A Rollover Study to Evaluate the Long-Term Safety and Efficacy of Atacicept
Part of paid clinical trials in Brisbane, California.
- Sponsor
- Vera Therapeutics, Inc.
- Study ID
- NCT06674577
- Phase
- PHASE2
- Status
- Enrolling By Invitation
Conditions
- Berger Disease
- IgA Nephropathy (IgAN)
- Renal and Urinary Disorders
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 99 Years
- Healthy Volunteers
- Not accepted
Interventions
- Atacicept 150 mg — DRUGThe atacicept drug product is available as a ready to use injection solution in the following prefilled syringe (PFS) that is composed of: \*BD Hypak™ SCF™ Barrel Glass barrel 1ml long with staked needle 27G ½" 5B with Rigid Needle Shield BD260 \*BD SCF™ Stopper 1ml long W4023 Flurotec
Study Details
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.
Key Dates
- Start date
- Dec 1, 2024
- Status verified
- Dec 2024
- Primary completion
- May 31, 2028
- Completion
- May 31, 2028
Study Design
- Enrollment
- 476 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Atacicept 150mg once weekly subcutaneous (SC) injectionOther Names: VT-001
Primary Outcome Measure
Incidence of adverse events observed during the dosing period [ Time Frame: Baseline until end of study up to week156 ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Vera Therapeutics | Brisbane | California | 94005 | - |
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