AT-02 for Amyloidosis

Recruiting at 9 trial locations

Overseen By Deepika Aggarwal

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Attralus, Inc.

Must not be taking: Prohibited medications

Disqualifiers: Pregnancy, Psychosis, Low eGFR, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 104 weeks

120 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that you cannot use any prohibited medications. It's best to discuss your current medications with the study team to see if they are allowed.

What is the purpose of this trial?

This trial tests a new medicine called AT-02 for people with systemic amyloidosis who were in an earlier study. It aims to see if the medicine is safe and effective over time.

Eligibility Criteria

This trial is for people who have systemic amyloidosis and were part of the AT01-001 study. They should be able to follow the study plan, not be in other trials recently, and not planning pregnancy. They must have finished previous parts of this research without serious issues and their kidneys must work well (eGFR >30 mL/min/1.73 m2).

Inclusion Criteria

Subject understands the study procedures and can give signed informed consent.

I am willing and able to follow the study rules and can participate for its full duration.

You must have been diagnosed with SA according to the rules in the main study's plan.

Exclusion Criteria

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.

Is pregnant, breastfeeding, or is planning to become pregnant or breastfeed during this study and follow-up period.

I have developed a new serious illness since joining the initial study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

8 weeks

Treatment

Participants receive AT-02 via intravenous infusion once every two or four weeks for 104 weeks

104 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

Open-label extension

Participants continue to receive AT-02 to evaluate long-term safety and tolerability

Long-term

Treatment Details

Interventions

• AT-02

Trial Overview The trial is testing a new treatment called AT-02 for systemic amyloidosis over a long period to see how safe it is, if there are any side effects, and how effective it might be at treating the condition.

Participant Groups

Group I: A (AT-02) Experimental Treatment 1 Intervention

Subjects will receive AT-02 via intravenous infusion once every two or 4 weeks for 104 weeks (52 total AT-02 administrations).

AT-02 is already approved in European Union, United States for the following indications:

Approved in European Union as AT-02 for:

• Transthyretin-associated amyloidosis (ATTR)
• Immunoglobulin light-chain-associated amyloidosis (AL)

Approved in United States as AT-02 for:

• Transthyretin-associated amyloidosis (ATTR)

Who Is Running the Clinical Trial?

Attralus, Inc.

Lead Sponsor

Trials

8

Recruited

670+

Novotech (Australia) Pty Limited

Industry Sponsor

Trials

76

Recruited

7,800+

Dr. John Moller

Novotech (Australia) Pty Limited

Chief Executive Officer

MD and MBA from the University of Oxford

Dr. Judith Ng-Cashin

Novotech (Australia) Pty Limited

Chief Medical Officer since 2023

MD