NCT03226678

Study to Assess the Safety, Tolerability, Efficacy and PK of APL-2 in Patients With Warm Type Autoimmune Hemolytic Anemia (wAIHA) or Cold Agglutinin Disease (CAD)

An Open Label, Prospective, Study to Assess the Safety, Tolerability, Efficacy and Pharmacokinetics of APL-2 in Patients With Warm Type Autoimmune Hemolytic Anemia (wAIHA) or Cold Agglutinin Disease (CAD)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Apellis Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is to assess the safety, tolerability, preliminary efficacy, and pharmacokinetics of APL-2 in subjects with warm Autoimmune Hemolytic Anemia (wAIHA) or Cold Agglutinin Disease (CAD).

Conditions

• Warm Autoimmune Hemolytic Anemia
• Cold Agglutinin Disease

Interventions

Type	Name	Description
DRUG	APL-2	Complement (C3) Inhibitor

Timeline

• Start date: 2017-08-31
• Primary completion: 2022-09-12
• Completion: 2022-09-12
• First posted: 2017-07-24
• Last updated: 2024-12-12
• Results posted: 2024-12-12

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study