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Completed

NCT Number: NCT04856930

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

Efficacy and safety of imsidolimab (ANB019) in participants with Hidradenitis Suppurativa

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Key information

Conditions

Hidradenitis Suppurativa Bacterial Infections Bacterial Infections and Mycoses Hidradenitis Infections Skin Diseases Skin Diseases, Bacterial Skin Diseases, Infectious Skin and Connective Tissue Diseases Suppuration Sweat Gland Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Site 11-106, Calgary, Alberta, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinically confirmed diagnosis of active HS with a disease duration of greater than or equal to (≥) 6 months before Day 1.
  • HS lesions present in at least 2 distinct anatomical areas.
  • Total Abscess and inflammatory nodule (AN) count ≥ 5.
  • Draining fistulas less than or equal to (≤) 20.
  • Stable HS for at least 6 weeks prior to Day 1 visit.

Exclusion criteria

  • Concomitant dermatological or medical conditions that may interfere with the Investigators' ability to evaluate the participant's response to therapy.

Treatment and study plan

Imsidolimab

Biological

Humanized Monoclonal Antibody

Other names: ANB019

Placebo

Biological

Placebo

Primary outcomes

  1. Change From Baseline in AN Count at Week 16: Placebo-Controlled Period

    Time frame: Baseline, Week 16

    The AN count was defined as the sum of the number of abscesses and inflammatory nodules from all locations.

Secondary outcomes

  1. Percent Change From Baseline in AN Count at Week 16: Placebo-Controlled Period

    Time frame: Baseline, Week 16

    The AN count was defined as the sum of the number of abscesses and inflammatory nodules from all locations.

  2. Number of Participants Achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50): Placebo-Controlled Period

    Time frame: Week 16

    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

  3. Change From Baseline in Worst HS Pain NRS Score at Week 16: Placebo-Controlled Period

    Time frame: Baseline, Week 16

    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).

  4. Change From Baseline in Average HS Pain NRS Score at Week 16: Placebo-Controlled Period

    Time frame: Baseline, Week 16

    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).

  5. Percent Change From Baseline in Worst HS Pain NRS Score at Week 16: Placebo-Controlled Period

    Time frame: Baseline, Week 16

    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.

  6. Percent Change From Baseline in Average HS Pain NRS Score at Week 16: Placebo-Controlled Period

    Time frame: Baseline, Week 16

    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.

  7. Number of Participants With Treatment-emergent Adverse Events (TEAEs): Placebo-Controlled Period

    Time frame: From first dose (placebo-controlled period) up to Week 16

    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.

  8. Number of Participants With TEAEs: Extension and Follow-up Period

    Time frame: From first dose (extension period) up to Week 40

    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.

Sponsors and collaborators

Lead sponsor

Vanda Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 23, 2021
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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