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A Study of AT-02 in Subjects With Systemic Amyloidosis.

PHASE2RECRUITING

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.

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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.

AT02-001 Part 2: Subjects must have completed the last follow-up visit in AT02-001 Part 2 without significant adverse events, as determined by the Investigator.

AT02-001 Part 3: Subjects must have completed the post-treatment imaging studies in AT02-001 Part 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.

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2023-09-21

Primary completion: 2026-02-28

Study completion finish: 2026-02-28

Study type

TREATMENT

Phase

PHASE2

Trial ID

NCT05951049

Intervention or treatment

DRUG: AT02

Conditions

• Amyloidosis; Systemic

Condition: Amyloidosis; Systemic
DRUG: AT02
Woolloongabba, Queensland, Australia and more
Sponsor: Attralus, Inc.

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Princess Alexandra Hospital

Research sites nearby

Select from list below to view details:

Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
Royal Perth Hospital
Perth, Western Australia, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
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).	DRUG: AT02 Dosage Form: Solution for injection/infusion Dosage level: Different dose levels of AT02 Route of Administration: Intravenous use

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
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)	Not Specified	Up to 112 weeks
To assess the safety and tolerability of AT-02 through change from baseline in clinical laboratory results	Not Specified	Up to 112 weeks

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
To assess PK of AT-02 during long-term administration	Parameter: maximum observed concentration of AT-02 (Cmax)	Up to 112 weeks
To assess PK of AT-02 during long-term administration	Parameter: time to maximum observed AT-02 concentration (Tmax)	Up to 112 weeks
To assess PK of AT-02 during long-term administration	Parameter: AUClast	Up to 112 weeks
To assess PK of AT-02 during long-term administration	Parameter: AUCinf	Up to 112 weeks
To assess PK of AT-02 during long-term administration	Parameter: volume of distribution at steady state (Vss)	Up to 112 weeks
To assess PK of AT-02 during long-term administration	Parameter: total body clearance (CL) of AT-02	Up to 112 weeks
To assess PK of AT-02 during long-term administration	Parameter: AT-02 half-life (t½)	Up to 112 weeks
Incidence of treatment-emergent Anti-drug antibodies (ADAs)	The number and percentage of subjects who develop detectable ADA will be summarized by dose cohort.	Up to 112 weeks
To evaluate the clinical efficacy of AT-02 during long-term administration through change from baseline in biomarkers	Biomarkers include serum N-terminal prohormone of brain natriuretic peptide (NT-proBNP)	Up to 112 weeks
To evaluate the clinical efficacy of AT-02 during long-term administration through change from baseline in biomarkers	Biomarkers include serum High-sensitivity cardiac troponin T (hsTnT)	Up to 112 weeks
To evaluate the clinical efficacy of AT-02 during long-term administration through change from baseline in biomarkers	Biomarkers include serum Urine albumin creatinine ratio (UACR)	Up to 112 weeks
Serial cardiac magnetic resonance assessments of systemic amyloidosis	Not Specified	Up to 112 weeks

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

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References

Clinical Trials Gov: A Study of AT-02 in Subjects With Systemic Amyloidosis.