EQUATOR is a Phase 3 clinical research study evaluating the safety and effectiveness of an investigational drug (itolizumab) in people who have recently developed aGVHD. Acute GVHD is a condition that can happen after a hematopoietic stem cell (blood cell) transplant. During the transplant, your body receives new immune cells. Sometimes these transplanted cells can instead attack the tissues in your own body, leading to aGVHD.
Acute GVHD symptoms can range from mild to life-threatening, and include, but are not limited to, the following:
Study participants may be able to join the study if they meet the following requirements:
12 years of age or older and over 40 kilograms (about 88 pounds)
Had a hematopoietic stem cell transplant
Diagnosed with severe aGVHD and have not started any treatment other than systemic corticosteroids*
*Note : systemic corticosteroids must be started less than 72 hours prior to enrolling in the study
Other study requirements will apply.
For those who qualify, participation will last about 1 year and will include:
Participation in a clinical study is voluntary. You may leave the study at any time, for any reason.
The investigational study drug, itolizumab, is designed to target a protein called CD6 on the surface of immune cells (T cells) and lower their ability to cause an immune response.
There is a 50% (1 in 2) chance of receiving the study drug. All patients will receive standard of care corticosteroids, even if they receive placebo.
Investigational means the study drug is not approved by regulatory authorities like the US Food and Drug Administration (FDA), and it can only be used in clinical research studies such as EQUATOR.
Acute GVHD is a condition that can happen after a hematopoietic stem cell (blood cell) transplant. During the transplant, your body receives new immune cells. Sometimes these transplanted immune cells can instead attack the tissues in your own body.
aGVHD symptoms can range from mild to life-threatening, and include, but are not limited to, the following:
Corticosteroids are standard therapy for aGVHD. Your study doctor will explain the benefits and risks of taking corticosteroids. If symptoms do not improve with corticosteroids, your doctor may prescribe other therapies for steroid refractory aGVHD.
Here are some common questions and answers about study participation.
Clinical research studies, or trials, help scientists and doctors explore whether a medical strategy, device, or medication is safe and effective for people. Before any medication can be approved and made available to the public, it must go through several phases of clinical research.
Phase 1: First study of the drug in people (often healthy volunteers but sometimes people with the condition that the drug is designed to improve).
Phase 2: Study of the drug in people with the condition the drug is designed to improve.
Phase 3: Study confirming how effective the drug is for improving the condition.
Phase 4: Continued research after the drug is approved for public use.
EQUATOR is a Phase 3 study.
Participation in clinical research studies is your choice, and you may withdraw from the study at any time. We appreciate and thank you for considering the EQUATOR study.
Before enrolling in a clinical trial, you must sign an Informed Consent Form (ICF). The ICF contains information about the study, including study goals, how long the study will last, benefits and risks, and the tests and procedures you will receive.
Study participation usually involves visiting a clinic regularly, taking or receiving an investigational medicine, and having assessments to monitor your health. You can still see your regular doctor, but you should let them know that you are participating in a study.
Participation in clinical research studies is your choice, and you may stop at any time.
If you have additional questions about participating in a clinical research study, contact a study clinic near you.
Use the interactive map below to find a study clinic location near you. Contact the study clinic to learn more.