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

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 participants with Hidradenitis Suppurativa

Study Overview

• Status: Completed
• Conditions: Hidradenitis Suppurativa
• Intervention / Treatment: Biological: Placebo; Biological: Imsidolimab

Detailed Description

This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of imsidolimab in adult participants with hidradenitis suppurativa (HS). This study will also characterize the pharmacokinetic (PK) profile of imsidolimab and explore the immune response to imsidolimab in participants with HS.

• Study Type: Interventional
• Enrollment (Actual): 149
• Phase: Phase 2

Contacts and Locations

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
  • Lodz, Poland, 90-265
    • Site 30-109
  • Olsztyn, Poland, 10-229
    • Site 30-106
  • Malopolska
    • Krakow, Malopolska, Poland, 30-074
      • Site 30-107
  • Podkarpackie Voivodeship
    • Rzeszów, Podkarpackie Voivodeship, Poland, 35-055
      • Site 30-104
  • Silesian Voivodeship
    • Katowice, Silesian Voivodeship, Poland, 40-611
      • Site 30-108
    • Ossy, Silesian Voivodeship, 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

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Clinically confirmed diagnosis of active HS with a disease duration of greater than or equal to (≥) 6 months before Day 1.
2. HS lesions present in at least 2 distinct anatomical areas.
3. Total Abscess and inflammatory nodule (AN) count ≥ 5.
4. Draining fistulas less than or equal to (≤) 20.
5. 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 participant's response to therapy.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Imsidolimab 400/200 milligrams (mg); 400 milligrams (mg) of imsidolimab on Day 1 followed by 200 mg imsidolimab every 4 weeks by subcutaneous (SC) injection up to 48 weeks	Biological: Imsidolimab; Humanized Monoclonal Antibody; Other Names: ANB019
Experimental: Imsidolimab 200/100 mg; 400 milligrams (mg) of imsidolimab on Day 1 followed by 200 mg imsidolimab every 4 weeks by subcutaneous (SC) injection up to 48 weeks	Biological: Imsidolimab; Humanized Monoclonal Antibody; Other Names: ANB019
Placebo Comparator: Placebo; Placebo-controlled period: Participants received imsidolimab matching placebo on Day 1 and thereafter, every 4 weeks (Days 29, 57 and 85) by SC injection. The placebo-controlled period ended at Day 113 (Week 16). Extension period: Participants received imsidolimab at the same dose as placebo-controlled period, SC every 4 weeks (Days 113, 141, 169, and 197). After discontinuation from treatment, participants remained in the study for safety follow-up period of 8 weeks.	Biological: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in AN Count at Week 16: Placebo-Controlled Period	The AN count was defined as the sum of the number of abscesses and inflammatory nodules from all locations.	Baseline, Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change From Baseline in AN Count at Week 16: Placebo-Controlled Period	The AN count was defined as the sum of the number of abscesses and inflammatory nodules from all locations.	Baseline, Week 16
Number of Participants Achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50): Placebo-Controlled Period	The number of participants with at least a 50% decrease from Baseline AN count, and no increase in abscesses or draining fistulas in comparison to baseline (HiSCR50) at Week 16 was calculated for each treatment group as follows: A responder HiSCR50 was defined as a participant with; at least a 50% decrease in AN count from Baseline, and; no increase in abscess count relative to Baseline, and; no increase in draining fistula count relative to Baseline	Week 16
Change From Baseline in Worst HS Pain NRS Score at Week 16: Placebo-Controlled Period	Participants were asked to assign a numerical score representing the HS worst pain intensity over the last 24 hours on a scale from 0 (no symptoms) to 10 (worst imaginable symptoms).	Baseline, Week 16
Change From Baseline in Average HS Pain NRS Score at Week 16: Placebo-Controlled Period	Participants were asked to assign a numerical score representing the average intensity over the last 7 days of their HS pain symptoms on a scale from 0 (no symptoms) to 10 (worst imaginable symptoms).	Baseline, Week 16
Percent Change From Baseline in Worst HS Pain NRS Score at Week 16: Placebo-Controlled Period	Participants were asked to assign a numerical score representing the HS worst pain intensity over the last 24 hours on a scale from 0 (no symptoms) to 10 (worst imaginable symptoms). Only participants that had Baseline score of >0 could be included in the analysis of Percent Change from Baseline.	Baseline, Week 16
Percent Change From Baseline in Average HS Pain NRS Score at Week 16: Placebo-Controlled Period	Participants were asked to assign a numerical score representing the average intensity over the last 7 days of their HS pain symptoms on a scale from 0 (no symptoms) to 10 (worst imaginable symptoms). Only participants that had Baseline score of >0 could be included in the analysis of Percent Change from Baseline.	Baseline, Week 16
Number of Participants With Treatment-emergent Adverse Events (TEAEs): Placebo-Controlled Period	An adverse event (AE) was any untoward medical occurrence in a participant temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An AE was considered treatment-emergent if the date of onset was during or after first dose of study treatment during placebo-controlled period, or if the AE present at baseline worsened in either intensity or frequency after first dose of study treatment.	From first dose (placebo-controlled period) up to Week 16
Number of Participants With TEAEs: Extension and Follow-up Period	An AE was any untoward medical occurrence in a participant temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An AE was considered treatment-emergent if the date of onset was during or after first dose of study treatment in extension period, or if the AE present at baseline worsened in either intensity or frequency after first dose of study treatment.	From first dose (extension period) up to Week 40

Collaborators and Investigators

• Sponsor: Vanda Pharmaceuticals

Study record dates

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): September 22, 2025
• Last Update Submitted That Met QC Criteria: September 2, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Interleukin 36; Imsidolimab; IL-36 receptor
• Additional Relevant MeSH Terms: Infections; Skin Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Sweat Gland Diseases; Skin Diseases, Bacterial; Skin Diseases, Infectious; Suppuration; Hidradenitis; Skin and Connective Tissue Diseases; Hidradenitis Suppurativa
• Other Study ID Numbers: ANB019-208; 2021-001440-99 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No