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NCT06033196 · ClinicalTrials.gov registry record · Phase 2

Tocilizumab in Lung Transplantation

A Phase 2 study of Lung Transplant, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Recruiting
Registry status
Phase 2
Development phase
350
Enrollment target
20
Study locations

NCT06033196: Recruiting Phase 2 study of Lung Transplant, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

NCT06033196 is a Phase 2 study of Lung Transplant that is actively recruiting participants, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 350 participants, below the 1,253-participant average among 15 other Lung Transplant trials with a reported enrollment target (72% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06033196, a Phase 2 study of Lung Transplant, is actively recruiting participants, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

RECRUITING
Registry status
Phase 2
Development phase
350 participants
Enrollment target
20
Study locations

Study Summary

This is a trial in which 350 primary lung transplant recipients will be randomized (1:1) to receive either Tocilizumab (six doses over 20 weeks) plus standard triple maintenance immunosuppression or placebo (sterile normal saline) plus standard triple maintenance immunosuppression (Tacrolimus, Mycophenolate Mofetil, corticosteroids). The primary objective is to test the hypothesis that treatment with triple maintenance immunosuppression plus Tocilizumab (TCZ) is superior to triple maintenance immunosuppression plus placebo (saline) as defined by a composite endpoint of a) CLAD, b) listed for re-transplantation, and c) death

Primary Outcome

1. The development of Chronic Lung Allograft Dysfunction (CLAD) * The development of any form of CLAD will be defined according to the standard 2019 The International Society for Heart and Lung Transplantation (ISHLT) criteria. 2. Listed for re-transplantation * Re-transplantation defined as the subject has been formally registered on the United Network for Organ Sharing (UNOS) waiting list to undergo a second lung transplant surgery 3. Death * Primary analysis will be conducted acco

Conditions Studied

Interventions

  • DRUG Tocilizumab
  • DRUG Placebo for Tocilizumab

Study Locations (20)

Texas

  • University of Texas Southwestern (Site #: 71187) - Dallas
  • Houston Methodist Hospital (Site #: 71120) - Houston
  • University of Texas Health Science at San Antonio (Site #: 71198) - San Antonio

California

  • Cedars Sinai Medical Center (Site #: 71146) - Beverly Hills
  • David Geffen School of Medicine at UCLA (Site #: 71123) - Los Angeles

Massachusetts

  • Massachusetts General Hospital (Site #: 71107) - Boston
  • Boston Children's Hospital and Harvard Medical School (Site #: 71001) - Boston

Missouri

  • Barnes Jewish Hospital/ Washington University SOM (Site #: 71191) - St Louis
  • St. Louis Children's Hospital of Washington University (Site #: 71006) - St Louis

Ohio

  • Cleveland Clinic (Site #: 71101) - Cleveland
  • Ohio State University Medical Center (Site #: 71196) - Columbus

Arizona

  • St. Joseph's Hospital and Medical Center (Site #: 71192) - Phoenix

Florida

  • University of Florida Shands Hospital (Site #: 71131) - Gainesville

Georgia

  • Emory University (Site #: 71103) - Atlanta

Trial Details

FieldValue
Enrollment Target 350 participants
Start Date 2024-02-13
Est. Completion 2029-01-08
Phase Phase 2

What NCT06033196 shows while recruiting

NCT06033196 is an interventional study that assigns participants to a tested intervention. The registered 350 participants enrollment target is mid-sized for trials with a published cap, below the 1,253-participant average among 15 other Lung Transplant trials with a reported enrollment target (72% lower).

The record links to 1 condition, with Lung Transplant appearing as the primary indexed condition, and to 2 interventions - of which Tocilizumab is the first listed.

NCT06033196 names 20 study sites across 14 states, led by Texas, California, Massachusetts.

Frequently Asked Questions

What is clinical trial NCT06033196 about?

NCT06033196 is a clinical study titled "Tocilizumab in Lung Transplantation". This is a trial in which 350 primary lung transplant recipients will be randomized (1:1) to receive either Tocilizumab (six doses over 20 weeks) plus standard triple maintenance immunosuppression or placebo (sterile normal saline) plus standard triple maintenance immunosuppression (Tacrolimus, Mycop...

What is the current status of trial NCT06033196?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 350 participants. The study started on 2024-02-13. Estimated completion is 2029-01-08.

What conditions does trial NCT06033196 study?

This clinical trial studies the following conditions: Lung Transplant.

What interventions are being tested in trial NCT06033196?

The interventions under investigation include: Tocilizumab (DRUG), Placebo for Tocilizumab (DRUG).

Who is sponsoring clinical trial NCT06033196?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06033196 being conducted?

This trial has 20 study locations across Arizona, California, Florida, Georgia, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Lung Transplant

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06033196's enrollment target sits among peer trials

350 3rd of 15 higher than 13 of 15 other Lung Transplant trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Lung Transplant 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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Source: ClinicalTrials.gov NCT06033196, the US trial registry maintained by the National Library of Medicine. NCT06033196 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.