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New treatment option for Lung Transplant
Official title Tocilizumab in Lung Transplantation
ClinicalTrials.gov ID: NCT06033196
What this study is testing
What is Tocilizumab?
Tocilizumab is an investigational medicine, being studied as a potential treatment for lung transplant.
Also referred to as ACTEMRA.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
- Time commitment: about 20 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 75
You may be able to join 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
You likely can't join 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
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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...
- 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...
- 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
What rules you out
- 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...
- 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...
- 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
- Any condition that in the opinion of the site Principal Investigator (PI) introduces undue risk by participating in this study Randomization:
- Recipient of multi-organ or tissue transplants
- Clinically stable, without clinical evidence of untreated infection
- Received a live virus vaccine within 30 days prior to randomization
- Received treatment to deplete HLA antibodies before transplantation to improve the possibility of transplantation
- Patients with known donor-specific antibody that will require intervention based on local clinical protocols
- History of GI tract perforation
- History of inflammatory bowel disease except fully excised ulcerative colitis
- History of diverticulitis (diverticulosis is not an exclusion) or diverticular bleeding
- History of severe allergic anaphylactic reactions to humanized or murine monoclonal antibodies
- Known hypersensitivity to ACTEMRA® (tocilizumab)
- Previous treatment with ACTEMRA® (tocilizumab) within the last 3 months.
- Recipient or donor with infection with human immunodeficiency virus (HIV)
- Recipient with hepatitis B virus surface antigen or hepatitis B core antibody positive
- Hepatitis B negative transplant recipient that received a transplant from a Hepatitis B core antibody positive donor unless the recipient has a Hepatitis B Surface Antigen (HBsAb) titer \>10U/L
- Recipient of a hepatitis C virus nucleic acid test (NAT) positive donor organ
- Latent TB infection (LTBI) and has not completed appropriate therapy
- 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 (except for non-melanoma skin cancer)
- 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
- Patients with AST or ALT levels \> 1.5 times upper limit of normal (last measurement within 1 day prior to randomization)
- Patients with platelet count \<100,000/mm\^3 (last measurement within 1 day prior to randomization)
- Patients with an absolute neutrophil count (ANC) \<2,000/mm\^3 (last measurement within 1 day prior to randomization)
- Patients who are administered anti-thymocyte globulin as induction therapy in the immediate post- transplant period
- Patients who have been treated in the past 3 months, or for whom it is anticipated that treatment with any immunomodulatory biological agents post-transplant are excluded
- Use of an investigational drug after transplant
- Smoking or vaping since enrollment
- Any condition that in the opinion of the site PI introduces undue risk by participating in this study
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Beverly Hills, California, United States
- Los Angeles, California, United States
- Gainesville, Florida, United States
- Atlanta, Georgia, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Rochester, Minnesota, United States
- St Louis, Missouri, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Cleveland, Ohio, United States
- Columbus, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Nashville, Tennessee, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
- Salt Lake City, Utah, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 20 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Beverly Hills, California, United States; Los Angeles, California, United States; Gainesville, Florida, United States; Atlanta, Georgia, United States; Baltimore, Maryland, United States and 13 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.