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Monoclonal Antibodies

AT-02 for Amyloidosis

Phase 2

Recruiting

Research Sponsored by Attralus, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject must have participated in the study AT01-001 and wishes to receive open-label AT-02.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 112 weeks

Awards & highlights

Study Summary

This trial studies the long-term effects of AT-02 on people with systemic amyloidosis. It looks at safety, tolerability, and how well it works.

Who is the study for?

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).Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Specific side effects of AT-02 aren't listed here but generally include reactions related to safety and tolerability that will be monitored throughout the trial since it's an investigational drug.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I was part of the AT01-001 study and want to continue with AT-02.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 112 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 112 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 112 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

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)

To assess the safety and tolerability of AT-02 through change from baseline in clinical laboratory results

Secondary outcome measures

Incidence of treatment-emergent Anti-drug antibodies (ADAs)

Serial cardiac magnetic resonance assessments of systemic amyloidosis

To assess PK of AT-02 during long-term administration

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: A (AT-02)Experimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

AT02

2008

Completed Phase 2

~80

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Attralus, Inc.Lead Sponsor

6 Previous Clinical Trials

230 Total Patients Enrolled

6 Trials studying Amyloidosis

230 Patients Enrolled for Amyloidosis

Novotech (Australia) Pty LimitedIndustry Sponsor

68 Previous Clinical Trials

7,302 Total Patients Enrolled

1 Trials studying Amyloidosis

100 Patients Enrolled for Amyloidosis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals have signed up for the clinical trial thus far?

"The trial needs to enroll 120 eligible individuals and is being administered by Attralus, Inc. at multiple locations; two of the most prominent sites are Johns Hopkins in Baltimore and Cleveland Clinic in Ohio."

Answered by AI

Is this research venture open to individuals older than fifty-five years?

"Patients of ages 18 to 85 are eligible for this particular trial, while a separate study is available to those younger than 18 and another one opened up for individuals 65 and above."

Answered by AI

Is the enrollment period of this study still active for participants?

"As evidenced on clinicaltrials.gov, this experiment is currently enrolling participants with the original post date of September 21st 2023 and most recent update occurring October 19th 2023."

Answered by AI

In what number of healthcare facilities is this trial underway?

"9 different clinical trial sites are looking to enrol patients, including Johns Hopkins in Baltimore, Cleveland Clinic in Cleveland and OHSU (Oregon Health & Science University) in Portland. Additionally, there are 6 other participating locations."

Answered by AI

Has AT-02 acquired federal recognition from the FDA?

"Our assessment at Power gave A (AT-02) a safety rating of 2, given that while there is evidence for its protection against harm, no clinical data supports the medication's therapeutic value."

Answered by AI

May I be considered an eligible participant in this clinical experiment?

"This clinical trial is set to accept 120 participants who are aged between 18 and 85, diagnosed with systemic amyloidosis. To be eligible for the study, individuals need to have completed AT02-001 satisfactorily without any major adversities, possess adequate understanding of protocol procedures and sign informed consent forms as well as meet all other safety criteria listed in the parent study. Furthermore, they must remain capable and willing throughout the duration of the experiment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "A Study of AT-02 in Subjects With Systemic Amyloidosis.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05951049.

All > Amyloidosis