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

Sponsor
AnaptysBio, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04856917
Collaborator
(none)
120
Enrollment
15
Locations
3
Arms
17
Anticipated Duration (Months)
8
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Efficacy and Safety of Imsidolimab in Subjects with Acne Vulgaris

Condition or Disease Intervention/Treatment Phase
Phase 2

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 subjects with acne vulgaris (AV). This study also will characterize the pharmacokinetic (PK) profile of Imsidolimab and explore the immune response to Imsidolimab in subjects with AV.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 2, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Subjects With Acne Vulgaris
Actual Study Start Date :
May 15, 2021
Anticipated Primary Completion Date :
May 15, 2022
Anticipated Study Completion Date :
Oct 15, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: High Dose Arm: Imsidolimab Biological humanized antibody

Drug: Imsidolimab
Humanized Monoclonal Antibody
Other Names:
  • ANB019

    		•
    Experimental: Low Dose Arm: Imsidolimab Biological humanized antibody

    Drug: Imsidolimab
    Humanized Monoclonal Antibody
    Other Names:
  • ANB019

    		•
    Placebo Comparator: Placebo

    Biological: Placebo
    Placebo

    Outcome Measures

    Primary Outcome Measures

    1. To determine the effect of Imsidolimab compared with placebo change from baseline in facial inflammatory lesion count at week 12. [Change from baseline in facial inflammatory lesion count at week 12]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Diagnosis of moderate to sever facial acne vulgaris

    • 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 noninflammatory lesions on the face.

    • No more than 5 nodules (≥5 mm) on the face

    Exclusion Criteria:
    • A subject with acne fulminans or conglobate or secondary acne will be excluded.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Site 10-114 Hot Springs Arkansas United States 71913
    2 Site 10-111 Fountain Valley California United States 92708
    3 Site 10-106 Sherman Oaks California United States 91403
    4 Site 10-113 Sweetwater Florida United States 33172
    5 Site 10-108 Tampa Florida United States 33607
    6 Site 10-107 Tampa Florida United States 33613
    7 Site 10-109 New Orleans Louisiana United States 70119
    8 Site 10-112 New Orleans Louisiana United States 70119
    9 Site 10-104 Detroit Michigan United States 48202
    10 Site 10-110 Portsmouth New Hampshire United States 03801
    11 Site 10-105 Murfreesboro Tennessee United States 37130
    12 Site 10-103 Austin Texas United States 78759
    13 Site 10-102 College Station Texas United States 77845
    14 Site 10-101 San Antonio Texas United States 78213
    15 Site 10-115 Waterloo Ontario Canada N2J1C4

    Sponsors and Collaborators

    • AnaptysBio, Inc.

    Investigators

    • Study Director: Bruce Randazzo, MD, AnaptysBio, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AnaptysBio, Inc.
    ClinicalTrials.gov Identifier:
    NCT04856917
    Other Study ID Numbers:
    • ANB019-209
    First Posted:
    Apr 23, 2021
    Last Update Posted:
    Dec 9, 2021
    Last Verified:
    Apr 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by AnaptysBio, Inc.
    LI-36 Receptor
    Interleukin 36
    Imsidolimab
    Additional relevant MeSH terms:
    Acne Vulgaris

    Study Results

    No Results Posted as of Dec 9, 2021