RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-09-21
Study Completion:2026-02-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05951049

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.

Ages Eligible for Study:18 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Subject understands the study procedures and can give signed informed consent.
  2. 2. Subject is willing and able to comply with this protocol and will be available for the entire duration of the study.
  3. 3. Subject must have a confirmed diagnosis of SA per the diagnostic criteria specified in the parent study protocol.
  4. 4. Subject must have participated in the study AT01-001 and wishes to receive open-label AT-02.
  5. 5. AT02-001 Part 2:
  6. 6. AT02-001 Part 3:
  7. 7. Must continue to satisfy the eligibility criteria in the parent study protocol for WOCBP, WONCBP, or male participants
  1. 1. Is pregnant, breastfeeding, or is planning to become pregnant or breastfeed during this study and follow-up period.
  2. 2. Is mentally or legally incapacitated, has significant emotional problems at the time of the study, or has a history of psychosis.
  3. 3. Has acquired any new, clinically significant underlying illness since enrollment in the parent study.
  4. 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. 5. Estimated glomerular filtration (eGFR) ≤30 mL/min/1.73 m2.
  6. 6. Currently using any prohibited concomitant medications.
  7. 7. Any contraindication to MRI or MRI contrast.
  8. 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.

Contacts and Locations

Study Contact

Scott Stephens
CONTACT
+1-321-228-7400
sstephens@attralus.com
Deepika Aggarwal
CONTACT
3 9960 7997
deepika.aggarwal@novotech-cro.com

Study Locations (Sites)

Midwest Heart and Vascular
Overland Park, Kansas, 66211
United States
Johns Hopkins
Baltimore, Maryland, 21287
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
OHSU (Oregon Health & Science University)
Portland, Oregon, 97239
United States
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: Attralus, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-21
Study Completion Date2026-02-28

Study Record Updates

Study Start Date2023-09-21
Study Completion Date2026-02-28

Terms related to this study

Additional Relevant MeSH Terms

  • Amyloidosis; Systemic