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A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Participants With Acne Vulgaris | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

NCT04856917•Vanda Pharmaceuticals

View on ClinicalTrials.gov

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.

Eligibility

Age

12 - 45 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Diagnosis of moderate to severe facial AV
•Facial IGA) score of 3 (moderate) or 4 (severe)
•At least 20 and no more than 100 inflammatory lesions on the face
•No more than 100 non-inflammatory lesions on the face.
•No more than 5 nodules (≥5 millimeter \[mm\]) on the face

Exclusion Criteria

•A participant with acne fulminans or conglobate or secondary acne will be excluded.

Locations (15)

Site 10-114

Hot Springs, Arkansas, United States

Site 10-111

Fountain Valley, California, United States

Site 10-106

Sherman Oaks, California, United States

Site 10-113

Sweetwater, Florida, United States

Site 10-108

Tampa, Florida, United States

Site 10-107

Tampa, Florida, United States

Site 10-109

New Orleans, Louisiana, United States

Site 10-112

New Orleans, Louisiana, United States

Site 10-104

Detroit, Michigan, United States

Site 10-110

Portsmouth, New Hampshire, United States

Key Dates

Start Date

May 15, 2021

Primary Completion Date

February 1, 2022

Completion Date

March 29, 2022

Last Updated

September 22, 2025

Enrollment

123

ACTUAL participants

Conditions

Acne Vulgaris

Interventions

Imsidolimab

DRUG

Placebo

BIOLOGICAL

Clindamycin Phosphate, Adapalene, and Benzoyl Peroxide Triple Combination Gel in Canadian Patients With Acne Vulgaris

NCT07205107

Acne Vulgaris

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RECRUITINGPHASE1/PHASE2

Clascoterone for Steroid-related Acne Vulgaris in Transgender Male Patients Receiving Masculinizing Hormone Therapy

NCT05891795

Acne Vulgaris

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RECRUITINGNA

Profiles Analysis of Genome Wide Association Study (GWAS) in Acne Vulgaris in Indonesia.

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 22, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Clindamycin Phosphate, Adapalene, and Benzoyl Peroxide Triple Combination Gel in Canadian Patients With Acne Vulgaris

Clascoterone for Steroid-related Acne Vulgaris in Transgender Male Patients Receiving Masculinizing Hormone Therapy

Profiles Analysis of Genome Wide Association Study (GWAS) in Acne Vulgaris in Indonesia.

Anti-inflammatory Effects of Topical Erythromycin and Clindamycin in Acne Patients

A Study Comparing Tretinoin Gel Microsphere, 0.04% and RETIN-A MICRO ® Gel Microsphere, 0.04% in the Treatment of Acne Vulgaris

Auricular Acupressure Combined With Adapalene for the Treatment of Acne Vulgaris