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

Description

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.

Conditions

Amyloidosis; Systemic

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Study Overview

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Study Details

Study overview

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.

A Phase 2, Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of AT-02

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

Condition
Amyloidosis; Systemic
Intervention / Treatment

-

Contacts and Locations

Overland Park

Midwest Heart and Vascular, Overland Park, Kansas, United States, 66211

Baltimore

Johns Hopkins, Baltimore, Maryland, United States, 21287

Cleveland

Cleveland Clinic, Cleveland, Ohio, United States, 44195

Portland

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

Philadelphia

Penn Presbyterian Medical Center, Philadelphia, Pennsylvania, United States, 19104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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:
  • 6. AT02-001 Part 3:
  • 7. Must continue to satisfy the eligibility criteria in the parent study protocol for WOCBP, WONCBP, or male participants
  • 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.

Ages Eligible for Study

18 Years to 85 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Attralus, Inc.,

Study Record Dates

2026-02-28