- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04856917
A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Participants With Acne Vulgaris
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 Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Ontario
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Waterloo, Ontario, Canada, N2J1C4
- Site 10-115
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Arkansas
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Hot Springs, Arkansas, United States, 71913
- Site 10-114
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California
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Fountain Valley, California, United States, 92708
- Site 10-111
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Sherman Oaks, California, United States, 91403
- Site 10-106
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Florida
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Sweetwater, Florida, United States, 33172
- Site 10-113
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Tampa, Florida, United States, 33607
- Site 10-108
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Tampa, Florida, United States, 33613
- Site 10-107
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Louisiana
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New Orleans, Louisiana, United States, 70119
- Site 10-109
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New Orleans, Louisiana, United States, 70119
- Site 10-112
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Michigan
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Detroit, Michigan, United States, 48202
- Site 10-104
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New Hampshire
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Portsmouth, New Hampshire, United States, 03801
- Site 10-110
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Tennessee
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Murfreesboro, Tennessee, United States, 37130
- Site 10-105
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Texas
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Austin, Texas, United States, 78759
- Site 10-103
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College Station, Texas, United States, 77845
- Site 10-102
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San Antonio, Texas, United States, 78213
- Site 10-101
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Imsidolimab 400/200 mg
Participants received imsidolimab 400 milligrams (mg) by subcutaneous (SC) injection on Day 1, followed by 200 mg on Days 29 and 57.
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Humanized Monoclonal Antibody
Other Names:
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Experimental: Imsidolimab 200/100 mg
Participants received imsidolimab 200 mg by SC injection on Day 1, followed by 100 mg on Days 29 and 57.
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Humanized Monoclonal Antibody
Other Names:
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Placebo Comparator: Placebo
Participants received imsidolimab matching placebo by SC injection on Days 1, 29, and 57.
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Placebo
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change From Baseline in Facial Inflammatory Lesion Counts at Week 12
Time Frame: Baseline, Week 12
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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.
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Baseline, Week 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Facial Inflammatory Lesion Counts at Weeks 2, 4, 8, and 20
Time Frame: Baseline, Weeks 2, 4, 8, and 20
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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.
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Baseline, Weeks 2, 4, 8, and 20
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Percent Change From Baseline in Facial Inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20
Time Frame: Baseline, Weeks 2, 4, 8, 12 and 20
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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.
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Baseline, Weeks 2, 4, 8, 12 and 20
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Change From Baseline in Facial Non-inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20
Time Frame: Baseline, Weeks 2, 4, 8, 12, and 20
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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.
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Baseline, Weeks 2, 4, 8, 12, and 20
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Percent Change From Baseline in Facial Non-Inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20
Time Frame: Baseline, Weeks 2, 4, 8, 12, and 20
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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.
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Baseline, Weeks 2, 4, 8, 12, and 20
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Change From Baseline in Total Facial Lesion (Inflammatory and Non-inflammatory Lesions) Counts at Weeks 2, 4, 8, 12, and 20
Time Frame: Baseline, Weeks 2, 4, 8, 12, and 20
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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.
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Baseline, Weeks 2, 4, 8, 12, and 20
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Percent Change From Baseline in Total Facial Lesion (Inflammatory and Non-inflammatory Lesions) Counts at Weeks 2, 4, 8, 12, and 20
Time Frame: Baseline, 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.
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Baseline, Weeks 2, 4, 8, 12, and 20
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Change From Baseline in Facial Investigator's Global Assessment (IGA) at Weeks 2, 4, 8, 12, and 20
Time Frame: Baseline, Weeks 2, 4, 8, 12, and 20
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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
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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
Time Frame: Baseline, Weeks 2, 4, 8, 12, and 20
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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
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Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20
Time Frame: Baseline, Weeks 2, 4, 8, 12, and 20
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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
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Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20
Time Frame: Baseline, Weeks 2, 4, 8, 12, and 20
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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
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Change From Baseline in Dermatology Life Quality Index Questionnaire (DLQI) Total Score at Weeks 2, 4, 8, 12, and 20
Time Frame: Baseline, Weeks 2, 4, 8, 12, and 20
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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.
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Baseline, Weeks 2, 4, 8, 12, and 20
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Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score at Weeks 2, 4, 8, 12, and 20
Time Frame: Baseline, Weeks 2, 4, 8, 12, and 20
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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.
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Baseline, Weeks 2, 4, 8, 12, and 20
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Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time Frame: First dose of study drug until end of study (up to 20 weeks)
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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.
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First dose of study drug until end of study (up to 20 weeks)
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Bruce Randazzo, MD, AnaptysBio, Inc.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ANB019-209
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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