Trial · NCT02317627
Phase 2, Open-label, Study of KD025 in Subjects With Psoriasis Vulgaris Who Failed First-line Therapy
NCT02317627, Phase 2, Completed, Kadmon Corporation, LLC; results first posted 2021-11-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase 2, Open-label, Study of KD025 in Subjects With Psoriasis Vulgaris Who Failed First-line Therapy. Trials, record NCT02317627. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02317627
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 2, Open-label, Study of KD025 in Subjects With Psoriasis Vulgaris Who Failed First-line Therapy
- NCT number
- NCT02317627
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 38 participants, actual
- Lead sponsor
- Kadmon Corporation, LLC
- Conditions
- Psoriasis Vulgaris
- Interventions
- KD025
- First posted
- 2014-12-16
- Last updated
- 2022-05-26
- Results first posted
- 2021-11-01
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Efficacy: Percentage of Subjects With ≥ 75% Decrease or ≥ 50% Decrease in PASI Score at EOT---ITT Population | 12 weeks | Percentage of available subjects who achieved at least a 75% reduction (PASI 75) or at least a 50% reduction from baseline in Psoriasis Area and Severity Index (PASI) score after 12 weeks of treatment with belumosudil or at the end of treatment with belumosudil in the Intent-to-Treat Population. \[The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign is assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis.\] |
| Primary | Efficacy: Percentage of Subjects With ≥ 75% Decrease or ≥ 50% Decrease With PASI Score at EOT---Evaluable Population | 12 weeks | Percentage of available subjects who achieved at least a 75% reduction and a 50% reduction from baseline in Psoriasis Area and Severity Index score at end of treatment with belumosudil in the Evaluable Population. \[The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign is assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis.\] |
| Primary | Safety: Percentage of Subjects With AEs by Severity and Relationship to Belumosudil--ITT Population | 12 weeks | Percentage of subjects who had an adverse event by severity in the Intent-to-Treat Population: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death. Percentage of subjects who had an adverse event by relationship to belumosudil in the Intent-to-Treat Population as assessed by the investigator: definitely related, probably related, possibly related, and not related to belumosudil. |
| Secondary | Efficacy: Mean Change in PASI Score at 12 Weeks From Baseline--ITT Population | 12 weeks | Mean change in Psoriasis Area and Severity Index score after 12 weeks of treatment or End of Treatment with KD025 from baseline in the Intent-to-Treat Population. \[The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign is assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis.\] Negative mean change is favorable; positive mean change is unfavorable |
| Secondary | Efficacy: Mean Change in PASI Score at 12 Weeks From Baseline--Evaluable Population | 12 weeks | Mean change in Psoriasis Area and Severity Index score after 12 weeks of treatment or end of treatment with belumosudil from baseline in the Evaluable Population. \[The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign is assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis.\] Negative mean change is favorable; positive mean change is unfavorable |
| Secondary | Efficacy: Percentage of Subjects With a Decrease in PASI After 4 Weeks---ITT Population | 4 weeks | The percentage of subjects who exhibit any decrease in the Psoriasis Area and Severity Index score from baseline after 4 weeks of treatment with belumosudil in the Intent-to-Treat Population. \[The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign is assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis.\] |
| Secondary | Efficacy: Percentage of Subjects With a Decrease in PASI Score After 8 Weeks---ITT Population | 8 weeks | The percentage of subjects who exhibit any decrease in the Psoriasis Area and Severity Index score from baseline after 8 weeks of treatment with belumosudil in the Intent-to-Treat Population. \[The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign is assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis.\] |
| Secondary | Efficacy: Percentage of Subjects With a Decrease in PASI Score at EOT---ITT Population | 12 weeks | The percentage of subjects who exhibit any decrease in the Psoriasis Area and Severity Index score from baseline at the end of treatment with belumosudil in the Intent-to-Treat Population. \[The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign is assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis.\] |
| Secondary | Efficacy: Percentage of Subjects With a Decrease in PASI Score After 4 Weeks, 8 Weeks, and 12 Weeks---Evaluable Population | 12 weeks | The percentage of subjects who exhibit any decrease in the Psoriasis Area and Severity Index score from baseline after 4 weeks, 8 weeks, and 12 weeks of treatment with belumosudil in the Evaluable Population. \[The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign is assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis.\] |
| Secondary | Efficacy: Mean Change in PASI Score After 4 Weeks---ITT Population | 4 weeks | Mean change in the Psoriasis Area and Severity Index score from baseline after 4 weeks of treatment with belumosudil in the Intent-to-Treat Population. \[The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign is assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis.\] Negative mean change is favorable; positive mean change is unfavorable |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
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 ≥ 75% Decrease or ≥ 50% Decrease in PASI Score at EOT---ITT Population | 12 weeks | Intent-to-Treat (ITT) Population: All subjects enrolled in study | Percentage of participants (%) | NUMBER |
| PRIMARY | Efficacy: Percentage of Subjects With ≥ 75% Decrease or ≥ 50% Decrease With PASI Score at EOT---Evaluable Population | 12 weeks | Evaluable Population: Subjects who receive at least 80% of the expected amount of study drug if the subject had completed the study | Percentage of participants (%) | NUMBER |
| PRIMARY | Safety: Percentage of Subjects With AEs by Severity and Relationship to Belumosudil--ITT Population | 12 weeks | ITT Population: All enrolled subjects | Percentage of participants (%) | NUMBER |
| SECONDARY | Efficacy: Mean Change in PASI Score at 12 Weeks From Baseline--ITT Population | 12 weeks | Intent-to-Treat (ITT) Population: All enrolled subjects | Score on a scale | MEAN |
| SECONDARY | Efficacy: Mean Change in PASI Score at 12 Weeks From Baseline--Evaluable Population | 12 weeks | Intent-to-Treat (ITT) Population: All enrolled subjects | Score on a scale | MEAN |
| SECONDARY | Efficacy: Percentage of Subjects With a Decrease in PASI After 4 Weeks---ITT Population | 4 weeks | Intent-to-Treat (ITT) Population: All enrolled subjects | Percentage of participants (%) | NUMBER |
| SECONDARY | Efficacy: Percentage of Subjects With a Decrease in PASI Score After 8 Weeks---ITT Population | 8 weeks | Intent-to-Treat (ITT) Population: All enrolled subjects | Percentage of participants (%) | NUMBER |
| SECONDARY | Efficacy: Percentage of Subjects With a Decrease in PASI Score at EOT---ITT Population | 12 weeks | Intent-to-Treat (ITT) Population: All enrolled subjects | Percentage of participants (%) | NUMBER |
| SECONDARY | Efficacy: Percentage of Subjects With a Decrease in PASI Score After 4 Weeks, 8 Weeks, and 12 Weeks---Evaluable Population | 12 weeks | Evaluable Population: Subjects who received at least 80% of the expected amount study drug if the subject had completed the study | Percentage of participants (%) | NUMBER |
| SECONDARY | Efficacy: Mean Change in PASI Score After 4 Weeks---ITT Population | 4 weeks | Intent-to-Treat (ITT) Population: All enrolled subjects | Score on a scale | NUMBER |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group214
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 ≥ 75% Decrease or ≥ 50% Decrease in PASI Score at EOT---ITT Population | 400 mg QD | ≥ 75% Reduction from Baseline | 16.7 | 95% Confidence Interval 2.1 to 48.4 | Percentage of participants (%) |
| Efficacy: Percentage of Subjects With ≥ 75% Decrease or ≥ 50% Decrease in PASI Score at EOT---ITT Population | 200 mg BID | ≥ 75% Reduction from Baseline | 8.3 | 95% Confidence Interval 0.2 to 38.5 | Percentage of participants (%) |
| Efficacy: Percentage of Subjects With ≥ 75% Decrease or ≥ 50% Decrease in PASI Score at EOT---ITT Population | 400 mg BID | ≥ 75% Reduction from Baseline | 9.1 | 95% Confidence Interval 0.2 to 41.3 | Percentage of participants (%) |
| Efficacy: Percentage of Subjects With ≥ 75% Decrease or ≥ 50% Decrease in PASI Score at EOT---ITT Population | Overall (All Subjects) | ≥ 75% Reduction from Baseline | 11.4 | 95% Confidence Interval 3.2 to 26.7 | Percentage of participants (%) |
| Efficacy: Percentage of Subjects With ≥ 75% Decrease or ≥ 50% Decrease in PASI Score at EOT---ITT Population | 400 mg QD | ≥ 50% Reduction from Baseline | 41.7 | 95% Confidence Interval 15.2 to 72.3 | Percentage of participants (%) |
| Efficacy: Percentage of Subjects With ≥ 75% Decrease or ≥ 50% Decrease in PASI Score at EOT---ITT Population | 200 mg BID | ≥ 50% Reduction from Baseline | 50.0 | 95% Confidence Interval 21.1 to 78.9 | Percentage of participants (%) |
| Efficacy: Percentage of Subjects With ≥ 75% Decrease or ≥ 50% Decrease in PASI Score at EOT---ITT Population | 400 mg BID | ≥ 50% Reduction from Baseline | 18.2 | 95% Confidence Interval 2.3 to 51.8 | Percentage of participants (%) |
| Efficacy: Percentage of Subjects With ≥ 75% Decrease or ≥ 50% Decrease in PASI Score at EOT---ITT Population | Overall (All Subjects) | ≥ 50% Reduction from Baseline | 37.1 | 95% Confidence Interval 21.5 to 55.1 | Percentage of participants (%) |
| Efficacy: Percentage of Subjects With ≥ 75% Decrease or ≥ 50% Decrease With PASI Score at EOT---Evaluable Population | 400 mg QD | ≥ 75% Reduction from Baseline | 16.7 | 95% Confidence Interval 2.1 to 48.4 | Percentage of participants (%) |
| Efficacy: Percentage of Subjects With ≥ 75% Decrease or ≥ 50% Decrease With PASI Score at EOT---Evaluable Population | 200 mg BID | ≥ 75% Reduction from Baseline | 14.3 | 95% Confidence Interval 0.4 to 57.9 | Percentage of participants (%) |
1 to 10 of 214Source ClinicalTrials.gov
See all 214 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 400 mg QD | 13 | |
| Overall Study | STARTED | 200 mg BID | 13 | |
| Overall Study | STARTED | 400 mg BID | 12 | |
| Overall Study | COMPLETED | 400 mg QD | 11 | |
| Overall Study | COMPLETED | 200 mg BID | 8 | |
| Overall Study | COMPLETED | 400 mg BID | 8 | |
| Overall Study | NOT COMPLETED | 400 mg QD | 2 | |
| Overall Study | NOT COMPLETED | 200 mg BID | 5 | |
| Overall Study | NOT COMPLETED | 400 mg BID | 4 |
Source ClinicalTrials.gov
Adverse events228
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 | Liver function test abnormal | Investigations | 400 mg QD | 1 | 13 | 1 |
| other | Liver function test abnormal | Investigations | 200 mg BID | 1 | 13 | 3 |
| other | Liver function test abnormal | Investigations | 400 mg BID | 1 | 12 | 2 |
| other | Liver function test abnormal | Investigations | Overall (All Subjects) | 3 | 38 | 6 |
| other | Transaminases increased | Investigations | 400 mg QD | 1 | 13 | 5 |
| other | Transaminases increased | Investigations | 200 mg BID | 1 | 13 | 1 |
| other | Transaminases increased | Investigations | 400 mg BID | 0 | 12 | 0 |
| other | Transaminases increased | Investigations | Overall (All Subjects) | 2 | 38 | 6 |
| other | Alanine aminotransaminase (ALT) increased | Investigations | 400 mg QD | 1 | 13 | 1 |
| other | Alanine aminotransaminase (ALT) increased | Investigations | 200 mg BID | 0 | 13 | 0 |
1 to 10 of 228Source ClinicalTrials.gov
See all 228 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 400 mg QD | 0 | 13 |
| Total, all-cause mortality | 200 mg BID | 0 | 13 |
| Total, all-cause mortality | 400 mg BID | 0 | 12 |
| Total, all-cause mortality | Overall (All Subjects) | 0 | 38 |
| Total, other adverse events | 400 mg QD | 12 | 13 |
| Total, other adverse events | 200 mg BID | 11 | 13 |
| Total, other adverse events | 400 mg BID | 8 | 12 |
| Total, other adverse events | Overall (All Subjects) | 31 | 38 |
| Total, serious adverse events | 400 mg QD | 0 | 13 |
| Total, serious adverse events | 200 mg BID | 0 | 13 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 28389592 | BACKGROUND |
Source PubMed
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/NCT02317627
GET https://conductscience.org/api/trials/v1/NCT02317627/registered?page=2