Using tocilizumab to treat acute chest syndrome in sickle cell disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II interventional study evaluates the effectiveness of a low dose of tocilizumab in treating acute chest syndrome in patients with sickle cell disease. Participants aged 12 and older will be randomly assigned to receive either tocilizumab or a placebo, with doses administered intravenously. The study will monitor oxygen levels, clinical outcomes, and laboratory markers over the course of hospitalization. The goal is to determine if tocilizumab can improve patient outcomes by targeting elevated interleukin-6 levels associated with acute chest syndrome.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adults ≥ 12 years of age
* Prior diagnosis of sickle cell disease (Hb SS, Hb SC, Hb Sb+, and Hb Sb0)

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 the upper 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 the following: 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 versions thereof) 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

Where it's running

• University of Chicago
  Chicago, Illinois, United States Recruiting

Study contacts

• Principal investigator: Gabrielle Lapping-Carr, MD — University of Chicago
• Study coordinator: Gabrielle Lapping-Carr, MD
• Email: glappingcarr@uchicago.edu
• Phone: 773-702-6808

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Tocilizumab for Acute Chest Syndrome in Sickle Cell Disease

  This study tests whether a single infusion of tocilizumab can help people with sickle cell disease and acute chest syndrome come off oxygen and respiratory support faster.

  Recruiting Phase 3 Assistance Publique - Hôpitaux de Paris · Paris · NCT06818266

• Morphine removal and kidney filtering in adults with sickle cell crises in intensive care

  This project will test how quickly morphine is cleared from the body in adults with sickle cell disease admitted to intensive care for vaso-occlusive crisis or acute chest syndrome, and whether faster kidney filtering leads to lower morphine levels.

  Recruiting University Hospital, Tours · Tours, France and 5 other locations · NCT07246265

• Anticoagulation Plus Tocilizumab for Acute Cerebral Venous Thrombosis

  This study tests whether adding a single dose of tocilizumab to standard blood thinners helps people with acute cerebral venous thrombosis.

  Recruiting Capital Medical University · Beijing, Beijing Municipality · NCT07801638

• Cerebrovascular Reactivity Testing with HD-DOT in Sickle Cell Patients

  This study tests whether high-density diffuse optical tomography can measure brain blood flow and oxygen use in people with sickle cell disease, to see how these signals relate to stroke risk.

  Recruiting Washington University School of Medicine · St Louis, Missouri · NCT07776444

• Adapting and testing PEN-Plus in Zambian primary care

  Aiming to see if the PEN-Plus package can be adapted and used in two Zambian hospitals to better manage chronic diseases like heart disease, diabetes, hypertension, and sickle cell in primary care.

  Recruiting Centre for Infectious Disease Research in Zambia · Lusaka, Lusaka Province · NCT07753681

• Newborn Sickle Cell Screening in Mozambique

  We’re testing a three-part plan to help babies in Mozambique get diagnosed early for sickle cell disease and start care quickly.

  Recruiting St. Jude Children's Research Hospital · Nhamatanda, Sofala · NCT07719972

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.