A Study of AT-02 in Subjects With Systemic Amyloidosis.
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| ClinicalTrials.gov Identifier: NCT05951049 |
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Recruitment Status :
Recruiting
First Posted : July 18, 2023
Last Update Posted : January 30, 2024
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Sponsor:
Attralus, Inc.
Collaborator:
Novotech (Australia) Pty Limited
Information provided by (Responsible Party):
Attralus, Inc.
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Brief Summary:
This is a Phase 2 open-label extension study to evaluate the long-term safety, tolerability, and clinical activity of AT-02.
AT-02 is an investigational medicinal product being developed to treat systemic amyloidosis.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Amyloidosis; Systemic | Drug: AT02 | Phase 2 |
The study will enroll subjects with systemic amyloidosis who have participated in AT02-001 study.
The study includes screening period (56 days), treatment period (week 104), follow up (week 112).
The total duration of participant in study is up to 120 weeks.
A Safety Review Committee (SRC) will periodically convene and review all available clinical and laboratory data during the study. A single SRC will monitor safety across all AT-02 studies to ensure that safety signals are assessed in aggregate.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 120 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 2, Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of AT-02 |
| Actual Study Start Date : | September 21, 2023 |
| Estimated Primary Completion Date : | February 28, 2026 |
| Estimated Study Completion Date : | February 28, 2026 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: A (AT-02)
Subjects will receive AT-02 via intravenous infusion once every two or 4 weeks for 104 weeks (52 total AT-02 administrations).
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Drug: AT02
Dosage Form: Solution for injection/infusion Dosage level: Different dose levels of AT02 Route of Administration: Intravenous use |
Primary Outcome Measures :
- Incidence, frequency, and severity of Treatment-emergent adverse events (TEAEs) as assessed National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 5.0) [ Time Frame: Up to 112 weeks ]
- To assess the safety and tolerability of AT-02 through change from baseline in clinical laboratory results [ Time Frame: Up to 112 weeks ]
Secondary Outcome Measures :
- To assess PK of AT-02 during long-term administration [ Time Frame: Up to 112 weeks ]Parameter: maximum observed concentration of AT-02 (Cmax)
- To assess PK of AT-02 during long-term administration [ Time Frame: Up to 112 weeks ]Parameter: time to maximum observed AT-02 concentration (Tmax)
- To assess PK of AT-02 during long-term administration [ Time Frame: Up to 112 weeks ]Parameter: AUClast
- To assess PK of AT-02 during long-term administration [ Time Frame: Up to 112 weeks ]Parameter: AUCinf
- To assess PK of AT-02 during long-term administration [ Time Frame: Up to 112 weeks ]Parameter: volume of distribution at steady state (Vss)
- To assess PK of AT-02 during long-term administration [ Time Frame: Up to 112 weeks ]Parameter: total body clearance (CL) of AT-02
- To assess PK of AT-02 during long-term administration [ Time Frame: Up to 112 weeks ]Parameter: AT-02 half-life (t½)
- Incidence of treatment-emergent Anti-drug antibodies (ADAs) [ Time Frame: Up to 112 weeks ]The number and percentage of subjects who develop detectable ADA will be summarized by dose cohort.
- To evaluate the clinical efficacy of AT-02 during long-term administration through change from baseline in biomarkers [ Time Frame: Up to 112 weeks ]Biomarkers include serum N-terminal prohormone of brain natriuretic peptide (NT-proBNP)
- To evaluate the clinical efficacy of AT-02 during long-term administration through change from baseline in biomarkers [ Time Frame: Up to 112 weeks ]Biomarkers include serum High-sensitivity cardiac troponin T (hsTnT)
- To evaluate the clinical efficacy of AT-02 during long-term administration through change from baseline in biomarkers [ Time Frame: Up to 112 weeks ]Biomarkers include serum Urine albumin creatinine ratio (UACR)
- Serial cardiac magnetic resonance assessments of systemic amyloidosis [ Time Frame: Up to 112 weeks ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subject understands the study procedures and can give signed informed consent.
- Subject is willing and able to comply with this protocol and will be available for the entire duration of the study.
- Subject must have a confirmed diagnosis of SA per the diagnostic criteria specified in the parent study protocol.
- Subject must have participated in the study AT01-001 and wishes to receive open-label AT-02.
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AT02-001 Part 2:
a. Subjects must have completed the last follow-up visit in AT02-001 Part 2 without significant adverse events, as determined by the Investigator.
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AT02-001 Part 3:
a. Subjects must have completed the post-treatment imaging studies in AT02-001Part 3 (e.g., CMR, echocardiogram) without significant AEs in the parent study as determined by the Investigator.
- Must continue to satisfy the eligibility criteria in the parent study protocol for WOCBP, WONCBP, or male participants
Exclusion Criteria:
- Is pregnant, breastfeeding, or is planning to become pregnant or breastfeed during this study and follow-up period.
- Is mentally or legally incapacitated, has significant emotional problems at the time of the study, or has a history of psychosis.
- Has acquired any new, clinically significant underlying illness since enrollment in the parent study.
- Has any clinically significant worsening of organ function associated with underlying SA or clinically significant change in concomitant medications for the treatment of SA since enrollment in the parent study.
- Estimated glomerular filtration (eGFR) ≤30 mL/min/1.73 m2.
- Currently using any prohibited concomitant medications.
- Any contraindication to MRI or MRI contrast.
- Is currently participating in an interventional clinical study or has participated in another clinical study (other than AT02-001) within the last four (4) weeks or within five (5) half-lives of the prior study treatment, whichever is longer.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05951049
Contacts
| Contact: Scott Stephens | +1-321-228-7400 | sstephens@attralus.com | |
| Contact: Deepika Aggarwal | 3 9960 7997 ext +61 | deepika.aggarwal@novotech-cro.com |
Locations
| United States, Kansas | |
| Midwest Heart and Vascular | Recruiting |
| Overland Park, Kansas, United States, 66211 | |
| Contact: Vasvi Singh, Dr Vasvi.singh@hcahealthcare.com | |
| United States, Maryland | |
| Johns Hopkins | Not yet recruiting |
| Baltimore, Maryland, United States, 21287 | |
| Contact: Joban Vaishnav, MD jvaishn1@jhmi.edu | |
| United States, Ohio | |
| Cleveland Clinic | Recruiting |
| Cleveland, Ohio, United States, 44195 | |
| Contact: Mazen Hanna, Dr hannam@ccf.org | |
| United States, Oregon | |
| OHSU (Oregon Health & Science University) | Not yet recruiting |
| Portland, Oregon, United States, 97239 | |
| Contact: Ahmad Masri masria@ohsu.edu | |
| United States, Pennsylvania | |
| Penn Presbyterian Medical Center | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Brian Drachman, Dr drachman@pennmedicine.upenn.edu | |
| Australia, Queensland | |
| Princess Alexandra Hospital | Recruiting |
| Woolloongabba, Queensland, Australia, 4102 | |
| Contact: Dr Dariusz Korczyk | |
| Principal Investigator: Dr Dariusz Korczyk | |
| Australia, South Australia | |
| Flinders Medical Centre | Recruiting |
| Bedford Park, South Australia, Australia, 5042 | |
| Contact: Joseph Selvanayagam, Prof | |
| Australia, Victoria | |
| Box Hill Hospital | Recruiting |
| Box Hill, Victoria, Australia, 3128 | |
| Contact: Dr Simon Gibbs | |
| Principal Investigator: Dr Simon Gibbs | |
| Australia, Western Australia | |
| Royal Perth Hospital | Not yet recruiting |
| Perth, Western Australia, Australia, 6000 | |
| Contact: Graham Hillis, Prof | |
| United Kingdom | |
| Royal Free London Nhs Foundation Trust Royal Free Hospital | Not yet recruiting |
| London, United Kingdom | |
| Contact: Julian Gillmore, Dr julian.gillmore@nhs.net | |
Sponsors and Collaborators
Attralus, Inc.
Novotech (Australia) Pty Limited
| Responsible Party: | Attralus, Inc. |
| ClinicalTrials.gov Identifier: | NCT05951049 |
| Other Study ID Numbers: |
AT02-003 |
| First Posted: | July 18, 2023 Key Record Dates |
| Last Update Posted: | January 30, 2024 |
| Last Verified: | January 2024 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Amyloidosis Proteostasis Deficiencies Metabolic Diseases |