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

Acne Vulgaris Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04856917
• Other study ID #: ANB019-209
• Status: Completed
• Phase: Phase 2
• Start date: May 15, 2021
• Est. completion date: March 29, 2022

Study information

• Verified date: May 2023
• Source: AnaptysBio, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Efficacy and Safety of Imsidolimab in Participants with Acne Vulgaris

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: March 29, 2022
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• Imsidolimab
Humanized Monoclonal Antibody

Biological:
• Placebo
Placebo

Locations

Country	Name	City	State
Canada	Site 10-115	Waterloo	Ontario
United States	Site 10-103	Austin	Texas
United States	Site 10-102	College Station	Texas
United States	Site 10-104	Detroit	Michigan
United States	Site 10-111	Fountain Valley	California
United States	Site 10-114	Hot Springs	Arkansas
United States	Site 10-105	Murfreesboro	Tennessee
United States	Site 10-109	New Orleans	Louisiana
United States	Site 10-112	New Orleans	Louisiana
United States	Site 10-110	Portsmouth	New Hampshire
United States	Site 10-101	San Antonio	Texas
United States	Site 10-106	Sherman Oaks	California
United States	Site 10-113	Sweetwater	Florida
United States	Site 10-107	Tampa	Florida
United States	Site 10-108	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AnaptysBio, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Facial Inflammatory Lesion Counts at Week 12	The number of facial inflammatory lesions (pustules, papules, and nodular lesions) on the forehead, left and right cheeks, nose, and chin were counted. Baseline was defined as the last available measurement taken prior to the first dose of study treatment.	Baseline, Week 12
Secondary	Change From Baseline in Facial Inflammatory Lesion Counts at Weeks 2, 4, 8, and 20	The number of facial inflammatory lesions (pustules, papules, and nodular lesions) on the forehead, left and right cheeks, nose, and chin were counted. Baseline was defined as the last available measurement taken prior to the first dose of study treatment.	Baseline, Weeks 2, 4, 8, and 20
Secondary	Percent Change From Baseline in Facial Inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20	The number of facial inflammatory lesions (pustules, papules, and nodular lesions) on the forehead, left and right cheeks, nose, and chin were counted. Baseline was defined as the last available measurement taken prior to the first dose of study treatment.	Baseline, Weeks 2, 4, 8, 12 and 20
Secondary	Change From Baseline in Facial Non-inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20	The number of facial non-inflammatory lesions (open and closed comedones) on the forehead, left and right cheeks, and chin was counted. Baseline was defined as the last available measurement taken prior to the first dose of study treatment.	Baseline, Weeks 2, 4, 8, 12, and 20
Secondary	Percent Change From Baseline in Facial Non-Inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20	The number of facial non-inflammatory lesions (open and closed comedones) on the forehead, left and right cheeks, and chin was counted. Baseline was defined as the last available measurement taken prior to the first dose of study treatment.	Baseline, Weeks 2, 4, 8, 12, and 20
Secondary	Change From Baseline in Total Facial Lesion (Inflammatory and Non-inflammatory Lesions) Counts at Weeks 2, 4, 8, 12, and 20	The number of facial inflammatory (pustules, papules, and nodular lesions) and non-inflammatory (open and closed comedones) lesions on the forehead, left and right cheeks, nose, and chin were counted. Baseline was defined as the last available measurement taken prior to the first dose of study treatment.	Baseline, Weeks 2, 4, 8, 12, and 20
Secondary	Percent Change From Baseline in Total Facial Lesion (Inflammatory and Non-inflammatory Lesions) Counts at Weeks 2, 4, 8, 12, and 20	The number of facial inflammatory (pustules, papules, and nodular lesions) and non-inflammatory (open and closed comedones) lesions on the forehead, left and right cheeks, nose, and chin were counted. Baseline was defined as the last available measurement taken prior to the first dose of study treatment.	Baseline, Weeks 2, 4, 8, 12, and 20
Secondary	Change From Baseline in Facial Investigator's Global Assessment (IGA) at Weeks 2, 4, 8, 12, and 20	The Facial IGA was a global assessment that was used to assess the current state of acne vulgaris (AV) on the face at each visit. It is a 5-point morphological assessment ranging from 0 (clear) to 4 (severe).; Clear (0): clear skin with no inflammatory or non-inflammatory lesions; Almost Clear (1): A few scattered comedowns and a few small papules; Mild (2): Easily recognizable; less than half the surface is involved. some comedowns and some papules and pustules; Moderate (3): More than half of the surface is involved. Many comedowns, papules, and pustules. One nodule may be present; Severe (4): Entire surface is involved. Covered with comedowns, numerous papules and pustules. Few nodules may be present.; The Facial IGA was an overall global evaluation that was performed at an arm's length distance from the participant and must be performed before the acne lesion count.	Baseline, Weeks 2, 4, 8, 12, and 20
Secondary	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	The Facial IGA was a global assessment that was used to assess the current state of AV on the face at each visit. It is a 5-point morphological assessment ranging from 0 (clear) to 4 (severe).; Clear (0): clear skin with no inflammatory or non-inflammatory lesions; Almost Clear (1): A few scattered comedowns and a few small papules; Mild (2): Easily recognizable; less than half the surface is involved. some comedowns and some papules and pustules; Moderate (3): More than half of the surface is involved. Many comedowns, papules, and pustules. One nodule may be present; Severe (4): Entire surface is involved. Covered with comedowns, numerous papules and pustules. Few nodules may be present.; The Facial IGA was an overall global evaluation that was performed at an arm's length distance from the participant and must be performed before the acne lesion count.	Baseline, Weeks 2, 4, 8, 12, and 20
Secondary	Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20	PGI- S was a single-item question, which asks the participant to rate the current severity of AV. The response options were: Clear Skin (1); Mild (2); Moderate (3); Severe (4); Higher score indicated more severity.	Baseline, Weeks 2, 4, 8, 12, and 20
Secondary	Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20	PGI-C was a single-item, self-administered questionnaire, which asked the participant to rate the change in their symptom severity. Scores ranged from 1 (Very much better) to 7 (Very much worse).; Very much better (1); Much better (2); A little better (3); No change (4); A little worse (5); Much worse (6); Very much worse (7); Higher score indicated more severity.	Baseline, Weeks 2, 4, 8, 12, and 20
Secondary	Change From Baseline in Dermatology Life Quality Index Questionnaire (DLQI) Total Score at Weeks 2, 4, 8, 12, and 20	DLQI was a simple 10-question validated questionnaire, each question was scored from 0 (not relevant/not at all) to 3 (very much). The DLQI total score ranged from 0 (no effect on participant's life) to 30 (extremely large effect on participant's life). The aim of this participant-reported questionnaire was to measure how much the skin condition had affected the participant's quality of life. The DLQI was administered to participants = 16 years of age. Participants were administered the same questionnaire during the entire study based on their age at Day 1.	Baseline, Weeks 2, 4, 8, 12, and 20
Secondary	Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score at Weeks 2, 4, 8, 12, and 20	CDLQI was a simple 10-question validated questionnaire, each question was scored from 0 (not relevant/not at all) to 3 (very much). The CDLQI total score ranged from 0 (no effect on participant's life) to 30 (extremely large effect on participant's life). The aim of this participant-reported questionnaire was to measure how much the skin condition had affected the participant's quality of life. The CDLQI was administered to participants < 16 years of age. Participants were administered the same questionnaire during the entire study based on their age at Day 1.	Baseline, Weeks 2, 4, 8, 12, and 20
Secondary	Number of Participants With Treatment Emergent Adverse Events (TEAEs)	An AE was defined as 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 could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment that did not necessarily have a causal relationship with treatment. An AE was considered "serious" if it resulted in death, life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, congenital anomaly/birth defect, other important medical events. TEAE was defined as a new event that occurred during or after first dose of study treatment or any event present at baseline that worsens in either intensity or frequency after first dose of study treatment.	First dose of study drug until end of study (up to 20 weeks)