The ElevAATe Study for patients with Alpha-1 Antitrypsin Deficiency (AATD) and emphysema Is NOW Enrolling!
About the ElevAATe Study
The INBRX101-01-201 Study (which is also called the ElevAATe study) is a Phase 2 randomized, double-blind, multi-center investigational study, that strives to improve the quality of life of the patients with AATD and emphysema, by potentially extending the time between dosing intervals for patients on augmentation therapy.
All participants in this investigational study will receive an active treatment, either INBRX-101 or Zemaira®. Zemaira® is a human alpha1-proteinase inhibitor (A1PI) augmentation therapy that is approved by the FDA to treat AATD emphysema.
INBRX-101 is a recombinant form of augmentation therapy that has been engineered to last longer in the body. This means that INBRX-101 could potentially be given less frequently than currently approved A1PI augmentation therapies like Zemaira®, while keeping the levels of AAT in the normal range.
Your participation in the ElevAATE study will last less than 1 year and compensation may be provided and travel costs, such as mileage, taxi, airfare, hotel stays related to study visits will be reimbursed.
If you complete the ElevAATe study, you may have the option to participate in a separate long term open label extension (OLE) study INBRX101-01-202 (ElevAATe-OLE). In this study, participants will receive INBRX-101 once every 3 weeks for approximately 3 years. The study drug and study visit assessments will be provided at no cost to you. In addition, the ElevAATe-OLE study is planning to include home/remote health care options to potentially allow some participants to make less frequent visits to the study site.
Who Can Participate in the ElevAATe Study?
You may be able to join the INBRX101-01-201 Trial if you:
- Individuals aged 18 to 80 years
- Have a confirmed diagnosis of AATD with a rare genotype (e.g., PiZZ, PiZNull, PiMaltonZ, PiNullNull, PiMheerlen or other rare genotypes)
- ***Unfortunately, PiSZ, PiMS, and PiMZ genotypes are excluded at this time.
- Have a confirmed or suspected diagnosis of Alpha-1 related emphysema
If you are interested, a participating research site can confirm your Alpha-1 genotype, as well as other study criteria, to determine your eligibility.
By answering the following questions, you agree to have the information you provide retained by the Alpha-1 Foundation and be contacted by phone or email (as provided) regarding interest in study participation only.
