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

Vanda Pharmaceuticals149 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

149

Conditions

Hidradenitis Suppurativa

Interventions

ImsidolimabBIOLOGICAL

Humanized Monoclonal Antibody

PlaceboBIOLOGICAL

Placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (34)

Outcomes

Primary Outcomes

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.

Time frame: Baseline, Week 16

Secondary Outcomes

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.

Time frame: 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 1. at least a 50% decrease in AN count from Baseline, and 2. no increase in abscess count relative to Baseline, and 3. no increase in draining fistula count relative to Baseline

Time frame: 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).

Time frame: Baseline, Week 16

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

Time frame: Baseline, Week 16

Data from ClinicalTrials.gov

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Site 10-108

Birmingham, Alabama, United States

Site 10-104

Fountain Valley, California, United States

Site 10-119

Northridge, California, United States

Site 10-102

Sacramento, California, United States

Site 10-109

Coral Gables, Florida, United States

Site 10-107

Largo, Florida, United States

Site 10-111

Tampa, Florida, United States

Site 10-110

Sandy Springs, Georgia, United States

Site 10-101

Fort Gratiot, Michigan, United States

Site 10-103

Portsmouth, New Hampshire, United States

...and 24 more locations

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

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