NCT06674577

A Rollover Study to Evaluate the Long-Term Safety and Efficacy of Atacicept

A Multicenter, Rollover Study to Evaluate the Long-Term Safety and Efficacy of Atacicept

• Status: Enrolling By Invitation
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 476 (estimated)
• Sponsor: Vera Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Eligible participants will receive atacicept 150 mg once weekly (QW) self-administered subcutaneously (SC). Participants will be grouped by whether they are restarting atacicept after cessation in the parent study (Group 1: Atacicept Drug Holiday) or are continuing atacicept with no disruption in treatment (Group 2: Continuous Atacicept Treatment). Long-term safety and tolerability of atacicept is assessed by routine clinical and laboratory tests and adverse events.

Conditions

• IgA Nephropathy (IgAN)
• Renal and Urinary Disorders
• Berger Disease

Interventions

Type	Name	Description
DRUG	Atacicept 150 mg	The 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

Timeline

• Start date: 2024-12-01
• Primary completion: 2028-05-31
• Completion: 2028-05-31
• First posted: 2024-11-05
• Last updated: 2025-04-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study