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NCT07493317 · ClinicalTrials.gov registry record · Phase 2
Neutralizing Interleukin (IL)-6
A Phase 2 study, sponsored by Icahn School of Medicine at Mount Sinai.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
NCT07493317 is a Phase 2 study that is actively recruiting participants, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 60 participants.
The verdict
NCT07493317, a Phase 2 study, is actively recruiting participants, sponsored by Icahn School of Medicine at Mount Sinai.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
Study Summary
The proposed study aims to establish the feasibility and safety of subcutaneous tocilizumab, a monoclonal antibody (mAb) against interleukin (IL)-6 receptor, in adults with Major Depressive Disorder (MDD) and evidence of peripheral immune activation. IL-6 is a pro-inflammatory cytokine implicated in the pathophysiology of depression. The investigators hypothesize that neutralizing peripheral immune signaling via IL-6 receptor blockade with tocilizumab will improve neural and behavioral measures of reward processing. This is an open-label, proof-of concept, trial in which up to N=20 adults with MDD meeting a specific immune enrichment criterion will receive open-label tocilizumab over 8 weeks. A healthy control (HC) group (N=20) will undergo baseline neuroimaging and blood-based biomarker assessment without receiving the study drug to aid interpretation of findings. Blood-based immune markers and brain MRI scans (including task-based reward activation and resting-state functional connectivity) will be assessed at baseline for all participants and again post treatment for the MDD group.
Interventions
- DRUG Tocilizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2026-03-26 |
| Est. Completion | 2031-02-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07493317
The ClinicalTrials.gov registry entry for NCT07493317 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Tocilizumab is the first listed.
NCT07493317 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07493317 about?
NCT07493317 is a clinical study titled "Neutralizing Interleukin (IL)-6". The proposed study aims to establish the feasibility and safety of subcutaneous tocilizumab, a monoclonal antibody (mAb) against interleukin (IL)-6 receptor, in adults with Major Depressive Disorder (MDD) and evidence of peripheral immune activation. IL-6 is a pro-inflammatory cytokine implicated in...
What is the current status of trial NCT07493317?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2026-03-26. Estimated completion is 2031-02-06.
What interventions are being tested in trial NCT07493317?
The interventions under investigation include: Tocilizumab (DRUG).
Who is sponsoring clinical trial NCT07493317?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
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