Tocilizumab for Acute Chest Syndrome

Last updated: April 1, 2025
Sponsor: University of Chicago
Overall Status: Active - Recruiting

Phase

2

Condition

Sickle Cell Disease

Red Blood Cell Disorders

Treatment

Tocilizumab

Clinical Study ID

NCT05640271
IRB22-0277
  • Ages > 12
  • All Genders

Study Summary

The investigators are evaluating the role of a low dose of tocilizumab in treating acute chest syndrome in patients with sickle cell disease. Tocilizumab inhibits interleukin-6 (IL-6) receptors and is used to treat rheumatoid arthritis and severe cytokine release syndrome, which can be seen with chimeric antigen receptor T-cell (CAR-T) therapy, and it is also authorized for treatment of COVID-19. Since IL-6 levels are elevated in the sputum of patients with acute chest syndrome, the investigators are hopeful that this will be an effective strategy. The investigators will be looking at how a low dose of tocilizumab affects oxygen status, clinical outcomes, and laboratory markers in patients admitted to the hospital with acute chest syndrome.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adults ≥ 12 years of age

  • Prior diagnosis of sickle cell disease (Hb SS, Hb SC, Hb Sb+, and Hb Sb0)

Exclusion

Exclusion Criteria:

  • Pregnant patients or breastfeeding mothers.

  • Prior treatment with gene therapy or a stem cell transplant.

  • Current enrollment in a clinical trial involving an FDA-regulated drug or biologic.

  • Current neutropenia (absolute neutrophil count < 1000/mm^3)

  • Current thrombocytopenia (platelet count < 50,000 mm^3)

  • Aspartate aminotransferase (AST) or alanine transaminase (ALT) > 10 times theupper limit of normal (ULN)

  • History of tuberculosis (TB).

  • Positive purified protein derivative (PPD) TB screening test.

  • On active therapy with a Bruton's tyrosine kinase-targeted agent, which include thefollowing: Acalabrutinib, Ibrutinib, Zanubrutinib

  • On active therapy with a JAK2-targeted agent, which include the following:Baricitinib, Ruxolitinib, Tofacitinib, Upadacitinib

  • Any of the following biologic immunosuppressive agent (and any biosimilar versionsthereof) administered in the past 6 months:

Abatacept, Adalimumab, Alemtuzumab, Atezolizumab, Belimumab, Blinatumomab, Brentuximab, Certolizumab, Daratumumab, Durvalumab, Eculizumab, Elotuzumab, Etanercept, Gemtuzumab, Golimumab, Ibritumomab, Infliximab, Inotuzumab, Ipilimumab, Ixekizumab, Moxetumomab, Nivolumab, Obinutuzumab, Ocrelizumab, Ofatumumab, Pembrolizumab, Polatuzumab, Rituximab, Sarilumab, Secukinumab, Tocilizumab, Tositumumab, Tremelimumab, Urelumab, Ustekinumab

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: Tocilizumab
Phase: 2
Study Start date:
April 10, 2023
Estimated Completion Date:
January 31, 2027

Study Description

In this randomized, placebo-controlled, double-blinded phase II study, enrolled patients admitted to the University of Chicago who are diagnosed with acute chest syndrome will receive one dose of tocilizumab 80 mg IV and one normal saline placebo dose. The order of these doses will be randomized at a 1:1 ratio. After collecting oxygenation data as a baseline for 8 hours, patients will then receive tocilizumab versus placebo as their early dose and then the opposite (placebo versus tocilizumab) 48 hours later. Clinical, laboratory, and patient-reported outcome data will be collected during their admission and compared between arms.

Connect with a study center

  • University of Chicago

    Chicago, Illinois 60637
    United States

    Active - Recruiting

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