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

Primary Purpose

Hidradenitis Suppurativa

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Imsidolimab
Placebo Solution
Sponsored by
AnaptysBio, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hidradenitis Suppurativa focused on measuring IL-36 receptor, Interleukin 36, Imsidolimab

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Site 10-108
  • Site 10-104
  • Site 10-119
  • Site 10-102
  • Site 10-109
  • Site 10-107
  • Site 10-111
  • Site 10-110
  • Site 10-101
  • Site 10-103
  • Site 10-115
  • Site 10-113
  • Site 10-118
  • Site 10-112
  • Site 10-117
  • Site 10-105
  • Site 10-106
  • Site 11-106
  • Site 11-103
  • Site 11-102
  • Site 11-105
  • Site 11-101
  • Site 59-106
  • Site 59-102
  • Site 59-104
  • Site 59-103
  • Site 59-105
  • Site 59-107
  • Site 30-107
  • Site 30-104
  • Site 30-108
  • Site 30-103
  • Site 30-106
  • Site 30-109

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

ANB019 Biological Humanized Monoclonal Antibody Low Dose

ANB019 Biological Humanized Monoclonal Antibody High Dose

Placebo Solution

Arm Description

Outcomes

Primary Outcome Measures

To evaluate the efficacy of imsidolimab in subjects with HS
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

Secondary Outcome Measures

Full Information

First Posted
April 20, 2021
Last Updated
February 13, 2023
Sponsor
AnaptysBio, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04856930
Brief Title
A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Subjects With Hidradenitis Suppurativa
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
July 7, 2021 (Actual)
Primary Completion Date
July 15, 2022 (Actual)
Study Completion Date
December 14, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AnaptysBio, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hidradenitis Suppurativa
Keywords
IL-36 receptor, Interleukin 36, Imsidolimab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
149 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ANB019 Biological Humanized Monoclonal Antibody Low Dose
Arm Type
Experimental
Arm Title
ANB019 Biological Humanized Monoclonal Antibody High Dose
Arm Type
Experimental
Arm Title
Placebo Solution
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
Imsidolimab
Other Intervention Name(s)
ANB019
Intervention Description
Humanized Monoclonal Antibody
Intervention Type
Biological
Intervention Name(s)
Placebo Solution
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
To evaluate the efficacy of imsidolimab in subjects with HS
Description
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
Time Frame
Change in baseline in abscess and inflammatory nodule (AN) count at Week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female aged 18 to 75 years (inclusive) at the time of signing informed consent. Clinically confirmed diagnosis of active HS with a disease duration of ≥ 6 months before Day 1. HS lesions present in at least 2 distinct anatomical areas. Total AN count ≥ 5. Draining fistulas ≤ 20. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce Randazzo, MD
Organizational Affiliation
AnaptysBio, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Site 10-108
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35224
Country
United States
Facility Name
Site 10-104
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Site 10-119
City
Northridge
State/Province
California
ZIP/Postal Code
91324
Country
United States
Facility Name
Site 10-102
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Site 10-109
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Site 10-107
City
Largo
State/Province
Florida
ZIP/Postal Code
33770
Country
United States
Facility Name
Site 10-111
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Site 10-110
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Site 10-101
City
Fort Gratiot
State/Province
Michigan
ZIP/Postal Code
48059
Country
United States
Facility Name
Site 10-103
City
Portsmouth
State/Province
New Hampshire
ZIP/Postal Code
03801
Country
United States
Facility Name
Site 10-115
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Site 10-113
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Site 10-118
City
Houston
State/Province
Texas
ZIP/Postal Code
77056
Country
United States
Facility Name
Site 10-112
City
Pflugerville
State/Province
Texas
ZIP/Postal Code
78660
Country
United States
Facility Name
Site 10-117
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78213
Country
United States
Facility Name
Site 10-105
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Site 10-106
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Site 11-106
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2J7E1
Country
Canada
Facility Name
Site 11-103
City
Cobourg
State/Province
Ontario
ZIP/Postal Code
K9A 0Z4
Country
Canada
Facility Name
Site 11-102
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P 1X3
Country
Canada
Facility Name
Site 11-105
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1N 4V3
Country
Canada
Facility Name
Site 11-101
City
Saint-Jérôme
State/Province
Quebec
ZIP/Postal Code
J7Z 7E2
Country
Canada
Facility Name
Site 59-106
City
Batumi
ZIP/Postal Code
6000
Country
Georgia
Facility Name
Site 59-102
City
Tbilisi
ZIP/Postal Code
112
Country
Georgia
Facility Name
Site 59-104
City
Tbilisi
ZIP/Postal Code
159
Country
Georgia
Facility Name
Site 59-103
City
Tbilisi
ZIP/Postal Code
160
Country
Georgia
Facility Name
Site 59-105
City
Tbilisi
ZIP/Postal Code
160
Country
Georgia
Facility Name
Site 59-107
City
Tbilisi
ZIP/Postal Code
162
Country
Georgia
Facility Name
Site 30-107
City
Kraków
State/Province
Malopolska
ZIP/Postal Code
30-074
Country
Poland
Facility Name
Site 30-104
City
Rzeszów
State/Province
Podkarpackie
ZIP/Postal Code
35-055
Country
Poland
Facility Name
Site 30-108
City
Katowice
State/Province
Silesia
ZIP/Postal Code
40-611
Country
Poland
Facility Name
Site 30-103
City
Ossy
State/Province
Slaskie
ZIP/Postal Code
42-624
Country
Poland
Facility Name
Site 30-106
City
Olsztyn
ZIP/Postal Code
10-229
Country
Poland
Facility Name
Site 30-109
City
Łódź
ZIP/Postal Code
90-265
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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