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Long-term, open-label study of SAR447537 (INBRX-101) in adults with alpha-1 antitrypsin deficiency emphysema
EU CTIS ID: 2023-508137-14-00
What this study is testing
To evaluate the long-term safety and tolerability of SAR447537.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Males or females 18-80 years of age, inclusive, at the time of screening.
- Diagnosis of AATD.
- Evidence of emphysema secondary to AATD.
- FEV1 of ≥ 30% predicted at screening and post-bronchodilator FEV1/FVC<0.7.
- Current non-smoking status.
You likely can't join if
- For Newly Identified Participants: Receipt of A1PI augmentation therapy within 5 weeks prior to the first dose of study drug.
- Known or suspected allergy to components of SAR447537, A1PI or human IgG.
- Received IV immunoglobulins, monoclonal antibodies and/or other biologic therapies within 30 days.
- On waiting list for lung or liver transplant.
- Acute respiratory tract infection or COPD exacerbation within 4 weeks prior to or during screening.
- Evidence of decompensated cirrhosis.
See the full eligibility criteria
- Males or females 18-80 years of age, inclusive, at the time of screening.
- Diagnosis of AATD.
- Evidence of emphysema secondary to AATD.
- FEV1 of ≥ 30% predicted at screening and post-bronchodilator FEV1/FVC<0.7.
- Current non-smoking status.
- For Newly Identified Participants: Receipt of A1PI augmentation therapy within 5 weeks prior to the first dose of study drug.
- Known or suspected allergy to components of SAR447537, A1PI or human IgG.
- Received IV immunoglobulins, monoclonal antibodies and/or other biologic therapies within 30 days.
- On waiting list for lung or liver transplant.
- Acute respiratory tract infection or COPD exacerbation within 4 weeks prior to or during screening.
- Evidence of decompensated cirrhosis.
- Active cancers or has a history of malignancy within 5 years prior to screening.
- History of unstable cor pulmonale.
- Uncontrolled diabetes mellitus despite adequate antidiabetic pharmacologic treatment with a screening HbA1c value ≥9%
The study team makes the final eligibility decision.
Where it's taking place
- New Zealand
- United Kingdom
- Australia
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Zealand; United Kingdom; Australia; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.