, United States
    Recruiting
  • Investigational Site Number : 0560003
    Ghent, 9000, Belgium
    Recruiting
  • Investigational Site Number : 0560001
    Leuven, 3000, Belgium
    Recruiting
  • Investigational Site Number : 1240001
    Vancouver, British Columbia V6H 3N1, Canada
    Recruiting
  • Investigational Site Number : 1240002
    Toronto, Canada
    Recruiting
  • Investigational Site Number : 1560003
    Beijing, 100045, China
    Recruiting
  • Investigational Site Number : 1560001
    Shanghai, 200040, China
    Recruiting
  • Investigational Site Number : 1560004
    Shenzhen, 518026, China
    Recruiting
  • Investigational Site Number : 1560002
    Suzhou, 215025, China
    Recruiting
  • Investigational Site Number : 2500002
    Marseille, 13885, France
    Recruiting
  • Investigational Site Number : 2500001
    Paris, 75019, France
    Recruiting
  • Investigational Site Number : 2760001
    Berlin, 13353, Germany
    Recruiting
  • Investigational Site Number : 3760005
    Haifa, 3109601, Israel
    Recruiting
  • Investigational Site Number : 3760002
    Jerusalem, 9112001, Israel
    Recruiting
  • Investigational Site Number : 3760004
    Petah Tikva, 4920235, Israel
    Recruiting
  • Investigational Site Number : 3760003
    Ramat Gan, 5262100, Israel
    Recruiting
  • Investigational Site Number : 3760001
    Tel Aviv, 6423906, Israel
    Recruiting
  • Investigational Site Number : 3800001
    Rome, Roma 00165, Italy
    Recruiting
  • Investigational Site Number : 3800003
    Turin, Torino 10126, Italy
    Recruiting
  • Investigational Site Number : 3800002
    Monza, 20900, Italy
    Recruiting
  • Investigational Site Number : 3920002
    Tokyo, 157-8535, Japan
    Recruiting
  • Investigational Site Number : 5280001
    Utrecht, 3584 CS, Netherlands
    Recruiting
  • Investigational Site Number : 7240003
    Esplugues de Llobregat, Barcelona [Barcelona] 08950, Spain
    Recruiting
  • Investigational Site Number : 7240001
    Barcelona, Catalunya [Cataluña] 08035, Spain
    Recruiting
  • Investigational Site Number : 7240002
    Madrid, 28009, Spain
    Recruiting
  • Investigational Site Number : 7920003
    Ankara, 06800, Turkey (Türkiye)
    Recruiting
  • Investigational Site Number : 7920001
    Izmir, 35100, Turkey (Türkiye)
    Recruiting
  • Investigational Site Number : 8260002
    Newcastle upon Tyne, England NE2 4HH, United Kingdom
    Recruiting
  • Investigational Site Number : 8260001
    London, London, City of WC1N 3JH, United Kingdom
    Recruiting
08

References and documents

Individual participant data

Plan to share: 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

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2025 (actual). Primary completion is estimated for Sep 2028, 33 months after the start.

Of 63 phase 2 interventional studies under Bronchiolitis Obliterans Syndrome, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 58. This study's planned 33 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 25, 2025
First posted
Aug 11, 2025
StartActual
Dec 2, 2025
Primary completionEst.
Sep 25, 2028
CompletionEst.
Feb 28, 2031
Last update
Sep 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07116031
Lead sponsor
Sanofi
Collaborators
Meiji Seika Pharma Co., Ltd.
Responsible party
Sponsor
First posted
Aug 11, 2025
Start date
Dec 2, 2025
Primary completion
Sep 25, 2028 (estimated)
Completion
Feb 28, 2031 (estimated)
Last update
Sep 22, 2026

Study contacts

Trial Transparency email recommended (Toll free for US & Canada)
Contact
contact-us@sanofi.com
800-633-1610 ext. option 6

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Studies of the drug tested here: Belumosudil

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