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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05897424




Registration number
NCT05897424
Ethics application status
Date submitted
31/05/2023
Date registered
9/06/2023

Titles & IDs
Public title
Open Label Extension Study of INBRX-101 in Adults With AATD Emphysema
Scientific title
This is a Phase 2, Single Arm, Open Label Extension Study, Evaluating the Long-Term Safety and Clinical Efficacy of INBRX-101 in Adults With Alpha-1 Antitrypsin Deficiency (AATD) Emphysema.
Secondary ID [1] 0 0
2023-508137-14-00
Secondary ID [2] 0 0
INBRX101-01-202
Universal Trial Number (UTN)
Trial acronym
ELEVAATE OLE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alpha 1-Antitrypsin Deficiency 0 0
Emphysema 0 0
Condition category
Condition code
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - INBRX-101

Experimental: INBRX-101 Q3W - IV every 3-weeks (Q3W)


Treatment: Drugs: INBRX-101
A1PI, Recombinant, Bivalent Fc Fusion Protein
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Long-term safety and tolerability
Timepoint [1] 0 0
3 years
Secondary outcome [1] 0 0
Change in lung density by quantitative computerized tomography (CT)
Timepoint [1] 0 0
3 years
Secondary outcome [2] 0 0
Trough INBRX-101 concentration changes
Timepoint [2] 0 0
3 years
Secondary outcome [3] 0 0
Trough serum functional AAT (fAAT) concentration changes
Timepoint [3] 0 0
3 years
Secondary outcome [4] 0 0
Covariate Analysis: Biometric Values: Weight
Timepoint [4] 0 0
3 years
Secondary outcome [5] 0 0
Covariate Analysis: Biometric Values: Height
Timepoint [5] 0 0
3 years
Secondary outcome [6] 0 0
Covariate Analysis: Biometric Values: Age
Timepoint [6] 0 0
3 years
Secondary outcome [7] 0 0
Covariate Analysis: Biometric Values: Sex
Timepoint [7] 0 0
3 years
Secondary outcome [8] 0 0
Anti-drug antibodies
Timepoint [8] 0 0
3 years

Eligibility
Key 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% predicted at screening and post-bronchodilator FEV1/FVC<0.7 (Cohort 1 new patients only)
5. Current non-smoking status
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 or suspected diagnosis of type 1 diabetes or diagnosed with uncontrolled type 2 diabetes
4. Received IV immunoglobulins, monoclonal antibodies and/or other biologic therapies within 30 days
5. On waiting list for lung or liver transplant
6. Acute respiratory tract infection or COPD exacerbation within 4 weeks prior to or during screening
7. Evidence of decompensated cirrhosis
8. Active cancers or has a history of malignancy within 5 years prior to screening
9. History of unstable cor pulmonale
10. Clinically significant congestive heart failure

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/06/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2028
Actual
Sample size
Target
130
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Lung Research Qld - Chermside
Recruitment postcode(s) [1] 0 0
4032 - Chermside

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Sciences & Operations
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Trial Transparency email recommended (Toll free for US & Canada)
Address 0 0
Country 0 0
Phone 0 0
800-633-1610
Fax 0 0
Email 0 0
Contact-us@sanofi.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05897424