Clinical trial
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
Name
INBRX101-01-201
Description
Phase 2 study to compare INBRX-101 to plasma derived A1PI therapy in adults with AATD emphysema
Trial arms
Trial start
2023-10-12
Estimated PCD
2025-05-01
Trial end
2025-06-01
Status
Recruiting
Phase
Early phase I
Treatment
INBRX-101
A1PI, Recombinant, Bivalent Fc Fusion Protein
Arms:
INBRX-101 Q3W, INBRX-101 Q4W
Zemaira
Alpha1-Proteinase Inhibitor (Human)
Arms:
Zemaira (A1PI)
Size
90
Primary endpoint
Serum functional AAT (fAAT) levels at steady-state
32 Weeks
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Double-blind, randomized, active-control, parallel group interventional study', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 90, 'type': 'ESTIMATED'}}
Updated at
2024-06-04
1 organization
2 products
2 indications
Organization
Inhibrx BiosciencesProduct
INBRX-101Indication
Alpha-1 Antitrypsin DeficiencyProduct
Zemaira