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

Phase 2

Completed

• Conditions: Hidradenitis Suppurativa
• Interventions: Biological: Imsidolimab; Biological: Placebo Solution

• Registration Number: NCT04856930
• Lead Sponsor: AnaptysBio, Inc.

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.

Study Timeline

• Study First Submitted: 2021-04-20
• Study First Submitted QC: 2021-04-20
• Study First Posted: 2021-04-23
• Study Start: 2021-07-07
• Primary Completion: 2022-07-15
• Study Completion: 2022-12-14
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-13
• Last Update Posted: 2023-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 149

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ANB019 Biological Humanized Monoclonal Antibody High Dose	Imsidolimab	-
ANB019 Biological Humanized Monoclonal Antibody Low Dose	Imsidolimab	-
Placebo Solution	Placebo Solution	-

Primary Outcome Measures

Name	Time	Method
To evaluate the efficacy of imsidolimab in subjects with HS	Change in baseline in abscess and inflammatory nodule (AN) count at Week 16	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

Trial Locations

Locations (34)

Site 59-106; 🇬🇪 Batumi, Georgia

Site 59-102; 🇬🇪 Tbilisi, Georgia

Site 30-106; 🇵🇱 Olsztyn, Poland

Site 59-104; 🇬🇪 Tbilisi, Georgia

Site 59-103; 🇬🇪 Tbilisi, Georgia

Site 30-107; 🇵🇱 Kraków, Malopolska, Poland

Site 30-103; 🇵🇱 Ossy, Slaskie, Poland

Site 30-108; 🇵🇱 Katowice, Silesia, Poland

Site 10-108; 🇺🇸 Birmingham, Alabama, United States

Site 10-107; 🇺🇸 Largo, Florida, United States

Site 10-102; 🇺🇸 Sacramento, California, United States

Site 10-110; 🇺🇸 Sandy Springs, Georgia, United States

Site 10-119; 🇺🇸 Northridge, California, United States

Site 10-104; 🇺🇸 Fountain Valley, California, United States

Site 10-111; 🇺🇸 Tampa, Florida, United States

Site 10-118; 🇺🇸 Houston, Texas, United States

Site 10-103; 🇺🇸 Portsmouth, New Hampshire, United States

Site 10-105; 🇺🇸 Norfolk, Virginia, United States

Site 11-105; 🇨🇦 Québec, Quebec, Canada

Site 30-104; 🇵🇱 Rzeszów, Podkarpackie, Poland

Site 11-106; 🇨🇦 Calgary, Alberta, Canada

Site 59-105; 🇬🇪 Tbilisi, Georgia

Site 59-107; 🇬🇪 Tbilisi, Georgia

Site 10-106; 🇺🇸 Spokane, Washington, United States

Site 30-109; 🇵🇱 Łódź, Poland

Site 11-101; 🇨🇦 Saint-Jérôme, Quebec, Canada

Site 10-117; 🇺🇸 San Antonio, Texas, United States

Site 11-103; 🇨🇦 Cobourg, Ontario, Canada

Site 10-112; 🇺🇸 Pflugerville, Texas, United States

Site 10-101; 🇺🇸 Fort Gratiot, Michigan, United States

Site 10-109; 🇺🇸 Coral Gables, Florida, United States

Site 10-115; 🇺🇸 Warwick, Rhode Island, United States

Site 10-113; 🇺🇸 Greenville, South Carolina, United States

Site 11-102; 🇨🇦 Markham, Ontario, Canada