Phase 2 Open-label Extension Study of AT-02 in Subjects with Systemic Amyloidosis
Research type
Research Study
Full title
A Phase 2, Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of AT-02.
IRAS ID
1008646
Contact name
Scott Stephens
Contact email
Sponsor organisation
Attralus, Inc.
Clinicaltrials.gov Identifier
Research summary
This is a Phase 2 open-label extension study to evaluate the long-term safety and tolerability of AT-02. The study will enroll subjects with systemic amyloidosis who have participated in study AT02-001, wish to receive open-label AT-02 and meet eligibility criteria. All subjects with SA who have participated in study AT02-001 are eligible for Screening in this open-label extension study. The Screening Period for subjects entering from AT02-001 Part 3 is up to 28 days. Informed consent may be obtained, and Screening procedures may be performed, for this study at the Week 8 visit of the parent study prior to initiating study-related procedures and AT-02 administration in this study. The following steps related to dosing are:
1. The first dose in this study must occur concurrently with the Week 8 visit in the AT02 001 Part 3 study;
2. Dosing occurs after all AT02-001 Part 3 Week 8 assessments are completed; and
3. Once dosing is initiated, participation in the AT02-001 study is concluded.
The follow-up visits (i.e., Week 12 and Week 16) in the parent study (AT02-001) should not be conducted. The Treatment Period begins on Day 1. Subjects will be treated with AT-02 via intravenous infusion once every 2 or 4 weeks for 104 weeks. The Safety Follow-up Period consists of 2 visits over a 12-week period after the last dose of AT-02, culminating with an end-of-study visit at Week 116. If subjects do not complete all study visits, or terminate early from the study, they will be asked to return to the study site for an Early Termination (ET) Visit, ideally ≤7 days from the decision to early terminate.
Total duration of each participant is up to 120 weeks, the treatment duration of each participant is approximately 104 weeks.REC name
HSC REC B
REC reference
23/NI/0127
Date of REC Opinion
29 Nov 2023
REC opinion
Further Information Favourable Opinion