Clinical Trial
Study Details
Status
RECRUITING
Study ID #
NCT05951049
Study Start
Primary Completion
Study Completion
Enrollment
120
Study Type
Interventional
Phase
Phase 2
Interventions
AT02

Dosage Form: Solution for injection/infusion Dosage level: Different dose levels of AT02 Route of Administration: Intravenous use

Primary Outcomes
Measure
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)
Timeframe
Up to 112 weeks
Measure
To assess the safety and tolerability of AT-02 through change from baseline in clinical laboratory results
Timeframe
Up to 112 weeks
Secondary Outcomes
Measure
To assess PK of AT-02 during long-term administration
Description

Parameter: maximum observed concentration of AT-02 (Cmax)

Timeframe
Up to 112 weeks
Measure
To assess PK of AT-02 during long-term administration
Description

Parameter: time to maximum observed AT-02 concentration (Tmax)

Timeframe
Up to 112 weeks
Measure
To assess PK of AT-02 during long-term administration
Description

Parameter: AUClast

Timeframe
Up to 112 weeks
Measure
To assess PK of AT-02 during long-term administration
Description

Parameter: AUCinf

Timeframe
Up to 112 weeks
Measure
To assess PK of AT-02 during long-term administration
Description

Parameter: volume of distribution at steady state (Vss)

Timeframe
Up to 112 weeks
Measure
To assess PK of AT-02 during long-term administration
Description

Parameter: total body clearance (CL) of AT-02

Timeframe
Up to 112 weeks
Measure
To assess PK of AT-02 during long-term administration
Description

Parameter: AT-02 half-life (t½)

Timeframe
Up to 112 weeks
Measure
Incidence of treatment-emergent Anti-drug antibodies (ADAs)
Description

The number and percentage of subjects who develop detectable ADA will be summarized by dose cohort.

Timeframe
Up to 112 weeks
Measure
To evaluate the clinical efficacy of AT-02 during long-term administration through change from baseline in biomarkers
Description

Biomarkers include serum N-terminal prohormone of brain natriuretic peptide (NT-proBNP)

Timeframe
Up to 112 weeks
Measure
To evaluate the clinical efficacy of AT-02 during long-term administration through change from baseline in biomarkers
Description

Biomarkers include serum High-sensitivity cardiac troponin T (hsTnT)

Timeframe
Up to 112 weeks
Measure
To evaluate the clinical efficacy of AT-02 during long-term administration through change from baseline in biomarkers
Description

Biomarkers include serum Urine albumin creatinine ratio (UACR)

Timeframe
Up to 112 weeks
Measure
Serial cardiac magnetic resonance assessments of systemic amyloidosis
Timeframe
Up to 112 weeks
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.

Description

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.

Conditions
Amyloidosis; Systemic
Study Contact
Name
Scott Stephens
Role
Contact
Phone
+1-321-228-7400
Email
sstephens@attralus.com
Name
Deepika Aggarwal
Role
Contact
Phone
3 9960 7997
Email
deepika.aggarwal@novotech-cro.com
Facility

Midwest Heart and Vascular
Overland Park, KS 66211
United States

Contacts
Study Contact
Name
Vasvi Singh, Dr
Email
Vasvi.singh@hcahealthcare.com
Role
Contact
Facility

Johns Hopkins
Baltimore, MD 21287
United States

Contacts
Study Contact
Name
Joban Vaishnav, MD
Email
jvaishn1@jhmi.edu
Role
Contact
Facility

Cleveland Clinic
Cleveland, OH 44195
United States

Contacts
Study Contact
Name
Mazen Hanna, Dr
Email
hannam@ccf.org
Role
Contact
Facility

OHSU (Oregon Health & Science University)
Portland, OR 97239
United States

Contacts
Study Contact
Name
Ahmad Masri
Email
masria@ohsu.edu
Role
Contact
Facility

Penn Presbyterian Medical Center
Philadelphia, PA 19104
United States

Contacts
Study Contact
Name
Brian Drachman, Dr
Email
drachman@pennmedicine.upenn.edu
Role
Contact
Facility

Princess Alexandra Hospital
Woolloongabba QLD 4102
Australia

Contacts
Study Contact
Name
Dr Dariusz Korczyk
Role
Principal Investigator
Facility

Flinders Medical Centre
Bedford Park SA 5042
Australia

Contacts
Study Contact
Name
Joseph Selvanayagam, Prof
Role
Contact
Facility

Box Hill Hospital
Box Hill VIC 3128
Australia

Contacts
Study Contact
Name
Dr Simon Gibbs
Role
Principal Investigator
Facility

Royal Perth Hospital
Perth WA 6000
Australia

Contacts
Study Contact
Name
Graham Hillis, Prof
Role
Contact
Facility

Royal Free London Nhs Foundation Trust Royal Free Hospital
London
United Kingdom

Contacts
Study Contact
Name
Julian Gillmore, Dr
Email
julian.gillmore@nhs.net
Role
Contact
Eligibility Criteria

Inclusion Criteria:

1. Subject understands the study procedures and can give signed informed consent.
2. Subject is willing and able to comply with this protocol and will be available for the entire duration of the study.
3. Subject must have a confirmed diagnosis of SA per the diagnostic criteria specified in the parent study protocol.
4. Subject must have participated in the study AT01-001 and wishes to receive open-label AT-02.
5. 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.
6. 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.
7. Must continue to satisfy the eligibility criteria in the parent study protocol for WOCBP, WONCBP, or male participants

Exclusion Criteria:

1. Is pregnant, breastfeeding, or is planning to become pregnant or breastfeed during this study and follow-up period.
2. Is mentally or legally incapacitated, has significant emotional problems at the time of the study, or has a history of psychosis.
3. Has acquired any new, clinically significant underlying illness since enrollment in the parent study.
4. 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.
5. Estimated glomerular filtration (eGFR) ≤30 mL/min/1.73 m2.
6. Currently using any prohibited concomitant medications.
7. Any contraindication to MRI or MRI contrast.
8. 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.

Eligibility Minimum Age
18 Years
Eligibility Maximum Age
85 Years
Sexes Eligible for Study
ALL
Eligibility Std Ages
Adult
Older Adult
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