| 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. | Participants in ITT Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | lesions | | Baseline, Week 12 | | | | ID | Title | Description |
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| OG000 | Imsidolimab 400/200 mg | Participants received imsidolimab 400 mg by SC injection on Day 1, followed by 200 mg on Days 29 and 57. | | OG001 | Imsidolimab 200/100 mg | Participants received imsidolimab 200 mg by SC injection on Day 1, followed by 100 mg on Days 29 and 57. | | OG002 | Placebo | Participants received imsidolimab matching placebo by SC injection on Days 1, 29, and 57. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-6.8± 13.63
- OG001-7.4± 16.38
- OG002-9.6± 10.66
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| Least square (LS) Mean, SE, 90% CI, & p-value was based on a linear repeated measures model (LRMM) which included treatment, visit, treatment by visit interaction & facial IGA at baseline (Grade 3 vs. 4) as categorical covariates & baseline facial inflammatory lesion count as continuous covariate. | LRMM | | 0.3757 | | LS Mean Difference | 2.9 | Standard Error of the Mean | 3.21 | 2-Sided | 90 | -2.47 | 8.19 | | | | | Superiority | | | |
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| 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. | Participants in the ITT Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | lesions | | Baseline, Weeks 2, 4, 8, and 20 | | | | ID | Title | Description |
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| OG000 | Imsidolimab 400/200 mg | Participants received imsidolimab 400mg by SC injection on Day 1, followed by 200 mg on Days 29 and 57. | | OG001 | Imsidolimab 200/100 mg | Participants received imsidolimab 200 mg by SC injection on Day 1, followed by 100 mg on Days 29 and 57. | | OG002 | Placebo | Participants received imsidolimab matching placebo by SC injection on Days 1, 29, and 57. |
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| 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. | Participants in the ITT Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | percent change | | Baseline, Weeks 2, 4, 8, 12 and 20 | | | | ID | Title | Description |
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| OG000 | Imsidolimab 400/200 mg | Participants received imsidolimab 400 mg by SC injection on Day 1, followed by 200 mg on Days 29 and 57. | | OG001 | Imsidolimab 200/100 mg | Participants received imsidolimab 200 mg by SC injection on Day 1, followed by 100 mg on Days 29 and 57. | | OG002 | Placebo | Participants received imsidolimab matching placebo by SC injection on Days 1, 29, and 57. |
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| 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. | Participants in the ITT Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | lesions | | Baseline, Weeks 2, 4, 8, 12, and 20 | | | | ID | Title | Description |
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| OG000 | Imsidolimab 400/200 mg | Participants received imsidolimab 400 mg by SC injection on Day 1, followed by 200 mg on Days 29 and 57. | | OG001 | Imsidolimab 200/100 mg | Participants received imsidolimab 200 mg by SC injection on Day 1, followed by 100 mg on Days 29 and 57. | | OG002 | Placebo | Participants received imsidolimab matching placebo by SC injection on Days 1, 29, and 57. |
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| 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. | Participants in the ITT Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | percent change | | Baseline, Weeks 2, 4, 8, 12, and 20 | | | | ID | Title | Description |
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| OG000 | Imsidolimab 400/200 mg | Participants received imsidolimab 400 mg by SC injection on Day 1, followed by 200 mg on Days 29 and 57. | | OG001 | Imsidolimab 200/100 mg | Participants received imsidolimab 200 mg by SC injection on Day 1, followed by 100 mg on Days 29 and 57. | | OG002 | Placebo | Participants received imsidolimab matching placebo by SC injection on Days 1, 29, and 57. |
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| 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. | Participants in the ITT Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | lesions | | Baseline, Weeks 2, 4, 8, 12, and 20 | | | | ID | Title | Description |
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| OG000 | Imsidolimab 400/200 mg | Participants received imsidolimab 400 mg by SC injection on Day 1, followed by 200 mg on Days 29 and 57. | | OG001 | Imsidolimab 200/100 mg | Participants received imsidolimab 200 mg by SC injection on Day 1, followed by 100 mg on Days 29 and 57. | | OG002 | Placebo | Participants received imsidolimab matching placebo by SC injection on Days 1, 29, and 57. |
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| 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. | Participants in the ITT Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | percent change | | Baseline, Weeks 2, 4, 8, 12, and 20 | | | | ID | Title | Description |
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| OG000 | Imsidolimab 400/200 mg | Participants received imsidolimab 400 mg by SC injection on Day 1, followed by 200 mg on Days 29 and 57. | | OG001 | Imsidolimab 200/100 mg | Participants received imsidolimab 200 mg by SC injection on Day 1, followed by 100 mg on Days 29 and 57. | | OG002 | Placebo | Participants received imsidolimab matching placebo by SC injection on Days 1, 29, and 57. |
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| 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. | Participants in the ITT Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Weeks 2, 4, 8, 12, and 20 | | | | ID | Title | Description |
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| OG000 | Imsidolimab 400/200 mg | Participants received imsidolimab 400 mg by SC injection on Day 1, followed by 200 mg on Days 29 and 57. | | OG001 | 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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| 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. | Participants in the ITT Analysis Set with available data were analyzed. | Posted | | Number | | percentage of participants | | Baseline, Weeks 2, 4, 8, 12, and 20 | | | | ID | Title | Description |
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| OG000 | Imsidolimab 400/200 mg | Participants received imsidolimab 400 mg by SC injection on Day 1, followed by 200 mg on Days 29 and 57. | | OG001 | 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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| 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. | Participants in the ITT Analysis Set with available data were analyzed. | Posted | | Number | | percentage of participants | | Baseline, Weeks 2, 4, 8, 12, and 20 | | | | ID | Title | Description |
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| OG000 | Imsidolimab 400/200 mg | Participants received imsidolimab 400 mg by SC injection on Day 1, followed by 200 mg on Days 29 and 57. | | OG001 | Imsidolimab 200/100 mg | Participants received imsidolimab 200 mg by SC injection on Day 1, followed by 100 mg on Days 29 and 57. | | OG002 | Placebo | Participants received imsidolimab matching placebo by SC injection on Days 1, 29, and 57. |
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| 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. | Participants in the ITT Analysis Set with available data were analyzed. | Posted | | Number | | percentage of participants | | Baseline, Weeks 2, 4, 8, 12, and 20 | | | | ID | Title | Description |
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| OG000 | Imsidolimab 400/200 mg | Participants received imsidolimab 400 mg by SC injection on Day 1, followed by 200 mg on Days 29 and 57. | | OG001 | Imsidolimab 200/100 mg | Participants received imsidolimab 200 mg by SC injection on Day 1, followed by 100 mg on Days 29 and 57. | | OG002 | Placebo | Participants received imsidolimab matching placebo by SC injection on Days 1, 29, and 57. |
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| 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. | Participants in the ITT Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Weeks 2, 4, 8, 12, and 20 | | | | ID | Title | Description |
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| OG000 | Imsidolimab 400/200 mg | Participants received imsidolimab 400 mg by SC injection on Day 1, followed by 200 mg on Days 29 and 57. | | OG001 | Imsidolimab 200/100 mg | Participants received imsidolimab 200 mg by SC injection on Day 1, followed by 100 mg on Days 29 and 57. | | OG002 | Placebo | Participants received imsidolimab matching placebo by SC injection on Days 1, 29, and 57. |
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| 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. | Participants in the ITT Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Weeks 2, 4, 8, 12, and 20 | | | | ID | Title | Description |
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| OG000 | Imsidolimab 400/200 mg | Participants received imsidolimab 400 mg by SC injection on Day 1, followed by 200 mg on Days 29 and 57. | | OG001 | Imsidolimab 200/100 mg | Participants received imsidolimab 200 mg by SC injection on Day 1, followed by 100 mg on Days 29 and 57. | | OG002 | Placebo | Participants received imsidolimab matching placebo by SC injection on Days 1, 29, and 57. |
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| 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. | | Posted | | Number | | participants | | First dose of study drug until end of study (up to 20 weeks) | | | | ID | Title | Description |
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| OG000 | Imsidolimab 400/200 mg | Participants received imsidolimab 400 mg by SC injection on Day 1, followed by 200 mg on Days 29 and 57. | | OG001 | 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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