Trial · NCT02106195
A Safety and Tolerability Study of Belumosudil (KD025) Treatment in Subjects With Moderately Severe Psoriasis Vulgaris
NCT02106195, Phase 2, Completed, Kadmon Corporation, LLC; results first posted 2021-09-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Safety and Tolerability Study of Belumosudil (KD025) Treatment in Subjects With Moderately Severe Psoriasis Vulgaris. Trials, record NCT02106195. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02106195
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Safety and Tolerability Study of Belumosudil (KD025) Treatment in Subjects With Moderately Severe Psoriasis Vulgaris
- NCT number
- NCT02106195
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 8 participants, actual
- Lead sponsor
- Kadmon Corporation, LLC
- Conditions
- Psoriasis Vulgaris
- Interventions
- Belumosudil
- First posted
- 2014-04-08
- Last updated
- 2022-03-23
- Results first posted
- 2021-09-13
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects Experiencing Adverse Events as a Measure of Safety and Tolerability | Up to 12 weeks:Up to 4 weeks screening (depending on signed informed consent + 4 weeks treatment + 4 weeks follow-up | To evaluate the safety and tolerability of 200 mg of belumosudil administered PO QD to subjects for treatment of psoriasis |
| Secondary | Efficacy: Change in Overall PASI (Psoriasis Area and Severity Index) From Baseline to Week 4 and Week 8 | 8 weeks: 4-week (28-day) treatment + 4-week (28-day) follow-up | The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. The measures are the changes in PASI score at Week 4 from baseline and Week 8 from baseline. Negative changes are favorable; positive changes are unfavorable. |
| Secondary | Efficacy: Physician Global Assessment (PGA) at Week 4 and Week 8 | 8 weeks: 4-week (28-day) treatment + 4-week (28-day) follow-up | PGA score after treatment with belumosudil 200 mg PO QD at 4 weeks (28 days treatment) and at 8 weeks (additional 4 weeks follow-up). Categories: 100% = clear; 75% to 99% clearing (Excellent) = marked improvement, nearly normal skin texture, some erythema may be present; 50% to 74% clear (Good) = moderate improvement, plaque has cleared to point of small scattered papules with normal intervening epidermis; 25% to 49% clearing (Fair) = slight improvement, decrease in scaling and softening of plaque; 0% to 24% clearing (Poor) = little or no change in scaling, erythema, or plaque elevation; Worse |
| Secondary | PK: Cmax and Cmin | Measured at Baseline (Day 1) and Week 4 (28 days): predose (0), 1, 2, 4, 8, and 24 hours post-dose | Pharmacokinetic measures: Cmax = maximum observed plasma concentration; Cmin = minimum observed plasma concentration over 1 dosing period; KD025 = Parent Drug KD025; M1 = Metabolite KD025 M1; KD025 M2 = Metabolite M2. Day 1 Cmax: 8 subjects each in KD025 and M2, and 6 subjects in M1. Day 28 Cmax: 4 subjects each in KD025 and M2, and 1 subject in M1. Day 1 Cmin: 8 subjects each in KD025 and M2, and 3 subjects in M1. Day 28 Cmin: 4 subjects each in KD025 and M2, and 1 subject in M1. |
| Secondary | PK: AUC(0-24) and AUC(Inf) | Measured at Baseline (Day 1) and Week 4 (28 days): predose (0), 1, 2, 4, 8, and 24 hours post-dose | Pharmacokinetic measures: AUC(0-24) = area under concentration time-curve from pre-dose (time 0) to 24 hours post-dose; AUC(inf) = area under concentration time-curve extrapolated from Day 1 to infinity; KD025 = Parent Drug KD025; M1 = Metabolite KD025 M1; KD025 M2 = Metabolite M2. |
| Secondary | PK: Tmax | Measured at Baseline (Day 1) and Week 4 (28 days): predose (0), 1, 2, 4, 8, and 24 hours post-dose | Pharmacokinetic measure: Tmax = time of maximum observed plasma concentration. Day 1 Tmax: 7 subjects each in KD025 and M2, and 5 subjects in M1. Day 28 Tmax: 4 subjects each in KD025 and M2, and 1 subject in M1. |
| Secondary | PK: t(1/2) | Measured at Baseline (Day 1) and Week 4 (28 days): predose (0), 1, 2, 4, 8, and 24 hours post-dose | KD025 = Parent Drug KD025; KD025 M2 = Metabolite M2; t(1/2) = apparent terminal elimination half-life |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects Experiencing Adverse Events as a Measure of Safety and Tolerability | Up to 12 weeks:Up to 4 weeks screening (depending on signed informed consent + 4 weeks treatment + 4 weeks follow-up | Safety Population: All subjects who received at least 1 dose of belumosudil 200 mg | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Efficacy: Change in Overall PASI (Psoriasis Area and Severity Index) From Baseline to Week 4 and Week 8 | 8 weeks: 4-week (28-day) treatment + 4-week (28-day) follow-up | All 8 subjects who received belumosudil 200 mg PO QD. 7 subjects available at follow-up visit. | Score on a scale | MEAN |
| SECONDARY | Efficacy: Physician Global Assessment (PGA) at Week 4 and Week 8 | 8 weeks: 4-week (28-day) treatment + 4-week (28-day) follow-up | All 8 subjects had PGA scoring at Day 29 and at the follow-up visit (30 days after last dose of study drug) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | PK: Cmax and Cmin | Measured at Baseline (Day 1) and Week 4 (28 days): predose (0), 1, 2, 4, 8, and 24 hours post-dose | One subject excluded from all the descriptive statistics due to a mix-up of samples between predose and 4 hours (KD025, M1 and M2); Two subjects had no measurable concentrations observed in their profiles for M1 at Day 1 | ng/mL | MEAN |
| SECONDARY | PK: AUC(0-24) and AUC(Inf) | Measured at Baseline (Day 1) and Week 4 (28 days): predose (0), 1, 2, 4, 8, and 24 hours post-dose | AUC(0-24) Day 1: 7 subjects in KD025 and 3 subjects in M2. AUC(0-24) Day 28: 4 subjects in KD025 and 2 subjects in M2. AUC(inf): 6 subjects in KD025 and 3 subject in M2. Neither AUC(0-24) nor AUC(inf) were calculated for M1. | ng*hr/mL | MEAN |
| SECONDARY | PK: Tmax | Measured at Baseline (Day 1) and Week 4 (28 days): predose (0), 1, 2, 4, 8, and 24 hours post-dose | Day 1: 7 subjects each in KD025 and M2, and 5 subjects in M1. Day 28: 4 subjects each in KD025 and M2, and 1 subject in M1. | hours | MEDIAN |
| SECONDARY | PK: t(1/2) | Measured at Baseline (Day 1) and Week 4 (28 days): predose (0), 1, 2, 4, 8, and 24 hours post-dose | One subject was excluded from all descriptive statistics due to a mix-up of samples between pre-dose and 4 hours on Day 1.~Three subjects were excluded from day 28 statistics due to varying protocol deviations. Four additional subjects were excluded from M1 Day 28. No data were collected for Metabolite M1. | hours | MEAN |
Source ClinicalTrials.gov
Results by group53
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects Experiencing Adverse Events as a Measure of Safety and Tolerability | Belumosudil 200 mg PO QD | All AEs | 4 | Participants | |
| Number of Subjects Experiencing Adverse Events as a Measure of Safety and Tolerability | Belumosudil 200 mg PO QD | Related AEs | 1 | Participants | |
| Number of Subjects Experiencing Adverse Events as a Measure of Safety and Tolerability | Belumosudil 200 mg PO QD | Grade ≥3 AEs | 1 | Participants | |
| Number of Subjects Experiencing Adverse Events as a Measure of Safety and Tolerability | Belumosudil 200 mg PO QD | Grade ≥3 Related AEs | 0 | Participants | |
| Number of Subjects Experiencing Adverse Events as a Measure of Safety and Tolerability | Belumosudil 200 mg PO QD | Grade 4 AEs | 0 | Participants | |
| Number of Subjects Experiencing Adverse Events as a Measure of Safety and Tolerability | Belumosudil 200 mg PO QD | Deaths | 0 | Participants | |
| Number of Subjects Experiencing Adverse Events as a Measure of Safety and Tolerability | Belumosudil 200 mg PO QD | SAEs | 1 | Participants | |
| Number of Subjects Experiencing Adverse Events as a Measure of Safety and Tolerability | Belumosudil 200 mg PO QD | Related SAEs | 0 | Participants | |
| Number of Subjects Experiencing Adverse Events as a Measure of Safety and Tolerability | Belumosudil 200 mg PO QD | AEs leading to discontinuation | 2 | Participants | |
| Efficacy: Change in Overall PASI (Psoriasis Area and Severity Index) From Baseline to Week 4 and Week 8 | Belumosudil 200 mg PO QD | Baseline (Day 1) | 17.5 | Standard Deviation 8.41 | Score on a scale |
1 to 10 of 53Source ClinicalTrials.gov
See all 53 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Belumosudil 200 mg PO QD | 8 | |
| Overall Study | COMPLETED | Belumosudil 200 mg PO QD | 5 | |
| Overall Study | NOT COMPLETED | Belumosudil 200 mg PO QD | 3 |
Source ClinicalTrials.gov
Adverse events15
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Transaminase increased | Investigations | Belumosudil 200 mg PO QD | 2 | 8 | 2 |
| other | Nausea | Gastrointestinal disorders | Belumosudil 200 mg PO QD | 1 | 8 | 2 |
| other | Vomiting | Gastrointestinal disorders | Belumosudil 200 mg PO QD | 1 | 8 | 2 |
| other | Anastomotic ulder | Injury, poisoning and procedural complications | Belumosudil 200 mg PO QD | 1 | 8 | 1 |
| other | Nephrolithiasis | Renal and urinary disorders | Belumosudil 200 mg PO QD | 1 | 8 | 1 |
| other | Pyrexia | General disorders | Belumosudil 200 mg PO QD | 1 | 8 | 1 |
| other | Hypokalemia | Metabolism and nutrition disorders | Belumosudil 200 mg PO QD | 1 | 8 | 1 |
| other | Rib Fracture | Injury, poisoning and procedural complications | Belumosudil 200 mg PO QD | 1 | 8 | 1 |
| other | Fall | Injury, poisoning and procedural complications | Belumosudil 200 mg PO QD | 1 | 8 | 1 |
| other | Somnolence | Nervous system disorders | Belumosudil 200 mg PO QD | 1 | 8 | 1 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Belumosudil 200 mg PO QD | 0 | 8 |
| Total, other adverse events | Belumosudil 200 mg PO QD | 4 | 8 |
| Total, serious adverse events | Belumosudil 200 mg PO QD | 1 | 8 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02106195
GET https://conductscience.org/api/trials/v1/NCT02106195/results?page=2