NCT04856930

A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Participants With Hidradenitis Suppurativa

A Phase 2, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Subjects With Hidradenitis Suppurativa

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 149 (actual)
• Sponsor: Vanda Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Efficacy and safety of imsidolimab (ANB019) in participants with Hidradenitis Suppurativa

Detailed description

This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of imsidolimab in adult participants with hidradenitis suppurativa (HS). This study will also characterize the pharmacokinetic (PK) profile of imsidolimab and explore the immune response to imsidolimab in participants with HS.

Conditions

• Hidradenitis Suppurativa

Interventions

Type	Name	Description
BIOLOGICAL	Imsidolimab	Humanized Monoclonal Antibody
BIOLOGICAL	Placebo	Placebo

Timeline

• Start date: 2021-07-07
• Primary completion: 2022-07-15
• Completion: 2022-12-14
• First posted: 2021-04-23
• Last updated: 2025-09-22
• Results posted: 2025-09-22

Locations

34 sites across 4 countries: United States, Canada, Georgia, Poland

Regulatory

• FDA-regulated drug study