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This study was performed to evaluate the safety, tolerability, activity, pharmacokinetics (PK), and daily dose regimen of KD025 administered orally (PO) for 12 weeks to subjects with psoriasis vulgaris who failed at least one line of systemic therapy.
Study KD025-206 was a phase 2, open-label, dose-finding, safety, tolerability, activity, and PK study of KD025 in subjects with psoriasis who had failed at least 1 line of systemic therapy or phototherapy.
Subjects received KD025 PO for 12 weeks. Planned enrollment was 36 subjects in 3 cohorts, 12 subjects per cohort:
Subjects were initially enrolled simultaneously in Cohort 1 and Cohort 2 according to a randomization schedule, with safety reviewed before any subjects. If safety guidelines were met, Cohort 3 was added to explore the efficacy and safety of KD025 at a dose of 400 mg PO BID.
Subjects underwent safety evaluations: medical history evaluations; physical examinations (PEs); vital sign measurements; weight measurements; adverse event (AE) assessments; concomitant medication assessments; blood sample collection for hematology, chemistry, and coagulation; lipid panel; thyroid-stimulating hormone; measurements of antinuclear antibody; anti-double-stranded deoxyribonucleic acid; Complement C; antiphospholipid antibody; liver ultrasound (US); pregnancy testing for females of childbearing potential; PK sampling (subset of subjects only); urinalysis; and electrocardiogram (ECG).
Subjects underwent efficacy evaluations: Psoriasis Area and Severity Index (PASI) scoring; Physicians Global Assessment (PGA) scoring; and Dermatologic Life Quality Index (DLQI) scoring.
Subjects participating in PK sampling were admitted to the clinic on Month 1 Day 1 (M1D1) for PK procedures and were discharged on M2D2. Blood samples for PK analyses were collected on M2D1 and Month 3 Day 1 (M3D1) on an outpatient basis. Subjects were not to take their morning dose until after blood samples were drawn.
A Follow-Up visit occurred 30 ± 3 days after the last dose of study drug.
The endpoints for efficacy were PASI, PGA, and DSQI scores.
Safety was assessed by standard clinical and laboratory tests (hematology, serum chemistry, and urinalysis), PEs, and reporting of treatment-emergent adverse events (TEAEs). Toxicity grades were defined using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. In addition, subjects had liver ultrasound and liver functioning testing assessed for possible steatosis.
Blood samples for determination of PK plasma concentrations of KD025 and its metabolites were collected for maximum concentration (Cmax); time of maximum concentration (Tmax); area under the concentration-time curve (AUC) at 0 to 24 hours, 0 to last, and 0 to infinity (0 to 24, 0 to last, 0 to infinity [inf]); half-life (t1/2); and accumulation ratio (metabolic-to-parent drug ratio).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | KD025 400 mg QD PO for 12 weeks |
|
| Cohort 2 | Experimental | KD025 200 mg BID PO for 12 weeks |
|
| Cohort 3 | Experimental | KD025 400 mg BID PO for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KD025 | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: Percentage of Subjects With ≥ 75% Decrease or ≥ 50% Decrease in PASI Score at EOT---ITT Population | 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.] | 12 weeks |
| Efficacy: Percentage of Subjects With ≥ 75% Decrease or ≥ 50% Decrease With PASI Score at EOT---Evaluable Population | 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.] | 12 weeks |
| Safety: Percentage of Subjects With AEs by Severity and Relationship to Belumosudil--ITT Population | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: Mean Change in PASI Score at 12 Weeks From Baseline--ITT Population | 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 |
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Inclusion Criteria:
Exclusion Criteria:
Non-plaque or drug-induced (antimalarials, lithium) psoriasis (If subject is taking angiotensin II receptor blockers or beta blockers doses had to be stable for 6 months prior to study entry)
Use of corticosteroid or immunosuppressive therapy within 4 weeks prior to study entry except for Class 5 or weaker topical corticosteroids or immunosuppressive therapies to the face, groin, or scalp.
Use of methotrexate, acitretin, or cyclosporine within 4 weeks prior to study entry
Use of phototherapy within 4 weeks prior to study entry
Use of biologic therapies, including antibodies to IL-17, within 3 months prior to study entry
Concomitant condition requiring treatment with moderate to high dose steroids in the 12 weeks prior to screening
Viral, fungal, or bacterial skin infection
Pregnant or lactating
History of gastrointestinal (GI) surgery including bariatric surgery, or any GI condition that might interfere with drug absorption
Currently participating in another study with an investigational drug or within 28 days of study entry
History or other evidence of severe illness or any other conditions that would make the subject, in the opinion of the investigator, unsuitable for the study (such as poorly controlled psychiatric disease or coronary artery disease)
Regular and excessive use of alcohol within the 2 years prior to study entry defined as alcohol intake > 14 drinks per week in a man or > 7 drinks per week in a woman. Approximately 10 g of alcohol equals one "drink" unit. One unit equals 1 ounce of distilled spirits, one 12-ounce beer, or one 4-ounce glass of wine
History or presence of any of the following:
QTc(F) interval (QT interval data corrected using Fridericia's formula) > 450 msec at the screening or predose ECG
Previous exposure to KD025 or known allergy/sensitivity to KD025 or any other ROCK-2 inhibitor
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arrowhead Health Centers | Glendale | Arizona | 85306 | United States | ||
| Southern California Dermatology, Inc. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28389592 | Background | Zanin-Zhorov A, Weiss JM, Trzeciak A, Chen W, Zhang J, Nyuydzefe MS, Arencibia C, Polimera S, Schueller O, Fuentes-Duculan J, Bonifacio KM, Kunjravia N, Cueto I, Soung J, Fleischmann RM, Kivitz A, Lebwohl M, Nunez M, Woodson J, Smith SL, West RF, Berger M, Krueger JG, Ryan JL, Waksal SD. Cutting Edge: Selective Oral ROCK2 Inhibitor Reduces Clinical Scores in Patients with Psoriasis Vulgaris and Normalizes Skin Pathology via Concurrent Regulation of IL-17 and IL-10. J Immunol. 2017 May 15;198(10):3809-3814. doi: 10.4049/jimmunol.1602142. Epub 2017 Apr 7. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 400 mg QD | Belumosudil 400 mg administered orally (PO) once daily (QD) for 12 weeks |
| FG001 | 200 mg BID | Belumosudil 200 mg administered PO twice daily (BID) for 12 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 12 weeks |
| 12 weeks |
| Efficacy: Mean Change in PASI Score at 12 Weeks From Baseline--Evaluable Population | 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 | 12 weeks |
| Efficacy: Percentage of Subjects With a Decrease in PASI After 4 Weeks---ITT Population | 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.] | 4 weeks |
| Efficacy: Percentage of Subjects With a Decrease in PASI Score After 8 Weeks---ITT Population | 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.] | 8 weeks |
| Efficacy: Percentage of Subjects With a Decrease in PASI Score at EOT---ITT Population | 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.] | 12 weeks |
| Efficacy: Percentage of Subjects With a Decrease in PASI Score After 4 Weeks, 8 Weeks, and 12 Weeks---Evaluable Population | 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.] | 12 weeks |
| Efficacy: Mean Change in PASI Score After 4 Weeks---ITT Population | 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 | 4 weeks |
| Efficacy: Mean Change in PASI Score After 8 Weeks---ITT Population | Mean change 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.] Negative mean change is favorable; positive mean change is unfavorable | 8 weeks |
| Efficacy: Mean Change in PASI Score at 4 and 8 Weeks---Evaluable Population | Mean change in the Psoriasis Area and Severity Index score from baseline after 4 and 8 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.] Negative mean change is favorable; positive mean change is unfavorable | 8 weeks |
| Efficacy: Percentage of Subjects With Improvement in PGA af 4 Weeks---ITT Population | Percentage of subjects evaluated by the Physician Global Assessment who improve (excellent, good, or fair) from baseline after 4 weeks of treatment with belumosudil in the Intent-to-Treat Population. The relative PGA documents the physician's assessment of the subject's psoriasis status. Consideration was given to the percent of body involvement as well as overall induration, scaling, and erythema. The PGA was assessed relative to baseline condition and was defined as: (1) clear; (2) excellent; (3) good; (4) fair; (5) poor; and (6) worse PGA improvement is defined as the categorical change from baseline: Clear = 100% improvement; Excellent = 75% to 99% improvement; Good = 50% to 74% improvement; Fair = 25% to 49% improvement | 4 weeks |
| Efficacy: Percentage of Subjects With Improvement in PGA af 8 Weeks---ITT Population | Percentage of subjects evaluated by the Physician Global Assessment who improve (excellent, good, or fair) from baseline after 8 weeks of treatment with belumosudil in the Intent-to-Treat Population. The relative PGA documents the physician's assessment of the subject's psoriasis status. Consideration was given to the percent of body involvement as well as overall induration, scaling, and erythema. The PGA was assessed relative to baseline condition and was defined as: (1) clear; (2) excellent; (3) good; (4) fair; (5) poor; and (6) worse. PGA improvement is defined as the categorical change from baseline: Clear = 100% improvement; Excellent = 75% to 99% improvement; Good = 50% to 74% improvement; Fair = 25% to 49% improvement | 8 weeks |
| Efficacy: Percentage of Subjects With Improvement in PGA af EOT--ITT Population | Percentage of subjects evaluated by the Physician Global Assessment who improve (excellent, good, or fair) from baseline after 12 weeks of treatment with belumosudil or at the end of treatment (EOT) in the Intent-to-Treat Population. The relative PGA documents the physician's assessment of the subject's psoriasis status. Consideration was given to the percent of body involvement as well as overall induration, scaling, and erythema. The PGA was assessed relative to baseline condition and was defined as: (1) clear; (2) excellent; (3) good; (4) fair; (5) poor; and (6) worse. PGA improvement is defined as the categorical change from baseline: Clear = 100% improvement; Excellent = 75% to 99% improvement; Good = 50% to 74% improvement; Fair = 25% to 49% improvement | 12 weeks |
| Efficacy: Percentage of Subjects With Improvement in PGA af 4, 8, and 12 Weeks---Evaluable Population | Percentage of subjects evaluated by the Physician Global Assessment who improve (excellent, good, or fair) from baseline after 4 weeks, after 8 weeks, and after 12 week of treatment with belumosudil in the Evaluable Population. The relative PGA documents the physician's assessment of the subject's psoriasis status. Consideration was given to the percent of body involvement as well as overall induration, scaling, and erythema. The PGA was assessed relative to baseline condition and was defined as: (1) clear; (2) excellent; (3) good; (4) fair; (5) poor; and (6) worse. PGA improvement is defined as the categorical change from baseline: Clear = 100% improvement; Excellent = 75% to 99% improvement; Good = 50% to 74% improvement; Fair = 25% to 49% improvement. | 12 weeks |
| Efficacy: Mean Changes in DLQI at EOT--ITT Population | Mean changes in the Dermatology Life Quality Index from baseline after 12 weeks of treatment with belumosudil or end of treatment with KD025 in the Intent-to-Treat Population [The Dermatology Life Quality Index (DLQI) is a skin disease-specific instrument designed to assess the impact of the disease on a subject's quality of life. The scale range is 0 to 30: 0-1=no effect on subject's quality of life; 2-5=small effect; 6-10= moderate effect; 11-20=very large effect; 21-30=extremely large effect.] Negative mean change is favorable; positive mean change is unfavorable | 12 weeks |
| Efficacy: Mean Changes in DLQI at 12 Weeks--Evaluable Population | Mean changes in the Dermatology Life Quality Index (DLQI) score from baseline after 12 weeks of treatment with belumosudil in the Evaluable Population. [The Dermatology Life Quality Index (DLQI) is a skin disease-specific instrument designed to assess the impact of the disease on a subject's quality of life. The scale range is 0 to 30: 0-1=no effect on subject's quality of life; 2-5=small effect; 6-10= moderate effect; 11-20=very large effect; 21-30=extremely large effect.] Negative mean change is favorable; positive mean change is unfavorable. | 12 weeks |
| Pharmacokinetics: Cmax of Parent Drug KD025, KD025m1, and KD025m2 | Maximum concentration (Cmax) of Parent drug (KD0250), Metabolite 1 (KD025m1), and Metabolite 2 (KD025m2) | 24 hours |
| Pharmacokinetics: AUC of Parent Drug KD025, KD025m1, and KD025m2 | Area Under Concentration Time Curve (AUC) for Parent Drug KD025, Metabolite 1 (KD025m1), and Metabolite 2 (KD025m2): AUC(0-12) = AUC from predose to 12 hours post-dose AUC(0-24) = AUC from predose to 24 hours post-dose AUC(0-t) = AUC from predose to a given time "t" post-dose | 24 hours |
| Pharmacokinetics: t(1/2) of KD025 | Half-life (t[1/2]) of Parent drug (KD025) | 24 hours |
| Pharmacokinetics: MR C(Max) and MR AUC(0-t) for KD025m1 and KD025m2 | Metabolite-to-parent ratio of maximum concentration (MR C[max]) and metabolite-to-parent ratio of the area under concentration time curve from pre-dose to a given time "t" for Metabolite 1 (KD025m1) and Metabolite 2 (KD025m2) | 24 hours |
| Santa Ana |
| California |
| 92701 |
| United States |
| Shondra L. Smith | Lake Charles | Louisiana | 70605 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Clinical Studies Group, LLC | Henderson | Nevada | 89074 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| High Point Clinical Trials Center | High Point | North Carolina | 27265 | United States |
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | 16635 | United States |
| Metroplex Clinical Research Center (MCRC) | Dallas | Texas | 75231 | United States |
| FG002 | 400 mg BID | Belumosudil 400 mg administered PO BID for 12 weeks |
| COMPLETED |
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| NOT COMPLETED |
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Intent-to-Treat (ITT) defined as all subjects enrolled in the study
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| ID | Title | Description |
|---|---|---|
| BG000 | 400 mg QD | Belumosudil 400 mg PO QD for 12 weeks |
| BG001 | 200 mg BID | Belumosudil 200 mg PO BID for 12 weeks |
| BG002 | 400 mg BID | Belumosudil 400 mg PO BID for 12 weeks |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| BMI (body mass index)--Mean | Mean | Standard Deviation | kg/m^2 |
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| BMI--Median | Median | Full Range | kg/m^2 |
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| Psoriasis Area and Severity Index (PASI) Score--Mean | 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. | Mean | Standard Deviation | Units on a scale |
| ||||||||||||||
| PASI--Median | 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. | Median | Full Range | Units on a scale |
| ||||||||||||||
| Physician Global Assessment (PGA) | The Physician Global Assessment (PGA) documents the physician's assessment of the subject's psoriasis and is 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. | Count of Participants | Participants |
| |||||||||||||||
| Dermatology Quality Life Index (DQLI)--Mean | The Dermatology Life Quality Index (DLQI) is a skin disease-specific instrument designed to assess the impact of the disease on a subject's quality of life. The scale range is 0 to 30: 0-1=no effect on subject's life; 2-5=small effect; 6-10= moderate effect; 11-20=very large effect; 21-30=extremely large effect. | Mean | Standard Deviation | Units on a scale |
| ||||||||||||||
| DLQI--Median | The Dermatology Life Quality Index (DLQI) is a skin disease-specific instrument designed to assess the impact of the disease on a subject's quality of life. The scale range is 0 to 30: 0-1=no effect on subject's life; 2-5=small effect; 6-10= moderate effect; 11-20=very large effect; 21-30=extremely large effect. | Median | Full Range | Units on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Efficacy: Percentage of Subjects With ≥ 75% Decrease or ≥ 50% Decrease in PASI Score at EOT---ITT Population | 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.] | Intent-to-Treat (ITT) Population: All subjects enrolled in study | Posted | Number | 95% Confidence Interval | Percentage of participants (%) | 12 weeks |
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| Primary | Efficacy: Percentage of Subjects With ≥ 75% Decrease or ≥ 50% Decrease With PASI Score at EOT---Evaluable Population | 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.] | Evaluable Population: Subjects who receive at least 80% of the expected amount of study drug if the subject had completed the study | Posted | Number | 95% Confidence Interval | Percentage of participants (%) | 12 weeks |
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| Primary | Safety: Percentage of Subjects With AEs by Severity and Relationship to Belumosudil--ITT Population | 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. | ITT Population: All enrolled subjects | Posted | Number | Percentage of participants (%) | 12 weeks |
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| Secondary | Efficacy: Mean Change in PASI Score at 12 Weeks From Baseline--ITT Population | 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 | Intent-to-Treat (ITT) Population: All enrolled subjects | Posted | Mean | 95% Confidence Interval | Score on a scale | 12 weeks |
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| Secondary | Efficacy: Mean Change in PASI Score at 12 Weeks From Baseline--Evaluable Population | 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 | Intent-to-Treat (ITT) Population: All enrolled subjects | Posted | Mean | 95% Confidence Interval | Score on a scale | 12 weeks |
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| Secondary | Efficacy: Percentage of Subjects With a Decrease in PASI After 4 Weeks---ITT Population | 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.] | Intent-to-Treat (ITT) Population: All enrolled subjects | Posted | Number | 95% Confidence Interval | Percentage of participants (%) | 4 weeks |
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| Secondary | Efficacy: Percentage of Subjects With a Decrease in PASI Score After 8 Weeks---ITT Population | 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.] | Intent-to-Treat (ITT) Population: All enrolled subjects | Posted | Number | 95% Confidence Interval | Percentage of participants (%) | 8 weeks |
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| Secondary | Efficacy: Percentage of Subjects With a Decrease in PASI Score at EOT---ITT Population | 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.] | Intent-to-Treat (ITT) Population: All enrolled subjects | Posted | Number | 95% Confidence Interval | Percentage of participants (%) | 12 weeks |
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| Secondary | Efficacy: Percentage of Subjects With a Decrease in PASI Score After 4 Weeks, 8 Weeks, and 12 Weeks---Evaluable Population | 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.] | Evaluable Population: Subjects who received at least 80% of the expected amount study drug if the subject had completed the study | Posted | Number | 95% Confidence Interval | Percentage of participants (%) | 12 weeks |
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| Secondary | Efficacy: Mean Change in PASI Score After 4 Weeks---ITT Population | 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 | Intent-to-Treat (ITT) Population: All enrolled subjects | Posted | Number | 95% Confidence Interval | Score on a scale | 4 weeks |
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| Secondary | Efficacy: Mean Change in PASI Score After 8 Weeks---ITT Population | Mean change 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.] Negative mean change is favorable; positive mean change is unfavorable | Intent-to-Treat (ITT) Population: All enrolled subjects | Posted | Number | 95% Confidence Interval | Score on a scale | 8 weeks |
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| Secondary | Efficacy: Mean Change in PASI Score at 4 and 8 Weeks---Evaluable Population | Mean change in the Psoriasis Area and Severity Index score from baseline after 4 and 8 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.] Negative mean change is favorable; positive mean change is unfavorable | Evaluable Population: Subjects who received at least 80% of the expected amount of study drug if the subject had completed the study | Posted | Number | 95% Confidence Interval | Score on a scale | 8 weeks |
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| Secondary | Efficacy: Percentage of Subjects With Improvement in PGA af 4 Weeks---ITT Population | Percentage of subjects evaluated by the Physician Global Assessment who improve (excellent, good, or fair) from baseline after 4 weeks of treatment with belumosudil in the Intent-to-Treat Population. The relative PGA documents the physician's assessment of the subject's psoriasis status. Consideration was given to the percent of body involvement as well as overall induration, scaling, and erythema. The PGA was assessed relative to baseline condition and was defined as: (1) clear; (2) excellent; (3) good; (4) fair; (5) poor; and (6) worse PGA improvement is defined as the categorical change from baseline: Clear = 100% improvement; Excellent = 75% to 99% improvement; Good = 50% to 74% improvement; Fair = 25% to 49% improvement | Intent-to-Treat (ITT) Population: All enrolled subjects | Posted | Number | Percentage of participants | 4 weeks |
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| Secondary | Efficacy: Percentage of Subjects With Improvement in PGA af 8 Weeks---ITT Population | Percentage of subjects evaluated by the Physician Global Assessment who improve (excellent, good, or fair) from baseline after 8 weeks of treatment with belumosudil in the Intent-to-Treat Population. The relative PGA documents the physician's assessment of the subject's psoriasis status. Consideration was given to the percent of body involvement as well as overall induration, scaling, and erythema. The PGA was assessed relative to baseline condition and was defined as: (1) clear; (2) excellent; (3) good; (4) fair; (5) poor; and (6) worse. PGA improvement is defined as the categorical change from baseline: Clear = 100% improvement; Excellent = 75% to 99% improvement; Good = 50% to 74% improvement; Fair = 25% to 49% improvement | Intent-to-Treat (ITT) Population: All enrolled subjects | Posted | Number | Percentage of participants | 8 weeks |
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| Secondary | Efficacy: Percentage of Subjects With Improvement in PGA af EOT--ITT Population | Percentage of subjects evaluated by the Physician Global Assessment who improve (excellent, good, or fair) from baseline after 12 weeks of treatment with belumosudil or at the end of treatment (EOT) in the Intent-to-Treat Population. The relative PGA documents the physician's assessment of the subject's psoriasis status. Consideration was given to the percent of body involvement as well as overall induration, scaling, and erythema. The PGA was assessed relative to baseline condition and was defined as: (1) clear; (2) excellent; (3) good; (4) fair; (5) poor; and (6) worse. PGA improvement is defined as the categorical change from baseline: Clear = 100% improvement; Excellent = 75% to 99% improvement; Good = 50% to 74% improvement; Fair = 25% to 49% improvement | Intent-to-Treat (ITT) Population: All enrolled subjects | Posted | Number | Percentage of participants | 12 weeks |
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| Secondary | Efficacy: Percentage of Subjects With Improvement in PGA af 4, 8, and 12 Weeks---Evaluable Population | Percentage of subjects evaluated by the Physician Global Assessment who improve (excellent, good, or fair) from baseline after 4 weeks, after 8 weeks, and after 12 week of treatment with belumosudil in the Evaluable Population. The relative PGA documents the physician's assessment of the subject's psoriasis status. Consideration was given to the percent of body involvement as well as overall induration, scaling, and erythema. The PGA was assessed relative to baseline condition and was defined as: (1) clear; (2) excellent; (3) good; (4) fair; (5) poor; and (6) worse. PGA improvement is defined as the categorical change from baseline: Clear = 100% improvement; Excellent = 75% to 99% improvement; Good = 50% to 74% improvement; Fair = 25% to 49% improvement. | Evaluable Population: Subjects who received at least 80% of the expected amount of study drug if the subject had completed the study | Posted | Number | Percentage of participants | 12 weeks |
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| Secondary | Efficacy: Mean Changes in DLQI at EOT--ITT Population | Mean changes in the Dermatology Life Quality Index from baseline after 12 weeks of treatment with belumosudil or end of treatment with KD025 in the Intent-to-Treat Population [The Dermatology Life Quality Index (DLQI) is a skin disease-specific instrument designed to assess the impact of the disease on a subject's quality of life. The scale range is 0 to 30: 0-1=no effect on subject's quality of life; 2-5=small effect; 6-10= moderate effect; 11-20=very large effect; 21-30=extremely large effect.] Negative mean change is favorable; positive mean change is unfavorable | Intent-to-Treat: All enrolled subjects. | Posted | Mean | Standard Deviation | Score on a scale | 12 weeks |
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| Secondary | Efficacy: Mean Changes in DLQI at 12 Weeks--Evaluable Population | Mean changes in the Dermatology Life Quality Index (DLQI) score from baseline after 12 weeks of treatment with belumosudil in the Evaluable Population. [The Dermatology Life Quality Index (DLQI) is a skin disease-specific instrument designed to assess the impact of the disease on a subject's quality of life. The scale range is 0 to 30: 0-1=no effect on subject's quality of life; 2-5=small effect; 6-10= moderate effect; 11-20=very large effect; 21-30=extremely large effect.] Negative mean change is favorable; positive mean change is unfavorable. | Evaluable Population: Subjects who received at least 80% of the expected amount of study drug if the subject had completed the study | Posted | Mean | Standard Deviation | Score on a scale | 12 weeks |
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| Secondary | Pharmacokinetics: Cmax of Parent Drug KD025, KD025m1, and KD025m2 | Maximum concentration (Cmax) of Parent drug (KD0250), Metabolite 1 (KD025m1), and Metabolite 2 (KD025m2) | PK Population: Subjects received at least 1 dose of study drug and had at least 1 post-dose PK sample drawn. Note: Not all subjects had all data available for PK parameters. | Posted | Mean | Standard Deviation | ng/mL | 24 hours |
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| Secondary | Pharmacokinetics: AUC of Parent Drug KD025, KD025m1, and KD025m2 | Area Under Concentration Time Curve (AUC) for Parent Drug KD025, Metabolite 1 (KD025m1), and Metabolite 2 (KD025m2): AUC(0-12) = AUC from predose to 12 hours post-dose AUC(0-24) = AUC from predose to 24 hours post-dose AUC(0-t) = AUC from predose to a given time "t" post-dose | PK Population: Subjects received at least 1 dose of study drug and had at least 1 post-dose PK sample drawn. Note: KD025m2 did not have AUC(0-12) or AUC(0-24) available. Not all subjects had all PK measurements. AUC(0-12) and AUC(0-24) for KD025m1 were not calculable. | Posted | Mean | Standard Deviation | hour*ng/mL | 24 hours |
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| Secondary | Pharmacokinetics: t(1/2) of KD025 | Half-life (t[1/2]) of Parent drug (KD025) | Subjects received at least 1 dose of study drug and had at least 1 post-dose PK sample drawn. One subject in 200 mg BID cohort did not have t(1/2) data available. | Posted | Mean | Standard Deviation | Hours | 24 hours |
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| Secondary | Pharmacokinetics: MR C(Max) and MR AUC(0-t) for KD025m1 and KD025m2 | Metabolite-to-parent ratio of maximum concentration (MR C[max]) and metabolite-to-parent ratio of the area under concentration time curve from pre-dose to a given time "t" for Metabolite 1 (KD025m1) and Metabolite 2 (KD025m2) | The metabolite-to-parent ratio is not applicable to parent drug KD025. Not all subjects had data for all PK parameters. | Posted | Mean | Standard Deviation | Number (ratio) | 24 hours |
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Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 400 mg QD | Belumosudil 400 mg PO QD for 12 weeks | 0 | 13 | 0 | 13 | 12 | 13 |
| EG001 | 200 mg BID | Belumosudil 200 mg PO BID for 12 weeks | 0 | 13 | 0 | 13 | 11 | 13 |
| EG002 | 400 mg BID | Belumosudil 400 mg PO BID for 12 weeks | 0 | 12 | 0 | 12 | 8 | 12 |
| EG003 | Overall (All Subjects) | Belumosudil 400 mg QD + 200 mg QD + 400 mg BID for 12 weeks | 0 | 38 | 0 | 38 | 31 | 38 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Liver function test abnormal | Investigations | MedDRA (17.1) | Systematic Assessment |
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| Transaminases increased | Investigations | MedDRA (17.1) | Systematic Assessment |
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| Alanine aminotransaminase (ALT) increased | Investigations | MedDRA (17.1) | Systematic Assessment |
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| Aspartate aminotransferase (AST) increased | Investigations | MedDRA (17.1) | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
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| Oral herpes | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
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| Blood bilirubin increased | Investigations | MedDRA (17.1) | Systematic Assessment |
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| Blood pressure increased | Investigations | MedDRA (17.1) | Systematic Assessment |
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| Hepatic enzyme increased | Investigations | MedDRA (17.1) | Systematic Assessment |
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| Gastrointestinal viral infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
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| Pharyngitis streptococcal | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
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| Tonsilitis | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
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| Tooth abscess | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
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| Viral upper respiratory tract infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
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| Hematochezia | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
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| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
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| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
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| Psoriatic arthropathy | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
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| Paransal sinus infection | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
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| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
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| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
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| Skin burning sensation | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
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| Skin discoloration | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
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| Hand fracture | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment |
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| Laceration | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment |
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| Ligament sprain | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment |
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| Postoperative wound complication | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment |
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| Procedural pain | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
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| Sinus headache | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
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| Hypercalcemia | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
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| Hyperglycemia | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
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| Hyperlipidemia | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
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| Fatigue | General disorders | MedDRA (17.1) | Systematic Assessment |
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| Edema peripheral | General disorders | MedDRA (17.1) | Systematic Assessment |
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| Anorgasmia | Psychiatric disorders | MedDRA (17.1) | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA (17.1) | Systematic Assessment |
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| Hypothyroidism | Endocrine disorders | MedDRA (17.1) | Systematic Assessment |
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| Seasonal allergy | Immune system disorders | MedDRA (17.1) | Systematic Assessment |
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| Vaginal discharge | Reproductive system and breast disorders | MedDRA (17.1) | Systematic Assessment |
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| Flushing | Vascular disorders | MedDRA (17.1) | Systematic Assessment |
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The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding results. The sponsor cannot require changes to the study results in the communication except to remove sponsor's confidential information. Sponsor cannot unilaterally extend the embargo.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Associate VP, Clinical Operations | Kadmon Corporation, LLC | 833-900-5366 | karin.herrera@kadmon.com |
| ID | Term |
|---|---|
| C000619755 | KD025 |
| C000718240 | belumosudil |
Not provided
Not provided
Not provided
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Excellent (75% to 99%) |
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| Good (50% to 74%) |
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| Fair (25% to 49%) |
|
| Poor (0% to 24%) |
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| Worse |
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| ≥ 50% Reduction from Baseline |
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Belumosudil 400 mg PO BID for 12 weeks
| OG003 | Overall (All Subjects) | Belumosudil 400 mg QD + 200 mg QD + 400 mg BID for 12 weeks |
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| OG003 | Overall (All Subjects) | Belumosudil 400 mg QD + 200 mg QD + 400 mg BID for 12 weeks |
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| OG003 | Overall (All Subjects) | Belumosudil 400 mg QD + 200 mg QD + 400 mg BID for 12 weeks |
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| OG003 | Overall (All Subjects) | Belumosudil 400 mg QD + 200 mg QD + 400 mg BID for 12 weeks |
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| OG003 | Overall (All Subjects) | Belumosudil 400 mg QD + 200 mg QD + 400 mg BID for 12 weeks |
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| OG003 | Overall (All Subjects) | Belumosudil 400 mg QD + 200 mg QD + 400 mg BID for 12 weeks |
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Belumosudil 400 mg PO BID for 12 weeks
| OG003 | Overall (All Subjects) | Belumosudil 400 mg QD + 200 mg QD + 400 mg BID for 12 weeks |
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| OG003 | Overall (All Subjects) | Belumosudil 400 mg QD + 200 mg QD + 400 mg BID for 12 weeks |
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| OG003 | Overall (All Subjects) | Belumosudil 400 mg QD + 200 mg QD + 400 mg BID for 12 weeks |
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| OG003 | Overall (All Subjects) | Belumosudil 400 mg QD + 200 mg QD + 400 mg BID for 12 weeks |
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| OG003 |
| Overall (All Subjects) |
Belumosudil 400 mg QD + 200 mg QD + 400 mg BID for 12 weeks |
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| OG003 |
| Overall (All Subjects) |
Belumosudil 400 mg QD + 200 mg QD + 400 mg BID for 12 weeks |
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| OG003 | Overall (All Subjects) | Belumosudil 400 mg PO QD + 200 mg PO QD + 400 mg PO BID for 12 weeks |
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Belumosudil 400 mg PO BID for 12 weeks
| OG003 | Overall (All Subjects) | Belumosudil 400 mg QD + 200 mg QD + 400 mg BID for 12 weeks |
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Belumosudil 400 mg QD + 200 mg QD + 400 mg BID for 12 weeks
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Belumosudil 400 mg PO QD + 200 mg PO QD + 400 mg PO BID for 12 weeks |
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