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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: Recruiting Phase 2 study, sponsored by Icahn School of Medicine at Mount Sinai.
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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Change in ventral stratal activation (brain response) during reward processing (fMRI)
Interventions
- DRUG Tocilizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2026-03-26 |
| Est. Completion | 2031-02-06 |
| Phase | Phase 2 |
What NCT07493317 shows while recruiting
NCT07493317 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 1 intervention - of which Tocilizumab is the first listed.
NCT07493317 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07493317's enrollment target sits among peer trials
60 1027th of 2000 higher than 868 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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