Trial Outcomes & Findings for Phase 2, Open-label, Study of KD025 in Subjects With Psoriasis Vulgaris Who Failed First-line Therapy (NCT NCT02317627)

Last Updated: 2022-05-26

Results Overview

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. \[The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign is assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis.\]

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

38 participants

Primary outcome timeframe

12 weeks

Results posted on

2022-05-26

Participant Flow

Participant milestones

Participant milestones
Measure	400 mg QD Belumosudil 400 mg administered orally (PO) once daily (QD) for 12 weeks	200 mg BID Belumosudil 200 mg administered PO twice daily (BID) for 12 weeks	400 mg BID Belumosudil 400 mg administered PO BID for 12 weeks
Overall Study STARTED	13	13	12
Overall Study COMPLETED	11	8	8
Overall Study NOT COMPLETED	2	5	4

Reasons for withdrawal

Reasons for withdrawal
Measure	400 mg QD Belumosudil 400 mg administered orally (PO) once daily (QD) for 12 weeks	200 mg BID Belumosudil 200 mg administered PO twice daily (BID) for 12 weeks	400 mg BID Belumosudil 400 mg administered PO BID for 12 weeks
Overall Study Withdrawal by Subject	0	1	1
Overall Study Lost to Follow-up	2	0	0
Overall Study Stopped by Investigator	0	1	0
Overall Study Adverse Event	0	2	3
Overall Study Non-compliance with study drug	0	1	0

Baseline Characteristics

Phase 2, Open-label, Study of KD025 in Subjects With Psoriasis Vulgaris Who Failed First-line Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	400 mg QD n=13 Participants Belumosudil 400 mg PO QD for 12 weeks	200 mg BID n=13 Participants Belumosudil 200 mg PO BID for 12 weeks	400 mg BID n=12 Participants Belumosudil 400 mg PO BID for 12 weeks	Total n=38 Participants Total of all reporting groups
Age, Continuous	46.0 years n=5 Participants	45.0 years n=7 Participants	54.5 years n=5 Participants	47.5 years n=4 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	6 Participants n=7 Participants	4 Participants n=5 Participants	15 Participants n=4 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	7 Participants n=7 Participants	8 Participants n=5 Participants	23 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants	15 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants	9 Participants n=7 Participants	6 Participants n=5 Participants	23 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants	12 Participants n=7 Participants	12 Participants n=5 Participants	35 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
BMI (body mass index)--Mean	34.42 kg/m^2 STANDARD_DEVIATION 7.132 • n=5 Participants	32.81 kg/m^2 STANDARD_DEVIATION 7.747 • n=7 Participants	32.65 kg/m^2 STANDARD_DEVIATION 10.582 • n=5 Participants	33.31 kg/m^2 STANDARD_DEVIATION 8.362 • n=4 Participants
BMI--Median	35.70 kg/m^2 n=5 Participants	31.40 kg/m^2 n=7 Participants	30.35 kg/m^2 n=5 Participants	31.50 kg/m^2 n=4 Participants
Psoriasis Area and Severity Index (PASI) Score--Mean	21.0 Units on a scale STANDARD_DEVIATION 10.85 • n=5 Participants	18.3 Units on a scale STANDARD_DEVIATION 8.51 • n=7 Participants	20.3 Units on a scale STANDARD_DEVIATION 7.24 • n=5 Participants	19.8 Units on a scale STANDARD_DEVIATION 8.87 • n=4 Participants
PASI--Median	18.0 Units on a scale n=5 Participants	16.2 Units on a scale n=7 Participants	18.5 Units on a scale n=5 Participants	17.3 Units on a scale n=4 Participants
Physician Global Assessment (PGA) Clear (100%)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Physician Global Assessment (PGA) Excellent (75% to 99%)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Physician Global Assessment (PGA) Good (50% to 74%)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Physician Global Assessment (PGA) Fair (25% to 49%)	1 Participants n=5 Participants	5 Participants n=7 Participants	2 Participants n=5 Participants	8 Participants n=4 Participants
Physician Global Assessment (PGA) Poor (0% to 24%)	12 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants	25 Participants n=4 Participants
Physician Global Assessment (PGA) Worse	0 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	5 Participants n=4 Participants
Dermatology Quality Life Index (DQLI)--Mean	14.6 Units on a scale STANDARD_DEVIATION 6.79 • n=5 Participants	14.2 Units on a scale STANDARD_DEVIATION 6.39 • n=7 Participants	10.3 Units on a scale STANDARD_DEVIATION 7.77 • n=5 Participants	13.1 Units on a scale STANDARD_DEVIATION 7.06 • n=4 Participants
DLQI--Median	16.0 Units on a scale n=5 Participants	15.0 Units on a scale n=7 Participants	10.0 Units on a scale n=5 Participants	12.5 Units on a scale n=4 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: Intent-to-Treat (ITT) Population: All subjects enrolled in study

Outcome measures

Outcome measures
Measure	400 mg QD n=12 Participants Belumosudil 400 mg PO QD for 12 weeks	200 mg BID n=12 Participants Belumosudil 200 mg PO BID for 12 weeks	400 mg BID n=11 Participants Belumosudil 400 mg PO BID for 12 weeks	Overall (All Subjects) n=35 Participants Belumosudil 400 mg QD + 200 mg QD + 400 mg BID for 12 weeks
Efficacy: Percentage of Subjects With ≥ 75% Decrease or ≥ 50% Decrease in PASI Score at EOT---ITT Population ≥ 75% Reduction from Baseline	16.7 Percentage of participants (%) Interval 2.1 to 48.4	8.3 Percentage of participants (%) Interval 0.2 to 38.5	9.1 Percentage of participants (%) Interval 0.2 to 41.3	11.4 Percentage of participants (%) Interval 3.2 to 26.7
Efficacy: Percentage of Subjects With ≥ 75% Decrease or ≥ 50% Decrease in PASI Score at EOT---ITT Population ≥ 50% Reduction from Baseline	41.7 Percentage of participants (%) Interval 15.2 to 72.3	50.0 Percentage of participants (%) Interval 21.1 to 78.9	18.2 Percentage of participants (%) Interval 2.3 to 51.8	37.1 Percentage of participants (%) Interval 21.5 to 55.1

PRIMARY outcome

Timeframe: 12 weeks

Population: Evaluable Population: Subjects who receive at least 80% of the expected amount of study drug if the subject had completed the study

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. \[The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign is assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis.\]

Outcome measures

Outcome measures
Measure	400 mg QD n=12 Participants Belumosudil 400 mg PO QD for 12 weeks	200 mg BID n=7 Participants Belumosudil 200 mg PO BID for 12 weeks	400 mg BID n=7 Participants Belumosudil 400 mg PO BID for 12 weeks	Overall (All Subjects) n=26 Participants Belumosudil 400 mg QD + 200 mg QD + 400 mg BID for 12 weeks
Efficacy: Percentage of Subjects With ≥ 75% Decrease or ≥ 50% Decrease With PASI Score at EOT---Evaluable Population ≥ 75% Reduction from Baseline	16.7 Percentage of participants (%) Interval 2.1 to 48.4	14.3 Percentage of participants (%) Interval 0.4 to 57.9	14.3 Percentage of participants (%) Interval 0.4 to 57.9	15.4 Percentage of participants (%) Interval 4.4 to 34.9
Efficacy: Percentage of Subjects With ≥ 75% Decrease or ≥ 50% Decrease With PASI Score at EOT---Evaluable Population ≥ 50% Reduction from Baseline	41.7 Percentage of participants (%) Interval 15.2 to 72.3	71.4 Percentage of participants (%) Interval 29.0 to 96.3	28.6 Percentage of participants (%) Interval 3.7 to 71.0	46.2 Percentage of participants (%) Interval 26.6 to 66.6

PRIMARY outcome

Timeframe: 12 weeks

Population: ITT Population: All enrolled subjects

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.

Outcome measures

Outcome measures
Measure	400 mg QD n=13 Participants Belumosudil 400 mg PO QD for 12 weeks	200 mg BID n=13 Participants Belumosudil 200 mg PO BID for 12 weeks	400 mg BID n=12 Participants Belumosudil 400 mg PO BID for 12 weeks	Overall (All Subjects) n=38 Participants Belumosudil 400 mg QD + 200 mg QD + 400 mg BID for 12 weeks
Safety: Percentage of Subjects With AEs by Severity and Relationship to Belumosudil--ITT Population All AEs	12 Percentage of participants (%)	11 Percentage of participants (%)	8 Percentage of participants (%)	31 Percentage of participants (%)
Safety: Percentage of Subjects With AEs by Severity and Relationship to Belumosudil--ITT Population Grade 1 (Mild)	69.2 Percentage of participants (%)	46.2 Percentage of participants (%)	33.3 Percentage of participants (%)	50.0 Percentage of participants (%)
Safety: Percentage of Subjects With AEs by Severity and Relationship to Belumosudil--ITT Population Grade 2 (Moderate)	69.2 Percentage of participants (%)	46.2 Percentage of participants (%)	50.0 Percentage of participants (%)	55.3 Percentage of participants (%)
Safety: Percentage of Subjects With AEs by Severity and Relationship to Belumosudil--ITT Population Grade 3 (Severe)	7.7 Percentage of participants (%)	7.7 Percentage of participants (%)	8.3 Percentage of participants (%)	7.9 Percentage of participants (%)
Safety: Percentage of Subjects With AEs by Severity and Relationship to Belumosudil--ITT Population Grade 4 (Life-threatening)	7.7 Percentage of participants (%)	0 Percentage of participants (%)	0 Percentage of participants (%)	2.6 Percentage of participants (%)
Safety: Percentage of Subjects With AEs by Severity and Relationship to Belumosudil--ITT Population Grade 5 (Death)	0 Percentage of participants (%)	0 Percentage of participants (%)	0 Percentage of participants (%)	0 Percentage of participants (%)
Safety: Percentage of Subjects With AEs by Severity and Relationship to Belumosudil--ITT Population Related to KD025	38.5 Percentage of participants (%)	23.1 Percentage of participants (%)	58.3 Percentage of participants (%)	39.5 Percentage of participants (%)
Safety: Percentage of Subjects With AEs by Severity and Relationship to Belumosudil--ITT Population Grade 3, 4, or 5 Related to KD025	0 Percentage of participants (%)	7.7 Percentage of participants (%)	0 Percentage of participants (%)	2.6 Percentage of participants (%)

SECONDARY outcome

Timeframe: 12 weeks

Population: Intent-to-Treat (ITT) Population: All enrolled subjects

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

Outcome measures

Outcome measures
Measure	400 mg QD n=12 Participants Belumosudil 400 mg PO QD for 12 weeks	200 mg BID n=12 Participants Belumosudil 200 mg PO BID for 12 weeks	400 mg BID n=11 Participants Belumosudil 400 mg PO BID for 12 weeks	Overall (All Subjects) n=35 Participants Belumosudil 400 mg QD + 200 mg QD + 400 mg BID for 12 weeks
Efficacy: Mean Change in PASI Score at 12 Weeks From Baseline--ITT Population End of Treatment (or 12 Weeks)	12.4 Score on a scale Interval 7.9 to 17.0	10.3 Score on a scale Interval 7.0 to 13.6	14.4 Score on a scale Interval 8.8 to 19.9	12.3 Score on a scale Interval 9.9 to 14.7
Efficacy: Mean Change in PASI Score at 12 Weeks From Baseline--ITT Population Change from Baseline at End of Treatment	-8.8 Score on a scale Interval -16.5 to -1.1	-6.0 Score on a scale Interval -9.5 to -2.4	-4.8 Score on a scale Interval -8.9 to -0.7	-6.6 Score on a scale Interval -9.5 to -3.7

SECONDARY outcome

Timeframe: 12 weeks

Population: Intent-to-Treat (ITT) Population: All enrolled subjects

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

Outcome measures

Outcome measures
Measure	400 mg QD n=12 Participants Belumosudil 400 mg PO QD for 12 weeks	200 mg BID n=7 Participants Belumosudil 200 mg PO BID for 12 weeks	400 mg BID n=7 Participants Belumosudil 400 mg PO BID for 12 weeks	Overall (All Subjects) n=26 Participants Belumosudil 400 mg QD + 200 mg QD + 400 mg BID for 12 weeks
Efficacy: Mean Change in PASI Score at 12 Weeks From Baseline--Evaluable Population 12 Weeks	12.4 Score on a scale Interval 7.9 to 17.0	7.6 Score on a scale Interval 5.6 to 9.6	15.5 Score on a scale Interval 5.8 to 25.1	12.0 Score on a scale Interval 8.9 to 15.0
Efficacy: Mean Change in PASI Score at 12 Weeks From Baseline--Evaluable Population Change from Baseline at 12 Weeks	-8.8 Score on a scale Interval -16.5 to -1.1	-7.9 Score on a scale Interval -11.9 to -3.9	-5.9 Score on a scale Interval -12.5 to 0.7	-7.8 Score on a scale Interval -11.4 to -4.1

SECONDARY outcome

Timeframe: 4 weeks

Population: Intent-to-Treat (ITT) Population: All enrolled subjects

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. \[The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign is assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis.\]

Outcome measures

Outcome measures
Measure	400 mg QD n=13 Participants Belumosudil 400 mg PO QD for 12 weeks	200 mg BID n=12 Participants Belumosudil 200 mg PO BID for 12 weeks	400 mg BID n=12 Participants Belumosudil 400 mg PO BID for 12 weeks	Overall (All Subjects) n=37 Participants Belumosudil 400 mg QD + 200 mg QD + 400 mg BID for 12 weeks
Efficacy: Percentage of Subjects With a Decrease in PASI After 4 Weeks---ITT Population	76.9 Percentage of participants (%) Interval 46.2 to 95.0	66.7 Percentage of participants (%) Interval 34.9 to 90.1	58.3 Percentage of participants (%) Interval 27.7 to 84.8	67.6 Percentage of participants (%) Interval 50.2 to 82.0

SECONDARY outcome

Timeframe: 8 weeks

Population: Intent-to-Treat (ITT) Population: All enrolled subjects

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. \[The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign is assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis.\]

Outcome measures

Outcome measures
Measure	400 mg QD n=12 Participants Belumosudil 400 mg PO QD for 12 weeks	200 mg BID n=9 Participants Belumosudil 200 mg PO BID for 12 weeks	400 mg BID n=7 Participants Belumosudil 400 mg PO BID for 12 weeks	Overall (All Subjects) n=28 Participants Belumosudil 400 mg QD + 200 mg QD + 400 mg BID for 12 weeks
Efficacy: Percentage of Subjects With a Decrease in PASI Score After 8 Weeks---ITT Population	83.3 Percentage of participants (%) Interval 51.6 to 97.9	100 Percentage of participants (%) Interval 66.4 to 100.0	85.7 Percentage of participants (%) Interval 42.1 to 99.6	89.3 Percentage of participants (%) Interval 71.8 to 97.7

SECONDARY outcome

Timeframe: 12 weeks

Population: Intent-to-Treat (ITT) Population: All enrolled subjects

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. \[The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign is assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis.\]

Outcome measures

Outcome measures
Measure	400 mg QD n=12 Participants Belumosudil 400 mg PO QD for 12 weeks	200 mg BID n=12 Participants Belumosudil 200 mg PO BID for 12 weeks	400 mg BID n=11 Participants Belumosudil 400 mg PO BID for 12 weeks	Overall (All Subjects) n=35 Participants Belumosudil 400 mg QD + 200 mg QD + 400 mg BID for 12 weeks
Efficacy: Percentage of Subjects With a Decrease in PASI Score at EOT---ITT Population	75.0 Percentage of participants (%) Interval 42.8 to 94.5	75.0 Percentage of participants (%) Interval 42.8 to 94.5	81.8 Percentage of participants (%) Interval 48.2 to 97.7	77.1 Percentage of participants (%) Interval 59.9 to 89.6

SECONDARY outcome

Timeframe: 12 weeks

Population: Evaluable Population: Subjects who received at least 80% of the expected amount study drug if the subject had completed the study

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. \[The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign is assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis.\]

Outcome measures

Outcome measures
Measure	400 mg QD n=12 Participants Belumosudil 400 mg PO QD for 12 weeks	200 mg BID n=7 Participants Belumosudil 200 mg PO BID for 12 weeks	400 mg BID n=7 Participants Belumosudil 400 mg PO BID for 12 weeks	Overall (All Subjects) n=26 Participants Belumosudil 400 mg QD + 200 mg QD + 400 mg BID for 12 weeks
Efficacy: Percentage of Subjects With a Decrease in PASI Score After 4 Weeks, 8 Weeks, and 12 Weeks---Evaluable Population 4 Weeks	75.0 Percentage of participants (%) Interval 42.8 to 94.5	85.7 Percentage of participants (%) Interval 42.1 to 99.6	71.4 Percentage of participants (%) Interval 29.0 to 96.3	76.9 Percentage of participants (%) Interval 56.4 to 91.0
Efficacy: Percentage of Subjects With a Decrease in PASI Score After 4 Weeks, 8 Weeks, and 12 Weeks---Evaluable Population 8 Weeks	83.3 Percentage of participants (%) Interval 51.6 to 97.9	100 Percentage of participants (%) Interval 59.0 to 100.0	85.7 Percentage of participants (%) Interval 42.1 to 99.6	88.5 Percentage of participants (%) Interval 69.8 to 97.6
Efficacy: Percentage of Subjects With a Decrease in PASI Score After 4 Weeks, 8 Weeks, and 12 Weeks---Evaluable Population 12 Weeks	75.0 Percentage of participants (%) Interval 42.8 to 94.5	100 Percentage of participants (%) Interval 59.0 to 100.0	85.7 Percentage of participants (%) Interval 42.1 to 99.6	84.6 Percentage of participants (%) Interval 65.1 to 95.6

SECONDARY outcome

Timeframe: 4 weeks

Population: Intent-to-Treat (ITT) Population: All enrolled subjects

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

Outcome measures

Outcome measures
Measure	400 mg QD n=13 Participants Belumosudil 400 mg PO QD for 12 weeks	200 mg BID n=12 Participants Belumosudil 200 mg PO BID for 12 weeks	400 mg BID n=12 Participants Belumosudil 400 mg PO BID for 12 weeks	Overall (All Subjects) n=37 Participants Belumosudil 400 mg QD + 200 mg QD + 400 mg BID for 12 weeks
Efficacy: Mean Change in PASI Score After 4 Weeks---ITT Population	-4.7 Score on a scale Interval -7.8 to -1.6	-2.6 Score on a scale Interval -5.3 to 0.0	-2.3 Score on a scale Interval -5.5 to 1.0	-3.2 Score on a scale Interval -4.8 to -1.6

SECONDARY outcome

Timeframe: 8 weeks

Population: Intent-to-Treat (ITT) Population: All enrolled subjects

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

Outcome measures

Outcome measures
Measure	400 mg QD n=12 Participants Belumosudil 400 mg PO QD for 12 weeks	200 mg BID n=9 Participants Belumosudil 200 mg PO BID for 12 weeks	400 mg BID n=7 Participants Belumosudil 400 mg PO BID for 12 weeks	Overall (All Subjects) n=28 Participants Belumosudil 400 mg QD + 200 mg QD + 400 mg BID for 12 weeks
Efficacy: Mean Change in PASI Score After 8 Weeks---ITT Population	-8.6 Score on a scale Interval -15.0 to -2.1	-6.4 Score on a scale Interval -9.6 to -3.2	-4.7 Score on a scale Interval -10.0 to 0.6	-6.9 Score on a scale Interval -9.8 to -4.0

SECONDARY outcome

Timeframe: 8 weeks

Population: Evaluable Population: Subjects who received at least 80% of the expected amount of study drug if the subject had completed the study

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

Outcome measures

Outcome measures
Measure	400 mg QD n=12 Participants Belumosudil 400 mg PO QD for 12 weeks	200 mg BID n=7 Participants Belumosudil 200 mg PO BID for 12 weeks	400 mg BID n=7 Participants Belumosudil 400 mg PO BID for 12 weeks	Overall (All Subjects) n=26 Participants Belumosudil 400 mg QD + 200 mg QD + 400 mg BID for 12 weeks
Efficacy: Mean Change in PASI Score at 4 and 8 Weeks---Evaluable Population 4 Weeks	-4.4 Score on a scale Interval -7.8 to -1.1	-3.5 Score on a scale Interval -7.2 to 0.2	-2.7 Score on a scale Interval -8.1 to 2.7	-3.7 Score on a scale Interval -5.7 to -1.7
Efficacy: Mean Change in PASI Score at 4 and 8 Weeks---Evaluable Population 8 Weeks	-8.6 Score on a scale Interval -15.0 to -2.1	-6.8 Score on a scale Interval -10.9 to -2.7	-4.7 Score on a scale Interval -10.0 to 0.6	-7.1 Score on a scale Interval -10.2 to -3.9

SECONDARY outcome

Timeframe: 4 weeks

Population: Intent-to-Treat (ITT) Population: All enrolled subjects

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

Outcome measures

Outcome measures
Measure	400 mg QD n=13 Participants Belumosudil 400 mg PO QD for 12 weeks	200 mg BID n=12 Participants Belumosudil 200 mg PO BID for 12 weeks	400 mg BID n=12 Participants Belumosudil 400 mg PO BID for 12 weeks	Overall (All Subjects) n=37 Participants Belumosudil 400 mg QD + 200 mg QD + 400 mg BID for 12 weeks
Efficacy: Percentage of Subjects With Improvement in PGA af 4 Weeks---ITT Population Clear/Excellent (75% to 100% Improvement)	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Efficacy: Percentage of Subjects With Improvement in PGA af 4 Weeks---ITT Population Good (50% to 74% Improvement)	7.7 Percentage of participants	8.3 Percentage of participants	8.3 Percentage of participants	8.1 Percentage of participants
Efficacy: Percentage of Subjects With Improvement in PGA af 4 Weeks---ITT Population Fair (25% to 49% Improvement)	46.2 Percentage of participants	58.3 Percentage of participants	41.7 Percentage of participants	48.6 Percentage of participants

SECONDARY outcome

Timeframe: 8 weeks

Population: Intent-to-Treat (ITT) Population: All enrolled subjects

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

Outcome measures

Outcome measures
Measure	400 mg QD n=12 Participants Belumosudil 400 mg PO QD for 12 weeks	200 mg BID n=9 Participants Belumosudil 200 mg PO BID for 12 weeks	400 mg BID n=7 Participants Belumosudil 400 mg PO BID for 12 weeks	Overall (All Subjects) n=28 Participants Belumosudil 400 mg QD + 200 mg QD + 400 mg BID for 12 weeks
Efficacy: Percentage of Subjects With Improvement in PGA af 8 Weeks---ITT Population Fair (25% to 49% Improvement)	25.0 Percentage of participants	88.9 Percentage of participants	42.9 Percentage of participants	50.0 Percentage of participants
Efficacy: Percentage of Subjects With Improvement in PGA af 8 Weeks---ITT Population Clear/Excellent (75% to 100% Improvement)	8.3 Percentage of participants	0 Percentage of participants	0 Percentage of participants	3.6 Percentage of participants
Efficacy: Percentage of Subjects With Improvement in PGA af 8 Weeks---ITT Population Good (50% to 74% Improvement)	25.0 Percentage of participants	11.1 Percentage of participants	14.3 Percentage of participants	17.9 Percentage of participants

SECONDARY outcome

Timeframe: 12 weeks

Population: Intent-to-Treat (ITT) Population: All enrolled subjects

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

Outcome measures

Outcome measures
Measure	400 mg QD n=12 Participants Belumosudil 400 mg PO QD for 12 weeks	200 mg BID n=12 Participants Belumosudil 200 mg PO BID for 12 weeks	400 mg BID n=11 Participants Belumosudil 400 mg PO BID for 12 weeks	Overall (All Subjects) n=35 Participants Belumosudil 400 mg QD + 200 mg QD + 400 mg BID for 12 weeks
Efficacy: Percentage of Subjects With Improvement in PGA af EOT--ITT Population Clear/Excellent (75% to 100% Improvement)	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Efficacy: Percentage of Subjects With Improvement in PGA af EOT--ITT Population Good (50% to 74% Improvement)	33.3 Percentage of participants	25.0 Percentage of participants	18.2 Percentage of participants	25.7 Percentage of participants
Efficacy: Percentage of Subjects With Improvement in PGA af EOT--ITT Population Fair (25% to 49% Improvement)	33.3 Percentage of participants	50.0 Percentage of participants	36.4 Percentage of participants	40.0 Percentage of participants

SECONDARY outcome

Timeframe: 12 weeks

Population: Evaluable Population: Subjects who received at least 80% of the expected amount of study drug if the subject had completed the study

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.

Outcome measures

Outcome measures
Measure	400 mg QD n=12 Participants Belumosudil 400 mg PO QD for 12 weeks	200 mg BID n=7 Participants Belumosudil 200 mg PO BID for 12 weeks	400 mg BID n=7 Participants Belumosudil 400 mg PO BID for 12 weeks	Overall (All Subjects) n=26 Participants Belumosudil 400 mg QD + 200 mg QD + 400 mg BID for 12 weeks
Efficacy: Percentage of Subjects With Improvement in PGA af 4, 8, and 12 Weeks---Evaluable Population 4 Weeks: Good	8.3 Percentage of participants	0 Percentage of participants	14.3 Percentage of participants	7.7 Percentage of participants
Efficacy: Percentage of Subjects With Improvement in PGA af 4, 8, and 12 Weeks---Evaluable Population 4 Weeks: Fair	41.7 Percentage of participants	85.7 Percentage of participants	42.9 Percentage of participants	53.8 Percentage of participants
Efficacy: Percentage of Subjects With Improvement in PGA af 4, 8, and 12 Weeks---Evaluable Population 8 Weeks: Clear/Excellent	8.3 Percentage of participants	0 Percentage of participants	0 Percentage of participants	3.8 Percentage of participants
Efficacy: Percentage of Subjects With Improvement in PGA af 4, 8, and 12 Weeks---Evaluable Population 8 Weeks: Good	25.0 Percentage of participants	0 Percentage of participants	14.3 Percentage of participants	15.4 Percentage of participants
Efficacy: Percentage of Subjects With Improvement in PGA af 4, 8, and 12 Weeks---Evaluable Population 8 Weeks: Fair	25.0 Percentage of participants	100 Percentage of participants	42.9 Percentage of participants	50.0 Percentage of participants
Efficacy: Percentage of Subjects With Improvement in PGA af 4, 8, and 12 Weeks---Evaluable Population 12 Weeks: Clear/Excellent	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Efficacy: Percentage of Subjects With Improvement in PGA af 4, 8, and 12 Weeks---Evaluable Population 12 Weeks: Good	33.3 Percentage of participants	14.3 Percentage of participants	28.6 Percentage of participants	26.9 Percentage of participants
Efficacy: Percentage of Subjects With Improvement in PGA af 4, 8, and 12 Weeks---Evaluable Population 12 Weeks: Fair	33.3 Percentage of participants	85.7 Percentage of participants	28.6 Percentage of participants	46.2 Percentage of participants
Efficacy: Percentage of Subjects With Improvement in PGA af 4, 8, and 12 Weeks---Evaluable Population 4 Weeks: Clear/Excellent	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants

SECONDARY outcome

Timeframe: 12 weeks

Population: Intent-to-Treat: All enrolled subjects.

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

Outcome measures

Outcome measures
Measure	400 mg QD n=12 Participants Belumosudil 400 mg PO QD for 12 weeks	200 mg BID n=12 Participants Belumosudil 200 mg PO BID for 12 weeks	400 mg BID n=11 Participants Belumosudil 400 mg PO BID for 12 weeks	Overall (All Subjects) n=35 Participants Belumosudil 400 mg QD + 200 mg QD + 400 mg BID for 12 weeks
Efficacy: Mean Changes in DLQI at EOT--ITT Population	-4.9 Score on a scale Standard Deviation 4.68	-5.1 Score on a scale Standard Deviation 5.35	-2.5 Score on a scale Standard Deviation 4.50	-4.2 Score on a scale Standard Deviation 4.86

SECONDARY outcome

Timeframe: 12 weeks

Population: Evaluable Population: Subjects who received at least 80% of the expected amount of study drug if the subject had completed the study

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.

Outcome measures

Outcome measures
Measure	400 mg QD n=12 Participants Belumosudil 400 mg PO QD for 12 weeks	200 mg BID n=7 Participants Belumosudil 200 mg PO BID for 12 weeks	400 mg BID n=7 Participants Belumosudil 400 mg PO BID for 12 weeks	Overall (All Subjects) n=26 Participants Belumosudil 400 mg QD + 200 mg QD + 400 mg BID for 12 weeks
Efficacy: Mean Changes in DLQI at 12 Weeks--Evaluable Population	-4.9 Score on a scale Standard Deviation 4.68	-6.3 Score on a scale Standard Deviation 5.82	-2.3 Score on a scale Standard Deviation 2.93	-4.6 Score on a scale Standard Deviation 4.71

SECONDARY outcome

Timeframe: 24 hours

Population: 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.

Maximum concentration (Cmax) of Parent drug (KD0250), Metabolite 1 (KD025m1), and Metabolite 2 (KD025m2)

Outcome measures

Outcome measures
Measure	400 mg QD n=7 Participants Belumosudil 400 mg PO QD for 12 weeks	200 mg BID n=6 Participants Belumosudil 200 mg PO BID for 12 weeks	400 mg BID Belumosudil 400 mg PO BID for 12 weeks	Overall (All Subjects) Belumosudil 400 mg QD + 200 mg QD + 400 mg BID for 12 weeks
Pharmacokinetics: Cmax of Parent Drug KD025, KD025m1, and KD025m2 KD025	3140 ng/mL Standard Deviation 1760	1770 ng/mL Standard Deviation 1190	—	—
Pharmacokinetics: Cmax of Parent Drug KD025, KD025m1, and KD025m2 KD025m1	23.2 ng/mL Standard Deviation 9.66	22.8 ng/mL Standard Deviation 15.3	—	—
Pharmacokinetics: Cmax of Parent Drug KD025, KD025m1, and KD025m2 KD025m2	632 ng/mL Standard Deviation 278	203 ng/mL Standard Deviation 204	—	—

SECONDARY outcome

Timeframe: 24 hours

Population: 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.

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

Outcome measures

Outcome measures
Measure	400 mg QD n=7 Participants Belumosudil 400 mg PO QD for 12 weeks	200 mg BID n=6 Participants Belumosudil 200 mg PO BID for 12 weeks	400 mg BID Belumosudil 400 mg PO BID for 12 weeks	Overall (All Subjects) Belumosudil 400 mg QD + 200 mg QD + 400 mg BID for 12 weeks
Pharmacokinetics: AUC of Parent Drug KD025, KD025m1, and KD025m2 KD025: AUC(0-12)	16200 hour*ng/mL Standard Deviation 8910	9150 hour*ng/mL Standard Deviation 5950	—	—
Pharmacokinetics: AUC of Parent Drug KD025, KD025m1, and KD025m2 KD025m2: AUC(0-12)	2300 hour*ng/mL Standard Deviation 907	757 hour*ng/mL Standard Deviation 823	—	—
Pharmacokinetics: AUC of Parent Drug KD025, KD025m1, and KD025m2 KD025: AUC(0-24)	18800 hour*ng/mL Standard Deviation 10600	21800 hour*ng/mL Standard Deviation 13900	—	—
Pharmacokinetics: AUC of Parent Drug KD025, KD025m1, and KD025m2 KD025m2: AUC(0-24)	2510 hour*ng/mL Standard Deviation 1180	1790 hour*ng/mL Standard Deviation 1850	—	—
Pharmacokinetics: AUC of Parent Drug KD025, KD025m1, and KD025m2 KD025: AUC(0-t)	18800 hour*ng/mL Standard Deviation 10600	25100 hour*ng/mL Standard Deviation 14800	—	—
Pharmacokinetics: AUC of Parent Drug KD025, KD025m1, and KD025m2 KD025m1: AUC(0-t)	93.4 hour*ng/mL Standard Deviation 18.1	250 hour*ng/mL Standard Deviation 0	—	—
Pharmacokinetics: AUC of Parent Drug KD025, KD025m1, and KD025m2 KD025m2: AUC(0-t)	2550 hour*ng/mL Standard Deviation 1080	1960 hour*ng/mL Standard Deviation 1950	—	—

SECONDARY outcome

Timeframe: 24 hours

Population: 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.

Half-life (t\[1/2\]) of Parent drug (KD025)

Outcome measures

Outcome measures
Measure	400 mg QD n=7 Participants Belumosudil 400 mg PO QD for 12 weeks	200 mg BID n=5 Participants Belumosudil 200 mg PO BID for 12 weeks	400 mg BID Belumosudil 400 mg PO BID for 12 weeks	Overall (All Subjects) Belumosudil 400 mg QD + 200 mg QD + 400 mg BID for 12 weeks
Pharmacokinetics: t(1/2) of KD025	8.00 Hours Standard Deviation 2.47	5.13 Hours Standard Deviation 1.12	—	—

SECONDARY outcome

Timeframe: 24 hours

Population: The metabolite-to-parent ratio is not applicable to parent drug KD025. Not all subjects had data for all PK parameters.

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)

Outcome measures

Outcome measures
Measure	400 mg QD n=7 Participants Belumosudil 400 mg PO QD for 12 weeks	200 mg BID n=6 Participants Belumosudil 200 mg PO BID for 12 weeks	400 mg BID Belumosudil 400 mg PO BID for 12 weeks	Overall (All Subjects) Belumosudil 400 mg QD + 200 mg QD + 400 mg BID for 12 weeks
Pharmacokinetics: MR C(Max) and MR AUC(0-t) for KD025m1 and KD025m2 KD025m2: MR C(max)	0.199 Number (ratio) Standard Deviation 0.0794	0.101 Number (ratio) Standard Deviation 0.0469	—	—
Pharmacokinetics: MR C(Max) and MR AUC(0-t) for KD025m1 and KD025m2 KD025m1: MR AUC(0-t)	0.00458 Number (ratio) Standard Deviation 0.00253	0.00577 Number (ratio) Standard Deviation 0	—	—
Pharmacokinetics: MR C(Max) and MR AUC(0-t) for KD025m1 and KD025m2 KD025m2: MR AUC(0-t)	0.133 Number (ratio) Standard Deviation 0.0449	0.0719 Number (ratio) Standard Deviation 0.0336	—	—
Pharmacokinetics: MR C(Max) and MR AUC(0-t) for KD025m1 and KD025m2 KD025m1: MR C(max)	0.00736 Number (ratio) Standard Deviation 0.00272	0.00984 Number (ratio) Standard Deviation 0.00287	—	—

Adverse Events

400 mg QD

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

200 mg BID

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

400 mg BID

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Overall (All Subjects)

Serious events: 0 serious events

Other events: 31 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Associate VP, Clinical Operations

Kadmon Corporation, LLC

Phone: 833-900-5366

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER

Other adverse events
Measure	400 mg QD n=13 participants at risk Belumosudil 400 mg PO QD for 12 weeks	200 mg BID n=13 participants at risk Belumosudil 200 mg PO BID for 12 weeks	400 mg BID n=12 participants at risk Belumosudil 400 mg PO BID for 12 weeks	Overall (All Subjects) n=38 participants at risk Belumosudil 400 mg QD + 200 mg QD + 400 mg BID for 12 weeks
Investigations Liver function test abnormal	7.7% 1/13 • Number of events 1 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	7.7% 1/13 • Number of events 3 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	8.3% 1/12 • Number of events 2 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	7.9% 3/38 • Number of events 6 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks
Investigations Transaminases increased	7.7% 1/13 • Number of events 5 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	7.7% 1/13 • Number of events 1 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	0.00% 0/12 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	5.3% 2/38 • Number of events 6 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks
Investigations Alanine aminotransaminase (ALT) increased	7.7% 1/13 • Number of events 1 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	0.00% 0/13 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	33.3% 4/12 • Number of events 4 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	13.2% 5/38 • Number of events 5 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks
Investigations Aspartate aminotransferase (AST) increased	7.7% 1/13 • Number of events 1 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	0.00% 0/13 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	16.7% 2/12 • Number of events 2 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	7.9% 3/38 • Number of events 3 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks
Gastrointestinal disorders Diarrhea	15.4% 2/13 • Number of events 2 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	0.00% 0/13 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	8.3% 1/12 • Number of events 1 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	7.9% 3/38 • Number of events 3 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks
Gastrointestinal disorders Nausea	0.00% 0/13 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	15.4% 2/13 • Number of events 2 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	8.3% 1/12 • Number of events 1 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	7.9% 3/38 • Number of events 3 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks
Gastrointestinal disorders Vomiting	7.7% 1/13 • Number of events 1 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	15.4% 2/13 • Number of events 2 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	0.00% 0/12 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	7.9% 3/38 • Number of events 3 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks
Musculoskeletal and connective tissue disorders Back pain	7.7% 1/13 • Number of events 1 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	0.00% 0/13 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	8.3% 1/12 • Number of events 1 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	5.3% 2/38 • Number of events 2 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/13 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	15.4% 2/13 • Number of events 2 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	0.00% 0/12 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	5.3% 2/38 • Number of events 2 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks
Skin and subcutaneous tissue disorders Pruritus	7.7% 1/13 • Number of events 1 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	0.00% 0/13 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	8.3% 1/12 • Number of events 1 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	5.3% 2/38 • Number of events 2 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks
Nervous system disorders Headache	7.7% 1/13 • Number of events 1 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	0.00% 0/13 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	8.3% 1/12 • Number of events 1 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	5.3% 2/38 • Number of events 2 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks
Infections and infestations Upper respiratory tract infection	0.00% 0/13 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	0.00% 0/13 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	16.7% 2/12 • Number of events 2 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	5.3% 2/38 • Number of events 2 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks
Infections and infestations Oral herpes	7.7% 1/13 • Number of events 2 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	0.00% 0/13 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	0.00% 0/12 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	2.6% 1/38 • Number of events 2 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks
Investigations Blood bilirubin increased	0.00% 0/13 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	0.00% 0/13 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	8.3% 1/12 • Number of events 1 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	2.6% 1/38 • Number of events 1 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks
Investigations Blood pressure increased	0.00% 0/13 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	7.7% 1/13 • Number of events 1 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	0.00% 0/12 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	2.6% 1/38 • Number of events 1 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks
Investigations Hepatic enzyme increased	0.00% 0/13 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	7.7% 1/13 • Number of events 1 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	0.00% 0/12 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	2.6% 1/38 • Number of events 1 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks
Infections and infestations Gastrointestinal viral infection	7.7% 1/13 • Number of events 1 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	0.00% 0/13 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	0.00% 0/12 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	2.6% 1/38 • Number of events 1 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks
Infections and infestations Nasopharyngitis	0.00% 0/13 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	0.00% 0/13 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	8.3% 1/12 • Number of events 1 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	2.6% 1/38 • Number of events 1 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks
Infections and infestations Pharyngitis streptococcal	0.00% 0/13 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	0.00% 0/13 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	8.3% 1/12 • Number of events 1 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	2.6% 1/38 • Number of events 1 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks
Infections and infestations Sinusitis	0.00% 0/13 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	0.00% 0/13 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	8.3% 1/12 • Number of events 1 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	2.6% 1/38 • Number of events 1 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks
Infections and infestations Tonsilitis	0.00% 0/13 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	7.7% 1/13 • Number of events 1 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	0.00% 0/12 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	2.6% 1/38 • Number of events 1 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks
Infections and infestations Tooth abscess	7.7% 1/13 • Number of events 1 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	0.00% 0/13 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	0.00% 0/12 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	2.6% 1/38 • Number of events 1 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks
Infections and infestations Urinary tract infection	7.7% 1/13 • Number of events 1 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	0.00% 0/13 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	0.00% 0/12 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	2.6% 1/38 • Number of events 1 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks
Infections and infestations Viral upper respiratory tract infection	7.7% 1/13 • Number of events 1 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	0.00% 0/13 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	0.00% 0/12 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	2.6% 1/38 • Number of events 1 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks
Gastrointestinal disorders Constipation	0.00% 0/13 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	7.7% 1/13 • Number of events 1 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	0.00% 0/12 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	2.6% 1/38 • Number of events 1 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks
Gastrointestinal disorders Dyspepsia	7.7% 1/13 • Number of events 1 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	0.00% 0/13 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	0.00% 0/12 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	2.6% 1/38 • Number of events 1 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks
Gastrointestinal disorders Hematochezia	7.7% 1/13 • Number of events 1 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	0.00% 0/13 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	0.00% 0/12 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	2.6% 1/38 • Number of events 1 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/13 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	0.00% 0/13 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	8.3% 1/12 • Number of events 2 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	2.6% 1/38 • Number of events 2 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks
Musculoskeletal and connective tissue disorders Joint stiffness	0.00% 0/13 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	7.7% 1/13 • Number of events 1 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	0.00% 0/12 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	2.6% 1/38 • Number of events 1 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/13 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	7.7% 1/13 • Number of events 1 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	0.00% 0/12 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	2.6% 1/38 • Number of events 1 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks
Musculoskeletal and connective tissue disorders Neck pain	7.7% 1/13 • Number of events 1 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	0.00% 0/13 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	0.00% 0/12 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	2.6% 1/38 • Number of events 1 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks
Musculoskeletal and connective tissue disorders Psoriatic arthropathy	7.7% 1/13 • Number of events 1 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	0.00% 0/13 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	0.00% 0/12 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	2.6% 1/38 • Number of events 1 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks
Respiratory, thoracic and mediastinal disorders Cough	7.7% 1/13 • Number of events 1 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	0.00% 0/13 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	0.00% 0/12 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	2.6% 1/38 • Number of events 1 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks
Respiratory, thoracic and mediastinal disorders Paransal sinus infection	7.7% 1/13 • Number of events 1 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	0.00% 0/13 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	0.00% 0/12 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	2.6% 1/38 • Number of events 1 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	7.7% 1/13 • Number of events 1 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	0.00% 0/13 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	0.00% 0/12 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	2.6% 1/38 • Number of events 1 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks
Respiratory, thoracic and mediastinal disorders Upper respiratory tract infection	7.7% 1/13 • Number of events 1 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	0.00% 0/13 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	0.00% 0/12 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	2.6% 1/38 • Number of events 1 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks
Skin and subcutaneous tissue disorders Skin burning sensation	7.7% 1/13 • Number of events 1 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	0.00% 0/13 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	0.00% 0/12 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	2.6% 1/38 • Number of events 1 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks
Skin and subcutaneous tissue disorders Skin discoloration	0.00% 0/13 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	7.7% 1/13 • Number of events 1 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	0.00% 0/12 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	2.6% 1/38 • Number of events 1 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/13 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	7.7% 1/13 • Number of events 1 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	0.00% 0/12 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	2.6% 1/38 • Number of events 1 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks
Injury, poisoning and procedural complications Hand fracture	0.00% 0/13 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	7.7% 1/13 • Number of events 1 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	0.00% 0/12 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks	2.6% 1/38 • Number of events 1 • Screening Period ≤ 4 week Screening Period + 12-week Treatment Period + 30-day Follow-up = Up to 20 weeks