Neutralizing Interleukin (IL)-6

Conditions

• Major Depressive Disorder

Eligibility Criteria

Sex

ALL

Age

18 Years - 70 Years

Healthy Volunteers

Accepted

Interventions

• Tocilizumab — DRUG
  One treatment condition in an open-label study design: subcutaneous injection of tocilizumab 162 mg at weeks 0, 2, 4, 6, and 8.

Study Details

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.

Key Dates

Start date

Mar 26, 2026

Status verified

Apr 2026

Primary completion

Feb 6, 2031

Completion

Feb 6, 2031

Study Design

Enrollment

60 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Participants with MDD
  MDD participants will receive 5 doses of tocilizumab 162 mg administered via subcutaneous injection every 2 weeks over an 8-week period.
• No Intervention: Healthy Control
  Healthy controls will serve as a baseline comparison group for neuroimaging and biomarker analyses only.

Primary Outcome Measure

Change in ventral stratal activation during reward processing (fMRI) [ Time Frame: at week 0 and week 10 ]

Central Contacts

• Alexia Lizzano
  3322437059
  [email protected]
• Mackenzie Hargrove
  3322437052
  [email protected]

Locations (1)

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