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

Hidradenitis Suppurativa Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04856930
• Other study ID #: ANB019-208
• Secondary ID: 2021-001440-99
• Status: Completed
• Phase: Phase 2
• Start date: July 7, 2021
• Est. completion date: December 14, 2022

Study information

• Verified date: February 2023
• Source: AnaptysBio, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: December 14, 2022
• Est. primary completion date: July 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hidradenitis
• Hidradenitis Suppurativa

Intervention

Biological:
• Imsidolimab
Humanized Monoclonal Antibody
• Placebo Solution
Placebo

Locations

Country	Name	City	State
Canada	Site 11-106	Calgary	Alberta
Canada	Site 11-103	Cobourg	Ontario
Canada	Site 11-102	Markham	Ontario
Canada	Site 11-105	Québec	Quebec
Canada	Site 11-101	Saint-Jérôme	Quebec
Georgia	Site 59-106	Batumi
Georgia	Site 59-102	Tbilisi
Georgia	Site 59-103	Tbilisi
Georgia	Site 59-104	Tbilisi
Georgia	Site 59-105	Tbilisi
Georgia	Site 59-107	Tbilisi
Poland	Site 30-108	Katowice	Silesia
Poland	Site 30-107	Kraków	Malopolska
Poland	Site 30-109	Lódz
Poland	Site 30-106	Olsztyn
Poland	Site 30-103	Ossy	Slaskie
Poland	Site 30-104	Rzeszów	Podkarpackie
United States	Site 10-108	Birmingham	Alabama
United States	Site 10-109	Coral Gables	Florida
United States	Site 10-101	Fort Gratiot	Michigan
United States	Site 10-104	Fountain Valley	California
United States	Site 10-113	Greenville	South Carolina
United States	Site 10-118	Houston	Texas
United States	Site 10-107	Largo	Florida
United States	Site 10-105	Norfolk	Virginia
United States	Site 10-119	Northridge	California
United States	Site 10-112	Pflugerville	Texas
United States	Site 10-103	Portsmouth	New Hampshire
United States	Site 10-102	Sacramento	California
United States	Site 10-117	San Antonio	Texas
United States	Site 10-110	Sandy Springs	Georgia
United States	Site 10-106	Spokane	Washington
United States	Site 10-111	Tampa	Florida
United States	Site 10-115	Warwick	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
AnaptysBio, Inc.

Countries where clinical trial is conducted

United States,  Canada,  Georgia,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in baseline in abscess and inflammatory nodule (AN) count at Week 16