| Primary | Change From Baseline in Hamilton Depression Rating Scale (HDRS-17) Total Score at Week 12 | The HDRS-17 is a clinician-administered rating scale designed to assess the severity of symptoms in participants diagnosed with depression with a score range of 0 to 52. Each of the 17 items is rated by the clinician on either a 3-point (0 to 2) or a 5-point scale (0 to 4). The point scale used a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). A total score (0 to 52) was calculated by adding the scores of all 17 items. For each item as well as the total score, a higher score represents a more severe condition. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Modified Intent-to-treat 1 (mITT1) analysis set: all randomized participants with high sensitivity c-reactive protein (hsCRP) >= 3.00 milligram per liter (mg/L) at screening and baseline who receive at least 1 dose of study drug and have both baseline and at least one postbaseline HDRS-17 total score in double-blind (DB) treatment period. | Posted | | Least Squares Mean | Standard Error | Units on a scale | | Baseline and Week 12 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received placebo subcutaneous (SC) injection on Day 1, Day 28 and Day 56, while continuing their baseline oral monoaminergic antidepressant(s). | | OG001 | Sirukumab 50 mg | Participants received sirukumab 50 milligram (mg) on Day 1, Day 28 and Day 56, while continuing their baseline oral monoaminergic antidepressant(s). |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-10.6± 1.43
- OG001-11.4± 1.52
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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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| | MMRM | Here 'MMRM' refers to Mixed-effect Model Using Repeated Measures. | 0.310 | | Difference of Least Square (LS) Means | -0.8 | Standard Error of the Mean | 1.67 | 2-Sided | 75 | -2.77 | 1.10 | | | | | Superiority | | |
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| Secondary | Change From Baseline in HDRS-17 Total Score at Weeks 1, 4 and 8 | The HDRS-17 is a clinician-administered rating scale designed to assess the severity of symptoms in participants diagnosed with depression with a score range of 0 to 52. Each of the 17 items is rated by the clinician on either a 3-point (0 to 2) or a 5-point scale (0 to 4). The point scale used a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). A total score (0 to 52) was calculated by adding the scores of all 17 items. For each item as well as the total score, a higher score represents a more severe condition. | mITT1 analysis set: all randomized participants with hsCRP >= 3.00 mg/L at screening and baseline who receive at least 1 dose of study drug and have both baseline and at least one postbaseline HDRS-17 total score in DB treatment period. 'n' (number of participants analyzed)- number of participants analyzed at each specified timepoint, for each arm. | Posted | | Least Squares Mean | Standard Error | Units on a scale | | Baseline, Weeks 1, 4 and 8 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received placebo subcutaneous (SC) injection on Day 1, Day 28 and Day 56, while continuing their baseline oral monoaminergic antidepressant(s). | | OG001 | Sirukumab 50 mg | Participants received sirukumab 50 milligram (mg) on Day 1, Day 28 and Day 56, while continuing their baseline oral monoaminergic antidepressant(s). |
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| Secondary | Percentage of Participants With Remission as Assessed by HDRS-17 Total Score at Week 12 | Remission- Percentage of participants with HDRS-17 total score less than or equal to (<=) 7 were considered as remitters. HDRS-17 defined as clinician-administered rating scale designed to assess severity of symptoms in participants diagnosed with depression with score range of 0 to 52. Each of 17 items is rated by clinician on either a 3-point (0 to 2) or a 5-point scale (0 to 4). The point scale used a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). A total score (0 to 52) was calculated by adding scores of all 17 items. For each item as well as total score, a higher score represents a more severe condition. | mITT1 analysis set: all randomized participants with hsCRP >=3.00 mg/L at screening and baseline who receive at least 1 dose of study drug and have both baseline and at least one postbaseline HDRS-17 total score in DB treatment period. 'N' (number of participants analyzed)- number of participants who were evaluable for this outcome measure. | Posted | | Number | | Percentage of participants | | Week 12 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received placebo subcutaneous (SC) injection on Day 1, Day 28 and Day 56, while continuing their baseline oral monoaminergic antidepressant(s). | | OG001 | Sirukumab 50 mg | Participants received sirukumab 50 milligram (mg) on Day 1, Day 28 and Day 56, while continuing their baseline oral monoaminergic antidepressant(s). |
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| Secondary | Percentage of Participants With Response as Assessed by HDRS-17 Total Score at Week 12 | Response- Percentage of participants with greater than or equal to (>=) 50 percent (%) improvement on the HDRS-17 total score from baseline at Week 12 were considered as responders. The HDRS-17 defined as clinician-administered rating scale designed to assess the severity of symptoms in participants diagnosed with depression with a score range of 0 to 52. Each of the 17 items is rated by the clinician on either a 3-point (0 to 2) or a 5-point scale (0 to 4). The point scale used a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). A total score (0 to 52) was calculated by adding the scores of all 17 items. For each item as well as the total score, a higher score represents a more severe condition. | mITT1 analysis set: all randomized participants with hsCRP >= 3.00 mg/L at screening and baseline who receive at least 1 dose of study drug and have both baseline and at least one postbaseline HDRS-17 total score in DB treatment period. 'N' (number of participants analyzed)- number of participants who were evaluable for this outcome measure. | Posted | | Number | | Percentage of participants | | Week 12 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received placebo subcutaneous (SC) injection on Day 1, Day 28 and Day 56, while continuing their baseline oral monoaminergic antidepressant(s). | | OG001 | Sirukumab 50 mg | |
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| Secondary | Change From Baseline in Clinical Global Impression - Severity (CGI-S) Total Score at Weeks 1, 4, 8, 12, 16, and 22 | CGI-S defined as clinician-rated scale that assesses the severity of mental illness on a scale of 0 to 7. Considering total clinical experience, a participant was assessed on severity of mental illness at the time of rating according to:1: normal, not at all ill; 2: borderline mentally ill; 3: mildly ill; 4: moderately ill; 5: markedly ill; 6: severely ill; 7: among the most extremely ill patients. A higher score implies a more severe condition. | mITT1 analysis set: all randomized participants with hsCRP >= 3.00 mg/L at screening and baseline who receive at least 1 dose of study drug and have both baseline and at least one postbaseline HDRS-17 total score in DB treatment period. 'n' (number of participants analyzed)- number of participants analyzed at each specified timepoint, for each arm. | Posted | | Least Squares Mean | Standard Error | Units on a scale | | Baseline and Weeks 1, 4, 8, 12, 16, and 22 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received placebo subcutaneous (SC) injection on Day 1, Day 28 and Day 56, while continuing their baseline oral monoaminergic antidepressant(s). | | OG001 | Sirukumab 50 mg | Participants received sirukumab 50 milligram (mg) on Day 1, Day 28 and Day 56, while continuing their baseline oral monoaminergic antidepressant(s). |
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| Secondary | Change From Baseline in Patient Health Questionnaire (PHQ-9) Total Score at Weeks 1, 4, 8, 12, 16, and 22 | The PHQ-9 used as a participant-reported measure of depressive symptomatology. The PHQ-9 is 9-item scale, where each item is rated on a 4-point scale (0=Not at all, 1=Several Days, 2=More than half the days, and 3=Nearly every day). The participant's item responses were summed to provide a total score range of 0 to 27. Higher scores indicates greater severity of depressive symptoms. The recall period is 2 weeks. | mITT1 analysis set: all randomized participants with hsCRP >= 3.00 mg/L at screening and baseline who receive at least 1 dose of study drug and have both baseline and at least one postbaseline HDRS-17 total score in DB treatment period. 'n' (number of participants analyzed)- number of participants analyzed at each specified timepoint, for each arm. | Posted | | Least Squares Mean | Standard Error | Units on a scale | | Baseline and Weeks 1, 4, 8, 12, 16, and 22 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received placebo subcutaneous (SC) injection on Day 1, Day 28 and Day 56, while continuing their baseline oral monoaminergic antidepressant(s). | | OG001 | Sirukumab 50 mg | Participants received sirukumab 50 milligram (mg) on Day 1, Day 28 and Day 56, while continuing their baseline oral monoaminergic antidepressant(s). |
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| Secondary | Change From Baseline in Snaith Hamilton Pleasure Scale (SHAPS) Total Score (Definition 1) at Weeks 1, 4, 8, 12, 16, and 22 | The Snaith-Hamilton Pleasure Scale (SHAPS) is short, 14-item instrument to measure anhedonia. Each of the 14 items has a set of four response categories (Definition 1): Definitely Agree (=1), Agree (= 2), Disagree (= 3), and Definitely Disagree (= 4). A SHAPS total score was calculated as the sum of the 14 item scores with a total score range from 14 to 56. A higher total score indicates higher levels of state anhedonia. | mITT1 analysis set: all randomized participants with hsCRP >= 3.00 mg/L at screening and baseline who receive at least 1 dose of study drug and have both baseline and at least one postbaseline HDRS-17 total score in DB treatment period. 'n' (number of participants analyzed)- number of participants analyzed at each specified timepoint, for each arm. | Posted | | Least Squares Mean | Standard Error | Units on a scale | | Baseline and Weeks 1, 4, 8, 12, 16, and 22 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received placebo subcutaneous (SC) injection on Day 1, Day 28 and Day 56, while continuing their baseline oral monoaminergic antidepressant(s). | | OG001 | Sirukumab 50 mg | Participants received sirukumab 50 milligram (mg) on Day 1, Day 28 and Day 56, while continuing their baseline oral monoaminergic antidepressant(s). |
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| Secondary | Change From Baseline in Snaith Hamilton Pleasure Scale (SHAPS) Total Score (Definition 2) at Weeks 1, 4, 8, 12, 16, and 22 | The Snaith-Hamilton Pleasure Scale (SHAPS) is short, 14-item instrument to measure anhedonia. Each of the 14 items has a set of four response categories (Definition 2): Definitely Agree (= 0), Agree (= 0), Disagree (= 1), and Definitely Disagree (= 1). A SHAPS total score was calculated as the sum of the 14 item scores with a score range from 0 to 14. A higher total score indicates higher levels of state anhedonia. | mITT1 analysis set: all randomized participants with hsCRP >= 3.00 mg/L at screening and baseline who receive at least 1 dose of study drug and have both baseline and at least one postbaseline HDRS-17 total score in DB treatment period. 'n' (number of participants analyzed)- number of participants analyzed at each specified timepoint, for each arm. | Posted | | Least Squares Mean | Standard Error | Units on a scale | | Baseline and Weeks 1, 4, 8, 12, 16, and 22 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received placebo subcutaneous (SC) injection on Day 1, Day 28 and Day 56, while continuing their baseline oral monoaminergic antidepressant(s). | | OG001 | Sirukumab 50 mg | Participants received sirukumab 50 milligram (mg) on Day 1, Day 28 and Day 56, while continuing their baseline oral monoaminergic antidepressant(s). |
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| Secondary | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Total Score at Weeks 1, 4, 8, 12, 16, and 22 | The FACIT-Fatigue is a questionnaire that assesses self-reported tiredness, weakness, and difficulty conducting usual activities due to fatigue. The subscale consists 13-item instrument to measure fatigue. Each of the 13 items has a set of five response categories: Not at all (=0), A little bit (=1), Somewhat (=2), Quite a bit (=3) and Very much (=4). A total FACIT-Fatigue subscale score was calculated as the sum of the 13 item scores (reserved scores [4 - score] for all except for 2 items: "I have energy" and "I am able to do my usual activities"), and ranges from 0 to 52, with a higher score indicating less fatigue. | mITT1 analysis set: all randomized participants with hsCRP >= 3.00 mg/L at screening and baseline who receive at least 1 dose of study drug and have both baseline and at least one postbaseline HDRS-17 total score in DB treatment period. 'n' (number of participants analyzed)- number of participants analyzed at each specified timepoint, for each arm. | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline and Weeks 1, 4, 8, 12, 16, and 22 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received placebo subcutaneous (SC) injection on Day 1, Day 28 and Day 56, while continuing their baseline oral monoaminergic antidepressant(s). | | OG001 | Sirukumab 50 mg | Participants received sirukumab 50 milligram (mg) on Day 1, Day 28 and Day 56, while continuing their baseline oral monoaminergic antidepressant(s). |
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