Active — Not RecruitingPhase 2

Long-term, Open-label Study of SAR447537 (INBRX-101) in Adults With Alpha-1 Antitrypsin Deficiency Emphysema

United States185 participantsStarted 2024-06-20

Plain-language summary

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

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✕. 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
✕. Uncontrolled diabetes mellitus despite adequate antidiabetic pharmacologic treatment with a screening HbA1c value ≥9%
✕. 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

Long-term safety and tolerability

Timeframe: 3 years

NCT IDNCT05897424

SponsorSanofi

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-06-30