Adults 12 to 45, any sex, with Acne Vulgaris. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline in Facial Inflammatory Lesion Counts at Week 12Primary· Baseline, 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.
Group
Value
95% CI
Imsidolimab 400/200 mg
-6.8
± 13.63
Imsidolimab 200/100 mg
-7.4
± 16.38
Placebo
-9.6
± 10.66
Change From Baseline in Facial Inflammatory Lesion Counts at Weeks 2, 4, 8, and 20Secondary· Baseline, 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.
Change at Week 2
Group
Value
95% CI
Imsidolimab 400/200 mg
-1.9
± 7.87
Imsidolimab 200/100 mg
-0.5
± 7.30
Placebo
-3.8
± 7.04
Change at Week 4
Group
Value
95% CI
Imsidolimab 400/200 mg
-0.3
± 15.21
Imsidolimab 200/100 mg
-4.4
± 9.87
Placebo
-8.0
± 9.64
Change at Week 8
Group
Value
95% CI
Imsidolimab 400/200 mg
-5.5
± 10.75
Imsidolimab 200/100 mg
-6.2
± 12.43
Placebo
-7.8
± 12.40
Change at Week 20
Group
Value
95% CI
Imsidolimab 400/200 mg
-8.7
± 11.42
Imsidolimab 200/100 mg
-12.0
± 16.58
Placebo
-11.7
± 9.00
Percent Change From Baseline in Facial Inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20Secondary· Baseline, 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.
Percent Change at Week 2
Group
Value
95% CI
Imsidolimab 400/200 mg
-6.6
± 27.87
Imsidolimab 200/100 mg
-1.9
± 27.37
Placebo
-13.6
± 25.76
Percent Change at Week 4
Group
Value
95% CI
Imsidolimab 400/200 mg
-2.9
± 44.00
Imsidolimab 200/100 mg
-14.1
± 31.98
Placebo
-29.3
± 33.39
Percent Change at Week 8
Group
Value
95% CI
Imsidolimab 400/200 mg
-21.50
± 33.89
Imsidolimab 200/100 mg
-19.6
± 39.15
Placebo
-28.4
± 42.87
Percent Change at Week 12
Group
Value
95% CI
Imsidolimab 400/200 mg
-26.8
± 42.68
Imsidolimab 200/100 mg
-20.5
± 53.96
Placebo
-37.6
± 40.73
Percent Change at Week 20
Group
Value
95% CI
Imsidolimab 400/200 mg
-34.3
± 37.50
Imsidolimab 200/100 mg
-36.4
± 48.53
Placebo
-46.9
± 32.95
Change From Baseline in Facial Non-inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20Secondary· Baseline, 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.
Change at Week 2
Group
Value
95% CI
Imsidolimab 400/200 mg
-2.2
± 11.28
Imsidolimab 200/100 mg
-0.9
± 9.95
Placebo
-3.2
± 14.07
Change at Week 4
Group
Value
95% CI
Imsidolimab 400/200 mg
-4.7
± 11.87
Imsidolimab 200/100 mg
-4.3
± 10.15
Placebo
-6.4
± 14.98
Change at Week 8
Group
Value
95% CI
Imsidolimab 400/200 mg
-6.5
± 21.57
Imsidolimab 200/100 mg
-2.2
± 16.65
Placebo
-8.1
± 15.30
Change at Week 12
Group
Value
95% CI
Imsidolimab 400/200 mg
-6.6
± 20.18
Imsidolimab 200/100 mg
-4.5
± 17.89
Placebo
-9.4
± 16.96
Change at Week 20
Group
Value
95% CI
Imsidolimab 400/200 mg
-9.9
± 15.31
Imsidolimab 200/100 mg
-4.0
± 20.90
Placebo
-11.0
± 15.01
Percent Change From Baseline in Facial Non-Inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20Secondary· Baseline, 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.
Percent Change at Week 2
Group
Value
95% CI
Imsidolimab 400/200 mg
-1.0
± 37.86
Imsidolimab 200/100 mg
1.0
± 49.80
Placebo
1.1
± 67.11
Percent Change at Week 4
Group
Value
95% CI
Imsidolimab 400/200 mg
-6.8
± 37.46
Imsidolimab 200/100 mg
-8.7
± 45.48
Placebo
-12.7
± 45.88
Percent Change at Week 8
Group
Value
95% CI
Imsidolimab 400/200 mg
-7.7
± 84.17
Imsidolimab 200/100 mg
11.4
± 117.96
Placebo
-18.1
± 32.73
Percent Change at Week 12
Group
Value
95% CI
Imsidolimab 400/200 mg
-2.4
± 68.07
Imsidolimab 200/100 mg
8.8
± 114.44
Placebo
-22.1
± 40.26
Percent Change at Week 20
Group
Value
95% CI
Imsidolimab 400/200 mg
-21.1
± 46.59
Imsidolimab 200/100 mg
-0.9
± 95.05
Placebo
-31.4
± 50.91
Change From Baseline in Total Facial Lesion (Inflammatory and Non-inflammatory Lesions) Counts at Weeks 2, 4, 8, 12, and 20Secondary· 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.
Change at Week 2
Group
Value
95% CI
Imsidolimab 400/200 mg
-4.1
± 15.03
Imsidolimab 200/100 mg
-1.3
± 11.95
Placebo
-7.0
± 12.36
Change at Week 4
Group
Value
95% CI
Imsidolimab 400/200 mg
-5.0
± 21.03
Imsidolimab 200/100 mg
-8.7
± 16.32
Placebo
-14.4
± 15.22
Change at Week 8
Group
Value
95% CI
Imsidolimab 400/200 mg
-12.0
± 28.0
Imsidolimab 200/100 mg
-8.4
± 23.85
Placebo
-15.9
± 19.50
Change at Week 12
Group
Value
95% CI
Imsidolimab 400/200 mg
-13.4
± 26.82
Imsidolimab 200/100 mg
-11.9
± 29.06
Placebo
-19.0
± 21.24
Change at Week 20
Group
Value
95% CI
Imsidolimab 400/200 mg
-18.6
± 22.01
Imsidolimab 200/100 mg
-16.0
± 31.82
Placebo
-22.7
± 18.65
Percent Change From Baseline in Total Facial Lesion (Inflammatory and Non-inflammatory Lesions) Counts at Weeks 2, 4, 8, 12, and 20Secondary· 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.
Percent Change at Week 2
Group
Value
95% CI
Imsidolimab 400/200 mg
-6.9
± 21.26
Imsidolimab 200/100 mg
-1.9
± 21.62
Placebo
-10.7
± 22.27
Percent Change at Week 4
Group
Value
95% CI
Imsidolimab 400/200 mg
-7.7
± 29.10
Imsidolimab 200/100 mg
-13.5
± 22.61
Placebo
-23.2
± 23.87
Percent Change at Week 8
Group
Value
95% CI
Imsidolimab 400/200 mg
-18.9
± 40.88
Imsidolimab 200/100 mg
-12.7
± 31.36
Placebo
-24.0
± 27.82
Percent Change at Week 12
Group
Value
95% CI
Imsidolimab 400/200 mg
-18.9
± 39.18
Imsidolimab 200/100 mg
-15.4
± 44.85
Placebo
-31.2
± 31.88
Percent Change at Week 20
Group
Value
95% CI
Imsidolimab 400/200 mg
-28.6
± 33.69
Imsidolimab 200/100 mg
-23.0
± 56.30
Placebo
-38.7
± 30.00
Change From Baseline in Facial Investigator's Global Assessment (IGA) at Weeks 2, 4, 8, 12, and 20Secondary· Baseline, 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
Change at Week 2
Group
Value
95% CI
Imsidolimab 400/200 mg
-0.2
± 0.46
Imsidolimab 200/100 mg
-0.0
± 0.16
Placebo
-0.2
± 0.43
Change at Week 4
Group
Value
95% CI
Imsidolimab 400/200 mg
-0.2
± 0.49
Imsidolimab 200/100 mg
-0.1
± 0.42
Placebo
-0.5
± 0.60
Change at Week 8
Group
Value
95% CI
Imsidolimab 400/200 mg
-0.4
± 0.62
Imsidolimab 200/100 mg
-0.3
± 0.53
Placebo
-0.6
± 0.60
Change at Week 12
Group
Value
95% CI
Imsidolimab 400/200 mg
-0.6
± 0.78
Imsidolimab 200/100 mg
-0.3
± 0.54
Placebo
-0.8
± 0.83
Change at Week 20
Group
Value
95% CI
Imsidolimab 400/200 mg
-0.7
± 0.91
Imsidolimab 200/100 mg
-0.7
± 0.80
Placebo
-0.9
± 0.71
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 20Secondary· Baseline, 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 surfac
Week 2
Group
Value
95% CI
Imsidolimab 400/200 mg
0
Imsidolimab 200/100 mg
0
Placebo
0
Week 4
Group
Value
95% CI
Imsidolimab 400/200 mg
0
Imsidolimab 200/100 mg
0
Placebo
2.6
Week 8
Group
Value
95% CI
Imsidolimab 400/200 mg
2.5
Imsidolimab 200/100 mg
0
Placebo
2.6
Week 12
Group
Value
95% CI
Imsidolimab 400/200 mg
11.8
Imsidolimab 200/100 mg
0
Placebo
13.9
Week 20
Group
Value
95% CI
Imsidolimab 400/200 mg
14.3
Imsidolimab 200/100 mg
8.6
Placebo
18.9
Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20Secondary· Baseline, 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.
Week 2: Clear Skin
Group
Value
95% CI
Imsidolimab 400/200 mg
0
Imsidolimab 200/100 mg
0
Placebo
0
Week 2: Mild
Group
Value
95% CI
Imsidolimab 400/200 mg
25.0
Imsidolimab 200/100 mg
23.7
Placebo
21.1
Week 2: Moderate
Group
Value
95% CI
Imsidolimab 400/200 mg
55.0
Imsidolimab 200/100 mg
63.2
Placebo
50.0
Week 2: Severe
Group
Value
95% CI
Imsidolimab 400/200 mg
20.0
Imsidolimab 200/100 mg
13.2
Placebo
28.9
Week 4: Clear Skin
Group
Value
95% CI
Imsidolimab 400/200 mg
0
Imsidolimab 200/100 mg
0
Placebo
0
Week 4: Mild
Group
Value
95% CI
Imsidolimab 400/200 mg
26.3
Imsidolimab 200/100 mg
21.6
Placebo
33.3
Week 4: Moderate
Group
Value
95% CI
Imsidolimab 400/200 mg
63.2
Imsidolimab 200/100 mg
70.3
Placebo
48.7
Week 4: Severe
Group
Value
95% CI
Imsidolimab 400/200 mg
10.5
Imsidolimab 200/100 mg
8.1
Placebo
17.9
Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20Secondary· Baseline, 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.
Week 2: Very much better
Group
Value
95% CI
Imsidolimab 400/200 mg
0
Imsidolimab 200/100 mg
0
Placebo
0
Week 2: Much better
Group
Value
95% CI
Imsidolimab 400/200 mg
5.0
Imsidolimab 200/100 mg
2.6
Placebo
2.6
Week 2: A little better
Group
Value
95% CI
Imsidolimab 400/200 mg
55.0
Imsidolimab 200/100 mg
50.0
Placebo
52.6
Week 2: No change
Group
Value
95% CI
Imsidolimab 400/200 mg
20.0
Imsidolimab 200/100 mg
18.4
Placebo
34.2
Week 2: A little worse
Group
Value
95% CI
Imsidolimab 400/200 mg
15.0
Imsidolimab 200/100 mg
18.4
Placebo
10.5
Week 2: Much worse
Group
Value
95% CI
Imsidolimab 400/200 mg
5.0
Imsidolimab 200/100 mg
10.5
Placebo
0
Week 2: Very much worse
Group
Value
95% CI
Imsidolimab 400/200 mg
0
Imsidolimab 200/100 mg
0
Placebo
0
Week 4: Very much better
Group
Value
95% CI
Imsidolimab 400/200 mg
0
Imsidolimab 200/100 mg
2.7
Placebo
0
Change From Baseline in Dermatology Life Quality Index Questionnaire (DLQI) Total Score at Weeks 2, 4, 8, 12, and 20Secondary· Baseline, 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.
Change at Week 2
Group
Value
95% CI
Imsidolimab 400/200 mg
-1.6
± 4.53
Imsidolimab 200/100 mg
-1.9
± 5.28
Placebo
-2.0
± 3.37
Change at Week 4
Group
Value
95% CI
Imsidolimab 400/200 mg
-2.6
± 5.01
Imsidolimab 200/100 mg
-3.6
± 5.20
Placebo
-2.3
± 4.19
Change at Week 8
Group
Value
95% CI
Imsidolimab 400/200 mg
-3.4
± 5.28
Imsidolimab 200/100 mg
-4.0
± 6.26
Placebo
-4.3
± 4.93
Change at Week 12
Group
Value
95% CI
Imsidolimab 400/200 mg
-4.2
± 4.71
Imsidolimab 200/100 mg
-2.9
± 5.14
Placebo
-4.0
± 4.98
Change at Week 20
Group
Value
95% CI
Imsidolimab 400/200 mg
-1.8
± 5.75
Imsidolimab 200/100 mg
-3.7
± 4.11
Placebo
-4.7
± 5.69
Adverse events — posted to ClinicalTrials.gov
Time frame: All-cause mortality: Randomization until end of study (up to 20 weeks) Adverse events: From first dose of study drug until end of study (up to 20 weeks).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Vanda Pharmaceuticals
Last refreshed: 22 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04856917.