Table of Contents
- Trial overview
- Conditions and patient groups
- Study designs and phases
- Outcomes measured in the trials
- Key trial details
- What these trials mean for patients
Trial overview
The trial program for Atacicept focuses on kidney diseases, especially IgA nephropathy (IgAN), which is also listed as Berger disease in the source data.[1][2] The studies are interventional, which means patients receive a study treatment and researchers measure the results over time.[1][2]
Four authorised trials are listed in the source data, and they range from Phase 2 to Phase 4.[1][2][3][4] Together, they study different dosing approaches, long-term follow-up, placebo comparison, and outcomes linked to kidney disease activity.[1][3][4]
Conditions and patient groups
Most of the research is in people with IgA nephropathy, a kidney disease that affects the filtering units of the kidney.[1][2][4] One study also includes multiple autoimmune glomerular diseases, which means several immune-related diseases of the kidney filters are being studied together.[3]
The trial data show both adult subjects and some pediatric cohorts, meaning groups of children are included in one of the studies.[3] The source data do not provide the full entry rules, so the exact age limits and medical requirements are not listed here.[1][3]
- Adult subjects with IgAN: one Phase 4 study compares Atacicept with placebo in adults.[4]
- Pediatric cohorts: one Phase 2 study includes children in specific cohorts named IgAN-6, IgAN-8, and IgAN-9.[3]
- Multiple autoimmune glomerular diseases: one Phase 2 study looks at a broader group of immune-related kidney diseases.[3]
Study designs and phases
All listed trials are interventional, so they are designed to test Atacicept as a study treatment rather than only observe patients.[1][2][3][4] Two studies are Phase 2, one is Phase 4, and one is also labelled Phase 2 even though its title includes a Phase 2b and Phase 3 program.[1][2][3][4]
One trial is a rollover study, which means people from a previous study can continue into a follow-up study to check long-term results.[2] Another trial uses both Atacicept and an autoinjector combination, which is a device-based way to give the injection more easily.[2][3]
- Phase 2: early or mid-stage testing for safety and early signs of benefit.[1][3]
- Phase 4: later-stage research in a broader setting.[4]
- Rollover design: follow-up from a prior study to learn about longer-term use.[2]
Outcomes measured in the trials
The main outcomes show whether Atacicept changes markers of kidney disease and whether it is safe to use over time.[1][2][3][4] The studies measure proteinuria, which means protein in the urine, because this is an important sign of kidney damage or improvement.[3][4]
One study measures Gd-IgA1 through Week 24, which is a disease-related marker in IgA nephropathy.[1] Another looks at urine protein to creatinine ratio (UPCR) at Week 24 or Week 36, which is a urine test used to estimate how much protein is being lost in the urine.[3][4]
- Safety and tolerability: checked with routine clinical and laboratory tests and adverse events.[2][3]
- Gd-IgA1 levels: measured in the Phase 2 monthly dosing study through Week 24.[1]
- UPCR: used as a main kidney outcome in the placebo-controlled and multi-disease studies.[3][4]
- Serum concentration: measured in pediatric cohorts to understand how much Atacicept is in the blood over time.[3]
Key trial details
The monthly dosing study is a Phase 2 trial in 90 patients with IgA nephropathy, and it tests Atacicept given every 4 weeks by subcutaneous injection.[1] Its main goal is to evaluate the effect on Gd-IgA1 levels through Week 24.[1]
The rollover study is also Phase 2 and includes 75 patients.[2] It focuses on long-term safety and efficacy, and the main safety checks include routine clinical and laboratory tests plus adverse events.[2]
The multi-disease study is a Phase 2 trial with 250 planned participants.[3] It evaluates safety, proteinuria change at Week 36, and drug levels in pediatric cohorts through Week 24.[3]
The ORIGIN and ORIGIN 3 study is a Phase 4 trial with 481 participants.[4] It compares Atacicept with placebo in adult subjects with IgA nephropathy and measures UPCR at Week 24 and Week 36 in different study parts.[4]
| Trial ID | Title | Phase | Enrollment | Main endpoint |
|---|---|---|---|---|
| 2025-521519-37-00 | A Study Evaluating Monthly (Every 4 Weeks) Dosing of Atacicept in Patients with IgAN | Phase 2 | 90 | Gd-IgA1 levels through Week 24 |
| 2024-516380-81-00 | A Rollover Study to Evaluate the Long-Term Safety and Efficacy of Atacicept | Phase 2 | 75 | Long-term safety and tolerability |
| 2024-518465-10-00 | Atacicept in Multiple Glomerular Diseases | Phase 2 | 250 | AE profile, UPCR change, serum concentration in pediatric cohorts |
| NCT04716231 | Atacicept in Subjects with IgA Nephropathy (ORIGIN and ORIGIN 3) | Phase 4 | 481 | UPCR at Week 24 and Week 36 |
What these trials mean for patients
These studies are trying to learn whether Atacicept can help people with IgA nephropathy and related kidney diseases by improving urine protein results and other disease markers.[1][3][4] They also aim to show whether the treatment can be used safely over time, including in follow-up and pediatric settings.[2][3]
Because the source data only list authorised studies and summary endpoints, they do not show final results here.[1][2][3][4] The trial program is still focused on learning which patients may benefit most and how the treatment performs across different study designs.[1][4]
