13 completed, 3 terminated, 2 recruiting, 1 active not recruiting. 12 Phase 2, 5 Phase 1, 2 Early Phase 1, 1 Phase 3, 1 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 12 | Completed 6, Terminated 3, Recruiting 2, Withdrawn 1 |
| Phase 1 | 5 | Completed 5 |
| Early Phase 1 | 2 | Completed 1, Unknown 1 |
| Phase 3 | 1 | Active not recruiting 1 |
| Phase 4 | 1 | Completed 1 |
Follow KD025: new trials by email Literature Review of KD025 trials Research Report on KD025
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Safety and Efficacy of Oral Belumosudil in Black or African American, American Indian or Alaska Native, and Native Hawaiian or Other Pacific Islander Male and Female Participants Aged 12 Years and Above With Chronic Graft Versus Host Disease (cGVHD) After At Least 2 Prior Lines of Systemic Therapy Belumosudil - Chronic Graft Versus Host Disease | Phase 2 | Withdrawn | Kadmon, a Sanofi Company | 2025-06-16 | 2026-02-12 | |
| A Clinical Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Belumosudil in Chinese Adolescents With cGVHD Who Have Had an Inadequate Response to Glucocorticoids or Other Systemic Therapies Belumosudil - Chronic Graft Versus Host Disease | Phase 4 | Completed | Sanofi | 6 | 2024-12-04 | 2026-05-27 |
| BElumosudil for Bronchiolitis Obliterans Prevention/Therapy (BEBOP) Belumosudil, Fluticasone, Azithromycin - Bronchiolitis Obliterans Syndrome, Bronchiolitis Obliterans | Phase 2 | Recruiting | Dana-Farber Cancer Institute | 45 | 2024-05-31 | 2026-06-10 |
| 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. Belumosudil, Placebo, Prednisone - Chronic Graft Versus Host Disease | Phase 3 | Active not recruiting | Sanofi | 260 | 2024-01-23 | 2026-10-16 |
| Belumosudil for the Pre-emptive Treatment of Patients With Chronic Graft Versus Host Disease Belumosudil, Biospecimen Collection, Electronic Health Record Review - Chronic Graft Versus Host Disease | Phase 2 | Recruiting | Fred Hutchinson Cancer Center | 82 | 2023-12-06 | 2026-09-17 |
| NKG2D CAR-T(KD-025) in the Treatment of Advanced NKG2DL+ Solid Tumors KD-025 - CRC, Solid Tumor | Early Phase 1 | Unknown | jianming xu | 18 | 2022-05-17 | 2022-05-19 |
| Efficacy and Safety of BN101 in Subjects With Chronic Graft Versus Host Disease (cGVHD) BN101 - GVHD, Chronic | Phase 2 | Completed | BioNova Pharmaceuticals (Shanghai) LTD. | 30 | 2021-04-27 | 2024-01-17 |
| Efficacy and Safety of Belumosudil in Subjects With Diffuse Cutaneous Systemic Sclerosis Belumosudil - Diffuse Cutaneous Systemic Sclerosis | Phase 2 | Terminated | Kadmon, a Sanofi Company | 10 | 2021-03-03 | 2023-06-05 |
| A Phase I Study to Evaluate the Taste of Belumosudil Oral Suspensions & Assess Relative Bioavailability Part 1: Belumosudil 40 mg/mL Sequence ABFCED, Part 1: Belumosudil 40 mg/mL Sequence BCADFE, Part 1: Belumosudil 40 mg/mL Sequence CDBEAF - Healthy Volunteers | Early Phase 1 | Completed | Kadmon Corporation, LLC | 30 | 2020-10-26 | 2022-05-11 |
| KD025 Hepatic Impairment Study With Normal Hepatic Function and Subjects With Varying Degrees of Hepatic Impairment KD025 - Hepatic Impairment | Phase 1 | Completed | Kadmon, a Sanofi Company | 35 | 2019-12-11 | 2022-07-18 |
| KD025 in Subjects With Diffuse Cutaneous Systemic Sclerosis Belumosudil (KD025), Placebo - System; Sclerosis, Diffuse Cutaneous Systemic Sclerosis | Phase 2 | Terminated | Kadmon, a Sanofi Company | 36 | 2019-06-26 | 2023-08-30 |
| Human Absorption, Distribution and Metabolism Study (hAME) [14C]-KD025 Belumosudil 200 mg tablet, [14C]-KD025 at a dose of 100 μg in a 5 mL solution IV microdose, [14C]-KD025 200 mg capsule - Autoimmune Diseases, Fibrosis | Phase 1 | Completed | Kadmon Corporation, LLC | 5 | 2019-04-05 | 2022-05-26 |
| Efficacy and Safety of KD025 in Subjects With cGVHD After At Least 2 Prior Lines of Systemic Therapy Belumosudil (KD025) - Chronic Graft-versus-host-disease | Phase 2 | Terminated | Kadmon, a Sanofi Company | 159 | 2018-10-11 | 2024-12-12 |
| A Study to Evaluate the Safety, Tolerability, and Activity of KD025 in Subjects With Chronic Graft Versus Host Disease Belumosudil (KD025) - Graft vs Host Disease | Phase 2 | Completed | Kadmon, a Sanofi Company | 54 | 2016-09-15 | 2023-06-28 |
| A Phase 2, Double-blind, Placebo-controlled Study of the Efficacy and Safety of Belumosudil in Subjects With Moderate/Severe Chronic Plaque Psoriasis Belumosudil, Placebo - Chronic Plaque Psoriasis | Phase 2 | Completed | Kadmon Corporation, LLC | 110 | 2016-09-14 | 2022-03-16 |
| A 2-Part, Phase 2 Open-label and Crossover Study of Belumosudil for Treatment of Idiopathic Pulmonary Fibrosis Belumosudil, BSC - Idiopathic Pulmonary Fibrosis | Phase 2 | Completed | Kadmon Corporation, LLC | 76 | 2016-05-26 | 2022-09-08 |
| Phase 2, Open-label, Study of KD025 in Subjects With Psoriasis Vulgaris Who Failed First-line Therapy KD025 - Psoriasis Vulgaris | Phase 2 | Completed | Kadmon Corporation, LLC | 38 | 2014-12-01 | 2022-05-26 |
| A Safety and Tolerability Study of Belumosudil (KD025) Treatment in Subjects With Moderately Severe Psoriasis Vulgaris Belumosudil - Psoriasis Vulgaris | Phase 2 | Completed | Kadmon Corporation, LLC | 8 | 2014-04-01 | 2022-03-23 |
| A Study to Determine the Effect of 500 mg Oral Dose of KD025 in Healthy Male and Post-menopausal Female Subjects Belumosudil mesylate, Placebo - Immune System Disorder (Healthy Volunteer) | Phase 1 | Completed | Kadmon, a Sanofi Company | 8 | 2014-03-28 | 2023-06-26 |
| A Study to Determine the Effect of Multiple Oral Doses and Regimens of KD025 in Healthy Male and Post-menopausal Female Subjects Belumosudil mesylate, Placebo - Immune System Disorder (Healthy Volunteer) | Phase 1 | Completed | Kadmon, a Sanofi Company | 32 | 2013-11-21 | 2023-06-26 |
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Bronchiolitis Obliterans Syndrome (7) · Immune System Diseases (4) · Fibrosis (2) · Lung Diseases (2) · Scleroderma, Diffuse (2) · Skin Diseases (2) · Autoimmune Diseases (1) · Bronchiolitis Obliterans (1) · Graft vs Host Disease (1) · Idiopathic Interstitial Pneumonias (1) · Idiopathic Pulmonary Fibrosis (1) · Plaque, Amyloid (1) · Pulmonary Fibrosis (1) · Scleroderma, Systemic (1)
Kadmon, a Sanofi Company (9) · Kadmon Corporation, LLC (6) · Sanofi (2) · BioNova Pharmaceuticals (Shanghai) LTD. (1) · Dana-Farber Cancer Institute (1) · Fred Hutchinson Cancer Center (1) · jianming xu (1)
United States (15) · China (4) · United Kingdom (3) · Argentina (1) · Australia (1) · Austria (1) · Belgium (1) · Brazil (1) · Canada (1) · Czechia (1) · Denmark (1) · France (1) · Germany (1) · Greece (1) · Hong Kong (1)
Corey Cutler, MD, MPH (1) · Depei Wu, Prof (1) · Nand Singh, BSc, MD, DPM (1) · Stephanie Lee, MD, MPH (1)
PMID 35781099, PMID 33877856, PMID 34265047, PMID 38532458, PMID 40088930, PMID 40311075, PMID 40614122
2018 (1), 2023 (1)