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NCT02473289 · ClinicalTrials.gov registry record · Phase 2
An Efficacy and Safety Study of Sirukumab in Participants With Major Depressive Disorder
A Phase 2 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 193
- Enrollment target
NCT02473289: Completed Phase 2 study, sponsored by Janssen Research & Development.
NCT02473289 is a Phase 2 study that has completed, run by Janssen Research & Development. The registered enrollment target is 193 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (45% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02473289, a Phase 2 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 193 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy of sirukumab as adjunctive treatment to antidepressant therapy (monoaminergic antidepressant) where sirukumab (administered as a 50 milligram (mg) subcutaneous (SC) injection at Day 1, Day 28 and Day 56 during the 12- week double-blind treatment period) is compared to adjunctive placebo based on the change from baseline to 12-week endpoint in depressive symptoms as measured by the total score on the Hamilton Depression Rating Scale (HDRS), in participants diagnosed with Major Depressive Disorder (MDD) who have had a suboptimal response to the current standard oral antidepressant therapy and have a screening high sensitivity C-Reactive Protein (hsCRP) \>=0.300 milligram per deciliters (mg/dL) (International System of Units (SI) 3.00 mg/L). A cohort of subjects with hsCRP \<0.300 milligram per deciliter will also be enrolled to allow a better understanding of the relationship between CRP and clinical changes.
Primary Outcome
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
Interventions
- DRUG Placebo
- DRUG Sirukumab 50 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 193 participants |
| Start Date | 2015-07-23 |
| Est. Completion | 2018-05-22 |
| Phase | Phase 2 |
What the finished NCT02473289 record still lists
NCT02473289 is an interventional study that assigns participants to a tested intervention. The registered 193 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (45% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02473289 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02473289 about?
NCT02473289 is a clinical study titled "An Efficacy and Safety Study of Sirukumab in Participants With Major Depressive Disorder". The purpose of this study is to evaluate the efficacy of sirukumab as adjunctive treatment to antidepressant therapy (monoaminergic antidepressant) where sirukumab (administered as a 50 milligram (mg) subcutaneous (SC) injection at Day 1, Day 28 and Day 56 during the 12- week double-blind treatment ...
What is the current status of trial NCT02473289?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 193 participants. The study started on 2015-07-23. Estimated completion is 2018-05-22.
What interventions are being tested in trial NCT02473289?
The interventions under investigation include: Placebo (DRUG), Sirukumab 50 mg (DRUG).
Who is sponsoring clinical trial NCT02473289?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02473289's enrollment target sits among peer trials
193 352nd of 2000 higher than 1,649 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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