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

Last updated: September 2, 2025
Sponsor: Vanda Pharmaceuticals
Overall Status: Completed

Phase

2

Condition

Rash

Scalp Disorders

Inflammatory Comedones

Treatment

Placebo

Imsidolimab

Clinical Study ID

NCT04856917
ANB019-209
  • Ages 12-45
  • All Genders

Study Summary

Efficacy and Safety of Imsidolimab in Participants with Acne Vulgaris

Eligibility Criteria

Inclusion

Key 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

Key Exclusion Criteria:

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

Study Design

Total Participants: 123
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
May 15, 2021
Estimated Completion Date:
March 29, 2022

Study 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.

Connect with a study center

  • Site 10-115

    Waterloo, Ontario N2J1C4
    Canada

    Site Not Available

  • Site 10-115

    Waterloo 6176823, Ontario 6093943 N2J1C4
    Canada

    Site Not Available

  • Site 10-114

    Hot Springs, Arkansas 71913
    United States

    Site Not Available

  • Site 10-114

    Hot Springs 4115412, Arkansas 4099753 71913
    United States

    Site Not Available

  • Site 10-111

    Fountain Valley, California 92708
    United States

    Site Not Available

  • Site 10-106

    Sherman Oaks, California 91403
    United States

    Site Not Available

  • Site 10-111

    Fountain Valley 5350207, California 5332921 92708
    United States

    Site Not Available

  • Site 10-106

    Sherman Oaks 5395244, California 5332921 91403
    United States

    Site Not Available

  • Site 10-113

    Sweetwater, Florida 33172
    United States

    Site Not Available

  • Site 10-107

    Tampa, Florida 33613
    United States

    Site Not Available

  • Site 10-108

    Tampa, Florida 33607
    United States

    Site Not Available

  • Site 10-113

    Sweetwater 4174600, Florida 4155751 33172
    United States

    Site Not Available

  • Site 10-107

    Tampa 4174757, Florida 4155751 33613
    United States

    Site Not Available

  • Site 10-108

    Tampa 4174757, Florida 4155751 33607
    United States

    Site Not Available

  • Site 10-109

    New Orleans, Louisiana 70119
    United States

    Site Not Available

  • Site 10-112

    New Orleans, Louisiana 70119
    United States

    Site Not Available

  • Site 10-109

    New Orleans 4335045, Louisiana 4331987 70119
    United States

    Site Not Available

  • Site 10-112

    New Orleans 4335045, Louisiana 4331987 70119
    United States

    Site Not Available

  • Site 10-104

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Site 10-104

    Detroit 4990729, Michigan 5001836 48202
    United States

    Site Not Available

  • Site 10-110

    Portsmouth, New Hampshire 03801
    United States

    Site Not Available

  • Site 10-110

    Portsmouth 5091383, New Hampshire 5090174 03801
    United States

    Site Not Available

  • Site 10-105

    Murfreesboro, Tennessee 37130
    United States

    Site Not Available

  • Site 10-105

    Murfreesboro 4644312, Tennessee 4662168 37130
    United States

    Site Not Available

  • Site 10-103

    Austin, Texas 78759
    United States

    Site Not Available

  • Site 10-102

    College Station, Texas 77845
    United States

    Site Not Available

  • Site 10-101

    San Antonio, Texas 78213
    United States

    Site Not Available

  • Site 10-103

    Austin 4671654, Texas 4736286 78759
    United States

    Site Not Available

  • Site 10-102

    College Station 4682464, Texas 4736286 77845
    United States

    Site Not Available

  • Site 10-101

    San Antonio 4726206, Texas 4736286 78213
    United States

    Site Not Available

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