Colitis, Ulcerative
Conditions
Keywords
OPC-6535, ulcerative colitis
Brief summary
The purpose of this study is to examine the safety and efficacy of OPC-6535 (tetomilast) and to determine its optimal dose by once-daily oral administration at 0, 12.5, 25, or 50 mg for 8 weeks in combination with a fixed oral dose of 5-aminosalicylic acid (5-ASA) in patients with active ulcerative colitis.
Interventions
Sponsors
Otsuka Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients with active ulcerative colitis * Patients who have been receiving an oral 5-ASA formulation at a fixed regimen and at a fixed dose * Either inpatient or outpatient
Exclusion criteria
* Patients who have a history of intestinal resection (other than appendiceal resection) * Patients who have a complication of malignant tumor * Female patients who are pregnant, lactating, or possibly pregnant, or who wish to become pregnant during the study period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Improvement Rate (Number of Subjects Showing Clinical Improvement/Number of Subjects Evaluated x 100) After 8 Weeks of Study Drug Administration | Weeks 4 and 8 | Definition of clinical improvement: Disease Activity Index (DAI) subscore for rectal bleeding improved to 0 or 1 and DAI subscore for mucosal appearance improved by at least 1 point from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From the Baseline in Total DAI Score After 4 and 8 Weeks of Study Drug Administration | Baseline, Weeks 4 and 8 | DAI measures disease activity through assessment of 4 items/subscales: stool frequency, rectal bleeding, mucosal appearance at endoscopy, and physician's rating of disease activity. Each item of the score is assessed on a 4-point scale from 0 to 3; the total score ranges from 0 to 12 with a higher score representing greater severity. A negative change in mean score indicates improvement. |
| Mean Change From the Baseline in DAI Subscores After 4 and 8 Weeks of Study Drug Administration | Baseline, Weeks 4 and 8 | DAI measures disease activity through assessment of 4 items/subscales: stool frequency, rectal bleeding, mucosal appearance at endoscopy, and physician's rating of disease activity. Each item of the score is assessed on a 4-point scale from 0 to 3 with a higher score representing greater severity. A negative change in mean score indicates improvement. |
| Mean Change From the Baseline in Total Clinical Activity Index (CAI) Score After 2, 4, and 8 Weeks of Study Drug Administration | Baseline, Weeks 2, 4 and 8 | CAI composed of 7 variables: number of stool weekly, blood in stools (weekly average), investigator's global assessment of symptomatic state, abdominal pain/cramps, temperature due to colitis, extraintestinal manifestations, and laboratory findings. The scores ranging from 0 to 29 points (higher scores meaning more severe disease). |
| Remission Rate (Number of Subjects Showing Remission/Number of Subjects Evaluated x 100) After 4 and 8 Weeks of Study Drug Administration | Weeks 4 and 8 | Definition of remission: DAI subscores for both rectal bleeding and mucosal appearance improved to 0 |
| Mean Change From the Baseline in IBDQ Subscale Scores After 8 Weeks of Study Drug Administration | Baseline and Week 8 | The IBDQ has been frequently adopted in Japanese and overseas clinical assessments as a scale for evaluating the quality of life (QOL) of subjects with inflammatory bowel disease. The IBDQ includes 32 items, which are divided into four subscales: bowel symptoms, systemic symptoms, emotional function and social function, and each item is scored on a 7-point scale, ranging from 1 (worst) to 7 (best). Total IBDQ score ranges from 32 to 224 with a higher score indicating a better QOL. |
| Clinical Improvement Rate After 4 Weeks of Study Drug Administration | Week 4 | Definition of clinical improvement: DAI subscore for rectal bleeding improved to 0 or 1 and DAI subscore for mucosal appearance improved by at least 1 point from baseline |
| Mean Change From the Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score After 8 Weeks of Study Drug Administration | Baseline and Week 8 | The IBDQ has been frequently adopted in Japanese and overseas clinical assessments as a scale for evaluating the quality of life (QOL) of subjects with inflammatory bowel disease. The IBDQ score was calculated as the sum of the responses (each ranging from 1 to 7) to all 32 questions that address symptoms as a result of Crohn's disease: bowel symptoms, systemic symptoms, emotional function, and social function. Total IBDQ score ranges from 32 to 224 with a higher score indicating a better QOL. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| OPC-6535 12.5 mg 12.5 mg OPC-6535 orally administered once daily in the morning for 8 weeks. | 11 |
| OPC-6535 25 mg 25 mg OPC-6535 orally administered once daily in the morning for 8 weeks. | 11 |
| OPC-6535 50 mg 25 mg OPC-6535 orally administered for the first week and then the dose was increased to 50 mg for the following 7 weeks. | 10 |
| Placebo 0 mg OPC-6535 orally administered once daily in the morning for 8 weeks. | 11 |
| Total | 43 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 | 0 |
| Overall Study | Lack of Efficacy | 1 | 1 | 0 | 3 |
| Overall Study | Physician Decision | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | OPC-6535 12.5 mg | OPC-6535 25 mg | OPC-6535 50 mg | Placebo | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants | 11 Participants | 10 Participants | 10 Participants | 42 Participants |
| Race/Ethnicity, Customized Japanese | 11 Participants | 11 Participants | 10 Participants | 11 Participants | 43 Participants |
| Region of Enrollment Japan | 11 Participants | 11 Participants | 10 Participants | 11 Participants | 43 Participants |
| Sex: Female, Male Female | 5 Participants | 6 Participants | 3 Participants | 5 Participants | 19 Participants |
| Sex: Female, Male Male | 6 Participants | 5 Participants | 7 Participants | 6 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 11 | 0 / 10 | 0 / 11 |
| other Total, other adverse events | 6 / 11 | 7 / 11 | 7 / 10 | 8 / 11 |
| serious Total, serious adverse events | 0 / 11 | 2 / 11 | 2 / 10 | 1 / 11 |
Outcome results
Primary
Clinical Improvement Rate (Number of Subjects Showing Clinical Improvement/Number of Subjects Evaluated x 100) After 8 Weeks of Study Drug Administration
Definition of clinical improvement: Disease Activity Index (DAI) subscore for rectal bleeding improved to 0 or 1 and DAI subscore for mucosal appearance improved by at least 1 point from baseline
Time frame: Weeks 4 and 8
Population: Efficacy was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the efficacy endpoints.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| OPC-6535 12.5 mg | Clinical Improvement Rate (Number of Subjects Showing Clinical Improvement/Number of Subjects Evaluated x 100) After 8 Weeks of Study Drug Administration | 27.3 percentage of participants |
| OPC-6535 25 mg | Clinical Improvement Rate (Number of Subjects Showing Clinical Improvement/Number of Subjects Evaluated x 100) After 8 Weeks of Study Drug Administration | 30.0 percentage of participants |
| OPC-6535 50 mg | Clinical Improvement Rate (Number of Subjects Showing Clinical Improvement/Number of Subjects Evaluated x 100) After 8 Weeks of Study Drug Administration | 50.0 percentage of participants |
| Placebo | Clinical Improvement Rate (Number of Subjects Showing Clinical Improvement/Number of Subjects Evaluated x 100) After 8 Weeks of Study Drug Administration | 9.1 percentage of participants |
Secondary
Clinical Improvement Rate After 4 Weeks of Study Drug Administration
Definition of clinical improvement: DAI subscore for rectal bleeding improved to 0 or 1 and DAI subscore for mucosal appearance improved by at least 1 point from baseline
Time frame: Week 4
Population: Efficacy was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the efficacy endpoints.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| OPC-6535 12.5 mg | Clinical Improvement Rate After 4 Weeks of Study Drug Administration | 12.5 percentage of participants |
| OPC-6535 25 mg | Clinical Improvement Rate After 4 Weeks of Study Drug Administration | 20.0 percentage of participants |
| OPC-6535 50 mg | Clinical Improvement Rate After 4 Weeks of Study Drug Administration | 14.3 percentage of participants |
| Placebo | Clinical Improvement Rate After 4 Weeks of Study Drug Administration | 10.0 percentage of participants |
Secondary
Mean Change From the Baseline in DAI Subscores After 4 and 8 Weeks of Study Drug Administration
DAI measures disease activity through assessment of 4 items/subscales: stool frequency, rectal bleeding, mucosal appearance at endoscopy, and physician's rating of disease activity. Each item of the score is assessed on a 4-point scale from 0 to 3 with a higher score representing greater severity. A negative change in mean score indicates improvement.
Time frame: Baseline, Weeks 4 and 8
Population: Efficacy was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the efficacy endpoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OPC-6535 12.5 mg | Mean Change From the Baseline in DAI Subscores After 4 and 8 Weeks of Study Drug Administration | Rectal bleeding at Week 8 | -0.7 score on a scale | Standard Deviation 0.9 |
| OPC-6535 12.5 mg | Mean Change From the Baseline in DAI Subscores After 4 and 8 Weeks of Study Drug Administration | Physician's rating of disease activity at Week 4 | -0.5 score on a scale | Standard Deviation 0.7 |
| OPC-6535 12.5 mg | Mean Change From the Baseline in DAI Subscores After 4 and 8 Weeks of Study Drug Administration | Rectal bleeding at Week 4 | -0.6 score on a scale | Standard Deviation 0.8 |
| OPC-6535 12.5 mg | Mean Change From the Baseline in DAI Subscores After 4 and 8 Weeks of Study Drug Administration | Mucosal appearance at Week 4 | -0.5 score on a scale | Standard Deviation 0.6 |
| OPC-6535 12.5 mg | Mean Change From the Baseline in DAI Subscores After 4 and 8 Weeks of Study Drug Administration | Physician's rating of disease activity at Week 8 | -0.5 score on a scale | Standard Deviation 0.5 |
| OPC-6535 12.5 mg | Mean Change From the Baseline in DAI Subscores After 4 and 8 Weeks of Study Drug Administration | Stool frequency at Week 8 | -0.5 score on a scale | Standard Deviation 1.1 |
| OPC-6535 12.5 mg | Mean Change From the Baseline in DAI Subscores After 4 and 8 Weeks of Study Drug Administration | Stool frequency at Week 4 | -0.4 score on a scale | Standard Deviation 1 |
| OPC-6535 12.5 mg | Mean Change From the Baseline in DAI Subscores After 4 and 8 Weeks of Study Drug Administration | Mucosal appearance at Week 8 | -0.7 score on a scale | Standard Deviation 0.7 |
| OPC-6535 25 mg | Mean Change From the Baseline in DAI Subscores After 4 and 8 Weeks of Study Drug Administration | Mucosal appearance at Week 4 | -0.3 score on a scale | Standard Deviation 0.6 |
| OPC-6535 25 mg | Mean Change From the Baseline in DAI Subscores After 4 and 8 Weeks of Study Drug Administration | Physician's rating of disease activity at Week 4 | -0.7 score on a scale | Standard Deviation 1 |
| OPC-6535 25 mg | Mean Change From the Baseline in DAI Subscores After 4 and 8 Weeks of Study Drug Administration | Physician's rating of disease activity at Week 8 | -0.5 score on a scale | Standard Deviation 0.9 |
| OPC-6535 25 mg | Mean Change From the Baseline in DAI Subscores After 4 and 8 Weeks of Study Drug Administration | Rectal bleeding at Week 8 | -0.9 score on a scale | Standard Deviation 1.1 |
| OPC-6535 25 mg | Mean Change From the Baseline in DAI Subscores After 4 and 8 Weeks of Study Drug Administration | Mucosal appearance at Week 8 | -0.5 score on a scale | Standard Deviation 0.7 |
| OPC-6535 25 mg | Mean Change From the Baseline in DAI Subscores After 4 and 8 Weeks of Study Drug Administration | Rectal bleeding at Week 4 | -1.0 score on a scale | Standard Deviation 1.1 |
| OPC-6535 25 mg | Mean Change From the Baseline in DAI Subscores After 4 and 8 Weeks of Study Drug Administration | Stool frequency at Week 4 | -0.8 score on a scale | Standard Deviation 1.2 |
| OPC-6535 25 mg | Mean Change From the Baseline in DAI Subscores After 4 and 8 Weeks of Study Drug Administration | Stool frequency at Week 8 | -0.3 score on a scale | Standard Deviation 1.3 |
| OPC-6535 50 mg | Mean Change From the Baseline in DAI Subscores After 4 and 8 Weeks of Study Drug Administration | Stool frequency at Week 4 | -0.8 score on a scale | Standard Deviation 0.8 |
| OPC-6535 50 mg | Mean Change From the Baseline in DAI Subscores After 4 and 8 Weeks of Study Drug Administration | Physician's rating of disease activity at Week 8 | -1.0 score on a scale | Standard Deviation 0.7 |
| OPC-6535 50 mg | Mean Change From the Baseline in DAI Subscores After 4 and 8 Weeks of Study Drug Administration | Stool frequency at Week 8 | -0.6 score on a scale | Standard Deviation 0.7 |
| OPC-6535 50 mg | Mean Change From the Baseline in DAI Subscores After 4 and 8 Weeks of Study Drug Administration | Rectal bleeding at Week 4 | -0.9 score on a scale | Standard Deviation 0.7 |
| OPC-6535 50 mg | Mean Change From the Baseline in DAI Subscores After 4 and 8 Weeks of Study Drug Administration | Rectal bleeding at Week 8 | -1.1 score on a scale | Standard Deviation 0.9 |
| OPC-6535 50 mg | Mean Change From the Baseline in DAI Subscores After 4 and 8 Weeks of Study Drug Administration | Mucosal appearance at Week 4 | -1.0 score on a scale | — |
| OPC-6535 50 mg | Mean Change From the Baseline in DAI Subscores After 4 and 8 Weeks of Study Drug Administration | Physician's rating of disease activity at Week 4 | -0.9 score on a scale | Standard Deviation 0.7 |
| OPC-6535 50 mg | Mean Change From the Baseline in DAI Subscores After 4 and 8 Weeks of Study Drug Administration | Mucosal appearance at Week 8 | -0.8 score on a scale | Standard Deviation 0.7 |
| Placebo | Mean Change From the Baseline in DAI Subscores After 4 and 8 Weeks of Study Drug Administration | Physician's rating of disease activity at Week 8 | -0.2 score on a scale | Standard Deviation 0.8 |
| Placebo | Mean Change From the Baseline in DAI Subscores After 4 and 8 Weeks of Study Drug Administration | Mucosal appearance at Week 4 | -0.7 score on a scale | Standard Deviation 1.2 |
| Placebo | Mean Change From the Baseline in DAI Subscores After 4 and 8 Weeks of Study Drug Administration | Rectal bleeding at Week 4 | -0.4 score on a scale | Standard Deviation 0.7 |
| Placebo | Mean Change From the Baseline in DAI Subscores After 4 and 8 Weeks of Study Drug Administration | Rectal bleeding at Week 8 | -0.5 score on a scale | Standard Deviation 0.7 |
| Placebo | Mean Change From the Baseline in DAI Subscores After 4 and 8 Weeks of Study Drug Administration | Mucosal appearance at Week 8 | -0.3 score on a scale | Standard Deviation 0.7 |
| Placebo | Mean Change From the Baseline in DAI Subscores After 4 and 8 Weeks of Study Drug Administration | Stool frequency at Week 4 | -0.4 score on a scale | Standard Deviation 0.7 |
| Placebo | Mean Change From the Baseline in DAI Subscores After 4 and 8 Weeks of Study Drug Administration | Stool frequency at Week 8 | -0.4 score on a scale | Standard Deviation 0.8 |
| Placebo | Mean Change From the Baseline in DAI Subscores After 4 and 8 Weeks of Study Drug Administration | Physician's rating of disease activity at Week 4 | -0.4 score on a scale | Standard Deviation 0.7 |
Secondary
Mean Change From the Baseline in IBDQ Subscale Scores After 8 Weeks of Study Drug Administration
The IBDQ has been frequently adopted in Japanese and overseas clinical assessments as a scale for evaluating the quality of life (QOL) of subjects with inflammatory bowel disease. The IBDQ includes 32 items, which are divided into four subscales: bowel symptoms, systemic symptoms, emotional function and social function, and each item is scored on a 7-point scale, ranging from 1 (worst) to 7 (best). Total IBDQ score ranges from 32 to 224 with a higher score indicating a better QOL.
Time frame: Baseline and Week 8
Population: Efficacy was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the efficacy endpoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OPC-6535 12.5 mg | Mean Change From the Baseline in IBDQ Subscale Scores After 8 Weeks of Study Drug Administration | Social function at Week 8 | 3.2 score on a scale | Standard Deviation 6.1 |
| OPC-6535 12.5 mg | Mean Change From the Baseline in IBDQ Subscale Scores After 8 Weeks of Study Drug Administration | Bowel symptoms at Week 8 | 9.3 score on a scale | Standard Deviation 12.2 |
| OPC-6535 12.5 mg | Mean Change From the Baseline in IBDQ Subscale Scores After 8 Weeks of Study Drug Administration | Emotional function at Week 8 | 5.5 score on a scale | Standard Deviation 8.6 |
| OPC-6535 12.5 mg | Mean Change From the Baseline in IBDQ Subscale Scores After 8 Weeks of Study Drug Administration | Systemic symptoms at Week 8 | 4.5 score on a scale | Standard Deviation 5.6 |
| OPC-6535 25 mg | Mean Change From the Baseline in IBDQ Subscale Scores After 8 Weeks of Study Drug Administration | Bowel symptoms at Week 8 | 4.5 score on a scale | Standard Deviation 18.6 |
| OPC-6535 25 mg | Mean Change From the Baseline in IBDQ Subscale Scores After 8 Weeks of Study Drug Administration | Systemic symptoms at Week 8 | -1.1 score on a scale | Standard Deviation 8.5 |
| OPC-6535 25 mg | Mean Change From the Baseline in IBDQ Subscale Scores After 8 Weeks of Study Drug Administration | Emotional function at Week 8 | 1.2 score on a scale | Standard Deviation 12.9 |
| OPC-6535 25 mg | Mean Change From the Baseline in IBDQ Subscale Scores After 8 Weeks of Study Drug Administration | Social function at Week 8 | 2.5 score on a scale | Standard Deviation 8.7 |
| OPC-6535 50 mg | Mean Change From the Baseline in IBDQ Subscale Scores After 8 Weeks of Study Drug Administration | Bowel symptoms at Week 8 | 5.8 score on a scale | Standard Deviation 13.4 |
| OPC-6535 50 mg | Mean Change From the Baseline in IBDQ Subscale Scores After 8 Weeks of Study Drug Administration | Systemic symptoms at Week 8 | 2.2 score on a scale | Standard Deviation 7 |
| OPC-6535 50 mg | Mean Change From the Baseline in IBDQ Subscale Scores After 8 Weeks of Study Drug Administration | Emotional function at Week 8 | 5.8 score on a scale | Standard Deviation 15 |
| OPC-6535 50 mg | Mean Change From the Baseline in IBDQ Subscale Scores After 8 Weeks of Study Drug Administration | Social function at Week 8 | 2.2 score on a scale | Standard Deviation 7.2 |
| Placebo | Mean Change From the Baseline in IBDQ Subscale Scores After 8 Weeks of Study Drug Administration | Emotional function at Week 8 | 4.0 score on a scale | Standard Deviation 10.9 |
| Placebo | Mean Change From the Baseline in IBDQ Subscale Scores After 8 Weeks of Study Drug Administration | Bowel symptoms at Week 8 | 4.5 score on a scale | Standard Deviation 11 |
| Placebo | Mean Change From the Baseline in IBDQ Subscale Scores After 8 Weeks of Study Drug Administration | Social function at Week 8 | 0.7 score on a scale | Standard Deviation 8.8 |
| Placebo | Mean Change From the Baseline in IBDQ Subscale Scores After 8 Weeks of Study Drug Administration | Systemic symptoms at Week 8 | 0.0 score on a scale | Standard Deviation 5.9 |
Secondary
Mean Change From the Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score After 8 Weeks of Study Drug Administration
The IBDQ has been frequently adopted in Japanese and overseas clinical assessments as a scale for evaluating the quality of life (QOL) of subjects with inflammatory bowel disease. The IBDQ score was calculated as the sum of the responses (each ranging from 1 to 7) to all 32 questions that address symptoms as a result of Crohn's disease: bowel symptoms, systemic symptoms, emotional function, and social function. Total IBDQ score ranges from 32 to 224 with a higher score indicating a better QOL.
Time frame: Baseline and Week 8
Population: Efficacy was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the efficacy endpoints.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OPC-6535 12.5 mg | Mean Change From the Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score After 8 Weeks of Study Drug Administration | 22.5 score on a scale | Standard Deviation 26.5 |
| OPC-6535 25 mg | Mean Change From the Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score After 8 Weeks of Study Drug Administration | 7.1 score on a scale | Standard Deviation 44.3 |
| OPC-6535 50 mg | Mean Change From the Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score After 8 Weeks of Study Drug Administration | 16.0 score on a scale | Standard Deviation 40.2 |
| Placebo | Mean Change From the Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score After 8 Weeks of Study Drug Administration | 9.3 score on a scale | Standard Deviation 32.9 |
Secondary
Mean Change From the Baseline in Total Clinical Activity Index (CAI) Score After 2, 4, and 8 Weeks of Study Drug Administration
CAI composed of 7 variables: number of stool weekly, blood in stools (weekly average), investigator's global assessment of symptomatic state, abdominal pain/cramps, temperature due to colitis, extraintestinal manifestations, and laboratory findings. The scores ranging from 0 to 29 points (higher scores meaning more severe disease).
Time frame: Baseline, Weeks 2, 4 and 8
Population: Efficacy was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the efficacy endpoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OPC-6535 12.5 mg | Mean Change From the Baseline in Total Clinical Activity Index (CAI) Score After 2, 4, and 8 Weeks of Study Drug Administration | Week 2 | -1.2 score on a scale | Standard Deviation 3.1 |
| OPC-6535 12.5 mg | Mean Change From the Baseline in Total Clinical Activity Index (CAI) Score After 2, 4, and 8 Weeks of Study Drug Administration | Week 8 | -1.9 score on a scale | Standard Deviation 2.2 |
| OPC-6535 12.5 mg | Mean Change From the Baseline in Total Clinical Activity Index (CAI) Score After 2, 4, and 8 Weeks of Study Drug Administration | Week 4 | -1.4 score on a scale | Standard Deviation 2.3 |
| OPC-6535 25 mg | Mean Change From the Baseline in Total Clinical Activity Index (CAI) Score After 2, 4, and 8 Weeks of Study Drug Administration | Week 2 | -2.4 score on a scale | Standard Deviation 3.7 |
| OPC-6535 25 mg | Mean Change From the Baseline in Total Clinical Activity Index (CAI) Score After 2, 4, and 8 Weeks of Study Drug Administration | Week 8 | -2.6 score on a scale | Standard Deviation 3.9 |
| OPC-6535 25 mg | Mean Change From the Baseline in Total Clinical Activity Index (CAI) Score After 2, 4, and 8 Weeks of Study Drug Administration | Week 4 | -2.6 score on a scale | Standard Deviation 4.1 |
| OPC-6535 50 mg | Mean Change From the Baseline in Total Clinical Activity Index (CAI) Score After 2, 4, and 8 Weeks of Study Drug Administration | Week 4 | -2.9 score on a scale | Standard Deviation 2.3 |
| OPC-6535 50 mg | Mean Change From the Baseline in Total Clinical Activity Index (CAI) Score After 2, 4, and 8 Weeks of Study Drug Administration | Week 2 | -1.8 score on a scale | Standard Deviation 1.5 |
| OPC-6535 50 mg | Mean Change From the Baseline in Total Clinical Activity Index (CAI) Score After 2, 4, and 8 Weeks of Study Drug Administration | Week 8 | -3.4 score on a scale | Standard Deviation 2.5 |
| Placebo | Mean Change From the Baseline in Total Clinical Activity Index (CAI) Score After 2, 4, and 8 Weeks of Study Drug Administration | Week 2 | -1.0 score on a scale | Standard Deviation 1.8 |
| Placebo | Mean Change From the Baseline in Total Clinical Activity Index (CAI) Score After 2, 4, and 8 Weeks of Study Drug Administration | Week 8 | -1.0 score on a scale | Standard Deviation 2.5 |
| Placebo | Mean Change From the Baseline in Total Clinical Activity Index (CAI) Score After 2, 4, and 8 Weeks of Study Drug Administration | Week 4 | -1.1 score on a scale | Standard Deviation 2.3 |
Secondary
Mean Change From the Baseline in Total DAI Score After 4 and 8 Weeks of Study Drug Administration
DAI measures disease activity through assessment of 4 items/subscales: stool frequency, rectal bleeding, mucosal appearance at endoscopy, and physician's rating of disease activity. Each item of the score is assessed on a 4-point scale from 0 to 3; the total score ranges from 0 to 12 with a higher score representing greater severity. A negative change in mean score indicates improvement.
Time frame: Baseline, Weeks 4 and 8
Population: Efficacy was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the efficacy endpoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OPC-6535 12.5 mg | Mean Change From the Baseline in Total DAI Score After 4 and 8 Weeks of Study Drug Administration | Week 4 | -2.5 score on a scale | Standard Deviation 2.4 |
| OPC-6535 12.5 mg | Mean Change From the Baseline in Total DAI Score After 4 and 8 Weeks of Study Drug Administration | Week 8 | -2.6 score on a scale | Standard Deviation 2.2 |
| OPC-6535 25 mg | Mean Change From the Baseline in Total DAI Score After 4 and 8 Weeks of Study Drug Administration | Week 8 | -1.9 score on a scale | Standard Deviation 3.4 |
| OPC-6535 25 mg | Mean Change From the Baseline in Total DAI Score After 4 and 8 Weeks of Study Drug Administration | Week 4 | -1.0 score on a scale | Standard Deviation 3 |
| OPC-6535 50 mg | Mean Change From the Baseline in Total DAI Score After 4 and 8 Weeks of Study Drug Administration | Week 4 | -5.0 score on a scale | — |
| OPC-6535 50 mg | Mean Change From the Baseline in Total DAI Score After 4 and 8 Weeks of Study Drug Administration | Week 8 | -3.8 score on a scale | Standard Deviation 2.2 |
| Placebo | Mean Change From the Baseline in Total DAI Score After 4 and 8 Weeks of Study Drug Administration | Week 4 | -2.3 score on a scale | Standard Deviation 4.2 |
| Placebo | Mean Change From the Baseline in Total DAI Score After 4 and 8 Weeks of Study Drug Administration | Week 8 | -1.4 score on a scale | Standard Deviation 2.3 |
Secondary
Remission Rate (Number of Subjects Showing Remission/Number of Subjects Evaluated x 100) After 4 and 8 Weeks of Study Drug Administration
Definition of remission: DAI subscores for both rectal bleeding and mucosal appearance improved to 0
Time frame: Weeks 4 and 8
Population: Efficacy was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the efficacy endpoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| OPC-6535 12.5 mg | Remission Rate (Number of Subjects Showing Remission/Number of Subjects Evaluated x 100) After 4 and 8 Weeks of Study Drug Administration | Week 4 | 0.0 percentage of participants |
| OPC-6535 12.5 mg | Remission Rate (Number of Subjects Showing Remission/Number of Subjects Evaluated x 100) After 4 and 8 Weeks of Study Drug Administration | Week 8 | 0.0 percentage of participants |
| OPC-6535 25 mg | Remission Rate (Number of Subjects Showing Remission/Number of Subjects Evaluated x 100) After 4 and 8 Weeks of Study Drug Administration | Week 8 | 9.1 percentage of participants |
| OPC-6535 25 mg | Remission Rate (Number of Subjects Showing Remission/Number of Subjects Evaluated x 100) After 4 and 8 Weeks of Study Drug Administration | Week 4 | 0.0 percentage of participants |
| OPC-6535 50 mg | Remission Rate (Number of Subjects Showing Remission/Number of Subjects Evaluated x 100) After 4 and 8 Weeks of Study Drug Administration | Week 4 | 0.0 percentage of participants |
| OPC-6535 50 mg | Remission Rate (Number of Subjects Showing Remission/Number of Subjects Evaluated x 100) After 4 and 8 Weeks of Study Drug Administration | Week 8 | 10.0 percentage of participants |
| Placebo | Remission Rate (Number of Subjects Showing Remission/Number of Subjects Evaluated x 100) After 4 and 8 Weeks of Study Drug Administration | Week 4 | 9.1 percentage of participants |
| Placebo | Remission Rate (Number of Subjects Showing Remission/Number of Subjects Evaluated x 100) After 4 and 8 Weeks of Study Drug Administration | Week 8 | 9.1 percentage of participants |