| Primary | Maintenance Phase: Percentage of Participants in Remission at Week 62 Among Randomized Participants With a Clinical Response at Week 10, as Determined by the Mayo Clinic Score (MCS) | MCS is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Clinical Response is MCS with ≥3-point decrease and 30% reduction from baseline as well as ≥1-point decrease in rectal bleeding subscore or an absolute rectal bleeding score of 0 or 1. Remission is MCS ≤2 with individual subscores ≤1 and a rectal bleeding subscore of 0. | Participants in the Maintenance phase of the study that received an intervention | Posted | | Number | | percentage of participants | | Week 62 | | | | ID | Title | Description |
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| OG000 | Double-Blind Maintenance Phase: Etrolizumab | Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive etrolizumab 105 mg SC injection Q4W from Week 12 up to Week 62. | | OG001 | Double-Blind Maintenance Phase: Placebo | Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive placebo (matched to etrolizumab) SC injection Q4W from Week 12 up to Week 62. |
| | | Title | Denominators | Categories |
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | Cochran-Mantel-Haenszel | | 0.1942 | | Adjusted difference in response rates | 7.7 | | | 2-Sided | 95 | -4.2 | 19.2 | | | | | Superiority | | |
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| Secondary | Maintenance Phase: Percentage of Participants Who Maintained Clinical Remission at Week 62 Among Randomized Participants in Clinical Remission at Week 10, as Determined by the MCS | MCS is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Clinical Remission is MCS ≤2 with individual subscores ≤1. | Participants in the Maintenance phase of the study that had Clinical Remission at Week 10 | Posted | | Number | | percentage of participants | | Week 62 | | | | ID | Title | Description |
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| OG000 | Double-Blind Maintenance Phase: Etrolizumab | Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive etrolizumab 105 mg SC injection Q4W from Week 12 up to Week 62. | | OG001 | Double-Blind Maintenance Phase: Placebo | Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive placebo (matched to etrolizumab) SC injection Q4W from Week 12 up to Week 62. |
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| Secondary | Maintenance Phase: Percentage of Participants in Clinical Remission at Week 62, as Determined by the MCS | MCS is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Clinical Remission is MCS ≤2 with individual subscores ≤1. | Participants in the Maintenance phase of the study that received an intervention | Posted | | Number | | percentage of participants | | Week 62 | | | | ID | Title | Description |
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| OG000 | Double-Blind Maintenance Phase: Etrolizumab | Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive etrolizumab 105 mg SC injection Q4W from Week 12 up to Week 62. | | OG001 | Double-Blind Maintenance Phase: Placebo | Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive placebo (matched to etrolizumab) SC injection Q4W from Week 12 up to Week 62. |
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| Secondary | Maintenance Phase: Percentage of Participants in Remission at Week 62 Among Randomized Participants in Remission at Week 10, as Determined by the MCS | MCS is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Remission is MCS ≤2 with individual subscores ≤1 and a rectal bleeding subscore of 0. | Participants in the Maintenance phase of the study that had Remission at Week 10 | Posted | | Number | | percentage of participants | | Week 62 | | | | ID | Title | Description |
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| OG000 | Double-Blind Maintenance Phase: Etrolizumab | Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive etrolizumab 105 mg SC injection Q4W from Week 12 up to Week 62. | | OG001 | Double-Blind Maintenance Phase: Placebo | Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive placebo (matched to etrolizumab) SC injection Q4W from Week 12 up to Week 62. |
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| Secondary | Maintenance Phase: Percentage of Participants With Improvement From Baseline in Endoscopic Appearance of the Mucosa at Week 62, as Determined by the MCS Endoscopic Subscore | MCS is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Improvement in endoscopic appearance of the mucosa is Endoscopy subscore ≤1. | Participants in the Maintenance phase of the study that received an intervention | Posted | | Number | | percentage of participants | | Baseline, Week 62 | | | | ID | Title | Description |
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| OG000 | Double-Blind Maintenance Phase: Etrolizumab | Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive etrolizumab 105 mg SC injection Q4W from Week 12 up to Week 62. | | OG001 | Double-Blind Maintenance Phase: Placebo | Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive placebo (matched to etrolizumab) SC injection Q4W from Week 12 up to Week 62. |
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| Secondary | Maintenance Phase: Percentage of Participants With Endoscopic Remission at Week 62, as Determined by the MCS Endoscopic Subscore | MCS is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Endoscopic Remission is Endoscopy subscore = 0. | Participants in the Maintenance phase of the study that received an intervention | Posted | | Number | | percentage of participants | | Week 62 | | | | ID | Title | Description |
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| OG000 | Double-Blind Maintenance Phase: Etrolizumab | Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive etrolizumab 105 mg SC injection Q4W from Week 12 up to Week 62. | | OG001 | Double-Blind Maintenance Phase: Placebo | Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive placebo (matched to etrolizumab) SC injection Q4W from Week 12 up to Week 62. |
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| Secondary | Maintenance Phase: Percentage of Participants With Histologic Remission at Week 62, as Determined by the Nancy Histological Index | Nancy Histological Index (NHI) is a 5-level classification ranging from grade 0 (No histologically significant disease) to grade 4 (severely active disease). Histologic remission is defined as a Nancy histological index of 0 or 1. | Participants in the Maintenance phase of the study that were evaluated using the Nancy histological index (enrolled after the latest protocol amendment) | Posted | | Number | | percentage of participants | | Week 62 | | | | ID | Title | Description |
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| OG000 | Double-Blind Maintenance Phase: Etrolizumab | Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive etrolizumab 105 mg SC injection Q4W from Week 12 up to Week 62. | | OG001 | Double-Blind Maintenance Phase: Placebo | Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive placebo (matched to etrolizumab) SC injection Q4W from Week 12 up to Week 62. |
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| Secondary | Maintenance Phase: Percentage of Participants With Corticosteroid-Free Clinical Remission at Week 62 Among Participants Who Were Receiving Corticosteroids at Baseline, as Determined by the MCS | MCS is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Clinical Remission is MCS ≤2 with individual subscores ≤1. | Participants in the Maintenance phase of the study receiving Corticosteroids at baseline | Posted | | Number | | percentage of participants | | Baseline, Week 62 | | | | ID | Title | Description |
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| OG000 | Double-Blind Maintenance Phase: Etrolizumab | Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive etrolizumab 105 mg SC injection Q4W from Week 12 up to Week 62. | | OG001 | Double-Blind Maintenance Phase: Placebo | Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive placebo (matched to etrolizumab) SC injection Q4W from Week 12 up to Week 62. |
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| Secondary | Maintenance Phase: Percentage of Participants With Corticosteroid-Free Remission at Week 62 Among Participants Who Were Receiving Corticosteroids at Baseline, as Determined by the MCS | MCS is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Remission is MCS ≤2 with individual subscores ≤1 and a rectal bleeding subscore of 0. | Participants in the Maintenance phase of the study receiving Corticosteroids at baseline | Posted | | Number | | percentage of participants | | Baseline, Week 62 | | | | ID | Title | Description |
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| OG000 | Double-Blind Maintenance Phase: Etrolizumab | Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive etrolizumab 105 mg SC injection Q4W from Week 12 up to Week 62. | | OG001 | Double-Blind Maintenance Phase: Placebo | Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive placebo (matched to etrolizumab) SC injection Q4W from Week 12 up to Week 62. |
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| Secondary | Maintenance Phase: Change From Baseline to Week 62 in UC Bowel Movement Signs and Symptoms, as Assessed by the Ulcerative Colitis Patient-Reported Outcome Signs and Symptoms (UC-PRO/SS) Questionnaire | The UC-PRO questionnaire is collected in the e-diary and completed by participants for at least 9-12 consecutive days prior to a study visit. The UC-PRO is being reported in three domains; two domains are key endpoints and reported as UC-PRO Signs and Symptoms (UC-PRO/SS). The bowel domain score ranges from 0-27, with a higher score indicating a worse disease state. | Participants in the Maintenance phase of the study that completed a baseline and at least 1 post-baseline questionnaire | Posted | | Least Squares Mean | Standard Error | score on a scale | | Baseline, Week 62 | | | | ID | Title | Description |
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| OG000 | Double-Blind Maintenance Phase: Etrolizumab | Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive etrolizumab 105 mg SC injection Q4W from Week 12 up to Week 62. | | OG001 | Double-Blind Maintenance Phase: Placebo | Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive placebo (matched to etrolizumab) SC injection Q4W from Week 12 up to Week 62. |
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| Secondary | Maintenance Phase: Change From Baseline to Week 62 in UC Functional Symptoms, as Assessed by the UC-PRO/SS Questionnaire | The UC-PRO questionnaire is collected in the e-diary and completed by participants for at least 9-12 consecutive days prior to a study visit. The UC-PRO is being reported in three domains; two domains are key endpoints and reported as UC-PRO Signs and Symptoms (UC-PRO/SS). The functional domain score ranges from 0-12, with a higher score indicating a worse disease state. | Participants in the Maintenance phase of the study that completed a baseline and at least 1 post-baseline questionnaire | Posted | | Least Squares Mean | Standard Error | score on a scale | | Baseline, Week 62 | | | | ID | Title | Description |
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| OG000 | Double-Blind Maintenance Phase: Etrolizumab | Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive etrolizumab 105 mg SC injection Q4W from Week 12 up to Week 62. | | OG001 | Double-Blind Maintenance Phase: Placebo | Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive placebo (matched to etrolizumab) SC injection Q4W from Week 12 up to Week 62. |
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| Secondary | Maintenance Phase: Change From Baseline to Week 62 in Health-Related Quality of Life, as Assessed by the Overall Score of the Inflammatory Bowel Disease Questionnaire (IBDQ) | The IBDQ is used to assess participant's health-related quality of life (QOL). The 32-item questionnaire contains four domains: bowel symptoms (10 items), systemic symptoms (5 items), emotional function (12 items), and social function (5 items). The items are scored on a 7-point Likert scale with a higher score indicating better health-related QOL. IBDQ score is a total score summed up from across all 32 questions on the questionnaire. The score can range from 32-224 and the higher score indicates a better quality of life. | Participants in the Maintenance phase of the study that received an intervention | Posted | | Least Squares Mean | Standard Error | scores on a scale | | Baseline, Week 62 | | | | ID | Title | Description |
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| OG000 | Double-Blind Maintenance Phase: Etrolizumab | Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive etrolizumab 105 mg SC injection Q4W from Week 12 up to Week 62. | | OG001 | Double-Blind Maintenance Phase: Placebo | Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive placebo (matched to etrolizumab) SC injection Q4W from Week 12 up to Week 62. |
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| Secondary | Number of Participants With at Least One Adverse Event by Severity, According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE v4.0) | All adverse events (AEs) were graded for severity using the NCI-CTCAE v4.0. Any AE not specifically listed was assessed per the following 5 grades: Grade 1 = mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; or intervention not indicated. Grade 2 = moderate; minimal, local, or non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living. Grade 3 = severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living. Grade 4 = life-threatening consequences or urgent intervention indicated. Grade 5 = death related to AE. Not all grades are appropriate for all AEs; some AEs have fewer than 5 options. The terms "severe" and "serious" are not synonymous and are independently assessed for each AE. Multiple occurrences of AEs were counted only once per participant at the highest (worst) grade. | All participants that received an intervention | Posted | | Number | | participants | | From Baseline up to Week 74 | | | | ID | Title | Description |
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| OG000 | Open-Label Induction Phase: Etrolizumab | All participants will receive treatment with open-label etrolizumab 105 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) up to Week 10. | | OG001 | Double-Blind Maintenance Phase: Etrolizumab |
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| Secondary | Number of Participants With Adverse Events Leading to Study Drug Discontinuation | | All participants that received an intervention | Posted | | Number | | participants | | From Baseline up to Week 74 | | | | ID | Title | Description |
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| OG000 | Open-Label Induction Phase: Etrolizumab | All participants will receive treatment with open-label etrolizumab 105 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) up to Week 10. | | OG001 | Double-Blind Maintenance Phase: Etrolizumab | Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive etrolizumab 105 mg SC injection Q4W from Week 12 up to Week 62. | | OG002 | Double-Blind Maintenance Phase: Placebo | Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive placebo (matched to etrolizumab) SC injection Q4W from Week 12 up to Week 62. |
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| Secondary | Number of Participants With Serious Infection-Related Adverse Events | | All participants that received an intervention | Posted | | Number | | participants | | From Baseline up to Week 74 | | | | ID | Title | Description |
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| OG000 | Open-Label Induction Phase: Etrolizumab | All participants will receive treatment with open-label etrolizumab 105 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) up to Week 10. | | OG001 | Double-Blind Maintenance Phase: Etrolizumab | Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive etrolizumab 105 mg SC injection Q4W from Week 12 up to Week 62. | | OG002 | Double-Blind Maintenance Phase: Placebo | Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive placebo (matched to etrolizumab) SC injection Q4W from Week 12 up to Week 62. |
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| Secondary | Number of Participants With Infection-Related Adverse Events by Severity, According to NCI-CTCAE v4.0 | All adverse events (AEs) were graded for severity using the NCI-CTCAE v4.0. Any AE not specifically listed was assessed per the following 5 grades: Grade 1 = mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; or intervention not indicated. Grade 2 = moderate; minimal, local, or non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living. Grade 3 = severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living. Grade 4 = life-threatening consequences or urgent intervention indicated. Grade 5 = death related to AE. Not all grades are appropriate for all AEs; some AEs have fewer than 5 options. The terms "severe" and "serious" are not synonymous and are independently assessed for each AE. Multiple occurrences of AEs were counted only once per participant at the highest (worst) grade. | All participants that received an intervention | Posted | | Number | | participants | | From Baseline up to Week 74 | | | | ID | Title | Description |
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| OG000 | Open-Label Induction Phase: Etrolizumab | All participants will receive treatment with open-label etrolizumab 105 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) up to Week 10. | | OG001 | Double-Blind Maintenance Phase: Etrolizumab | |
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| Secondary | Number of Participants With Injection-Site Reactions by Severity, According to NCI-CTCAE v4.0 | All adverse events (AEs) were graded for severity using the NCI-CTCAE v4.0. Any AE not specifically listed was assessed per the following 5 grades: Grade 1 = mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; or intervention not indicated. Grade 2 = moderate; minimal, local, or non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living. Grade 3 = severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living. Grade 4 = life-threatening consequences or urgent intervention indicated. Grade 5 = death related to AE. Not all grades are appropriate for all AEs; some AEs have fewer than 5 options. The terms "severe" and "serious" are not synonymous and are independently assessed for each AE. Multiple occurrences of AEs were counted only once per participant at the highest (worst) grade. | All participants that received an intervention | Posted | | Number | | participants | | From Baseline up to Week 74 | | | | ID | Title | Description |
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| OG000 | Open-Label Induction Phase: Etrolizumab | All participants will receive treatment with open-label etrolizumab 105 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) up to Week 10. | | OG001 | Double-Blind Maintenance Phase: Etrolizumab | |
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| Secondary | Number of Participants With Hypersensitivity Reaction Events by Severity, According to NCI-CTCAE v4.0 | All adverse events (AEs) were graded for severity using the NCI-CTCAE v4.0. Any AE not specifically listed was assessed per the following 5 grades: Grade 1 = mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; or intervention not indicated. Grade 2 = moderate; minimal, local, or non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living. Grade 3 = severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living. Grade 4 = life-threatening consequences or urgent intervention indicated. Grade 5 = death related to AE. Not all grades are appropriate for all AEs; some AEs have fewer than 5 options. The terms "severe" and "serious" are not synonymous and are independently assessed for each AE. Multiple occurrences of AEs were counted only once per participant at the highest (worst) grade. | All participants that received an intervention | Posted | | Number | | participants | | From Baseline up to Week 74 | | | | ID | Title | Description |
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| OG000 | Open-Label Induction Phase: Etrolizumab | All participants will receive treatment with open-label etrolizumab 105 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) up to Week 10. | | OG001 | Double-Blind Maintenance Phase: Etrolizumab | |
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| Secondary | Number of Participants With Malignancies | | All participants that received an intervention | Posted | | Number | | participants | | From Baseline up to Week 74 | | | | ID | Title | Description |
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| OG000 | Open-Label Induction Phase: Etrolizumab | All participants will receive treatment with open-label etrolizumab 105 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) up to Week 10. | | OG001 | Double-Blind Maintenance Phase: Etrolizumab | Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive etrolizumab 105 mg SC injection Q4W from Week 12 up to Week 62. | | OG002 | Double-Blind Maintenance Phase: Placebo | Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive placebo (matched to etrolizumab) SC injection Q4W from Week 12 up to Week 62. |
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| Secondary | Number of Participants With Anti-Therapeutic Antibodies (ATAs) to Etrolizumab | | Participants who received at least one dose of study treatment and had at least one baseline or post-baseline ATA result from at least one sample. | Posted | | Number | | participants | | Baseline, Weeks 4, 12, 24, 44, and 62, and and Early Termination/End of Safety Follow-Up (up to Week 74) | | | | ID | Title | Description |
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| OG000 | Open-Label Induction Phase: Etrolizumab | All participants will receive treatment with open-label etrolizumab 105 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) up to Week 10. | | OG001 | Double-Blind Maintenance Phase: Etrolizumab | Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive etrolizumab 105 mg SC injection Q4W from Week 12 up to Week 62. | | OG002 | Double-Blind Maintenance Phase: Placebo | Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive placebo (matched to etrolizumab) SC injection Q4W from Week 12 up to Week 62. |
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| Secondary | Maintenance Phase: Etrolizumab Serum Trough Concentration (for Arms/Timepoints Above LLOQ) | As per protocol, the timepoints for each arm where more than a third of the samples were above the lower limit of quantitation (LLOQ), full summary statistics (Mean and Standard Deviation) were reported. For timepoints below the LLOQ, only the Median and Max were reported as a separate outcome measure below. | All participants who received at least one dose of study drug and had evaluable PK data. | Posted | | Mean | Standard Deviation | micrograms per millilitre (μg/mL) | | Pre-dose (0 hour) at Baseline and Weeks 12, 24, 44, and 62 | | | | ID | Title | Description |
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| OG000 | Double-Blind Maintenance Phase: Etrolizumab | Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive etrolizumab 105 mg SC injection Q4W from Week 12 up to Week 62. | | OG001 | Double-Blind Maintenance Phase: Placebo | Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive placebo (matched to etrolizumab) SC injection Q4W from Week 12 up to Week 62. |
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| Secondary | Maintenance Phase: Etrolizumab Serum Trough Concentration (for Arms/Timepoints Below LLOQ) | As per protocol, the timepoints for each arm where more than a third of the samples were below the LLOQ only the Median and Max were reported. | All participants who received at least one dose of study drug, had evaluable PK data and were part of the timepoint that had more than a third of samples below LLOQ. | Posted | | Median | Full Range | micrograms per millilitre (μg/mL) | | Pre-dose (0 hour) at Baseline and Weeks 12, 24, 44, and 62 | | | | ID | Title | Description |
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| OG000 | Double-Blind Maintenance Phase: Placebo | Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive placebo (matched to etrolizumab) SC injection Q4W from Week 12 up to Week 62. |
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