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ElevAAte - New Treatment for Adults with Alpha-1 Antitrypsin Deficiency (AATD) Emphysems
Alpha-1 Antitrypsin Deficiency (AATD) Emphysema
Current approved medicines that treat AATD which contain AAT (called as Alpha-1 Proteinase Inhibitor, A1PI) replaces the AAT protein when the body does not produce it enough. They are injected slowly (infused) into the patient’s vein approximately every week.
INBRX 101 is an artificial form of AAT that has been changed to last longer in the body. This means that INBRX-101 could be given less frequently than the currently approved Alpha-1 Proteinase Inhibitor (A1PI) augmentation therapies because it works for longer in the body.
- Category
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Trial status
Recruiting
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Trial phase
Phase 2 Drug TrialEarly stage studies investigating efficacy and safety compared to standard therapies, as well as final dose determination in moderate sized patient cohorts.
- Registry listing
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ERM Project ID
98073
Trial contact details
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Contact person
RIO Clinical Trials Unit
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Phone
07 3163 1369
What you need to know
Who can take part?
- Males or females 18-80 years of age, inclusive, at the time of screening
- Diagnosis of AATD
- Evidence of emphysema secondary to AATD
- FEV1 of ≥ 30% and ≤ 80% predicted at screening
- Current non-smoking status.
What is involved for you?
Your participation will last up to 51 weeks;
- Screening Period (up to 7 weeks – 2 Visits)
- Treatment Period (32 weeks – 10 Visits)(You will have to visit the study center weekly once study drug is assigned to you until the end of the treatment period)
- Safety Follow-up Period (12 weeks – 2 Visits)
Study Events:
- Ability to give informed consent
- Eligibility A1P1 genotype confirmation
- Demographics
- Medical and Smoking History
- Physical Examination
- Height and Weight
- Vital Signs
- Prior and concomitant medication, therapies and procedures
- Adverse Events
- Pulmonary exacerbation event assessments
- Eligibility safety laboratory test
- Eligibility antigenic AAT lab test
- Pregnancy Test
- Urine Drug Test
- Electrocardiogram (ECG)
- Nasal brushing/swab for biomarker
- Pulmonary function tests
- Patient reported questionnaires
- CT Scan
- Blood Tests
Trial dates
October 2023 - March 2025
