Clinical trial NCT04856930: A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Subjects With Hidradenitis Suppurativa
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hidradenitis Suppurativa
Keywords: IL-36 receptor
Interleukin 36
Imsidolimab
Lead sponsor: AnaptysBio, Inc.
Sponsor class: INDUSTRY
First posted: 2021-04-23
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: To evaluate the efficacy of imsidolimab in subjects with HS
timeFrame: Change in baseline in abscess and inflammatory nodule (AN) count at Week 16
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Site 10-108
state: Alabama
city: Fountain Valley
country: United States
facility: Site 10-104
state: California
city: Northridge
country: United States
facility: Site 10-119
state: California
city: Sacramento
country: United States
facility: Site 10-102
state: California
city: Coral Gables
country: United States
facility: Site 10-109
state: Florida
city: Largo
country: United States
facility: Site 10-107
state: Florida
city: Tampa
country: United States
facility: Site 10-111
state: Florida
city: Sandy Springs
country: United States
facility: Site 10-110
state: Georgia
city: Fort Gratiot
country: United States
facility: Site 10-101
state: Michigan
city: Portsmouth
country: United States
facility: Site 10-103
state: New Hampshire
city: Warwick
country: United States
facility: Site 10-115
state: Rhode Island
city: Greenville
country: United States
facility: Site 10-113
state: South Carolina
city: Houston
country: United States
facility: Site 10-118
state: Texas
city: Pflugerville
country: United States
facility: Site 10-112
state: Texas
city: San Antonio
country: United States
facility: Site 10-117
state: Texas
city: Norfolk
country: United States
facility: Site 10-105
state: Virginia
city: Spokane
country: United States
facility: Site 10-106
state: Washington
city: Calgary
country: Canada
facility: Site 11-106
state: Alberta
city: Cobourg
country: Canada
facility: Site 11-103
state: Ontario
city: Markham
country: Canada
facility: Site 11-102
state: Ontario
city: Québec
country: Canada
facility: Site 11-105
state: Quebec
city: Saint-Jérôme
country: Canada
facility: Site 11-101
state: Quebec
city: Batumi
country: Georgia
facility: Site 59-106
city: Tbilisi
country: Georgia
facility: Site 59-102
city: Tbilisi
country: Georgia
facility: Site 59-104
city: Tbilisi
country: Georgia
facility: Site 59-103
city: Tbilisi
country: Georgia
facility: Site 59-105
city: Tbilisi
country: Georgia
facility: Site 59-107
city: Kraków
country: Poland
facility: Site 30-107
state: Malopolska
city: Rzeszów
country: Poland
facility: Site 30-104
state: Podkarpackie
city: Katowice
country: Poland
facility: Site 30-108
state: Silesia
city: Ossy
country: Poland
facility: Site 30-103
state: Slaskie
city: Olsztyn
country: Poland
facility: Site 30-106
city: Łódź
country: Poland
facility: Site 30-109
Study officials:
affiliation: AnaptysBio, Inc.
name: Bruce Randazzo, MD
role: STUDY_DIRECTOR
References: