A Rollover Study to Evaluate the Long-Term Safety and Efficacy of Atacicept (NCT06674577) | Clinical Trial Compass
By InvitationPhase 2
A Rollover Study to Evaluate the Long-Term Safety and Efficacy of Atacicept
United States750 participantsStarted 2024-12-01
Plain-language summary
The purpose of this study is to collect long-term safety and tolerability data for atacicept in patients with IgAN that completed Vera trial investigating atacicept in IgAN population.
Who can participate
Age range
18 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study assessments
* Completed the protocol-defined treatment period on treatment in a parent study of atacicept in patients with IgAN
* For Atacicept Drug Holiday Group only: Systolic blood pressure ≤150 mmHg and diastolic blood pressure ≤90mmHg at screening and Day 1
* A participant who was assigned female at birth is eligible if not pregnant (ie, after a confirmed menstrual period, a negative serum pregnancy test at screening and has a negative urine pregnancy test at Day 1), is not breastfeeding (for at least three months prior to screening), and at least one of the following conditions applies:
* Is not a woman of childbearing potential (WOCBP) OR
* Is a WOCBP who agrees to use a highly effective contraceptive method (ie, has a failure rate of less than 1% per year) at least 7 days prior to enrollment, through 175 days after the last dose of study drug.
Exclusion Criteria:
* Evidence of rapidly progressive glomerulonephritis (loss of ≥50% of eGFR within 3 months of screening)
* For Atacicept Drug Holiday Group only: History of splenectomy
* Known hypersensitivity to atacicept or any component of the formulated atacicept
* For Atacicept Drug Holiday Group only: Major surgery within 6 weeks prior to screening or planned/expected major surgery during the study period (including the safety follow-up period). Major surgery of…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of adverse events observed during the dosing period
Timeframe: Baseline until end of study up to week156