NCT04856917

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 123 (actual)
• Sponsor: Vanda Pharmaceuticals · Industry
• Sex: All
• Age: 12 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

Efficacy and Safety of Imsidolimab in Participants with Acne Vulgaris

Detailed description

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

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	Imsidolimab	Humanized Monoclonal Antibody
BIOLOGICAL	Placebo	Placebo

Timeline

• Start date: 2021-05-15
• Primary completion: 2022-02-01
• Completion: 2022-03-29
• First posted: 2021-04-23
• Last updated: 2025-09-22
• Results posted: 2023-06-15

Locations

15 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study