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

February 13, 2023 updated by: AnaptysBio, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

149

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2J7E1
        • Site 11-106
    • Ontario
      • Cobourg, Ontario, Canada, K9A 0Z4
        • Site 11-103
      • Markham, Ontario, Canada, L3P 1X3
        • Site 11-102
    • Quebec
      • Québec, Quebec, Canada, G1N 4V3
        • Site 11-105
      • Saint-Jérôme, Quebec, Canada, J7Z 7E2
        • Site 11-101
  • Georgia
      • Batumi, Georgia, 6000
        • Site 59-106
      • Tbilisi, Georgia, 112
        • Site 59-102
      • Tbilisi, Georgia, 159
        • Site 59-104
      • Tbilisi, Georgia, 160
        • Site 59-103
      • Tbilisi, Georgia, 160
        • Site 59-105
      • Tbilisi, Georgia, 162
        • Site 59-107
  • Poland
      • Olsztyn, Poland, 10-229
        • Site 30-106
      • Łódź, Poland, 90-265
        • Site 30-109
    • Malopolska
      • Kraków, Malopolska, Poland, 30-074
        • Site 30-107
    • Podkarpackie
      • Rzeszów, Podkarpackie, Poland, 35-055
        • Site 30-104
    • Silesia
      • Katowice, Silesia, Poland, 40-611
        • Site 30-108
    • Slaskie
      • Ossy, Slaskie, Poland, 42-624
        • Site 30-103
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35224
        • Site 10-108
    • California
      • Fountain Valley, California, United States, 92708
        • Site 10-104
      • Northridge, California, United States, 91324
        • Site 10-119
      • Sacramento, California, United States, 95817
        • Site 10-102
    • Florida
      • Coral Gables, Florida, United States, 33134
        • Site 10-109
      • Largo, Florida, United States, 33770
        • Site 10-107
      • Tampa, Florida, United States, 33607
        • Site 10-111
    • Georgia
      • Sandy Springs, Georgia, United States, 30328
        • Site 10-110
    • Michigan
      • Fort Gratiot, Michigan, United States, 48059
        • Site 10-101
    • New Hampshire
      • Portsmouth, New Hampshire, United States, 03801
        • Site 10-103
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
        • Site 10-115
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • Site 10-113
    • Texas
      • Houston, Texas, United States, 77056
        • Site 10-118
      • Pflugerville, Texas, United States, 78660
        • Site 10-112
      • San Antonio, Texas, United States, 78213
        • Site 10-117
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Site 10-105
    • Washington
      • Spokane, Washington, United States, 99202
        • Site 10-106

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo Solution
Biological: Placebo Solution
Placebo
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the efficacy of imsidolimab in subjects with HS
Time Frame: 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
Change in baseline in abscess and inflammatory nodule (AN) count at Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AnaptysBio, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 7, 2021

Primary Completion (Actual)

July 15, 2022

Study Completion (Actual)

December 14, 2022

Study Registration Dates

First Submitted

April 20, 2021

First Submitted That Met QC Criteria

April 20, 2021

First Posted (Actual)

April 23, 2021

Study Record Updates

Last Update Posted (Actual)

February 15, 2023

Last Update Submitted That Met QC Criteria

February 13, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANB019-208
  • 2021-001440-99 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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