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AzTrials

Chronic Graft Versus Host DiseasePhase 3ROCKnrol-1NCT06143891

A Study to Test an Oral Medicine, Belumosudil, in Combination With Corticosteroids in Participants at Least 12 Years of Age With Newly Diagnosed Chronic Graft Versus Host Disease.

A Phase 3 study testing Belumosudil, Prednisone and Prednisolone in people with Chronic Graft Versus Host Disease, run by Sanofi at 151 sites in 24 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This is a parallel, Phase 3, two-arm study for the treatment of newly diagnosed moderate or severe chronic GVHD. The study duration for a participant includes up to 4 weeks for screening; a treatment period until clinically meaningful cGVHD progression (defined as progression requiring addition of new systemic… Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Chronic Graft Versus Host Disease
What is being tested?
Belumosudil, Prednisone and Prednisolone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
260 participants
Where
151 sitesin 24 countries
Study dates
23 Jan 2024to 29 Sep 2028
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 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Patients must be at least 12 years of age inclusive, at the time of signing the informed consent
  • Participants who have undergone allogenic HCT with newly diagnosed moderate to severe cGVHD according to NIH consensus diagnosis and staging criteria (2014)
  • Participants who require systemic treatment with corticosteroids for cGVHD
  • Participants who have not received any prior systemic treatment for cGVHD (including ECP)
  • If participants are receiving other immunosuppressive agents for the prophylaxis or treatment of acute GVHD, the dose should be under the threshold pre-defined in protocol
  • For adult participants, the body weight should be ≥40 kg. For adolescent participants, the body weight should be ≥30 kg
  • Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
  • Participants or their legally authorized representative must be capable of giving signed informed consent

Who cannot join

  • Participants are excluded from the study if any of the following criteria apply:
  • Medical conditions
  • Any evidence (histologic, cytogenetic, molecular, hematologic, or mixed) of progressive or relapsed underlying disease after the most recent allogeneic HCT
  • Post-transplant lymphoproliferative disease within 4 weeks prior to randomization
  • Female participants who are pregnant or breastfeeding
  • Unable to tolerate a prednisone equivalent dose of corticosteroids ≥ 1 mg/kg/day Prior/concomitant therapy
Show all 25Show fewer
  • Participant has had previous exposure to belumosudil.
  • Received any previous systemic treatment for cGVHD with the following exception: Corticosteroids for cGVHD received within 7 days prior to the planned administration of IMP only if in the interest of participant.
  • Prior/concurrent clinical study experience
  • Received any investigational agents, or any investigational device or procedure, or prohibited therapy for this study within 28 days or 5 elimination half-lives prior to randomization, whichever is longer Diagnostic assessments
  • Karnofsky (if aged ≥16 years)/Lansky (if aged <16 years) Performance Score of < 60
  • Platelets <25 x 109/L. Platelet transfusion is not allowed within 3 days before the screening hematological test
  • Absolute neutrophil count (ANC) <0.5 x 109/L. The use of granulocyte-colony stimulating factor (G-CSF) is not allowed to reach this level during screening
  • Estimated Glomerular Filtration Rate (eGFR) <30 mL/min/1.73 m2 using the MDRD-4 variable formula (if aged ≥18 years) or using the Bedside Schwartz formula (if aged <18 years)
  • Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >3 x ULN without liver cGVHD or>5 × ULN with liver) cGVHD
  • Total bilirubin >1.5 × (ULN) (>3 × ULN if Gilbert syndrome)
  • Participant has forced expiratory volume in 1 second (FEV1) of predicted ≤39% or has lung score of 3 according to NIH consensus diagnostic and staging criteria (2014)
  • 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, poorly controlled psychiatric disease or coronary artery disease)
  • Known history of human immunodeficiency virus (HIV)
  • Active viral disease including hepatitis B virus (HBV) or hepatitis C virus (HCV)
  • Active uncontrolled cytomegalovirus (CMV) and Epstein-Barr virus (EBV) infection. Infections are considered controlled if appropriate therapy has been instituted and, at the time of screening, no signs of infection worsening are present according to Investigator's judgement
  • Diagnosed or treated for another malignancy other than the underlying disease allogeneic HCT was indicated for, within 3 years prior to randomization with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in-situ malignancy, or low risk prostate cancer after curative therapy
  • Unable to swallow tablets
  • Participant 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
  • Any active, uncontrolled infections assessed to be clinically significant by the Investigator

Trial locations and contacts

151 sites in 24 countries.

151 sites in 24 countries

United States24 sites

  • St. David's South Austin Medical Center- Site Number : 8400002

    Austin, Texas, 78704

  • Johns Hopkins Hospital- Site Number : 8400033

    Baltimore, Maryland, 21287

  • Dana Farber Cancer Institute Site Number : 8400005

    Boston, Massachusetts, 02115

  • UNC Children's Hospital- Site Number : 8400025

    Chapel Hill, North Carolina, 27514

  • University of Virginia Comprehensive Cancer Center-Site Number : 8400031

    Charlottesville, Virginia, 22903

  • Northwestern University- Site Number : 8400017

    Chicago, Illinois, 60611

  • Oncology Hematology Care - Kenwood- Site Number : 8400030

    Cincinnati, Ohio, 45236

  • The Ohio State University Comprehensive Cancer Center (OSUCCC) - The James Cancer Hospital and Solove Research Institute- Site Number : 8400026

    Columbus, Ohio, 43210

  • Texas Oncology - Dallas - Worth Street- Site Number : 8400010

    Dallas, Texas, 75246

  • The Hope Clinic of Emory University- Site Number : 8400020

    Decatur, Georgia, 30030

  • Karmanos Cancer Institute - Detroit- Site Number : 8400013

    Detroit, Michigan, 48201

  • City of Hope National Medical Center- Site Number : 8400001

    Duarte, California, 91010

  • Indiana University Health University Hospital- Site Number : 8400006

    Indianapolis, Indiana, 46202

  • University of Kentucky Chandler Medical Center- Site Number : 8400024

    Lexington, Kentucky, 40536

  • University of Arkansas for Medical Sciences-Site Number : 8400019

    Little Rock, Arkansas, 72205

  • University of Wisconsin Carbone Cancer Center-Site Number : 8400029

    Madison, Wisconsin, 53792

  • Sarah Cannon Research Institute Site Number : 8400003

    Nashville, Tennessee, 37203

  • AdventHealth Orlando- Site Number : 8400023

    Orlando, Florida, 32803

  • UPMC Hillman Cancer Center- Site Number : 8400008

    Pittsburgh, Pennsylvania, 15232

  • Oregon Health and Science University- Site Number : 8400027

    Portland, Oregon, 97239

  • Texas Transplant Institute - Methodist Hospital- Site Number : 8400037

    San Antonio, Texas, 78229

  • University of California San Francisco - Parnassus Heights- Site Number : 8400035

    San Francisco, California, 94143

  • Fred Hutchinson Cancer Research Center- Site Number : 8400004

    Seattle, Washington, 98109

  • Atrium Health Wake Forest Baptist Medical Center - Winston-Salem - Medical Center Boulevard- Site Number : 8400007

    Winston-Salem, North Carolina, 27157

Other trials in United States

China16 sites

  • Investigational Site Number : 1560019

    Beijing, 100050

  • Investigational Site Number : 1560012

    Changchun, 130021

  • Investigational Site Number : 1560010

    Changsha, 410008

  • Investigational Site Number : 1560011

    Fuzhou, 350001

  • Investigational Site Number : 1560005

    Guangzhou, 510000

  • Investigational Site Number : 1560002

    Hangzhou, 310003

  • Investigational Site Number : 1560014

    Hefei, 230001

  • Investigational Site Number : 1560008

    Jinan, 250001

  • Investigational Site Number : 1560007

    Jinan, 250014

  • Investigational Site Number : 1560001

    Suzhou, 215006

  • Investigational Site Number : 1560006

    Suzhou, 215025

  • Investigational Site Number : 1560003

    Tianjin, 300020

  • Investigational Site Number : 1560004

    Tianjin, 300020

  • Investigational Site Number : 1560013

    Wuhan, 430022

  • Investigational Site Number : 1560015

    Wuhan, 430030

  • Investigational Site Number : 1560009

    Zhengzhou, 450008

Other trials in China

Italy12 sites

  • Investigational Site Number : 3800003

    Bergamo, 24127

  • Investigational Site Number : 3800004

    Bologna, 40138

  • Investigational Site Number : 3800005

    Genoa, Genova, 16132

  • Investigational Site Number : 3800009

    Milan, Milano, 20132

  • Investigational Site Number : 3800011

    Pavia, 27100

  • Investigational Site Number : 3800010

    Perugia, 06156

  • Investigational Site Number : 3800006

    Reggio Calabria, 89133

  • Investigational Site Number : 3800001

    Rome, Roma, 00168

  • Investigational Site Number : 3800002

    Rozzano, Milano, 20089

  • Investigational Site Number : 3800012

    Torette, Ancona, 60020

  • Investigational Site Number : 3800007

    Turin, Torino, 10126

  • Investigational Site Number : 3800008

    Udine, 33100

Other trials in Italy

Spain10 sites

  • Investigational Site Number : 7240005

    Barcelona, Catalunya [Cataluña], 08036

  • ICO Institut Català d'Oncologia-Site Number : 7240006

    Barcelona, Catalunya [Cataluña], 08908

  • Investigational Site Number : 7240004

    Madrid, 28007

  • Hospital Niño Jesús-Site Number : 7240002

    Madrid, 28009

  • Hospital Regional Universitarioa de Malaga-Site Number : 7240003

    Málaga, 29010

  • Hospital Universitario de Salamanca-Site Number : 7240007

    Salamanca, 37007

  • Investigational Site Number : 7240011

    Santander, Cantabria, 39008

  • Hospital Universitario Virgen del Rocío.-Site Number : 7240008

    Seville, 41013

  • Investigational Site Number : 7240012

    Valencia, 46010

  • Hospital Universitari i Politècnic La Fe-Site Number : 7240001

    Valencia, 46026

Other trials in Spain

Germany9 sites

  • Investigational Site Number : 2760007

    Berlin, 13353

  • Investigational Site Number : 2760003

    Cologne, 50937

  • Investigational Site Number : 2760001

    Dresden, 01307

  • Investigational Site Number : 2760005

    Freiburg im Breisgau, 79106

  • Investigational Site Number : 2760002

    Hamburg, 20246

  • Investigational Site Number : 2760010

    Kiel, 24105

  • Investigational Site Number : 2760009

    Münster, 48149

  • Investigational Site Number : 2760006

    Regensburg, 93053

  • Investigational Site Number : 2760008

    Tübingen, 72076

Other trials in Germany

France8 sites

  • Institut Paoli Calmettes-Investigational Site Number : 2500004

    Marseille, 13273

  • CHU Hotel Dieu-Investigational Site Number : 2500005

    Nantes, 44093

  • Investigational Site Number : 2500003

    Paris, 75010

  • Investigational Site Number : 2500001

    Paris, 75571

  • CHU Bordeaux-Hôpital Haut-Lévêque-Investigational Site Number : 2500002

    Pessac, 33600

  • Hôpital Lyon Sud-Investigational Site Number : 2500007

    Pierre-Bénite, 69310

  • Hôpital Pontchaillou - CHU de Rennes-Investigational Site Number : 2500008

    Rennes, 35033

  • Investigational Site Number : 2500006

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Argentina6 sites

  • Investigational Site Number : 0320005

    Buenos Aires, 1227

  • Investigational Site Number : 0320003

    Buenos Aires, 1280

  • Investigational Site Number : 0320001

    Buenos Aires, 1426

  • Investigational Site Number : 0320002

    Buenos Aires, 1431

  • Investigational Site Number : 0320004

    Córdoba, 5000

  • Investigational Site Number : 0320006

    Pilar, Buenos Aires, 1629

Other trials in Argentina

Belgium6 sites

  • Investigational Site Number : 0560006

    Bruges, 8000

  • UZ Gent-Investigational Site Number : 0560003

    Ghent, 9000

  • UZ Leuven-Investigational Site Number : 0560001

    Leuven, Vlaams-Brabant, 3000

  • CHU de Liège-Investigational Site Number : 0560004

    Liège, 4000

  • AZ Delta-Investigational Site Number : 0560002

    Roeselare, 8800

  • Cliniques Universitaires St. Luc-Investigational Site Number : 0560005

    Woluwe, Brussels Capital, 1200

Other trials in Belgium

Canada6 sites

  • Investigational Site Number : 1240007

    Calgary, Alberta, T2N 5G2

  • Hôpital Maisonneuve Rosemont-Investigational Site Number : 1240001

    Montreal, Quebec, H1T 2M4

  • CHU Sainte-Justine-Site Number : 1240003

    Montreal, Quebec, H3T1C5

  • Investigational Site Number : 1240002

    Montreal, Quebec, H4A 3J1

  • Investigational Site Number : 1240008

    Saskatoon, Saskatchewan, S7N 4H4

  • Investigational Site Number : 1240005

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Israel6 sites

  • Investigational Site Number : 3760002

    Haifa, 3109601

  • Investigational Site Number : 3760005

    Jerusalem, 9112001

  • Investigational Site Number : 3760006

    Petah Tikva, 4920235

  • Investigational Site Number : 3760003

    Ramat Gan, 5262100

  • Investigational Site Number : 3760004

    Ramat Gan, 5262100

  • Investigational Site Number : 3760001

    Tel Aviv, 6423906

Other trials in Israel

Turkey (Türkiye)6 sites

  • Investigational Site Number : 7920006

    Adana, 01120

  • Investigational Site Number : 7920002

    Ankara, 06200

  • Investigational Site Number : 7920004

    Ankara, 06560

  • Investigational Site Number : 7920001

    Ankara, 06620

  • Investigational Site Number : 7920005

    Istanbul, 34010

  • Investigational Site Number : 7920003

    Izmir, 35100

Other trials in Turkey (Türkiye)

Brazil5 sites

  • Hospital de Clinicas da Universidade Federal do Parana- Site Number : 0760008

    Curitiba, Paraná, 80060-900

  • INCA - Hospital do Câncer - Rio de Janeiro - Praça Da Cruz Vermelha- Site Number : 0760007

    Rio de Janeiro, 20230-130

  • Fundação Faculdade Regional de Medicina de São José do Rio Preto- Site Number : 0760006

    São José do Rio Preto, São Paulo, 15090-000

  • Hospital das Clinicas FMUSP- Site Number : 0760004

    São Paulo, 05403-000

  • Hospital Israelita Albert Einstein- Site Number : 0760003

    São Paulo, 05651-901

Other trials in Brazil

United Kingdom5 sites

  • Investigational Site Number : 8260006

    Cardiff, Cardiff [Caerdydd Gb-crd], CF14 4XW

  • Investigational Site Number : 8260003

    Leeds, LS9 7TF

  • Investigational Site Number : 8260002

    London, London, City of, SE5 9RL

  • Investigational Site Number : 8260001

    Manchester, M20 4BX

  • Investigational Site Number : 8260004

    Newcastle upon Tyne, NE7 7DN

Other trials in United Kingdom

Australia4 sites

  • Investigational Site Number : 0360003

    Brisbane, Queensland, 4029

  • Investigational Site Number : 0360001

    Melbourne, Victoria, 3000

  • Investigational Site Number : 0360004

    Murdoch, Western Australia, 6150

  • Investigational Site Number : 0360005

    Westmead, New South Wales, 2145

Other trials in Australia

Czechia4 sites

  • Interni hematologicka a onkologicka klinika Fakultni nemocnice Brno-Site Number : 2030003

    Brno, 62500

  • IV. Interni hematologicka klinika, Fakultni nemocnice Hradec Kralove-Site Number : 2030002

    Hradec Králové, 50005

  • Klinika hematoonkologie, Fakultni nemocnice Ostrava-Site Number : 2030001

    Ostrava, 70852

  • Ustav hematologie a krevni transfuze-Site Number : 2030004

    Prague, 128 00

Other trials in Czechia

Netherlands4 sites

  • Amsterdam Universitair Medisch Centrum-Site Number : 5280005

    Amsterdam, 1081 HV

  • Investigational Site Number : 5280003

    Groningen, 9713 GR

  • Investigational Site Number : 5280002

    Rotterdam, 3015 CE

  • Investigational Site Number : 5280001

    Utrecht, 3584 CS

Other trials in Netherlands

South Korea4 sites

  • Investigational Site Number : 4100002

    Seoul, Seoul-teukbyeolsi, 03080

  • Investigational Site Number : 4100003

    Seoul, Seoul-teukbyeolsi, 03722

  • Investigational Site Number : 4100004

    Seoul, Seoul-teukbyeolsi, 06351

  • Investigational Site Number : 4100001

    Seoul, Seoul-teukbyeolsi, 06591

Other trials in South Korea

Austria3 sites

  • Investigational Site Number : 0400003

    Graz, 8036

  • Investigational Site Number : 0400001

    Linz, 4020

  • Investigational Site Number : 0400004

    Vienna, 1090

Other trials in Austria

Denmark3 sites

  • Department of hematology-Investigational Site Number : 2080001

    Aarhus, Jutland, 8200

  • Rigshospitalet Copenhagen University Hospital-Investigational Site Number : 2080002

    Copenhagen, Capital, 2100

  • Odense University Hospital-Investigational Site Number : 2080003

    Odense, Funen, 5000

Other trials in Denmark

Sweden3 sites

  • Investigational Site Number : 7520003

    Gothenburg, 413 45

  • Investigational Site Number : 7520001

    Huddinge, 141 57

  • Investigational Site Number : 7520002

    Lund, 221 85

Other trials in Sweden

Greece2 sites

  • Nosokomeio Paidon I Agia Sofia-Site Number : 3000002

    Athens, 115 27

  • General Hospital of Thessaloniki "George Papanikolaou"-Site Number : 3000001

    Thessaloniki, 570 10

Other trials in Greece

Poland2 sites

  • Investigational Site Number : 6160001

    Gdansk, Pomeranian Voivodeship, 80-952

  • Investigational Site Number : 6160008

    Szczecin, 71-252

Other trials in Poland

Portugal2 sites

  • Investigational Site Number : 6200003

    Lisbon, 1099-023

  • Investigational Site Number : 6200002

    Lisbon, 1649-035

Other trials in Portugal

Hong Kong1 site

  • Investigational Site Number : 3440001

    Pok Fu Lam, 999077

Other trials in Hong Kong

About this study

Official title: A Randomized, Double-blind, Multicenter, Phase 3 Study to Evaluate Efficacy and Safety of Belumosudil in Combination With Corticosteroids Versus Placebo in Combination With Corticosteroids in Participants at Least 12 Years of Age With Newly Diagnosed Chronic Graft Versus Host Disease (cGVHD)

This is a parallel, Phase 3, two-arm study for the treatment of newly diagnosed moderate or severe chronic GVHD.

The study duration for a participant includes up to 4 weeks for screening; a treatment period until clinically meaningful cGVHD progression (defined as progression requiring addition of new systemic treatment for cGVHD), relapse/recurrence of the underlying disease, participant starts new systemic treatment for cGVHD or experiences an unacceptable toxicity, at the request of the participants or the investigators, or until the end of study is reached, whichever comes first; at least 30 days follow-up of adverse events (AEs) after the last dose until resolution or stabilization, if applicable; and long-term follow-up until death or study close-out, whichever comes first.

Read the detailed description

Up to 2.5 years

Being tested
Belumosudil, Placebo, Prednisone, Prednisolone
Medical subject headings
Bronchiolitis Obliterans Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BelumosudilDrug

    Also called SAR445761/ KD025, REZUROCK

    Pharmaceutical form:Tablet-Route of administration:oral

  • PlaceboDrug

    Pharmaceutical form:Table-Route of administration:oral

  • PrednisoneDrug

    Pharmaceutical form:Tablet-Route of administration:oral

  • PrednisoloneDrug

    Pharmaceutical form:Tablet-Route of administration:oral

Study groups in NCT06143891
Study groupRoleWhat they receive
BelumosudilExperimentalParticipants will receive belumosudil 200 mg tablets per os(PO) once daily (QD) per 28-day cycles starting on Day 1 until discontinuation criteria are met or until end of study Note: 200mg two times a day (BID) is used in some cases, when the subject is taking a proton pump inhibitor or a strong CYP3A4 inducer)
Receives: Drug: Belumosudil; Drug: Prednisone; Drug: Prednisolone
PlaceboPlacebo comparatorParticipants will receive matching placebo tablets PO QD per 28-day cycles starting on Day 1 until discontinuation criteria are met or until end of study
Receives: Drug: Placebo; Drug: Prednisone; Drug: Prednisolone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Event-Free Survival (EFS)

    From the date of randomization to the date of any predefined event, whichever occurs first

    Measured: Until the end of the study (up to 2.5 years since first patient in).

Secondary outcomes (13)

  1. Modified Lee Symptom Scale (mLSS)

    Proportion of participants who achieve a clinically relevant reduction in mLSS of at least 6 points from baseline (Only in participants at least 18 years of age)

    Measured: Until the end of the study (up to 2.5 years since first patient in).

  2. Durable overall response rate

    Proportion of participants who achieve an overall response (PR or CR) as per 2014 NIH consensus response criteria by 48 weeks and maintained the response for a duration of at least 6 months

    Measured: Until the end of the study (up to 2.5 years since first patient in).

  3. Rate of corticosteroid withdrawal

    Proportion of participants who successfully discontinue all systemic corticosteroids for cGVHD for at least 30 days before the occurrence of cGVHD progression, or start of a new systemic treatment for cGVHD, relapse or recurrence of the underlying disease, or unacceptable toxicity

    Measured: Until the end of the study (up to 2.5 years since first patient in).

  4. Overall response rate (ORR)

    Proportion of participants who achieve an overall response (CR or PR) as per 2014 NIH consensus response criteria at any time before the start of new systemic treatment for cGVHD

    Measured: Until the end of the study (up to 2.5 years since first patient in).

  5. ORR by 24 weeks

    Proportion of participants who achieve an overall response (CR or PR) as per 2014 NIH consensus response criteria by 24 weeks (Cycle 7 Day 1) before the start of new systemic treatment for cGVHD

    Measured: Until the end of the study (up to 2.5 years since first patient in).

  6. Duration of response (DOR)

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

    Measured: Until the end of the study (up to 2.5 years since first patient in).

  7. Dose reduction in corticosteroid

    Proportion of participants with a reduction in daily corticosteroid dose

    Measured: Until the end of the study (up to 2.5 years since first patient in).

  8. Failure Free Survival (FFS)

    Failure Free Survival (FFS) is defined as the time from the date of randomization to the date of start of a new systemic treatment for cGVHD, relapse or recurrence of the underlying disease, or death, whichever occurs first.

    Measured: Until the end of the study (up to 2.5 years since first patient in).

  9. Change in patient reported outcome (PRO)

    Change from baseline in Patient-Reported Outcomes Measurement Information System Global Health (PROMIS-GH) (Only in participants at least 18 years of age) and the European Quality of Life Group Questionnaire with 5 Dimensions and 5 Levels (EQ5D5L)

    Measured: Until the end of the study (up to 2.5 years since first patient in).

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

    Measured: Until the end of the study (up to 2.5 years since first patient in).

  11. Overall survival

    The time from the date of randomization to the date of death due to any cause

    Measured: Until the end of the study (up to 2.5 years since first patient in).

  12. Time to response (TTR)

    Time to Response is defined as the time from randomization to the date the patient has first response (CR or PR).

    Measured: Until the end of study (up to 2.5 years since first patient in)

  13. Response by organ

    Proportion of participants who achieve CR or PR as per NIH consensus response criteria (2014) at any time point in each involved organ and before the start of a new systemic therapy for cGVHD.

    Measured: Until the end of study (up to 2.5 years since first patient in)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2023
  2. Study start23 Jan 2024
  3. Primary completion29 Sep 2028 (estimated)
  4. Study completion29 Sep 2028 (estimated)

Resources

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
260 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06143891
Sponsor's protocol ID
EFC17757
Other IDs
2023-505394-32, U1111-1280-4918, 2023
Acronym
ROCKnrol-1
Status last verified
Oct 2026
First submitted
16 Nov 2023
Last updated
16 Oct 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Belumosudil, Prednisone and Prednisolone in people with Chronic Graft Versus Host Disease, run by Sanofi at 151 sites in 24 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 8 inclusion and 25 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: under way, not looking for participants, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 151 sites in United States, China, Italy, Spain, Germany and 19 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Event-Free Survival (EFS) (time frame: Until the end of the study (up to 2.5 years since first patient in).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06143891.

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 16 Oct 2026.

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