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

Sponsor
AnaptysBio, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04856930
Collaborator
(none)
120
Enrollment
34
Locations
3
Arms
20.8
Anticipated Duration (Months)
3.5
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Efficacy and Safety of Imsidolimab (ANB019) in Subjects with Hidradenitis Suppurativa

Condition or Disease Intervention/Treatment Phase
  • Biological: Imsidolimab
  • Biological: Placebo Solution
 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 adult subjects with hidradenitis suppurativa (HS). This study also will characterize the pharmacokinetic (PK) profile of imsidolimab and explore the immune response to imsidolimab in subjects with HS.

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 Hidradenitis Suppurativa
Actual Study Start Date :
Jul 7, 2021
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Apr 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: ANB019 Biological Humanized Monoclonal Antibody Low Dose

Biological: Imsidolimab
Humanized Monoclonal Antibody
Other Names:
  • ANB019

    		•
    Experimental: ANB019 Biological Humanized Monoclonal Antibody High Dose

    Biological: Imsidolimab
    Humanized Monoclonal Antibody
    Other Names:
  • ANB019

    		•
    Placebo Comparator: Placebo Solution

    Biological: Placebo Solution
    Placebo

    Outcome Measures

    Primary Outcome Measures

    1. To evaluate the efficacy of imsidolimab in subjects with HS [Change in baseline in abscess and inflammatory nodule (AN) count at Week 16]

      To evaluate the efficacy of imsidolimab in subjects with HS and compare with placebo change from Baseline in abscess and inflammatory nodule (AN) count at Week 16

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Male or female aged 18 to 75 years (inclusive) at the time of signing informed consent.

    2. Clinically confirmed diagnosis of active HS with a disease duration of ≥ 6 months before Day 1.

    3. HS lesions present in at least 2 distinct anatomical areas.

    4. Total AN count ≥ 5.

    5. Draining fistulas ≤ 20.

    6. Stable HS for at least 6 weeks prior to Day 1 visit.

    Exclusion Criteria:
    1. Concomitant dermatological or medical conditions that may interfere with the Investigators' ability to evaluate the subject's response to therapy.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Site 10-108 Birmingham Alabama United States 35224
    2 Site 10-104 Fountain Valley California United States 92708
    3 Site 10-119 Northridge California United States 91324
    4 Site 10-102 Sacramento California United States 95817
    5 Site 10-109 Coral Gables Florida United States 33134
    6 Site 10-107 Largo Florida United States 33770
    7 Site 10-111 Tampa Florida United States 33607
    8 Site 10-110 Sandy Springs Georgia United States 30328
    9 Site 10-101 Fort Gratiot Michigan United States 48059
    10 Site 10-103 Portsmouth New Hampshire United States 03801
    11 Site 10-115 Warwick Rhode Island United States 02886
    12 Site 10-113 Greenville South Carolina United States 29615
    13 Site 10-118 Houston Texas United States 77056
    14 Site 10-112 Pflugerville Texas United States 78660
    15 Site 10-117 San Antonio Texas United States 78213
    16 Site 10-105 Norfolk Virginia United States 23502
    17 Site 10-106 Spokane Washington United States 99202
    18 Site 11-106 Calgary Alberta Canada T2J7E1
    19 Site 11-103 Cobourg Ontario Canada K9A 0Z4
    20 Site 11-102 Markham Ontario Canada L3P 1X3
    21 Site 11-105 Québec Quebec Canada G1N 4V3
    22 Site 11-101 Saint-Jérôme Quebec Canada J7Z 7E2
    23 Site 59-106 Batumi Georgia 6000
    24 Site 59-102 Tbilisi Georgia 112
    25 Site 59-104 Tbilisi Georgia 159
    26 Site 59-103 Tbilisi Georgia 160
    27 Site 59-105 Tbilisi Georgia 160
    28 Site 59-107 Tbilisi Georgia 162
    29 Site 30-107 Kraków Malopolska Poland 30-074
    30 Site 30-104 Rzeszów Podkarpackie Poland 35-055
    31 Site 30-108 Katowice Silesia Poland 40-611
    32 Site 30-103 Ossy Slaskie Poland 42-624
    33 Site 30-106 Olsztyn Poland 10-229
    34 Site 30-109 Łódź Poland 90-265

    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:
    NCT04856930
    Other Study ID Numbers:
    • ANB019-208
    • 2021-001440-99
    First Posted:
    Apr 23, 2021
    Last Update Posted:
    Dec 7, 2021
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by AnaptysBio, Inc.
    IL-36 receptor
    Interleukin 36
    Imsidolimab
    Additional relevant MeSH terms:
    Hidradenitis Suppurativa
    Hidradenitis

    Study Results

    No Results Posted as of Dec 7, 2021