A Phase 2 interventional study of Belumosudil 200 mg QD and Belumosudil 200 mg BID in Chronic Graft-versus-host-disease, sponsored by Kadmon, a Sanofi Company. Completed at 8 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-02.
Sponsored by Kadmon, a Sanofi Company (part of Sanofi) · Phase 2, Interventional, and Treatment
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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.
Among the 14 studies testing belumosudil in Bronchiolitis Obliterans Syndrome, this one is the 11th largest by enrollment, is the only one that started in 2022, is one of 8 in phase 2, and was the 3rd registered.
714 studies on the registry are indexed under Bronchiolitis Obliterans Syndrome; 128 are open to participants now.
Browse Bronchiolitis Obliterans Syndrome studies →7 of the 14 studies testing belumosudil in Bronchiolitis Obliterans Syndrome are open now, in 12 countries. Recruiting first, the newest first:
Sanofi · Sites in Netherlands, Spain
Ages 12+
M.D. Anderson Cancer Center · Sites in United States
Ages 18+
Sanofi · Sites in United States, Belgium, Canada and 10 more countries
Ages 1–18
Dana-Farber Cancer Institute · Sites in United States
Ages 18+
Fred Hutchinson Cancer Center · Sites in United States
Ages 18+
By country, each count listing its studies:
belumosudil: first FDA approval 2021 (REZUROCK), first EMA approval 2026. What it is approved for, and how studies give it, is on its page →
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: 18 Years and older · 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.
14 studies; the count open now beside each. This study's row is marked.
First in 2018; this study’s year is marked. 1 started in 2022.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 23 is below the median of 50 across 565 interventional studies indexed under Bronchiolitis Obliterans Syndrome.
Median enrollment 34 across the 14 interventional studies. Of the 4 that completed or were terminated, 3 (75%) have results posted.
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10 of 14 have an industry lead sponsor. The 7 most frequent:
This study is registered under Kadmon, a Sanofi Company, one of the names counted as Sanofi. Under that name alone:
Kadmon, a Sanofi Company is the lead sponsor of 14 studies on the registry; none are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
11 studies in Bronchiolitis Obliterans Syndrome by Sanofi: 4 open now, 5 under way, 2 of them phase 3. Of 5 finished, 3 (60%) have results posted.
Among the 11 studies in Bronchiolitis Obliterans Syndrome by Sanofi, this one is the 9th largest by enrollment, is the only one that started in 2022, is one of 5 in phase 2, and was the 4th registered.
Sanofi’s Bronchiolitis Obliterans Syndrome studies by the year they started, since 2006.
3 of the studies testing belumosudil in Bronchiolitis Obliterans Syndrome that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07726914SanofiStudy to Compare the Plasma Concentration of Belumosudil Given as an Oral Suspension and as a Tablet to Healthy Adult Male Participants | 2027-01-26 |
| NCT05922761Dana-Farber Cancer InstituteBElumosudil for Bronchiolitis Obliterans Prevention/Therapy (BEBOP) | 2027-06-30 |
| NCT07135973SanofiA Study to Investigate Safety of Belumosudil in Participants Aged 12 Years and Above, With Chronic Graft-versus-host Disease (cGVHD) | 2027-08-30 |
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Among the 14 studies testing belumosudil in Bronchiolitis Obliterans Syndrome, from their registry updates:
Among Sanofi’s 11 in Bronchiolitis Obliterans Syndrome:
This tab as a report to print or save as PDF → With an account.
Extended Treatment and Follow-up of Subjects Treated with Belumosudil in Study KD025-208 or Study KD025-213
This is a Phase 2, open-label, long-term treatment and follow-up study in subjects with cGVHD who have been previously treated with belumosudil in Study KD025-208 or Study KD025-213. Subjects will not be screened. Subjects who have signed the informed consent form will be enrolled in Study KD025-217 if they have met 1 of the following conditions:
Approximately 20 Study Centers will participate with approximately 70 subjects participating overall.
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.
Subjects must have been treated with belumosudil for at least 1 of the following:
Exclusion Criteria:
The assigned arm is per the previous study KD025-213 or study KD025-208
Drug: Belumosudil 200 mg QD
The assigned arm is per the previous study KD025-213 or study KD025-208
Drug: Belumosudil 200 mg BID
The assigned arm is per the previous study KD025-213 or study KD025-208
Drug: Belumosudil 400 mg QD
Belumosudil is an orally available Rho-associated protein kinase-2 (ROCK2) selective inhibitor.
Also known as: REZUROCK
Belumosudil is an orally available Rho-associated protein kinase-2 (ROCK2) selective inhibitor.
Also known as: REZUROCK
Belumosudil is an orally available Rho-associated protein kinase-2 (ROCK2) selective inhibitor.
Also known as: REZUROCK
Duration of Response (DOR)
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.Mixed LR was defined as complete or partial response in at least 1 organ accompanied by progression in another organ. Unchanged LR was defined as outcomes that did not meet criteria for CR, PR, progression or mixed response. Progression LR was defined as progression in at least 1 organ or site without a response in any other organ or site. Confidence interval (CI) is calculated using Kaplan-Meier method.
Time frame: At Baseline (Day 1), Month 3 and every 3 months thereafter (+/-14 days), up to 23 months
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)
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 scale. A total score was calculated as average of all non-missing domain scores if more than 50% of them were non-missing, ranged from 0-100. A higher score indicated more bothersome symptoms. A 7-point difference on the total score of cGVHD symptom scale was found to be clinically meaningful.
Time frame: Baseline (Day 1) up to 23 months
Duration of >=7 Point Reduction as Assessed by Lee Symptom Scale
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 scale. A total score was calculated as average of all non-missing domain scores if more than 50% of them were non-missing, ranged from 0-100. A higher score indicated more bothersome symptoms. A 7-point difference on the total score of cGVHD symptom scale was found to be clinically meaningful. Mean of duration of \>=7PtR is presented.
Time frame: Baseline (Day 1) up to 23 months
Time to Next Treatment (TTNT)
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.
Time frame: At Baseline (Day 1), Month 3 and every 3 months thereafter (+/-14 days), up to 23 months
Failure-Free Survival (FFS)
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.
Time frame: At Baseline (Day 1), Month 3 and every 3 months thereafter (+/-14 days), up to 23 months
Overall Survival (OS)
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.
Time frame: From first dose of study drug (Day 1) to the date of death due to any cause, up to approximately 24 months
Percentage of Participants With Complete Response (CR) and Partial Response (PR)
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.
Time frame: At Baseline (Day 1), Month 3 and every 3 months thereafter (+/-14 days), up to 23 months
Number of Participants With Best Response by Organ System
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.
Time frame: At Baseline (Day 1), Month 3 and every 3 months thereafter (+/-14 days), up to 23 months
Percent Change From Baseline in Corticosteroid Dose to Greatest Reduction
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 \[NCT03640481\]).
Time frame: Baseline (Day 1) and Month 23
Number of Participants With Maximal Improvement From Baseline in Global Severity Rating (GSR) Based on Clinician-Reported Chronic Graft-Versus-Host-Disease Assessment
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 \[NCT02841995\] or KD025-213 \[NCT03640481\]). Maximal improvement from Baseline was calculated as lowest GSR score on scheduled visits minus GSR score at Baseline with possible ranges from -10 to 10. The lower the number means the better improvement in cGVHD symptoms.
Time frame: From Baseline (Day 1) up to 23 months
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), Grade >=3 Treatment-Emergent Adverse Events and Deaths
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 each AE was graded using the Common Terminology Criteria for Adverse Events version 4.03 scale. TEAEs were defined as AEs that developed, worsened or became serious during the TE period.
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
This study was conducted at 8 sites in the United States from 23-Feb-2022 to 06-Jun-2024.
| Milestone | Belumosudil 200 mg QD | Belumosudil 200 mg BID | Belumosudil 400 mg QD |
|---|---|---|---|
| Started | 13 | 9 | 1 |
| Completed | 0 | 0 | 0 |
| Not completed | 13 | 9 | 1 |
| Withdrew: Other | 3 | 2 | 0 |
| Withdrew: Sponsor decision | 2 | 1 | 0 |
| Withdrew: Protocol violation | 0 | 1 | 0 |
| Withdrew: Investigator decision | 1 | 2 | 0 |
| Withdrew: Progression of cgvhd (progression requiring addition of new systemic therapy for cgvhd) | 3 | 0 | 0 |
| Withdrew: Adverse event | 1 | 1 | 0 |
| Withdrew: Enrolled but never dosed | 3 | 2 | 1 |
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.Mixed LR was defined as complete or partial response in at least 1 organ accompanied by progression in another organ. Unchanged LR was defined as outcomes that did not meet criteria for CR, PR, progression or mixed response. Progression LR was defined as progression in at least 1 organ or site without a response in any other organ or site. Confidence interval (CI) is calculated using Kaplan-Meier method.
| months | Belumosudil 200 mg QD | Belumosudil 200 mg BID | Belumosudil 400 mg QD |
|---|---|---|---|
| Duration of Response (DOR) | NA (5.55 to NA) | NA (5.78 to NA) | — |
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 scale. A total score was calculated as average of all non-missing domain scores if more than 50% of them were non-missing, ranged from 0-100. A higher score indicated more bothersome symptoms. A 7-point difference on the total score of cGVHD symptom scale was found to be clinically meaningful.
| Participants | Belumosudil 200 mg QD | Belumosudil 200 mg BID | Belumosudil 400 mg QD |
|---|---|---|---|
| >=7PtR From Baseline | 8 | 2 | 0 |
| >=7PtR From Baseline on 2 Consecutive Post-Baseline Assessment | 8 | 1 | 0 |
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 scale. A total score was calculated as average of all non-missing domain scores if more than 50% of them were non-missing, ranged from 0-100. A higher score indicated more bothersome symptoms. A 7-point difference on the total score of cGVHD symptom scale was found to be clinically meaningful. Mean of duration of \>=7PtR is presented.
| weeks | Belumosudil 200 mg QD | Belumosudil 200 mg BID | Belumosudil 400 mg QD |
|---|---|---|---|
| Duration of >=7 Point Reduction as Assessed by Lee Symptom Scale | 67.2 ± 26.8 | 49.5 ± 54.2 | — |
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.
| months | Belumosudil 200 mg QD | Belumosudil 200 mg BID | Belumosudil 400 mg QD |
|---|---|---|---|
| Time to Next Treatment (TTNT) | NA (NA to NA) | NA (5.14 to NA) | NA (NA to NA) |
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.
| months | Belumosudil 200 mg QD | Belumosudil 200 mg BID | Belumosudil 400 mg QD |
|---|---|---|---|
| Failure-Free Survival (FFS) | NA (NA to NA) | NA (8.80 to NA) | NA (NA to NA) |
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.
| months | Belumosudil 200 mg QD | Belumosudil 200 mg BID | Belumosudil 400 mg QD |
|---|---|---|---|
| Overall Survival (OS) | NA (NA to NA) | NA (NA to NA) | NA (NA to NA) |
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.
| percentage of participants | Belumosudil 200 mg QD | Belumosudil 200 mg BID | Belumosudil 400 mg QD |
|---|---|---|---|
| CR | 30.8 | 11.1 | 0 |
| PR | 30.8 | 77.8 | 0 |
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.
| Participants | Belumosudil 200 mg QD | Belumosudil 200 mg BID | Belumosudil 400 mg QD |
|---|---|---|---|
| Skin | 6 | 5 | 0 |
| Eyes | 6 | 4 | 0 |
| Mouth | 4 | 3 | 0 |
| Esophagus | 1 | 2 | 0 |
| Upper GI | 0 | 0 | 0 |
| Lower GI | 0 | 1 | 0 |
| Liver | 1 | 0 | 0 |
| Lungs | 1 | 3 | 0 |
| Joints and Fascia | 5 | 7 | 0 |
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 \[NCT03640481\]).
| percent change | Belumosudil 200 mg QD | Belumosudil 200 mg BID | Belumosudil 400 mg QD |
|---|---|---|---|
| Percent Change From Baseline in Corticosteroid Dose to Greatest Reduction | -50.00 (-100.00 to 0.0) | 0.0 (0.0 to 0.0) | — |
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 \[NCT02841995\] or KD025-213 \[NCT03640481\]). Maximal improvement from Baseline was calculated as lowest GSR score on scheduled visits minus GSR score at Baseline with possible ranges from -10 to 10. The lower the number means the better improvement in cGVHD symptoms.
| Participants | Belumosudil 200 mg QD | Belumosudil 200 mg BID | Belumosudil 400 mg QD |
|---|---|---|---|
| -8 | 1 | 1 | 0 |
| -7 | 0 | 1 | 0 |
| -6 | 3 | 0 | 0 |
| -5 | 2 | 2 | 0 |
| -4 | 0 | 1 | 0 |
| -3 | 1 | 1 | 0 |
| -2 | 1 | 1 | 0 |
| -1 | 1 | 1 | 0 |
| 0 | 1 | 0 | 0 |
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 each AE was graded using the Common Terminology Criteria for Adverse Events version 4.03 scale. TEAEs were defined as AEs that developed, worsened or became serious during the TE period.
| Participants | Belumosudil 200 mg QD | Belumosudil 200 mg BID | Belumosudil 400 mg QD |
|---|---|---|---|
| TEAEs | 8 | 7 | 0 |
| TESAEs | 4 | 2 | 0 |
| Grade >=3 TEAEs | 3 | 4 | 0 |
| Deaths | 0 | 0 | 0 |
Collected over From the first dose of study drug (Day 1) up to 28 days after the last dose of study drug, approximately 24 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Belumosudil 200 mg QD | 0/13 (0%) | 4/13 (30.8%) | 8/13 (61.5%) |
| Belumosudil 200 mg BID | 0/9 (0%) | 2/9 (22.2%) | 7/9 (77.8%) |
| Belumosudil 400 mg QD | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| Event | Belumosudil 200 mg QD | Belumosudil 200 mg BID | Belumosudil 400 mg QD |
|---|---|---|---|
| Covid-19Infections and infestations | 0/13 | 1/9 | 0/1 |
| Rhinovirus InfectionInfections and infestations | 0/13 | 1/9 | 0/1 |
| HyponatraemiaMetabolism and nutrition disorders | 1/13 | 0/9 | 0/1 |
| Dacryoadenitis AcquiredEye disorders | 1/13 | 0/9 | 0/1 |
| Superior Vena Cava SyndromeVascular disorders | 1/13 | 0/9 | 0/1 |
| Tongue DysplasiaGastrointestinal disorders | 1/13 | 0/9 | 0/1 |
| Event | Belumosudil 200 mg QD | Belumosudil 200 mg BID | Belumosudil 400 mg QD |
|---|---|---|---|
| ConjunctivitisInfections and infestations | 0/13 | 2/9 | 0/1 |
| HypokalaemiaMetabolism and nutrition disorders | 0/13 | 2/9 | 0/1 |
| HypophosphataemiaMetabolism and nutrition disorders | 0/13 | 2/9 | 0/1 |
| HypertensionVascular disorders | 0/13 | 2/9 | 0/1 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 1/13 | 2/9 | 0/1 |
| Dry MouthGastrointestinal disorders | 0/13 | 2/9 | 0/1 |
| Influenza Like IllnessGeneral disorders | 0/13 | 2/9 | 0/1 |
| Aspartate Aminotransferase IncreasedInvestigations | 0/13 | 2/9 | 0/1 |
| Haemoglobin IncreasedInvestigations | 0/13 | 2/9 | 0/1 |
| Rhinovirus InfectionInfections and infestations | 0/13 | 1/9 | 0/1 |
The full analysis set included all participants enrolled in the study.
| Age, Customized(Participants) | Belumosudil 200 mg QD | Belumosudil 200 mg BID | Belumosudil 400 mg QD | Total |
|---|---|---|---|---|
| 24-74 years | 13 | 9 | 1 | 23 |
| Sex: Female, Male(Participants) | Belumosudil 200 mg QD | Belumosudil 200 mg BID | Belumosudil 400 mg QD | Total |
|---|---|---|---|---|
| Female | 4 | 2 | 1 | 7 |
| Male | 9 | 7 | 0 | 16 |
| Race/Ethnicity, Customized(Participants) | Belumosudil 200 mg QD | Belumosudil 200 mg BID | Belumosudil 400 mg QD | Total |
|---|---|---|---|---|
| White or Caucasian | 12 | 9 | 1 | 22 |
| Not reported | 1 | 0 | 0 | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Feb 2022 to primary completion in Jun 2024, 27 months.
Results were first posted in May 2025, 10 months after primary completion.
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 27 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Belumosudil
Bronchiolitis Obliterans Syndrome →