What is the SApHiAre Study?
This is a research study for adults with warm autoimmune hemolytic anemia (wAIHA). The purpose of this study is to learn if a new investigational drug called obexelimab [ah-bex-EL-ih-mab] can safely help anemia caused by wAIHA.
Who can join this study?
The study will include approximately 134 participants worldwide. You may be able to join the study if you:
Age
Are at least 18 years old and have reached the age of consent in your region
Symptoms
Have symptoms of anemia related to wAIHA requiring treatment
Diagnosis
Have been diagnosed with wAIHA
Also...
There are additional criteria to join. The study doctor will discuss them with you.
How long does the study last?
The study is divided into Parts A, B, and C.
If you are able to join the study, you will be assigned to Part A or Part B.
After you complete Part A or Part B, you may have the option to continue to Part C, which lasts 1 year.
Screening
Tests will be done to see if the study is right for you.
Part A or Part B:
Study Treatment Period
You will take the study drug (in Part A, active study drug; in Part B, either active study drug or placebo) for 6 months (24 weeks). There will be study visits at the study clinic in between at-home study drug administrations.
Part C:
Open-label Extension (OLE)
If you have completed all study visits up to Week 24 and meet eligibility, you will be asked if you wish to enroll in Part C, where all participants will receive active study drug for 1 year.
Follow-Up
The study doctor will check on you about 3 months (12 weeks) after the final treatment visit.
What is the study drug?
If you are in Part A, you will receive obexelimab. If you are in Part B, you will be randomly assigned, like tossing a coin, to receive obexelimab or placebo.
Having some participants take a placebo helps the study doctors and researchers tell the difference between what effects are caused by obexelimab and what effects may be happening by chance. In Part B, neither you nor your study doctor will know which one you are receiving.
The study drug (obexelimab or placebo) is given as an injection under the skin every 7 days. At first you will receive the injection at the study clinic. Then, you or a caregiver may be trained to give the injection at home, or you can continue to come to the study clinic for the injection.
You can take rescue medication or get a blood transfusion if you need to at any time during the study.
What happens during the study?
At study visits, you’ll generally answer questions and have health checks and tests. There will be at least 18 study clinic visits if you are in Part A and at least 16 study clinic visits if you are in Part B. For Part C: Open-label Extension, there will be a minimum of 15 study clinic visits.
Health review
Medication review
Questionnaires
Vital signs
Physical exam
ECG heart test
Blood tests
Urine test
Pregnancy test
(if applicable)