Tocilizumab in Lung Transplantation

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Lung Transplant

In brief

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

Key facts

Study ID

NCT06033196

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

350

Starts

2024-02-13

Expected to finish

2029-01-08

Last updated by the study team

2026-06-16

Who can join

Age: 12 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Study Entry:
• Subject and/or parent guardian must be able to understand the purpose of the study and willing to participate and sign informed consent/assent
• Greater than or equal to 30 kg body weight
• Listed or received for a primary lung transplant
• No previous or planned desensitization therapy prior to transplant
• Serum Immunoglobulin G (IgG) level greater than 400 mg/dL. Patients treated with intravenous immune globulin (IVIG) for hypogammaglobulinemia are eligible for enrollment if their serum IgG level is greater than 400 mg/dL 14 or more days after the most recent IVIG treatment
• For women of child-bearing potential, willingness to use highly-effective contraception; according to the Food and Drug Administration (FDA) Office of Women's Health (http://www.fda.gov/birthcontrol).
• Female participants of child-bearing potential must consult with their physician and determine the most suitable method(s) from this list to be used for the duration of the study. Those who choose oral contraception must agree to use a second form of contraception after administration of study drug for a period of 1 year after the last dose of study drug
• Tested negative for latent TB infection (LTBI) using a PPD or interferon-gamma release assay (i.e., QuantiFERON-TB, T-SPOT.TB) within 1 year prior to transplant or has completed appropriate LTBI therapy within the 1 year prior to transplant
• Vaccinations must be up to date per the Division of Allergy, Immunology, and Transplantation (DAIT) Guidance for Patients in Transplant Trials
• Randomization:
• Provide written informed consent for the study participation, and agree to continue in the study
• Received a single or bilateral lung transplant
• Agreement to use contraception; according to the FDA Office of Women's Health (http://www.fda.gov/birthcontrol), there are a number of birth control methods that are more than 80% effective. Female participants of child-bearing potential must consult with their physician and determine the most suitable method(s) from this list to be used for the duration of the study. Those who choose oral contraception must agree to use a second form of contraception after administration of study drug for a period of 1 year after the last dose of study drug
• Negative physical crossmatch at the time of transplant or a crossmatch result that did not require specific treatment per the site's clinical protocol
• Underwent bronchoscopy and found to have satisfactory bronchial anastomotic healing
• No desensitization therapy prior to transplant
• Negative pregnancy test (serum or urine) for women of child-bearing potential within 48 hours prior to randomization
• Recipient of lungs that have been supported with ex vivo lung perfusion (EVLP) devices are permitted

You may not qualify if…

• Study Entry:
• Listed for multi-organ transplant (e.g., heart-lung, liver-lung, kidney-lung)
• Prior history of allogeneic organ or cellular transplantation
• Received treatment to deplete Human Leukocyte Antigens (HLA) antibodies before transplantation
• Currently breast-feeding a child or plans to become pregnant during the timeframe of the study follow up period
• History of severe allergic and/or anaphylactic reactions to humanized or murine monoclonal antibodies
• Known hypersensitivity or previous treatment with ACTEMRA(R) (tocilizumab) within the last 3 months
• Infection with human immunodeficiency virus (HIV)
• Hepatitis B virus surface antigen or core antibody positive
• Hepatitis C virus PCR positive (HCV+) patients who have failed to demonstrate sustained viral remission (2 consecutive PCR or Nucleic Acid Tests (NAT) negative tests at least 24 weeks apart), with or without anti-viral treatment;
• Chronic infection with Burkholderia cenocepacia or Burkholderia gladioli
• Non-tuberculous mycobacterial (NTM) pulmonary disease; if there is a history of NTM pulmonary disease, culture conversion is necessary for eligibility
• Presence of active malignancy or history of malignancy less than 5 years in remission, excluding adequately treated in-situ cervical carcinoma, low grade prostate carcinoma, or adequately treated basal or squamous cell carcinoma of the skin
• History of hemolytic-uremic syndrome/ thrombotic thrombocytopenia purpura
• History of demyelinating disorders (e.g., multiple sclerosis, chronic inflammation demyelinating polyneuropathy)
• Current treatment with alkylating agents such as cyclophosphamide
• History of gastrointestinal (GI) tract perforation
• History of inflammatory bowel disease except fully excised ulcerative colitis
• Any history of diverticulitis (event if not perforated) or confirmed diverticular bleeding. (Diverticulosis is not an exclusion).
• Patients with a platelet count < 100,000/mm\^3 (last measurement within 7 days prior to enrollment)
• Patients with an absolute neutrophil count (ANC) < 2,000/mm\^3 (last measurement within 7 days prior to enrollment)
• Patients with Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) levels >3 times upper limit of normal
• Patients who use illegal drugs
• Smoking or vaping within 6 months of listing for transplant
• Use of investigational drugs within 4 weeks prior to enrollment

Where it is running

• St. Joseph's Hospital and Medical Center (Site #: 71192) — Phoenix, Arizona, United States (enrolling)
• Cedars Sinai Medical Center (Site #: 71146) — Beverly Hills, California, United States (enrolling)
• David Geffen School of Medicine at UCLA (Site #: 71123) — Los Angeles, California, United States (enrolling)
• Massachusetts General Hospital (Site #: 71107) — Boston, Massachusetts, United States (enrolling)
• Barnes Jewish Hospital/ Washington University SOM (Site #: 71191) — St Louis, Missouri, United States (enrolling)
• Columbia University Medical Center (Site #: 71113) — New York, New York, United States (enrolling)
• Duke University Medical Center (Site #: 71139) — Durham, North Carolina, United States (enrolling)
• Cleveland Clinic (Site #: 71101) — Cleveland, Ohio, United States (enrolling)
• Ohio State University Medical Center (Site #: 71196) — Columbus, Ohio, United States (enrolling)
• University of Texas Southwestern (Site #: 71187) — Dallas, Texas, United States (enrolling)
• University of Utah Medical Center (Site #: 71126) — Salt Lake City, Utah, United States (enrolling)
• Temple University (Site #: 71197) — Philadelphia, Pennsylvania, United States
• Vanderbilt University (Site #: 71174) — Nashville, Tennessee, United States
• University of Florida Shands Hospital (Site #: 71131) — Gainesville, Florida, United States
• Emory University (Site #: 71103) — Atlanta, Georgia, United States
• University of Maryland Medical Center (Site #: 71138) — Baltimore, Maryland, United States
• University of Texas Health Science at San Antonio (Site #: 71198) — San Antonio, Texas, United States
• Boston Children's Hospital and Harvard Medical School (Site #: 71001) — Boston, Massachusetts, United States
• Mayo Clinic Rochester (Site #: 71160) — Rochester, Minnesota, United States
• Houston Methodist Hospital (Site #: 71120) — Houston, Texas, United States
• St. Louis Children's Hospital of Washington University (Site #: 71006) — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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