SAR447537 for Emphysema

(ELEVAATE OLE Trial)

Recruiting at 41 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

130 Participants Needed

Trial Summary

What is the purpose of this trial?

Phase 2 open label extension study to evaluate SAR447537 (INBRX-101) in adults with AATD emphysema

Research Team

Clinical Sciences & Operations

Principal Investigator

Sanofi

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+