SAR447537 for Emphysema

(ELEVAATE OLE Trial)

Recruiting at 56 trial locations

Overseen By Trial Transparency email recommended (Toll free for US & Canada)

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Inhibrx Biosciences, Inc

Must not be taking: A1PI, Immunoglobulins, Biologics, others

Disqualifiers: Diabetes, Cancer, Heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 3 years

185 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called SAR447537 for individuals with emphysema caused by Alpha-1 Antitrypsin Deficiency (AATD). The researchers aim to evaluate the treatment's effectiveness and safety. The experimental approach administers the treatment through an intravenous (IV) injection. Suitable candidates for this trial have emphysema due to AATD, are non-smokers, and have not recently received certain treatments. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group, providing an opportunity to contribute to significant medical advancements.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot have received certain treatments like A1PI therapy or biologic therapies shortly before starting the trial.

Is there any evidence suggesting that SAR447537 is likely to be safe for humans?

Research has shown that SAR447537 (also known as INBRX-101) demonstrates promising safety results. One study reported excellent safety for this treatment in rare lung conditions like alpha-1 antitrypsin deficiency (AATD) emphysema. Participants experienced only minor side effects and handled the treatment well.

Another study examined the safety and tolerability of INBRX-101 and found it dependable. Participants had few side effects, and the treatment was generally well-accepted. These findings suggest that SAR447537 could be a safe option for those considering joining a clinical trial for emphysema related to AATD. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for emphysema focus on symptom management and slowing disease progression, often using bronchodilators, steroids, or supplemental oxygen. But SAR447537 stands out because it is a recombinant, bivalent Fc fusion protein designed for intravenous injection. This unique mechanism targets alpha-1 proteinase inhibitor (A1PI) deficiencies, which are linked to emphysema. Researchers are excited because this approach could address the underlying cause of emphysema in some patients, potentially offering more than just symptom relief.

What evidence suggests that SAR447537 might be an effective treatment for emphysema?

Research shows that SAR447537, also known as INBRX-101, could be a promising treatment for emphysema caused by Alpha-1 Antitrypsin Deficiency (AATD). Studies have found that this treatment can increase levels of the protective protein Alpha-1 Antitrypsin (AAT) in the body more effectively than traditional methods. This is important because AAT helps protect the lungs from damage. Participants in this trial will receive SAR447537. Previous research indicates that patients generally tolerated it well, meaning their bodies accepted the treatment without major side effects. Although research is ongoing, early results are encouraging and suggest that SAR447537 might help improve lung health in people with AATD emphysema. ^{1 3 6 7 8}

Who Is on the Research Team?

Clinical Sciences & Operations

Principal Investigator

Sanofi

Are You a Good Fit for This Trial?

Adults aged 18-80 with Alpha-1 Antitrypsin Deficiency (AATD) and emphysema can join this study. They should have a certain level of lung function, not smoke, and have a confirmed AATD diagnosis. It's not for people outside the age range or those who don't meet these specific health conditions.

Inclusion Criteria

My lung function test shows FEV1 is at least 30% of what's expected and my FEV1/FVC ratio is less than 0.7 after using a bronchodilator.

I have emphysema due to Alpha-1 Antitrypsin Deficiency.

Current non-smoking status

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive SAR447537 (INBRX-101) to evaluate long-term safety and clinical efficacy

3 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• SAR447537

Trial Overview The trial is testing SAR447537 (INBRX-101), which is potentially a new treatment for adults with emphysema due to AATD. This Phase 2 trial allows participants to use the drug over an extended period to assess its long-term effects.

How Is the Trial Designed?

Group I: SAR447537 (INBRX-101) Experimental Treatment 1 Intervention

A1PI, Recombinant, Bivalent Fc Fusion Protein, in a solution for intravenous injection

Who Is Running the Clinical Trial?

Inhibrx Biosciences, Inc

Lead Sponsor

Trials

9

Recruited

1,700+

Sanofi

Lead Sponsor

Trials

2,246

Recruited

4,085,000+

Paul Hudson

Sanofi

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Christopher Corsico

Sanofi

Chief Medical Officer

MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University

Inhibrx, Inc.

Lead Sponsor

Trials

9

Recruited

1,700+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05897424

Study Details | NCT05897424 | Long-term, Open-label ... This is a Phase 2, Single Arm, Open Label Extension Study, Evaluating the Long-Term Safety and Clinical Efficacy of SAR447537 (INBRX-101) in Adults With ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11216232/

Recombinant Alpha-1 Antitrypsin–Fc Fusion Protein INBRX ... The primary endpoint was safety and tolerability. Secondary endpoints were pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of ...

3. sanofi.com sanofi.com/en/media-room/press-releases/2025/2025-10-22-05-00-00-3170787

Press Release: Sanofi's efdoralprin alfa met all primary and ... “These data demonstrate that efdoralprin alfa achieved consistently higher normal functional AAT levels, with less frequent dosing, compared to ...

4. health.ucdavis.edu health.ucdavis.edu/news/headlines/new-trial-produces-excellent-safety-results-for-rare-pulmonary-condition/2024/07

New trial produces excellent safety results for rare ... “This is a really complex drug, and we were quite pleased the data showed it safe and tolerable,” said Brooks Kuhn, associate professor of ...

5. sanofistudies.com sanofistudies.com/cwout/CW-V9DEXS//gb/en/listing/312937/study-of-sar447537-inbrx-101/

Study of SAR447537 (INBRX-101) Compared to Plasma ... This is a Phase 2, Double-Blind, Randomized, Active-Control, Parallel Group Study to Assess the Pharmacokinetics, Pharmacodynamics, ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05856331

NCT05856331 | Study of SAR447537 (INBRX-101) ... Phase 2 study to compare SAR447537 (INBRX-101) to plasma derived A1PI therapy in adults with AATD emphysema.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38809792/

Recombinant Alpha-1 Antitrypsin-Fc Fusion Protein INBRX ... The primary endpoint was safety and tolerability. Secondary endpoints were pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of ...

8. journal.copdfoundation.org journal.copdfoundation.org/jcopdf/id/1483/Recombinant-Alpha-1-AntitrypsinFc-Fusion-Protein-INBRX-101-in-Adults-With-Alpha-1-Antitrypsin-Deficiency-A-Phase-1-Study

Phase 1 Study of INBRX-101 in Adults With AATD The primary endpoint was safety and tolerability. Secondary endpoints were pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of INBRX-101.