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Study of INBRX-101 Compared to Plasma-derived A1PI Therapy in Adults With AATD Emphysema (ELEVAATE)

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Sanofi

Status and phase

Enrolling
Phase 2

Conditions

Emphysema
Alpha 1-Antitrypsin Deficiency

Treatments

Drug: Zemaira
Drug: INBRX-101

Study type

Interventional

Funder types

Industry

Identifiers

NCT05856331
2023-508084-76-00 (EU Trial (CTIS) Number)
INBRX101-01-201

Details and patient eligibility

About

Phase 2 study to compare INBRX-101 to plasma derived A1PI therapy in adults with AATD emphysema

Full description

This is a Phase 2, Double-Blind, Randomized, Active-Control, Parallel Group Study to Assess the Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Safety of INBRX-101 Compared to Plasma-Derived Alpha1-Proteinase Inhibitor (A1PI) Augmentation Therapy in Adults With Alpha-1 Antitrypsin Deficiency (AATD) Emphysema.

Enrollment

90 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Males or females 18-80 years of age, inclusive, at the time of screening
  2. Diagnosis of AATD
  3. Evidence of emphysema secondary to AATD
  4. FEV1 of ≥ 30% and ≤ 80% predicted at screening
  5. Current non-smoking status.

Exclusion criteria

  1. Receipt of A1PI augmentation therapy within 5 weeks prior to the first dose of study drug
  2. Known or suspected allergy to components of INBRX-101, A1PI or human IgG
  3. Known selective or severe Immunoglobulin A (IgA) deficiency
  4. Known or suspected diagnosis of type 1 diabetes or diagnosed with uncontrolled type 2 diabetes
  5. Received IV immunoglobulins, monoclonal antibodies and/or other biologic therapies within 30 days
  6. On waiting list for lung or liver transplant
  7. Acute respiratory tract infection or COPD exacerbation within 4 weeks prior to or during screening
  8. Evidence of decompensated cirrhosis
  9. Active cancers or has a history of malignancy within 5 years prior to screening
  10. History of unstable cor pulmonale
  11. Clinically significant congestive heart failure

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

90 participants in 3 patient groups

INBRX-101 Q3W
Experimental group
Description:
IV every 3-weeks (Q3W) and placebo (normal saline)
Treatment:
Drug: INBRX-101
INBRX-101 Q4W
Experimental group
Description:
IV every 4-weeks (Q4W) and placebo (normal saline)
Treatment:
Drug: INBRX-101
Zemaira (A1PI)
Active Comparator group
Description:
60 mg/kg IV once weekly (QW) and placebo (normal saline)
Treatment:
Drug: Zemaira

Trial contacts and locations

41

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Central trial contact

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

Data sourced from clinicaltrials.gov

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