Trial · NCT02852967
A Phase 2, Double-blind, Placebo-controlled Study of the Efficacy and Safety of Belumosudil in Subjects With Moderate/Severe Chronic Plaque Psoriasis
NCT02852967, 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 Phase 2, Double-blind, Placebo-controlled Study of the Efficacy and Safety of Belumosudil in Subjects With Moderate/Severe Chronic Plaque Psoriasis. Trials, record NCT02852967. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02852967
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 2, Double-blind, Placebo-controlled Study of the Efficacy and Safety of Belumosudil in Subjects With Moderate/Severe Chronic Plaque Psoriasis
- NCT number
- NCT02852967
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 110 participants, actual
- Lead sponsor
- Kadmon Corporation, LLC
- Conditions
- Chronic Plaque Psoriasis
- Interventions
- Belumosudil, Placebo
- First posted
- 2016-08-02
- Last updated
- 2022-03-16
- Results first posted
- 2021-09-13
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Efficacy: Percentage of Subjects With a ≥ 75% Decrease in PASI (PASI 75) at Week 16 (Double-blind Period)--LOCF and Observed | 16 weeks | The percentage of subjects who exhibited a 75% decrease or greater in the Psoriasis Area and Severity Index Score (PASI 75) whether they completed 16 weeks of treatment or not (last observation carried forward \[LOCF\]) and those who did complete 16 weeks of treatment (observed). \[PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign is assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis.\] |
| Secondary | Efficacy: Mean Change of Raw PASI Score From Baseline to Week 16 and Week 48--LOCF and Observed | 48 weeks | The mean change in the raw Psoriasis Area and Severity Index (PASI) score from baseline score to Week 16 and to Week 48 whether the subject completed 16 and 48 weeks, respectively (last observation carried forward \[LOCF\]), or for only those subjects who completed 16 and 48 weeks (observed), respectively. Negative values represent favorable results; positive values represent unfavorable results. \[The PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign is assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis.\] |
| Secondary | Efficacy: Percentage Change in Mean PASI Score From Baseline to Week 16 and to Week 48--LOCF and Observed | 48 weeks | The percentage (%) change in the mean Psoriasis Area and Severity Index (PASI) score from baseline ore to Week 16 and to Week 48 whether the subject completed 16 and 48 weeks, respectively (last observation carried forward \[LOCF\]) or for only those subjects who completed 16 and 48 weeks (observed), respectively. \[The PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign is assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis.\] |
| Secondary | Efficacy: Number of Subjects With Clear or Almost Clear PGA at Week 16--LOCF | 16 weeks | The number of subjects who had a "Clear" or "Almost Clear" assessment, using the Physician Global Assessment Scale (PGA), at Week 16 of all subjects whether they completed 16 weeks or not (last observation carried forward \[LOCF\]) \[The PGA documents the physician's assessment of the subject's psoriasis and was assessed relative to baseline conditions. The PGA rating is from 1-6, where 1 = 100% clearing of psoriasis (clear), 5 = 0 to 24% clearing (little or no change), and 6 = worse.\] |
| Secondary | Efficacy: Percentage of Subjects With Clear or Almost Clear PGA Comparing Belumosudil to Placebo at Week 16--LOCF | 16 weeks | The percentage (%) of subjects who had a "Clear" or "Almost Clear" assessment using the Physician Global Assessment Scale at Week 16 of belumosudil vs. placebo for all subjects whether they completed 16 weeks or not (last observation carried forward \[LOCF\]). \[The PGA documents the physician's assessment of the subject's psoriasis and was assessed relative to baseline conditions. The PGA rating is from 1-6, where 1 = 100% clearing of psoriasis (clear), 5 = 0 to 24% clearing (little or no change), and 6 = worse.\] |
| Secondary | Efficacy: Change in Mean DLQI Raw Score at Week 16 and at Week 48 | Up to 48 weeks | Changes in mean Dermatology Life Quality Index (DLQI) score from baseline at Week 16 (End of Double-blind Period) and at Week 48 (End of Study Treatment). \[The DLQI is a skin disease-specific instrument designed to assess the impact of the disease on a subject's quality of life. DLQI scoring as measured on subject's life: 0-1 = no effect; 2-5 = small effect; 6-10 = moderate effect; 11 to 20 = very large effect; 21 to 30 = extremely large effect. Change \< 0% is improvement; \> 0% is worsening. The total rating ranges from 0 (no effect on a subject's life) to 30 (extremely large effect on a subject's life.\] |
| Secondary | Efficacy: Percentage Change of Mean DLQI Score From Baseline to Week 16 and Week 48 | Up to 48 weeks | Mean percentage changes in Dermatology Life Quality Index (DLQI) from baseline at Week 16 (End of Double-blind Period) and at Week 48 (End of Study Treatment). \[The DLQI is a skin disease-specific instrument designed to assess the impact of the disease on a subject's quality of life. The rating ranges from 0 (no effect on a subject's life) to 30 (extremely large effect on a subject's life.\] |
| Secondary | Safety: Number of Subjects With TEAEs, SAEs, and Deaths Throughout the Study | Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up | The number of subjects who had treatment-emergent adverse events (TEAEs), severity of TEAEs, relationship of TEAEs to study medication, serious TEAEs (SAEs), dose interruption, discontinuations, and deaths. Treatment-emergent adverse events (TEAEs) are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP. Severity: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = Death. Related to study medication is defined as possible related, probable related, and related |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Efficacy: Percentage of Subjects With a ≥ 75% Decrease in PASI (PASI 75) at Week 16 (Double-blind Period)--LOCF and Observed | 16 weeks | PASI 75 determined by Last Observation Carried Forward (LOCF) and Observed at the end of Double-blind Period: 16 weeks | Percentage of participants | NUMBER |
| SECONDARY | Efficacy: Mean Change of Raw PASI Score From Baseline to Week 16 and Week 48--LOCF and Observed | 48 weeks | Not all subjects had PASI performed | Score on a scale | MEAN |
| SECONDARY | Efficacy: Percentage Change in Mean PASI Score From Baseline to Week 16 and to Week 48--LOCF and Observed | 48 weeks | Not all subjects had PASI performed | Percentage Change in PASI Score | MEAN |
| SECONDARY | Efficacy: Number of Subjects With Clear or Almost Clear PGA at Week 16--LOCF | 16 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Efficacy: Percentage of Subjects With Clear or Almost Clear PGA Comparing Belumosudil to Placebo at Week 16--LOCF | 16 weeks | Not all subjects had a response to treatment | Percentage (%) of subjects | NUMBER |
| SECONDARY | Efficacy: Change in Mean DLQI Raw Score at Week 16 and at Week 48 | Up to 48 weeks | Not all subjects could be evaluated at all visits. | Score on a scale | MEAN |
| SECONDARY | Efficacy: Percentage Change of Mean DLQI Score From Baseline to Week 16 and Week 48 | Up to 48 weeks | Not all subjects could be evaluated at all visits. Mean decrease in mean DLQI score is favorable; mean increase is not favorable | Percentage change of DLQI score | MEAN |
| SECONDARY | Safety: Number of Subjects With TEAEs, SAEs, and Deaths Throughout the Study | Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group161
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Efficacy: Percentage of Subjects With a ≥ 75% Decrease in PASI (PASI 75) at Week 16 (Double-blind Period)--LOCF and Observed | Belumosudil 200 mg QD + Placebo | LOCF (%) | 8.7 | 95% Confidence Interval 1.1 to 28.0 | Percentage of participants |
| Efficacy: Percentage of Subjects With a ≥ 75% Decrease in PASI (PASI 75) at Week 16 (Double-blind Period)--LOCF and Observed | Belumosudil 200 mg BID (Twice Daily) + Placebo | LOCF (%) | 9.1 | 95% Confidence Interval 1.1 to 29.2 | Percentage of participants |
| Efficacy: Percentage of Subjects With a ≥ 75% Decrease in PASI (PASI 75) at Week 16 (Double-blind Period)--LOCF and Observed | Belumosudil 400 mg QD + Placebo | LOCF (%) | 19.0 | 95% Confidence Interval 5.4 to 41.9 | Percentage of participants |
| Efficacy: Percentage of Subjects With a ≥ 75% Decrease in PASI (PASI 75) at Week 16 (Double-blind Period)--LOCF and Observed | Belumosudil 600 mg/Day | LOCF (%) | 7.7 | 95% Confidence Interval 0.9 to 25.1 | Percentage of participants |
| Efficacy: Percentage of Subjects With a ≥ 75% Decrease in PASI (PASI 75) at Week 16 (Double-blind Period)--LOCF and Observed | Placebo | LOCF (%) | 16.7 | 95% Confidence Interval 3.6 to 41.4 | Percentage of participants |
| Efficacy: Percentage of Subjects With a ≥ 75% Decrease in PASI (PASI 75) at Week 16 (Double-blind Period)--LOCF and Observed | All Belumosudil | LOCF (%) | 10.9 | 95% Confidence Interval 5.3 to 19.1 | Percentage of participants |
| Efficacy: Percentage of Subjects With a ≥ 75% Decrease in PASI (PASI 75) at Week 16 (Double-blind Period)--LOCF and Observed | Belumosudil 200 mg QD + Placebo | Observed (%) | 7.1 | 95% Confidence Interval 0.2 to 33.9 | Percentage of participants |
| Efficacy: Percentage of Subjects With a ≥ 75% Decrease in PASI (PASI 75) at Week 16 (Double-blind Period)--LOCF and Observed | Belumosudil 200 mg BID (Twice Daily) + Placebo | Observed (%) | 13.3 | 95% Confidence Interval 1.7 to 40.5 | Percentage of participants |
| Efficacy: Percentage of Subjects With a ≥ 75% Decrease in PASI (PASI 75) at Week 16 (Double-blind Period)--LOCF and Observed | Belumosudil 400 mg QD + Placebo | Observed (%) | 23.5 | 95% Confidence Interval 6.8 to 49.9 | Percentage of participants |
| Efficacy: Percentage of Subjects With a ≥ 75% Decrease in PASI (PASI 75) at Week 16 (Double-blind Period)--LOCF and Observed | Belumosudil 600 mg/Day | Observed (%) | 12.5 | 95% Confidence Interval 1.6 to 38.3 | Percentage of participants |
1 to 10 of 161Source ClinicalTrials.gov
See all 161 results by groupParticipant flow25
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Belumosudil 200 mg QD + Placebo | 23 | |
| Overall Study | STARTED | Belumosudil 200 mg BID (Twice Daily) + Placebo | 22 | |
| Overall Study | STARTED | Belumosudil 400 mg QD + Placebo | 21 | |
| Overall Study | STARTED | Belumosudil 600 mg/Day | 26 | |
| Overall Study | STARTED | Placebo | 18 | |
| Overall Study | Completed Period 1: Double-blind | Belumosudil 200 mg QD + Placebo | 14 | |
| Overall Study | Completed Period 1: Double-blind | Belumosudil 200 mg BID (Twice Daily) + Placebo | 15 | |
| Overall Study | Completed Period 1: Double-blind | Belumosudil 400 mg QD + Placebo | 17 | |
| Overall Study | Completed Period 1: Double-blind | Belumosudil 600 mg/Day | 16 | |
| Overall Study | Completed Period 1: Double-blind | Placebo | 10 |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 participant flowAdverse events192
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 | Viral upper respiratory tract infection | Infections and infestations | Belumosudil 200 mg QD + Placebo | 2 | 23 | |
| other | Viral upper respiratory tract infection | Infections and infestations | Belumosudil 200 mg BID (Twice Daily) + Placebo | 3 | 22 | |
| other | Viral upper respiratory tract infection | Infections and infestations | Belumosudil 400 mg QD + Placebo | 0 | 21 | |
| other | Viral upper respiratory tract infection | Infections and infestations | Belumosudil 600 mg/Day | 1 | 26 | |
| other | Viral upper respiratory tract infection | Infections and infestations | Placebo | 0 | 92 | |
| other | Viral upper respiratory tract infection | Infections and infestations | All Belumosudil | 6 | 92 | |
| other | Influenza | Infections and infestations | Belumosudil 200 mg QD + Placebo | 0 | 23 | |
| other | Influenza | Infections and infestations | Belumosudil 200 mg BID (Twice Daily) + Placebo | 1 | 22 | |
| other | Influenza | Infections and infestations | Belumosudil 400 mg QD + Placebo | 3 | 21 | |
| other | Influenza | Infections and infestations | Belumosudil 600 mg/Day | 0 | 26 |
1 to 10 of 192Source ClinicalTrials.gov
See all 192 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Belumosudil 200 mg QD + Placebo | 1 | 23 |
| Total, all-cause mortality | Belumosudil 200 mg BID (Twice Daily) + Placebo | 0 | 22 |
| Total, all-cause mortality | Belumosudil 400 mg QD + Placebo | 0 | 21 |
| Total, all-cause mortality | Belumosudil 600 mg/Day | 0 | 26 |
| Total, all-cause mortality | Placebo | 0 | 18 |
| Total, all-cause mortality | All Belumosudil | 1 | 92 |
| Total, other adverse events | Belumosudil 200 mg QD + Placebo | 14 | 23 |
| Total, other adverse events | Belumosudil 200 mg BID (Twice Daily) + Placebo | 13 | 22 |
| Total, other adverse events | Belumosudil 400 mg QD + Placebo | 14 | 21 |
| Total, other adverse events | Belumosudil 600 mg/Day | 16 | 26 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers0
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/NCT02852967
GET https://conductscience.org/api/trials/v1/NCT02852967/results?page=2