Clinical trial NCT04856917: A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Participants With Acne Vulgaris
Official title: A Phase 2, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Participants With Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acne Vulgaris
Keywords: LI-36 Receptor
Interleukin 36
Imsidolimab
Lead sponsor: AnaptysBio, Inc.
Sponsor class: INDUSTRY
First posted: 2021-04-23
Enrollment: 123
Sex: ALL
Minimum age (years): 12
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Efficacy and Safety of Imsidolimab in Participants with Acne Vulgaris

Detailed description: This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of imsidolimab in adolescent and adult participants with acne vulgaris (AV). This study also will characterize the pharmacokinetic (PK) profile of imsidolimab and explore the immune response to imsidolimab in participants with AV.

Eligibility criteria: Key Inclusion Criteria:

* Diagnosis of moderate to severe facial AV
* Facial IGA) score of 3 (moderate) or 4 (severe)
* At least 20 and no more than 100 inflammatory lesions on the face
* No more than 100 non-inflammatory lesions on the face.
* No more than 5 nodules (≥5 millimeter \[mm\]) on the face

Key Exclusion Criteria:

* A participant with acne fulminans or conglobate or secondary acne will be excluded.

Primary outcomes:
measure: Change From Baseline in Facial Inflammatory Lesion Counts at Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Change From Baseline in Facial Inflammatory Lesion Counts at Weeks 2, 4, 8, and 20
timeFrame: Baseline, Weeks 2, 4, 8, and 20
measure: Percent Change From Baseline in Facial Inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20
timeFrame: Baseline, Weeks 2, 4, 8, 12 and 20
measure: Change From Baseline in Facial Non-inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20
timeFrame: Baseline, Weeks 2, 4, 8, 12, and 20
measure: Percent Change From Baseline in Facial Non-Inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20
timeFrame: Baseline, Weeks 2, 4, 8, 12, and 20
measure: Change From Baseline in Total Facial Lesion (Inflammatory and Non-inflammatory Lesions) Counts at Weeks 2, 4, 8, 12, and 20
timeFrame: Baseline, Weeks 2, 4, 8, 12, and 20
measure: Percent Change From Baseline in Total Facial Lesion (Inflammatory and Non-inflammatory Lesions) Counts at Weeks 2, 4, 8, 12, and 20
timeFrame: Baseline, Weeks 2, 4, 8, 12, and 20
measure: Change From Baseline in Facial Investigator's Global Assessment (IGA) at Weeks 2, 4, 8, 12, and 20
timeFrame: Baseline, Weeks 2, 4, 8, 12, and 20
measure: Percentage of Participants Achieving a Facial IGA of Clear (0) or Almost Clear (1) With at Least a 2-grade Decrease From Baseline at Weeks 2, 4, 8, 12, and 20
timeFrame: Baseline, Weeks 2, 4, 8, 12, and 20
measure: Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20
timeFrame: Baseline, Weeks 2, 4, 8, 12, and 20
measure: Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20
timeFrame: Baseline, Weeks 2, 4, 8, 12, and 20
measure: Change From Baseline in Dermatology Life Quality Index Questionnaire (DLQI) Total Score at Weeks 2, 4, 8, 12, and 20
timeFrame: Baseline, Weeks 2, 4, 8, 12, and 20
measure: Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score at Weeks 2, 4, 8, 12, and 20
timeFrame: Baseline, Weeks 2, 4, 8, 12, and 20
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
timeFrame: First dose of study drug until end of study (up to 20 weeks)
Other outcomes:
Locations:
city: Hot Springs
country: United States
facility: Site 10-114
state: Arkansas
city: Fountain Valley
country: United States
facility: Site 10-111
state: California
city: Sherman Oaks
country: United States
facility: Site 10-106
state: California
city: Sweetwater
country: United States
facility: Site 10-113
state: Florida
city: Tampa
country: United States
facility: Site 10-108
state: Florida
city: Tampa
country: United States
facility: Site 10-107
state: Florida
city: New Orleans
country: United States
facility: Site 10-109
state: Louisiana
city: New Orleans
country: United States
facility: Site 10-112
state: Louisiana
city: Detroit
country: United States
facility: Site 10-104
state: Michigan
city: Portsmouth
country: United States
facility: Site 10-110
state: New Hampshire
city: Murfreesboro
country: United States
facility: Site 10-105
state: Tennessee
city: Austin
country: United States
facility: Site 10-103
state: Texas
city: College Station
country: United States
facility: Site 10-102
state: Texas
city: San Antonio
country: United States
facility: Site 10-101
state: Texas
city: Waterloo
country: Canada
facility: Site 10-115
state: Ontario
Study officials:
affiliation: AnaptysBio, Inc.
name: Bruce Randazzo, MD
role: STUDY_DIRECTOR
References: