The ElevAATe-OLE Study for patients with Alpha-1 Antitrypsin Deficiency (Alpha-1) and emphysema is NOW Enrolling!
About the ElevAATe-OLE Study
The INBRX101-01-202 Study (which is also called the ElevAATe-OLE Study) is a phase 2, open-label extension (OLE) of the ElevAATe study, developed to evaluate long term safety and clinical efficacy of SAR447537(INBRX-101) in adults with Alpha-1 emphysema.
This multi-center investigational study strives to improve the quality of life of the patients with Alpha-1 and emphysema, by potentially extending the time between dosing intervals for patients on augmentation therapy. In this study, participants will receive SAR447537 (INBRX-101) once every 3 weeks or every 4 weeks for approximately 3 years.
All participants in this investigational study will receive only SAR447537 (INBRX-101) and there will be no placebo group.
SAR447537 (INBRX-101) is a recombinant form of augmentation therapy that has been engineered to last longer in the body. This means that SAR447537 (INBRX-101) could potentially be given less frequently than currently approved A1PI augmentation therapies, while keeping the levels of AAT in the normal range.
Your participation in the ElevAATe-OLE study will last up to 175 weeks and compensation may be provided and travel costs, such as mileage, taxi, airfare, hotel stays related to study visits will be reimbursed.
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-OLE Study?
You may be able to join the INBRX101-01-202 Trial if you:
- Individuals aged 18 to 80 years
- Have a confirmed diagnosis of Alpha-1 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.
