Trial Outcomes & Findings for A Study to Evaluate the Effectiveness and Safety of SKI-O-703 in Patients Experiencing Active Rheumatoid Arthritis Despite Treatment With Conventional Therapies. (NCT NCT04057118)

Last Updated: 2024-07-31

Results Overview

Mean change from baseline in disease activity score for 28 joints (DAS28) using hsCRP (high sensitivity C-reactive protein). Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), and high sensitivity C-reactive protein (hsCRP) (milligrams per liter). DAS28 was calculated using following formula: DAS28-CRP=0.56\*square root (sqrt)(TJC28)+0.28\*sqrt(SJC28)+0.36\*natural log(hsCRP+1)\*1.10+1.15. High DAS28-hsCRP value indicates more severe disease activity, by value of \>5.1 indicating relatively high disease activity, whereas value of \<3.2 indicating achieved lower disease activity (no theoretical full range available).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

163 participants

Primary outcome timeframe

Baseline and Week 12

Results posted on

2024-07-31

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Placebo: Oral administration, twice per day	SKI-O-703 100 mg SKI-O-703: Oral administration, twice per day	SKI-O-703 200 mg SKI-O-703: Oral administration, twice per day	SKI-O-703 400 mg SKI-O-703: Oral administration, twice per day
Overall Study STARTED	41	41	40	41
Overall Study COMPLETED	38	39	37	36
Overall Study NOT COMPLETED	3	2	3	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Placebo: Oral administration, twice per day	SKI-O-703 100 mg SKI-O-703: Oral administration, twice per day	SKI-O-703 200 mg SKI-O-703: Oral administration, twice per day	SKI-O-703 400 mg SKI-O-703: Oral administration, twice per day
Overall Study Adverse Event	1	0	1	1
Overall Study Physician Decision	0	0	1	1
Overall Study Withdrawal by Subject	2	2	0	2
Overall Study Not Specific	0	0	1	1

Baseline Characteristics

A Study to Evaluate the Effectiveness and Safety of SKI-O-703 in Patients Experiencing Active Rheumatoid Arthritis Despite Treatment With Conventional Therapies.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=41 Participants Placebo: Oral administration, twice per day	SKI-O-703 100 mg n=41 Participants SKI-O-703: Oral administration, twice per day	SKI-O-703 200 mg n=40 Participants SKI-O-703: Oral administration, twice per day	SKI-O-703 400 mg n=41 Participants SKI-O-703: Oral administration, twice per day	Total n=163 Participants Total of all reporting groups
Age, Continuous	55.4 years STANDARD_DEVIATION 12.03 • n=5 Participants	56.8 years STANDARD_DEVIATION 10.90 • n=7 Participants	55.2 years STANDARD_DEVIATION 11.51 • n=5 Participants	52.3 years STANDARD_DEVIATION 12.80 • n=4 Participants	54.9 years STANDARD_DEVIATION 11.84 • n=21 Participants
Age, Customized Age Category · Less than 65 years old	30 Participants n=5 Participants	31 Participants n=7 Participants	31 Participants n=5 Participants	36 Participants n=4 Participants	128 Participants n=21 Participants
Age, Customized Age Category · Greater than 65 to less than 75 years old	9 Participants n=5 Participants	9 Participants n=7 Participants	9 Participants n=5 Participants	3 Participants n=4 Participants	30 Participants n=21 Participants
Age, Customized Age Category · 75 years old or greater	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	5 Participants n=21 Participants
Sex: Female, Male Female	34 Participants n=5 Participants	29 Participants n=7 Participants	32 Participants n=5 Participants	33 Participants n=4 Participants	128 Participants n=21 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	12 Participants n=7 Participants	8 Participants n=5 Participants	8 Participants n=4 Participants	35 Participants n=21 Participants
Race/Ethnicity, Customized Race · White	36 Participants n=5 Participants	41 Participants n=7 Participants	37 Participants n=5 Participants	38 Participants n=4 Participants	152 Participants n=21 Participants
Race/Ethnicity, Customized Race · Black or African-American	3 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	4 Participants n=21 Participants
Race/Ethnicity, Customized Race · Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	4 Participants n=21 Participants
Race/Ethnicity, Customized Race · American-Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized Race · 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	0 Participants n=21 Participants
Race/Ethnicity, Customized Race · Other	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Height (cm)	166.07 centimeter STANDARD_DEVIATION 5.995 • n=5 Participants	165.61 centimeter STANDARD_DEVIATION 9.003 • n=7 Participants	163.33 centimeter STANDARD_DEVIATION 7.918 • n=5 Participants	163.18 centimeter STANDARD_DEVIATION 8.098 • n=4 Participants	164.55 centimeter STANDARD_DEVIATION 7.867 • n=21 Participants
Weight (kg)	75.68 kilogram STANDARD_DEVIATION 12.590 • n=5 Participants	77.09 kilogram STANDARD_DEVIATION 16.243 • n=7 Participants	78.71 kilogram STANDARD_DEVIATION 20.177 • n=5 Participants	70.83 kilogram STANDARD_DEVIATION 13.372 • n=4 Participants	75.56 kilogram STANDARD_DEVIATION 15.973 • n=21 Participants
Body mass index (kg/m^2)	27.48 kg/m^2 STANDARD_DEVIATION 4.602 • n=5 Participants	28.04 kg/m^2 STANDARD_DEVIATION 5.076 • n=7 Participants	29.50 kg/m^2 STANDARD_DEVIATION 7.474 • n=5 Participants	26.56 kg/m^2 STANDARD_DEVIATION 4.357 • n=4 Participants	27.88 kg/m^2 STANDARD_DEVIATION 5.555 • n=21 Participants
Time since RA onset (years)	9.05 years STANDARD_DEVIATION 6.418 • n=5 Participants	6.86 years STANDARD_DEVIATION 5.587 • n=7 Participants	6.12 years STANDARD_DEVIATION 5.578 • n=5 Participants	8.83 years STANDARD_DEVIATION 7.260 • n=4 Participants	7.72 years STANDARD_DEVIATION 6.321 • n=21 Participants
Nicotine use Never a smoker or user	34 Participants n=5 Participants	32 Participants n=7 Participants	30 Participants n=5 Participants	31 Participants n=4 Participants	127 Participants n=21 Participants
Nicotine use Prior smoker or user	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants	2 Participants n=4 Participants	14 Participants n=21 Participants
Nicotine use Current smoker or user	5 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	8 Participants n=4 Participants	22 Participants n=21 Participants
Alcohol history Never a drinker	32 Participants n=5 Participants	34 Participants n=7 Participants	27 Participants n=5 Participants	31 Participants n=4 Participants	124 Participants n=21 Participants
Alcohol history Prior drinker, but no longer a drinker	2 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	9 Participants n=21 Participants
Alcohol history Current drinker	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants	8 Participants n=4 Participants	30 Participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline and Week 12

Outcome measures

Outcome measures
Measure	Placebo n=37 Participants Placebo: Oral administration, twice per day	SKI-O-703 100 mg n=36 Participants SKI-O-703: Oral administration, twice per day	SKI-O-703 200 mg n=36 Participants SKI-O-703: Oral administration, twice per day	SKI-O-703 400 mg n=36 Participants SKI-O-703: Oral administration, twice per day
Change in Disease Activity Score	-0.95 score on a scale Standard Error 0.152	-0.91 score on a scale Standard Error 0.155	-1.06 score on a scale Standard Error 0.155	-1.15 score on a scale Standard Error 0.155

SECONDARY outcome

Timeframe: Baseline and Weeks 2, 4 8 and 12

Population: The number analyzed in some rows decreased as weeks increased, as some patients withdrew from the study or had missing data.

ACR20 score is the percentage of patients showing ≥20% improvement from baseline in tender joint count (68 joint counts), ≥20% improvement in swollen joint count (66 joint counts), and ≥20% improvement in at least 3 of the following: patient's global assessment of arthritis pain; patient's global assessment of disease activity; physician's global assessment of disease activity; health assessment questionnaire-disability index (HAQ-DI); hsCRP (high sensitivity C-reactive protein)

Outcome measures

Outcome measures
Measure	Placebo n=27 Participants Placebo: Oral administration, twice per day	SKI-O-703 100 mg n=29 Participants SKI-O-703: Oral administration, twice per day	SKI-O-703 200 mg n=28 Participants SKI-O-703: Oral administration, twice per day	SKI-O-703 400 mg n=24 Participants SKI-O-703: Oral administration, twice per day
• Percentage of Patients With ACR20 (American College of Rheumatology 20) Score Week 2	2 Participants	3 Participants	5 Participants	5 Participants
• Percentage of Patients With ACR20 (American College of Rheumatology 20) Score Week 4	7 Participants	4 Participants	6 Participants	9 Participants
• Percentage of Patients With ACR20 (American College of Rheumatology 20) Score Week 8	10 Participants	9 Participants	9 Participants	7 Participants
• Percentage of Patients With ACR20 (American College of Rheumatology 20) Score Week 12	12 Participants	9 Participants	14 Participants	9 Participants

SECONDARY outcome

Timeframe: Baseline and Weeks 2, 4 8 and 12

Population: The number analyzed in some rows decreased as weeks increased, as some patients withdrew from the study or had missing data.

ACR50 score is the percentage of patients showing ≥50% improvement from baseline in tender joint count (68 joint counts), ≥50% improvement in swollen joint count (66 joint counts), and ≥50% improvement in at least 3 of the following: patient's global assessment of arthritis pain; patient's global assessment of disease activity; physician's global assessment of disease activity; health assessment questionnaire-disability index (HAQ-DI); hsCRP (high sensitivity C-reactive protein)

Outcome measures

Outcome measures
Measure	Placebo n=27 Participants Placebo: Oral administration, twice per day	SKI-O-703 100 mg n=29 Participants SKI-O-703: Oral administration, twice per day	SKI-O-703 200 mg n=28 Participants SKI-O-703: Oral administration, twice per day	SKI-O-703 400 mg n=24 Participants SKI-O-703: Oral administration, twice per day
• Percentage of Patients With ACR50 (American College of Rheumatology 50) Score Week 2	0 Participants	0 Participants	0 Participants	2 Participants
• Percentage of Patients With ACR50 (American College of Rheumatology 50) Score Week 4	2 Participants	2 Participants	1 Participants	6 Participants
• Percentage of Patients With ACR50 (American College of Rheumatology 50) Score Week 8	3 Participants	4 Participants	4 Participants	5 Participants
• Percentage of Patients With ACR50 (American College of Rheumatology 50) Score Week 12	4 Participants	4 Participants	6 Participants	5 Participants

SECONDARY outcome

Timeframe: Baseline and Weeks 2, 4 8 and 12

Population: The number analyzed in some rows decreased as weeks increased, as some patients withdrew from the study or had missing data.

ACR70 score is the percentage of patients showing ≥70% improvement from baseline in tender joint count (68 joint counts), ≥70% improvement in swollen joint count (66 joint counts), and ≥70% improvement in at least 3 of the following: patient's global assessment of arthritis pain; patient's global assessment of disease activity; physician's global assessment of disease activity; health assessment questionnaire-disability index (HAQ-DI); hsCRP (high sensitivity C-reactive protein)

Outcome measures

Outcome measures
Measure	Placebo n=27 Participants Placebo: Oral administration, twice per day	SKI-O-703 100 mg n=29 Participants SKI-O-703: Oral administration, twice per day	SKI-O-703 200 mg n=28 Participants SKI-O-703: Oral administration, twice per day	SKI-O-703 400 mg n=24 Participants SKI-O-703: Oral administration, twice per day
• Percentage of Patients With ACR70 (American College of Rheumatology 70) Score Week 2	0 Participants	0 Participants	0 Participants	1 Participants
• Percentage of Patients With ACR70 (American College of Rheumatology 70) Score Week 4	0 Participants	0 Participants	0 Participants	1 Participants
• Percentage of Patients With ACR70 (American College of Rheumatology 70) Score Week 8	0 Participants	0 Participants	2 Participants	3 Participants
• Percentage of Patients With ACR70 (American College of Rheumatology 70) Score Week 12	1 Participants	0 Participants	3 Participants	3 Participants

SECONDARY outcome

Timeframe: Baseline and Weeks 2, 4 8 and 12

Population: The number analyzed in some rows decreased as weeks increased, as some patients withdrew from the study or had missing data.

Change from baseline measured by disability index The Health Assessment Questionnaire-Disability Index (HAQ-DI) is a subject-reported questionnaire that is commonly used to measure the disease associated disability. It consists of 8 sections which are dressing or grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, ranging from 0 (no disability) to 3 (worst disability), higher score showing more disability. A decrease in HAQ-DI score indicated an improvement in the participant's condition.

Outcome measures

Outcome measures
Measure	Placebo n=41 Participants Placebo: Oral administration, twice per day	SKI-O-703 100 mg n=41 Participants SKI-O-703: Oral administration, twice per day	SKI-O-703 200 mg n=40 Participants SKI-O-703: Oral administration, twice per day	SKI-O-703 400 mg n=41 Participants SKI-O-703: Oral administration, twice per day
Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Change from Baseline at Week 4	-0.2179 score on a scale Standard Deviation 0.3228	-0.2906 score on a scale Standard Deviation 0.3494	-0.2895 score on a scale Standard Deviation 0.2979	-0.3718 score on a scale Standard Deviation 0.4646
Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Change from Baseline at Week 8	-0.3816 score on a scale Standard Deviation 0.4171	-0.3781 score on a scale Standard Deviation 0.3968	-0.3311 score on a scale Standard Deviation 0.4362	-0.4306 score on a scale Standard Deviation 0.5040
Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Change from Baseline at Week 12	-0.4459 score on a scale Standard Deviation 0.4765	-0.5208 score on a scale Standard Deviation 0.4758	-0.4444 score on a scale Standard Deviation 0.5040	-0.4514 score on a scale Standard Deviation 0.5246
Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Change from Baseline at Week 2	-0.0969 score on a scale Standard Deviation 0.3171	-0.1375 score on a scale Standard Deviation 0.2953	-0.2340 score on a scale Standard Deviation 0.3037	-0.3397 score on a scale Standard Deviation 0.4035

SECONDARY outcome

Timeframe: Up to Week 16

Outcome measures

Outcome measures
Measure	Placebo n=41 Participants Placebo: Oral administration, twice per day	SKI-O-703 100 mg n=41 Participants SKI-O-703: Oral administration, twice per day	SKI-O-703 200 mg n=40 Participants SKI-O-703: Oral administration, twice per day	SKI-O-703 400 mg n=41 Participants SKI-O-703: Oral administration, twice per day
Adverse Events (AEs) Participants with any Treatment Emergent Adverse Event (TEAE)	19 Participants	16 Participants	23 Participants	25 Participants
Adverse Events (AEs) Participants with any treatment-related TEAE	8 Participants	4 Participants	12 Participants	14 Participants

SECONDARY outcome

Timeframe: Up to Week 16

Outcome measures

Outcome measures
Measure	Placebo n=41 Participants Placebo: Oral administration, twice per day	SKI-O-703 100 mg n=41 Participants SKI-O-703: Oral administration, twice per day	SKI-O-703 200 mg n=40 Participants SKI-O-703: Oral administration, twice per day	SKI-O-703 400 mg n=41 Participants SKI-O-703: Oral administration, twice per day
Serious Adverse Events (SAEs) Participants with any treatment-emergent SAE	1 Participants	1 Participants	0 Participants	1 Participants
Serious Adverse Events (SAEs) Participants with any treatment-related, treatment-emergent SAE	0 Participants	0 Participants	0 Participants	0 Participants

Adverse Events

Placebo

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

SKI-O-703 100 mg

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

SKI-O-703 200 mg

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

SKI-O-703 400 mg

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=41 participants at risk Placebo: Oral administration, twice per day	SKI-O-703 100 mg n=41 participants at risk SKI-O-703: Oral administration, twice per day	SKI-O-703 200 mg n=40 participants at risk SKI-O-703: Oral administration, twice per day	SKI-O-703 400 mg n=41 participants at risk SKI-O-703: Oral administration, twice per day
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.00% 0/41 • 16 weeks At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. They were also asked if they had been hospitalized or had any accidents. In addition to subject observations, AEs identified from any study data (eg, laboratory values, physical examination findings, ECG changes) or identified from review of other documents that were relevant to subject safety were documented.	0.00% 0/41 • 16 weeks At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. They were also asked if they had been hospitalized or had any accidents. In addition to subject observations, AEs identified from any study data (eg, laboratory values, physical examination findings, ECG changes) or identified from review of other documents that were relevant to subject safety were documented.	0.00% 0/40 • 16 weeks At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. They were also asked if they had been hospitalized or had any accidents. In addition to subject observations, AEs identified from any study data (eg, laboratory values, physical examination findings, ECG changes) or identified from review of other documents that were relevant to subject safety were documented.	2.4% 1/41 • 16 weeks At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. They were also asked if they had been hospitalized or had any accidents. In addition to subject observations, AEs identified from any study data (eg, laboratory values, physical examination findings, ECG changes) or identified from review of other documents that were relevant to subject safety were documented.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial adenocarcinoma	0.00% 0/41 • 16 weeks At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. They were also asked if they had been hospitalized or had any accidents. In addition to subject observations, AEs identified from any study data (eg, laboratory values, physical examination findings, ECG changes) or identified from review of other documents that were relevant to subject safety were documented.	2.4% 1/41 • 16 weeks At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. They were also asked if they had been hospitalized or had any accidents. In addition to subject observations, AEs identified from any study data (eg, laboratory values, physical examination findings, ECG changes) or identified from review of other documents that were relevant to subject safety were documented.	0.00% 0/40 • 16 weeks At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. They were also asked if they had been hospitalized or had any accidents. In addition to subject observations, AEs identified from any study data (eg, laboratory values, physical examination findings, ECG changes) or identified from review of other documents that were relevant to subject safety were documented.	0.00% 0/41 • 16 weeks At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. They were also asked if they had been hospitalized or had any accidents. In addition to subject observations, AEs identified from any study data (eg, laboratory values, physical examination findings, ECG changes) or identified from review of other documents that were relevant to subject safety were documented.
Cardiac disorders Myocarditis	2.4% 1/41 • 16 weeks At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. They were also asked if they had been hospitalized or had any accidents. In addition to subject observations, AEs identified from any study data (eg, laboratory values, physical examination findings, ECG changes) or identified from review of other documents that were relevant to subject safety were documented.	0.00% 0/41 • 16 weeks At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. They were also asked if they had been hospitalized or had any accidents. In addition to subject observations, AEs identified from any study data (eg, laboratory values, physical examination findings, ECG changes) or identified from review of other documents that were relevant to subject safety were documented.	0.00% 0/40 • 16 weeks At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. They were also asked if they had been hospitalized or had any accidents. In addition to subject observations, AEs identified from any study data (eg, laboratory values, physical examination findings, ECG changes) or identified from review of other documents that were relevant to subject safety were documented.	0.00% 0/41 • 16 weeks At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. They were also asked if they had been hospitalized or had any accidents. In addition to subject observations, AEs identified from any study data (eg, laboratory values, physical examination findings, ECG changes) or identified from review of other documents that were relevant to subject safety were documented.
Infections and infestations Pneumonia viral	2.4% 1/41 • 16 weeks At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. They were also asked if they had been hospitalized or had any accidents. In addition to subject observations, AEs identified from any study data (eg, laboratory values, physical examination findings, ECG changes) or identified from review of other documents that were relevant to subject safety were documented.	0.00% 0/41 • 16 weeks At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. They were also asked if they had been hospitalized or had any accidents. In addition to subject observations, AEs identified from any study data (eg, laboratory values, physical examination findings, ECG changes) or identified from review of other documents that were relevant to subject safety were documented.	0.00% 0/40 • 16 weeks At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. They were also asked if they had been hospitalized or had any accidents. In addition to subject observations, AEs identified from any study data (eg, laboratory values, physical examination findings, ECG changes) or identified from review of other documents that were relevant to subject safety were documented.	0.00% 0/41 • 16 weeks At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. They were also asked if they had been hospitalized or had any accidents. In addition to subject observations, AEs identified from any study data (eg, laboratory values, physical examination findings, ECG changes) or identified from review of other documents that were relevant to subject safety were documented.

Other adverse events

Other adverse events
Measure	Placebo n=41 participants at risk Placebo: Oral administration, twice per day	SKI-O-703 100 mg n=41 participants at risk SKI-O-703: Oral administration, twice per day	SKI-O-703 200 mg n=40 participants at risk SKI-O-703: Oral administration, twice per day	SKI-O-703 400 mg n=41 participants at risk SKI-O-703: Oral administration, twice per day
Investigations Alanine aminotransferase increased	0.00% 0/41 • 16 weeks At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. They were also asked if they had been hospitalized or had any accidents. In addition to subject observations, AEs identified from any study data (eg, laboratory values, physical examination findings, ECG changes) or identified from review of other documents that were relevant to subject safety were documented.	4.9% 2/41 • 16 weeks At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. They were also asked if they had been hospitalized or had any accidents. In addition to subject observations, AEs identified from any study data (eg, laboratory values, physical examination findings, ECG changes) or identified from review of other documents that were relevant to subject safety were documented.	0.00% 0/40 • 16 weeks At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. They were also asked if they had been hospitalized or had any accidents. In addition to subject observations, AEs identified from any study data (eg, laboratory values, physical examination findings, ECG changes) or identified from review of other documents that were relevant to subject safety were documented.	9.8% 4/41 • 16 weeks At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. They were also asked if they had been hospitalized or had any accidents. In addition to subject observations, AEs identified from any study data (eg, laboratory values, physical examination findings, ECG changes) or identified from review of other documents that were relevant to subject safety were documented.
Investigations Aspartate aminotransferase increased	0.00% 0/41 • 16 weeks At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. They were also asked if they had been hospitalized or had any accidents. In addition to subject observations, AEs identified from any study data (eg, laboratory values, physical examination findings, ECG changes) or identified from review of other documents that were relevant to subject safety were documented.	2.4% 1/41 • 16 weeks At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. They were also asked if they had been hospitalized or had any accidents. In addition to subject observations, AEs identified from any study data (eg, laboratory values, physical examination findings, ECG changes) or identified from review of other documents that were relevant to subject safety were documented.	0.00% 0/40 • 16 weeks At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. They were also asked if they had been hospitalized or had any accidents. In addition to subject observations, AEs identified from any study data (eg, laboratory values, physical examination findings, ECG changes) or identified from review of other documents that were relevant to subject safety were documented.	7.3% 3/41 • 16 weeks At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. They were also asked if they had been hospitalized or had any accidents. In addition to subject observations, AEs identified from any study data (eg, laboratory values, physical examination findings, ECG changes) or identified from review of other documents that were relevant to subject safety were documented.
Nervous system disorders Headache	4.9% 2/41 • 16 weeks At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. They were also asked if they had been hospitalized or had any accidents. In addition to subject observations, AEs identified from any study data (eg, laboratory values, physical examination findings, ECG changes) or identified from review of other documents that were relevant to subject safety were documented.	2.4% 1/41 • 16 weeks At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. They were also asked if they had been hospitalized or had any accidents. In addition to subject observations, AEs identified from any study data (eg, laboratory values, physical examination findings, ECG changes) or identified from review of other documents that were relevant to subject safety were documented.	15.0% 6/40 • 16 weeks At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. They were also asked if they had been hospitalized or had any accidents. In addition to subject observations, AEs identified from any study data (eg, laboratory values, physical examination findings, ECG changes) or identified from review of other documents that were relevant to subject safety were documented.	14.6% 6/41 • 16 weeks At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. They were also asked if they had been hospitalized or had any accidents. In addition to subject observations, AEs identified from any study data (eg, laboratory values, physical examination findings, ECG changes) or identified from review of other documents that were relevant to subject safety were documented.
Gastrointestinal disorders Nausea	4.9% 2/41 • 16 weeks At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. They were also asked if they had been hospitalized or had any accidents. In addition to subject observations, AEs identified from any study data (eg, laboratory values, physical examination findings, ECG changes) or identified from review of other documents that were relevant to subject safety were documented.	0.00% 0/41 • 16 weeks At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. They were also asked if they had been hospitalized or had any accidents. In addition to subject observations, AEs identified from any study data (eg, laboratory values, physical examination findings, ECG changes) or identified from review of other documents that were relevant to subject safety were documented.	7.5% 3/40 • 16 weeks At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. They were also asked if they had been hospitalized or had any accidents. In addition to subject observations, AEs identified from any study data (eg, laboratory values, physical examination findings, ECG changes) or identified from review of other documents that were relevant to subject safety were documented.	4.9% 2/41 • 16 weeks At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. They were also asked if they had been hospitalized or had any accidents. In addition to subject observations, AEs identified from any study data (eg, laboratory values, physical examination findings, ECG changes) or identified from review of other documents that were relevant to subject safety were documented.
Gastrointestinal disorders Constipation	9.8% 4/41 • 16 weeks At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. They were also asked if they had been hospitalized or had any accidents. In addition to subject observations, AEs identified from any study data (eg, laboratory values, physical examination findings, ECG changes) or identified from review of other documents that were relevant to subject safety were documented.	7.3% 3/41 • 16 weeks At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. They were also asked if they had been hospitalized or had any accidents. In addition to subject observations, AEs identified from any study data (eg, laboratory values, physical examination findings, ECG changes) or identified from review of other documents that were relevant to subject safety were documented.	0.00% 0/40 • 16 weeks At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. They were also asked if they had been hospitalized or had any accidents. In addition to subject observations, AEs identified from any study data (eg, laboratory values, physical examination findings, ECG changes) or identified from review of other documents that were relevant to subject safety were documented.	2.4% 1/41 • 16 weeks At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. They were also asked if they had been hospitalized or had any accidents. In addition to subject observations, AEs identified from any study data (eg, laboratory values, physical examination findings, ECG changes) or identified from review of other documents that were relevant to subject safety were documented.
Gastrointestinal disorders Dyspepsia	0.00% 0/41 • 16 weeks At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. They were also asked if they had been hospitalized or had any accidents. In addition to subject observations, AEs identified from any study data (eg, laboratory values, physical examination findings, ECG changes) or identified from review of other documents that were relevant to subject safety were documented.	0.00% 0/41 • 16 weeks At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. They were also asked if they had been hospitalized or had any accidents. In addition to subject observations, AEs identified from any study data (eg, laboratory values, physical examination findings, ECG changes) or identified from review of other documents that were relevant to subject safety were documented.	7.5% 3/40 • 16 weeks At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. They were also asked if they had been hospitalized or had any accidents. In addition to subject observations, AEs identified from any study data (eg, laboratory values, physical examination findings, ECG changes) or identified from review of other documents that were relevant to subject safety were documented.	0.00% 0/41 • 16 weeks At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. They were also asked if they had been hospitalized or had any accidents. In addition to subject observations, AEs identified from any study data (eg, laboratory values, physical examination findings, ECG changes) or identified from review of other documents that were relevant to subject safety were documented.

Additional Information

Sungsil Lee/Team Leader of Clinical Development

Oscotec Inc.

Phone: +82316287624

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER