Who is sponsoring NCT05305989?

NCT05305989 is sponsored by Kadmon, a Sanofi Company.

What drugs are being tested in NCT05305989?

Interventions in NCT05305989: Belumosudil 200 mg QD, Belumosudil 200 mg BID, Belumosudil 400 mg QD.

What condition does NCT05305989 study?

NCT05305989 studies Chronic Graft-versus-host-disease.

Is NCT05305989 still recruiting?

NCT05305989 is currently completed. Last updated 2 May 2025.

Are results published for NCT05305989?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-05-02 · How we verify

NCT05305989

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Extended Treatment and Follow-up of Subjects Treated With Belumosudil in Study KD025-208 or Study KD025-213

Completed Phase 2 Results posted Last updated 2 May 2025

What this trial tests

Phase 2 trial testing Belumosudil 200 mg QD in Chronic Graft-versus-host-disease in 23 participants. Completed in 6 June 2024.

Timeline

23 February 2022

Primary endpoint
6 June 2024

6 June 2024

Quick facts

Lead sponsor	Kadmon, a Sanofi Company
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	23
Start date	23 February 2022
Primary completion	6 June 2024
Estimated completion	6 June 2024
Sites	8 locations across United States

Drugs / interventions tested

Belumosudil 200 mg QD — full drug profile →
Belumosudil 200 mg BID — full drug profile →
Belumosudil 400 mg QD — full drug profile →

Conditions studied

Chronic Graft-versus-host-disease — all drugs for Chronic Graft-versus-host-disease →

Sponsor

Kadmon, a Sanofi Company — full company profile →

Who can join

18 and older, any sex, with Chronic Graft-versus-host-disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Duration of Response (DOR) Primary · At Baseline (Day 1), Month 3 and every 3 months thereafter (+/-14 days), up to 23 months

DOR is defined as time from first documentation of response to time of first documentation of deterioration from best response (e.g., complete response \[CR\] to partial response \[PR\], or PR to Lack of response \[LR\]). As per the 2014 National Institutes of Health (NIH) Consensus Development Project for clinical trials in cGVHD criteria: CR was defined as resolution of all manifestations of cGVHD in each organ or site.PR was defined as the improvement in at least 1 organ or site without progression in any other organ or site.LR included response status of mixed, unchanged, or progression.Mi

Group	Value	95% CI
Belumosudil 200 mg QD	NA	5.55 – NA
Belumosudil 200 mg BID	NA	5.78 – NA

Number of Participants With a >=7 Point Reduction (7PtR) From Baseline and >=7 Point Reduction From Baseline on 2 Consecutive Post-Baseline Assessments as Assessed by Lee Symptom Scale (LSS) Primary · Baseline (Day 1) up to 23 months

The questionnaire asked participants to indicate the degree of bother that they experienced due to symptoms in 7 domains potentially affected by cGVHD. It consists of 30 items of 7 domains: skin, eyes and mouth, breathing, eating and digestion, muscles and joints, energy, and mental and emotional. Each question was rated/scored as 0-not at all, 1-slightly, 2-moderately, 3-quite a bit, 4-extremely with lower values representing better outcome. A domain score was calculated for each domain by taking the mean of all items completed if more than 50% were answered and normalizing to a 0 to 100 scal

>=7PtR From Baseline

Group	Value	95% CI
Belumosudil 200 mg QD	8
Belumosudil 200 mg BID	2
Belumosudil 400 mg QD	0

>=7PtR From Baseline on 2 Consecutive Post-Baseline Assessment

Group	Value	95% CI
Belumosudil 200 mg QD	8
Belumosudil 200 mg BID	1
Belumosudil 400 mg QD	0

Duration of >=7 Point Reduction as Assessed by Lee Symptom Scale Primary · Baseline (Day 1) up to 23 months

The questionnaire asked participants to indicate the degree of bother that they experienced due to symptoms in 7 domains potentially affected by cGVHD. It consisted of 30 items of 7 domains: skin, eyes and mouth, breathing, eating and digestion, muscles and joints, energy, and mental and emotional. Each question was rated/scored as 0-not at all, 1-slightly, 2-moderately, 3-quite a bit, 4-extremely with lower values representing better outcome. A domain score was calculated for each domain by taking the mean of all items completed if more than 50% were answered and normalizing to a 0 to 100 sca

Group	Value	95% CI
Belumosudil 200 mg QD	67.2	± 26.8
Belumosudil 200 mg BID	49.5	± 54.2

Time to Next Treatment (TTNT) Primary · At Baseline (Day 1), Month 3 and every 3 months thereafter (+/-14 days), up to 23 months

The TTNT was measured as the time from first treatment to the time of new systemic cGVHD treatment, censored by last response assessment or long term follow up assessment, whichever was the latest and available. TTNT was analyzed by the Kaplan-Meier survival method.

Group	Value	95% CI
Belumosudil 200 mg QD	NA	NA – NA
Belumosudil 200 mg BID	NA	5.14 – NA
Belumosudil 400 mg QD	NA	NA – NA

Failure-Free Survival (FFS) Primary · At Baseline (Day 1), Month 3 and every 3 months thereafter (+/-14 days), up to 23 months

FFS was defined as the absence of new cGVHD systemic therapy, non-relapse mortality and recurrent malignancy (i.e. underlying disease) and was censored by last response assessment or long term follow up assessment, whichever was the latest and available. Kaplan-Meier method was used for the analysis.

Group	Value	95% CI
Belumosudil 200 mg QD	NA	NA – NA
Belumosudil 200 mg BID	NA	8.80 – NA
Belumosudil 400 mg QD	NA	NA – NA

Overall Survival (OS) Primary · From first dose of study drug (Day 1) to the date of death due to any cause, up to approximately 24 months

OS was defined as time from first dose of belumosudil to the date of death due to any cause. CI was calculated using Kaplan-Meier method.

Group	Value	95% CI
Belumosudil 200 mg QD	NA	NA – NA
Belumosudil 200 mg BID	NA	NA – NA
Belumosudil 400 mg QD	NA	NA – NA

Percentage of Participants With Complete Response (CR) and Partial Response (PR) Primary · At Baseline (Day 1), Month 3 and every 3 months thereafter (+/-14 days), up to 23 months

As per the 2014 NIH Consensus Development Project for clinical trials in cGVHD criteria: CR was defined as resolution of all manifestations of cGVHD in each organ or site. PR was defined as the improvement in at least 1 organ or site without progression in any other organ or site.

Group	Value	95% CI
Belumosudil 200 mg QD	30.8
Belumosudil 200 mg BID	11.1
Belumosudil 400 mg QD	0

Group	Value	95% CI
Belumosudil 200 mg QD	30.8
Belumosudil 200 mg BID	77.8
Belumosudil 400 mg QD	0

Number of Participants With Best Response by Organ System Primary · At Baseline (Day 1), Month 3 and every 3 months thereafter (+/-14 days), up to 23 months

The best response (CR, PR) for individual organs (skin, eyes, mouth, esophagus, upper gastrointestinal \[GI\], lower GI, liver, lungs, joints and fascia) was summarized. As per the 2014 NIH Consensus Development Project for clinical trials in cGVHD criteria, CR was defined as resolution of all manifestations of cGVHD in each organ or site. PR was defined as the improvement in at least 1 organ or site without progression in any other organ or site.

Skin

Group	Value	95% CI
Belumosudil 200 mg QD	6
Belumosudil 200 mg BID	5
Belumosudil 400 mg QD	0

Eyes

Group	Value	95% CI
Belumosudil 200 mg QD	6
Belumosudil 200 mg BID	4
Belumosudil 400 mg QD	0

Mouth

Group	Value	95% CI
Belumosudil 200 mg QD	4
Belumosudil 200 mg BID	3
Belumosudil 400 mg QD	0

Esophagus

Group	Value	95% CI
Belumosudil 200 mg QD	1
Belumosudil 200 mg BID	2
Belumosudil 400 mg QD	0

Upper GI

Group	Value	95% CI
Belumosudil 200 mg QD	0
Belumosudil 200 mg BID	0
Belumosudil 400 mg QD	0

Lower GI

Group	Value	95% CI
Belumosudil 200 mg QD	0
Belumosudil 200 mg BID	1
Belumosudil 400 mg QD	0

Liver

Group	Value	95% CI
Belumosudil 200 mg QD	1
Belumosudil 200 mg BID	0
Belumosudil 400 mg QD	0

Lungs

Group	Value	95% CI
Belumosudil 200 mg QD	1
Belumosudil 200 mg BID	3
Belumosudil 400 mg QD	0

Percent Change From Baseline in Corticosteroid Dose to Greatest Reduction Primary · Baseline (Day 1) and Month 23

Change in corticosteroid doses was analyzed by using prednisone dose equivalents. If participants were not using prednisone as the systemic corticosteroid, then the prednisone dose equivalent would be determined according to following conversion ratios: 1 mg prednisone is equivalent to: 4.0 mg Hydrocortisone; 0.8 mg Methylprednisolone; 0.15 mg Dexamethasone; 1.0 mg Prednisolone and 0.8 mg Triamcinolone. Baseline was defined as the valid and last non-missing value obtained within 28 days prior to participant receiving the first study drug in parent study (KD025-208 \[NCT02841995\] or KD025-213

Group	Value	95% CI
Belumosudil 200 mg QD	-50.00	-100.00 – 0.0
Belumosudil 200 mg BID	0.0	0.0 – 0.0

Number of Participants With Maximal Improvement From Baseline in Global Severity Rating (GSR) Based on Clinician-Reported Chronic Graft-Versus-Host-Disease Assessment Primary · From Baseline (Day 1) up to 23 months

The GSR assessment was performed by asking the participants to rate their disease severity of cGVHD symptoms on a 0 to 10-point numeric rating scale, where score 0 indicated 'not at all severe cGVHD symptoms' and score 10 indicated 'most severe cGVHD symptoms possible'. The response was defined using scores from 9 organs: skin, eyes, mouth, esophagus, upper GI track, lower GI tract, liver, lungs, and joints and fascia plus GSR. Baseline was defined as the valid and last non-missing value obtained within 28 days prior to participant receiving the first study drug in parent study (KD025-208 \[NC

-8

Group	Value	95% CI
Belumosudil 200 mg QD	1
Belumosudil 200 mg BID	1
Belumosudil 400 mg QD	0

-7

Group	Value	95% CI
Belumosudil 200 mg QD	0
Belumosudil 200 mg BID	1
Belumosudil 400 mg QD	0

-6

Group	Value	95% CI
Belumosudil 200 mg QD	3
Belumosudil 200 mg BID	0
Belumosudil 400 mg QD	0

-5

Group	Value	95% CI
Belumosudil 200 mg QD	2
Belumosudil 200 mg BID	2
Belumosudil 400 mg QD	0

-4

Group	Value	95% CI
Belumosudil 200 mg QD	0
Belumosudil 200 mg BID	1
Belumosudil 400 mg QD	0

-3

Group	Value	95% CI
Belumosudil 200 mg QD	1
Belumosudil 200 mg BID	1
Belumosudil 400 mg QD	0

-2

Group	Value	95% CI
Belumosudil 200 mg QD	1
Belumosudil 200 mg BID	1
Belumosudil 400 mg QD	0

-1

Group	Value	95% CI
Belumosudil 200 mg QD	1
Belumosudil 200 mg BID	1
Belumosudil 400 mg QD	0

Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), Grade >=3 Treatment-Emergent Adverse Events and Deaths Primary · From the first dose of study drug (Day 1) up to 28 days after the last dose of study drug, approximately 24 months

An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial participant associated with the use of a study drug, whether or not considered drug-related. Serious adverse event (SAE) was any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, was a congenital anomaly/birth defect or was an important medical event. The severity of ea

TEAEs

Group	Value	95% CI
Belumosudil 200 mg QD	8
Belumosudil 200 mg BID	7
Belumosudil 400 mg QD	0

TESAEs

Group	Value	95% CI
Belumosudil 200 mg QD	4
Belumosudil 200 mg BID	2
Belumosudil 400 mg QD	0

Grade >=3 TEAEs

Group	Value	95% CI
Belumosudil 200 mg QD	3
Belumosudil 200 mg BID	4
Belumosudil 400 mg QD	0

Deaths

Group	Value	95% CI
Belumosudil 200 mg QD	0
Belumosudil 200 mg BID	0
Belumosudil 400 mg QD	0

Adverse events — posted to ClinicalTrials.gov

Time frame: From the first dose of study drug (Day 1) up to 28 days after the last dose of study drug, approximately 24 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Belumosudil 200 mg QD

Serious: 4/13 (31%)

Deaths: 0/13

Belumosudil 200 mg BID

Serious: 2/9 (22%)

Deaths: 0/9

Belumosudil 400 mg QD

Serious: 0/1 (0%)

Deaths: 0/1

Serious adverse events (6 terms)

Reaction	System	Belumosudil 200 mg QD	Belumosudil 200 mg BID	Belumosudil 400 mg QD
Covid-19	Infections and infestations	—	—	—
Rhinovirus Infection	Infections and infestations	—	—	—
Hyponatraemia	Metabolism and nutrition disorders	—	—	—
Dacryoadenitis Acquired	Eye disorders	—	—	—
Superior Vena Cava Syndrome	Vascular disorders	—	—	—
Tongue Dysplasia	Gastrointestinal disorders	—	—	—

Other adverse events (70 terms — click to expand)

Reaction	System	Belumosudil 200 mg QD	Belumosudil 200 mg BID	Belumosudil 400 mg QD
Conjunctivitis	Infections and infestations	—	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—	—
Hypophosphataemia	Metabolism and nutrition disorders	—	—	—
Hypertension	Vascular disorders	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—
Dry Mouth	Gastrointestinal disorders	—	—	—
Influenza Like Illness	General disorders	—	—	—
Aspartate Aminotransferase Increased	Investigations	—	—	—
Haemoglobin Increased	Investigations	—	—	—
Covid-19	Infections and infestations	—	—	—
Ear Infection	Infections and infestations	—	—	—
Fungal Infection	Infections and infestations	—	—	—
Gastroenteritis	Infections and infestations	—	—	—
Haemophilus Infection	Infections and infestations	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—
Onychomycosis	Infections and infestations	—	—	—
Otitis Externa	Infections and infestations	—	—	—
Respiratory Tract Infection	Infections and infestations	—	—	—
Rhinovirus Infection	Infections and infestations	—	—	—
Upper Respiratory Tract Infection	Infections and infestations	—	—	—
Intraductal Papillary-Mucinous Carcinoma Of Pancreas	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—
Lymphadenopathy	Blood and lymphatic system disorders	—	—	—
Decreased Appetite	Metabolism and nutrition disorders	—	—	—
Hypocalcaemia	Metabolism and nutrition disorders	—	—	—
Polydipsia	Metabolism and nutrition disorders	—	—	—
Depression	Psychiatric disorders	—	—	—
Dizziness	Nervous system disorders	—	—	—
Dysgeusia	Nervous system disorders	—	—	—
Headache	Nervous system disorders	—	—	—
Cataract	Eye disorders	—	—	—
Vision Blurred	Eye disorders	—	—	—
Bundle Branch Block Right	Cardiac disorders	—	—	—
Hypotension	Vascular disorders	—	—	—
Superior Vena Cava Syndrome	Vascular disorders	—	—	—
Atelectasis	Respiratory, thoracic and mediastinal disorders	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—
Epistaxis	Respiratory, thoracic and mediastinal disorders	—	—	—
Nasal Disorder	Respiratory, thoracic and mediastinal disorders	—	—	—
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	—	—	—

Most-reported serious reactions: Covid-19, Rhinovirus Infection, Hyponatraemia, Dacryoadenitis Acquired, Superior Vena Cava Syndrome, Tongue Dysplasia.

Data from ClinicalTrials.gov NCT05305989 adverse events section.

Sponsor's own description

Extended Treatment and Follow-up of Subjects Treated with Belumosudil in Study KD025-208 or Study KD025-213

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Belumosudil for Chronic Graft-Versus-Host Disease: Analysis of Long-Term Results from the KD025-208 and ROCKstar Studies.
Lee SJ, Pavletic S, Blazar BR, Yao Y, et al · · 2025 · cited 2× · PMID 40318736 · DOI 10.1016/j.jtct.2025.04.020
Chronic Graft-versus-host Disease, Part 1: How Preclinical Models Shape Our Understanding of Biology and Pave the Way for Future Therapeutic Interventions.
Hartigan CR, McDonald-Hyman C, Pavletic SZ, Blazar BR. · · 2025 · PMID 40551306 · DOI 10.1097/tp.0000000000005444

Verify or expand the search:

Other recruiting trials for Chronic Graft-versus-host-disease

Currently open trials in the same condition.

NCT07124078 — A Study to Evaluate Axatilimab Versus Best Available Therapy in Pediatric Participants With Chronic Graft-Versus-Host Di · Phase 2 · recruiting
NCT06843408 — A Ph1b/2 Study of Axatilimab Monotherapy in Chinese Participants With Recurrent or Refractory cGVHD · Phase 1, PHASE2 · recruiting
NCT06821542 — A Study to Evaluate Axatilimab Versus Best Available Therapy in Participants With Chronic Graft Versus Host Disease Afte · Phase 3 · active not recruiting
NCT06585774 — A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease · Phase 3 · recruiting
NCT06388564 — A Study to Evaluate the Safety and Efficacy of Axatilimab in Combination With Ruxolitinib in Participants With Newly Dia · Phase 2 · recruiting

Other Kadmon, a Sanofi Company trials

Trials by the same sponsor.

NCT05567406 — Safety and Efficacy of Oral Belumosudil in Black or African American, American Indian or Alaska Native, and Native Hawai · Phase 2 · withdrawn
NCT04242147 — A Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of KD033 (SAR445710) in · Phase 1 · terminated
NCT05806567 — A Study to Assess the Effect of Oral Belumosudil on Inhibition of Various Proteins in the Fed State in Healthy Male Subj · Phase 1 · completed
NCT04680975 — Efficacy and Safety of Belumosudil in Subjects With Diffuse Cutaneous Systemic Sclerosis · Phase 2 · terminated
NCT04166942 — KD025 Hepatic Impairment Study With Normal Hepatic Function and Subjects With Varying Degrees of Hepatic Impairment · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05305989 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Kadmon, a Sanofi Company
Last refreshed: 2 May 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05305989.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing