NCT04697069

A Study to Evaluate of the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Acneiform Rash

A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ANB019 in the Treatment of Acneiform Rash in Subjects With Neoplasm Receiving EGFRi or MEKi Therapy

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Vanda Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Efficacy and Safety of imsidolimab in participants with epidermal growth factor receptor inhibitor (EGFRi)/mitogen-activated protein (MAP)/extracellular signal-regulated kinase (ERK) kinase inhibitor (MEKi)-associated acneiform Rash

Detailed description

This study is a Phase 2a, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of imsidolimab compared with placebo in cancer participants with EGFRi/MEKi-associated acneiform rash. This study will also characterize the pharmacokinetic (PK) profile of imsidolimab and explore the immune response to imsidolimab in participants with EGFRi/MEKi-associated acneiform rash.

Conditions

• Acneiform Eruptions

Interventions

Type	Name	Description
BIOLOGICAL	Imsidolimab	Humanized monoclonal antibody
BIOLOGICAL	Placebo	Placebo

Timeline

• Start date: 2021-05-04
• Primary completion: 2021-12-13
• Completion: 2021-12-13
• First posted: 2021-01-06
• Last updated: 2025-09-22
• Results posted: 2023-01-09

Locations

18 sites across 5 countries: United States, Czechia, Georgia, Latvia, Poland

Regulatory

• FDA-regulated drug study