Recruiting
Phase 2

Tocilizumab

Sponsor:

University of Chicago

Code:

NCT05640271

Conditions

Sickle Cell Disease

Acute Chest Syndrome

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

Interventions

Tocilizumab

Study Details

Brief 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.

Conditions

Sickle Cell Disease

Acute Chest Syndrome

Study ID

NCT05640271

Start date

Apr 10, 2023

Status verified date

Mar, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Early Tocilizumab

This arm will receive tocilizumab 80 mg at the time of acute chest syndrome diagnosis and subsequent randomization. Then, two days later, they will receive 50 mL of normal saline.

active comparator: Delayed Tocilizumab

This arm will receive 50 mL of normal saline at the time of acute chest syndrome diagnosis and subsequent randomization. Then, two days later, they will receive tocilizumab 80 mg. Thus, this delayed arm will serve as a placebo comparator for the first 48 hours and then as an active comparator for the remaining duration on study.

Interventions

Tocilizumab

Tocilizumab 80 mg IV dose (one time per patient)

Primary outcome measure

  • Time-weighted SaO2/FiO2 ratio [ Time Frame: Total of 4 days (Day 0 to Day 4) ]

Central Contacts and Locations

Central contacts

Austin Wesevich, MD

773-834-6732austin.wesevich@uchicagomedicine.org

Gabrielle Lapping-Carr, MD

773-702-6808glappingcarr@uchicago.edu

Locations

University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Austin Wesevich, MD

773-834-6732austin.wesevich@uchicagomedicine.org

More Information

Sponsor

University of Chicago

Last update posted

Jul 14, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Chicago on 2026-07-14.