Trial Outcomes & Findings for An Efficacy and Safety Study of Sirukumab in Participants With Major Depressive Disorder (NCT NCT02473289)
NCT ID: NCT02473289
Last Updated: 2025-04-29
Results Overview
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.
COMPLETED
PHASE2
193 participants
Baseline and Week 12
2025-04-29
Participant Flow
Participant milestones
| Measure |
Placebo
Participants received placebo subcutaneous (SC) injection on Day 1, Day 28 and Day 56, while continuing their baseline oral monoaminergic antidepressant(s).
|
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).
|
|---|---|---|
|
Overall Study
STARTED
|
99
|
94
|
|
Overall Study
COMPLETED
|
88
|
81
|
|
Overall Study
NOT COMPLETED
|
11
|
13
|
Reasons for withdrawal
| Measure |
Placebo
Participants received placebo subcutaneous (SC) injection on Day 1, Day 28 and Day 56, while continuing their baseline oral monoaminergic antidepressant(s).
|
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).
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Withdrawal of consent
|
6
|
7
|
|
Overall Study
Treatment Unblinded + Adverse event
|
0
|
1
|
|
Overall Study
Other
|
2
|
0
|
Baseline Characteristics
An Efficacy and Safety Study of Sirukumab in Participants With Major Depressive Disorder
Baseline characteristics by cohort
| Measure |
Placebo
n=99 Participants
Participants received placebo subcutaneous (SC) injection on Day 1, Day 28 and Day 56, while continuing their baseline oral monoaminergic antidepressant(s).
|
Sirukumab 50 mg
n=94 Participants
Participants received sirukumab 50 milligram (mg) on Day 1, Day 28 and Day 56, while continuing their baseline oral monoaminergic antidepressant(s).
|
Total
n=193 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Female
|
75 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
149 Participants
n=5 Participants
|
|
Age, Continuous
|
44.1 years
STANDARD_DEVIATION 11.73 • n=5 Participants
|
45.4 years
STANDARD_DEVIATION 10.83 • n=7 Participants
|
44.7 years
STANDARD_DEVIATION 11.29 • n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
95 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
184 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
86 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
173 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White Non-Hispanic
|
82 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
165 Participants
n=5 Participants
|
|
Region of Enrollment
CANADA
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
POLAND
|
21 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Region of Enrollment
RUSSIAN FEDERATION
|
48 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
|
Region of Enrollment
UNITED KINGDOM
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
UNITED STATES
|
23 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=42 Participants
Participants received placebo subcutaneous (SC) injection on Day 1, Day 28 and Day 56, while continuing their baseline oral monoaminergic antidepressant(s).
|
Sirukumab 50 mg
n=44 Participants
Participants received sirukumab 50 milligram (mg) on Day 1, Day 28 and Day 56, while continuing their baseline oral monoaminergic antidepressant(s).
|
|---|---|---|
|
Change From Baseline in Hamilton Depression Rating Scale (HDRS-17) Total Score at Week 12
|
-10.6 Units on a scale
Standard Error 1.43
|
-11.4 Units on a scale
Standard Error 1.52
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1, 4 and 8Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=47 Participants
Participants received placebo subcutaneous (SC) injection on Day 1, Day 28 and Day 56, while continuing their baseline oral monoaminergic antidepressant(s).
|
Sirukumab 50 mg
n=47 Participants
Participants received sirukumab 50 milligram (mg) on Day 1, Day 28 and Day 56, while continuing their baseline oral monoaminergic antidepressant(s).
|
|---|---|---|
|
Change From Baseline in HDRS-17 Total Score at Weeks 1, 4 and 8
Change at Week 1
|
-5.1 Units on a scale
Standard Error 1.03
|
-4.6 Units on a scale
Standard Error 1.15
|
|
Change From Baseline in HDRS-17 Total Score at Weeks 1, 4 and 8
Change at Week 4
|
-7.5 Units on a scale
Standard Error 1.21
|
-7.8 Units on a scale
Standard Error 1.33
|
|
Change From Baseline in HDRS-17 Total Score at Weeks 1, 4 and 8
Change at Week 8
|
-7.9 Units on a scale
Standard Error 1.29
|
-11.0 Units on a scale
Standard Error 1.39
|
SECONDARY outcome
Timeframe: Week 12Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=42 Participants
Participants received placebo subcutaneous (SC) injection on Day 1, Day 28 and Day 56, while continuing their baseline oral monoaminergic antidepressant(s).
|
Sirukumab 50 mg
n=44 Participants
Participants received sirukumab 50 milligram (mg) on Day 1, Day 28 and Day 56, while continuing their baseline oral monoaminergic antidepressant(s).
|
|---|---|---|
|
Percentage of Participants With Remission as Assessed by HDRS-17 Total Score at Week 12
|
19.0 Percentage of participants
|
15.9 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 12Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=42 Participants
Participants received placebo subcutaneous (SC) injection on Day 1, Day 28 and Day 56, while continuing their baseline oral monoaminergic antidepressant(s).
|
Sirukumab 50 mg
n=44 Participants
Participants received sirukumab 50 milligram (mg) on Day 1, Day 28 and Day 56, while continuing their baseline oral monoaminergic antidepressant(s).
|
|---|---|---|
|
Percentage of Participants With Response as Assessed by HDRS-17 Total Score at Week 12
|
33.3 Percentage of participants
|
34.1 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Weeks 1, 4, 8, 12, 16, and 22Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=47 Participants
Participants received placebo subcutaneous (SC) injection on Day 1, Day 28 and Day 56, while continuing their baseline oral monoaminergic antidepressant(s).
|
Sirukumab 50 mg
n=47 Participants
Participants received sirukumab 50 milligram (mg) on Day 1, Day 28 and Day 56, while continuing their baseline oral monoaminergic antidepressant(s).
|
|---|---|---|
|
Change From Baseline in Clinical Global Impression - Severity (CGI-S) Total Score at Weeks 1, 4, 8, 12, 16, and 22
Change at Week 1
|
-0.6 Units on a scale
Standard Error 0.14
|
-0.7 Units on a scale
Standard Error 0.15
|
|
Change From Baseline in Clinical Global Impression - Severity (CGI-S) Total Score at Weeks 1, 4, 8, 12, 16, and 22
Change at Week 4
|
-1.1 Units on a scale
Standard Error 0.16
|
-1.0 Units on a scale
Standard Error 0.17
|
|
Change From Baseline in Clinical Global Impression - Severity (CGI-S) Total Score at Weeks 1, 4, 8, 12, 16, and 22
Change at Week 8
|
-1.4 Units on a scale
Standard Error 0.18
|
-1.5 Units on a scale
Standard Error 0.19
|
|
Change From Baseline in Clinical Global Impression - Severity (CGI-S) Total Score at Weeks 1, 4, 8, 12, 16, and 22
Change at Week 12
|
-1.5 Units on a scale
Standard Error 0.21
|
-1.9 Units on a scale
Standard Error 0.22
|
|
Change From Baseline in Clinical Global Impression - Severity (CGI-S) Total Score at Weeks 1, 4, 8, 12, 16, and 22
Change at Week 16
|
-1.9 Units on a scale
Standard Error 0.23
|
-2.1 Units on a scale
Standard Error 0.24
|
|
Change From Baseline in Clinical Global Impression - Severity (CGI-S) Total Score at Weeks 1, 4, 8, 12, 16, and 22
Change at Week 22
|
-2.0 Units on a scale
Standard Error 0.24
|
-2.3 Units on a scale
Standard Error 0.25
|
SECONDARY outcome
Timeframe: Baseline and Weeks 1, 4, 8, 12, 16, and 22Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=47 Participants
Participants received placebo subcutaneous (SC) injection on Day 1, Day 28 and Day 56, while continuing their baseline oral monoaminergic antidepressant(s).
|
Sirukumab 50 mg
n=47 Participants
Participants received sirukumab 50 milligram (mg) on Day 1, Day 28 and Day 56, while continuing their baseline oral monoaminergic antidepressant(s).
|
|---|---|---|
|
Change From Baseline in Patient Health Questionnaire (PHQ-9) Total Score at Weeks 1, 4, 8, 12, 16, and 22
Change at Week 1
|
-2.5 Units on a scale
Standard Error 0.58
|
-3.1 Units on a scale
Standard Error 0.61
|
|
Change From Baseline in Patient Health Questionnaire (PHQ-9) Total Score at Weeks 1, 4, 8, 12, 16, and 22
Change at Week 4
|
-4.4 Units on a scale
Standard Error 0.75
|
-5.3 Units on a scale
Standard Error 0.79
|
|
Change From Baseline in Patient Health Questionnaire (PHQ-9) Total Score at Weeks 1, 4, 8, 12, 16, and 22
Change at Week 8
|
-5.6 Units on a scale
Standard Error 0.86
|
-7.6 Units on a scale
Standard Error 0.87
|
|
Change From Baseline in Patient Health Questionnaire (PHQ-9) Total Score at Weeks 1, 4, 8, 12, 16, and 22
Change at Week 12
|
-7.5 Units on a scale
Standard Error 0.98
|
-8.9 Units on a scale
Standard Error 1.00
|
|
Change From Baseline in Patient Health Questionnaire (PHQ-9) Total Score at Weeks 1, 4, 8, 12, 16, and 22
Change at Week 16
|
-8.2 Units on a scale
Standard Error 0.98
|
-9.6 Units on a scale
Standard Error 1.00
|
|
Change From Baseline in Patient Health Questionnaire (PHQ-9) Total Score at Weeks 1, 4, 8, 12, 16, and 22
Change at Week 22
|
-9.1 Units on a scale
Standard Error 1.04
|
-10.7 Units on a scale
Standard Error 1.05
|
SECONDARY outcome
Timeframe: Baseline and Weeks 1, 4, 8, 12, 16, and 22Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=47 Participants
Participants received placebo subcutaneous (SC) injection on Day 1, Day 28 and Day 56, while continuing their baseline oral monoaminergic antidepressant(s).
|
Sirukumab 50 mg
n=47 Participants
Participants received sirukumab 50 milligram (mg) on Day 1, Day 28 and Day 56, while continuing their baseline oral monoaminergic antidepressant(s).
|
|---|---|---|
|
Change From Baseline in Snaith Hamilton Pleasure Scale (SHAPS) Total Score (Definition 1) at Weeks 1, 4, 8, 12, 16, and 22
Change at Week 1
|
-1.4 Units on a scale
Standard Error 0.72
|
-3.3 Units on a scale
Standard Error 0.74
|
|
Change From Baseline in Snaith Hamilton Pleasure Scale (SHAPS) Total Score (Definition 1) at Weeks 1, 4, 8, 12, 16, and 22
Change at Week 4
|
-3.9 Units on a scale
Standard Error 0.75
|
-5.1 Units on a scale
Standard Error 0.78
|
|
Change From Baseline in Snaith Hamilton Pleasure Scale (SHAPS) Total Score (Definition 1) at Weeks 1, 4, 8, 12, 16, and 22
Change at Week 8
|
-5.8 Units on a scale
Standard Error 0.87
|
-7.0 Units on a scale
Standard Error 0.88
|
|
Change From Baseline in Snaith Hamilton Pleasure Scale (SHAPS) Total Score (Definition 1) at Weeks 1, 4, 8, 12, 16, and 22
Change at Week 12
|
-5.9 Units on a scale
Standard Error 1.00
|
-8.9 Units on a scale
Standard Error 1.02
|
|
Change From Baseline in Snaith Hamilton Pleasure Scale (SHAPS) Total Score (Definition 1) at Weeks 1, 4, 8, 12, 16, and 22
Change at Week 16
|
-7.0 Units on a scale
Standard Error 1.11
|
-8.8 Units on a scale
Standard Error 1.12
|
|
Change From Baseline in Snaith Hamilton Pleasure Scale (SHAPS) Total Score (Definition 1) at Weeks 1, 4, 8, 12, 16, and 22
Change at Week 22
|
-7.8 Units on a scale
Standard Error 1.11
|
-10.6 Units on a scale
Standard Error 1.12
|
SECONDARY outcome
Timeframe: Baseline and Weeks 1, 4, 8, 12, 16, and 22Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=47 Participants
Participants received placebo subcutaneous (SC) injection on Day 1, Day 28 and Day 56, while continuing their baseline oral monoaminergic antidepressant(s).
|
Sirukumab 50 mg
n=47 Participants
Participants received sirukumab 50 milligram (mg) on Day 1, Day 28 and Day 56, while continuing their baseline oral monoaminergic antidepressant(s).
|
|---|---|---|
|
Change From Baseline in Snaith Hamilton Pleasure Scale (SHAPS) Total Score (Definition 2) at Weeks 1, 4, 8, 12, 16, and 22
Change at Week 1
|
-1.2 Units on a scale
Standard Error 0.45
|
-2.0 Units on a scale
Standard Error 0.47
|
|
Change From Baseline in Snaith Hamilton Pleasure Scale (SHAPS) Total Score (Definition 2) at Weeks 1, 4, 8, 12, 16, and 22
Change at Week 4
|
-2.2 Units on a scale
Standard Error 0.49
|
-3.3 Units on a scale
Standard Error 0.51
|
|
Change From Baseline in Snaith Hamilton Pleasure Scale (SHAPS) Total Score (Definition 2) at Weeks 1, 4, 8, 12, 16, and 22
Change at Week 8
|
-3.6 Units on a scale
Standard Error 0.57
|
-4.4 Units on a scale
Standard Error 0.57
|
|
Change From Baseline in Snaith Hamilton Pleasure Scale (SHAPS) Total Score (Definition 2) at Weeks 1, 4, 8, 12, 16, and 22
Change at Week 12
|
-3.7 Units on a scale
Standard Error 0.64
|
-5.4 Units on a scale
Standard Error 0.66
|
|
Change From Baseline in Snaith Hamilton Pleasure Scale (SHAPS) Total Score (Definition 2) at Weeks 1, 4, 8, 12, 16, and 22
Change at Week 16
|
-4.1 Units on a scale
Standard Error 0.69
|
-5.6 Units on a scale
Standard Error 0.70
|
|
Change From Baseline in Snaith Hamilton Pleasure Scale (SHAPS) Total Score (Definition 2) at Weeks 1, 4, 8, 12, 16, and 22
Change at Week 22
|
-4.6 Units on a scale
Standard Error 0.71
|
-6.8 Units on a scale
Standard Error 0.72
|
SECONDARY outcome
Timeframe: Baseline and Weeks 1, 4, 8, 12, 16, and 22Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=47 Participants
Participants received placebo subcutaneous (SC) injection on Day 1, Day 28 and Day 56, while continuing their baseline oral monoaminergic antidepressant(s).
|
Sirukumab 50 mg
n=47 Participants
Participants received sirukumab 50 milligram (mg) on Day 1, Day 28 and Day 56, while continuing their baseline oral monoaminergic antidepressant(s).
|
|---|---|---|
|
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Total Score at Weeks 1, 4, 8, 12, 16, and 22
Change at Week 1
|
1.75 Units on a scale
Standard Deviation 4.671
|
4.91 Units on a scale
Standard Deviation 10.097
|
|
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Total Score at Weeks 1, 4, 8, 12, 16, and 22
Change at Week 4
|
6.87 Units on a scale
Standard Deviation 10.119
|
6.44 Units on a scale
Standard Deviation 9.633
|
|
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Total Score at Weeks 1, 4, 8, 12, 16, and 22
Change at Week 8
|
8.93 Units on a scale
Standard Deviation 9.913
|
10.09 Units on a scale
Standard Deviation 10.346
|
|
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Total Score at Weeks 1, 4, 8, 12, 16, and 22
Change at Week 12
|
11.65 Units on a scale
Standard Deviation 13.476
|
13.82 Units on a scale
Standard Deviation 11.486
|
|
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Total Score at Weeks 1, 4, 8, 12, 16, and 22
Change at Week 16
|
13.55 Units on a scale
Standard Deviation 12.029
|
13.95 Units on a scale
Standard Deviation 12.066
|
|
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Total Score at Weeks 1, 4, 8, 12, 16, and 22
Change at Week 22
|
14.54 Units on a scale
Standard Deviation 13.585
|
17.23 Units on a scale
Standard Deviation 12.051
|
Adverse Events
Placebo
Sirukumab 50 mg
Serious adverse events
| Measure |
Placebo
n=99 participants at risk
Participants received placebo subcutaneous (SC) injection on Day 1, Day 28 and Day 56, while continuing their baseline oral monoaminergic antidepressant(s).
|
Sirukumab 50 mg
n=94 participants at risk
Participants received sirukumab 50 milligram (mg) on Day 1, Day 28 and Day 56, while continuing their baseline oral monoaminergic antidepressant(s).
|
|---|---|---|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.00%
0/99 • Approximately 26 weeks
|
1.1%
1/94 • Approximately 26 weeks
|
|
Infections and infestations
Cellulitis
|
0.00%
0/99 • Approximately 26 weeks
|
1.1%
1/94 • Approximately 26 weeks
|
|
Investigations
Transaminases Increased
|
1.0%
1/99 • Approximately 26 weeks
|
0.00%
0/94 • Approximately 26 weeks
|
|
Psychiatric disorders
Depression Suicidal
|
0.00%
0/99 • Approximately 26 weeks
|
1.1%
1/94 • Approximately 26 weeks
|
|
Psychiatric disorders
Suicide Attempt
|
1.0%
1/99 • Approximately 26 weeks
|
0.00%
0/94 • Approximately 26 weeks
|
Other adverse events
| Measure |
Placebo
n=99 participants at risk
Participants received placebo subcutaneous (SC) injection on Day 1, Day 28 and Day 56, while continuing their baseline oral monoaminergic antidepressant(s).
|
Sirukumab 50 mg
n=94 participants at risk
Participants received sirukumab 50 milligram (mg) on Day 1, Day 28 and Day 56, while continuing their baseline oral monoaminergic antidepressant(s).
|
|---|---|---|
|
General disorders
Injection Site Erythema
|
0.00%
0/99 • Approximately 26 weeks
|
11.7%
11/94 • Approximately 26 weeks
|
|
General disorders
Injection Site Pain
|
1.0%
1/99 • Approximately 26 weeks
|
5.3%
5/94 • Approximately 26 weeks
|
|
Nervous system disorders
Headache
|
12.1%
12/99 • Approximately 26 weeks
|
5.3%
5/94 • Approximately 26 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
- Publication restrictions are in place
Restriction type: OTHER