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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.