Help Shape the Future of Warm Autoimmune Hemolytic Anemia Research
Learn more about the warm autoimmune hemolytic anemia (wAIHA) SApHiAre clinical study and how you or a loved one can participate.
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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 call obexelimab
[ah-bex-El-ih-mab] can safely help improve 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:
Why Should I Participate?
By enrolling in this study, your participation may help to advance research.
The study will evaluate if an investigational drug helps to improve anemia and associated symptoms such as:
The study will evaluate if an investigational drug helps to improve anemia and associated symptoms such as:
Fatigue
Weakness
Pallor
Shortness
of breath
of breath
Headache
Rapid Heartbeat
What's Involved?
Phone Call with PatientWing
If you pre-qualify, a PatientWing representative will call you to discuss the study, additional eligibility criteria, and answer your questions. If you are still eligible at the end of this pre-screening call, you will be connected to a member of the team at a study clinic location for additional screening.
Screening at the Study Clinic
Before joining the study, the study team will ensure you have a thorough understanding of the study objectives, procedures, potential risks, and benefits. The team at a participating study clinic will determine if you are eligible to participate in the study.
Study
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.
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:
Study Treatment Period
Once enrolled in the study, you will receive the study drug once a week for 6 months. Some or all of these drug administrations will be done at the study site. If your study doctor agrees, certain visits can be completed at home instead of at the study site.
After the first 6 months of treatment, you and your study doctor can discuss if you are eligible for 1 more year of treatment (see Part C below).
After the first 6 months of treatment, you and your study doctor can discuss if you are eligible for 1 more year of treatment (see Part C below).
Part B:
Study Treatment Period
Once enrolled in the study, you will either receive the study drug or placebo once a week for 6 months. Some or all of these drug administrations will be done at the study site. If your study doctor agrees, certain visits can be completed at home instead of at the study site.
After the first 6 months of treatment on either the study drug or placebo, you and your study doctor can discuss if you are eligible to participate for 1 more year on the study where all patients will receive study drug even if they received placebo before (see Part C below).
After the first 6 months of treatment on either the study drug or placebo, you and your study doctor can discuss if you are eligible to participate for 1 more year on the study where all patients will receive study drug even if they received placebo before (see Part C below).
Part C:
Open-label Extension (OLE)
If you have completed all study visits up to 6 months 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 happens during the study?
Health Review
Medication Review
Questionnaires
Vital Signs
Physical Exams
ECG heart test
Blood tests
Urine test
Pregnancy test
(If applicable)
What is the study Drug?
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.
About the study team
Zenas BioPharma
Zenas BioPharma is a global biopharmaceutical company committed to becoming a leader in the development and delivery of immune-based therapies for patients in need.
PatientWing
Our mission to bring better treatments to more people faster starts with you. We help sponsors find patients to participate in their clinical studies. With our focus on rare diseases and expertise in navigating the enrollment process, we're here for you every step of the way.
Learn About Warm Autoimmune Hemolytic Anemia (wAIHA)
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