Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Participants With Acne Vulgaris (NCT NCT04856917)
NCT ID: NCT04856917
Last Updated: 2025-09-22
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
123 participants
Primary outcome timeframe
Baseline, Week 12
Results posted on
2025-09-22
Participant Flow
Participant milestones
| Measure |
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.
|
Imsidolimab 200/100 mg
Participants received imsidolimab 200 mg by SC injection on Day 1, followed by 100 mg on Days 29 and 57.
|
Placebo
Participants received imsidolimab matching placebo by SC injection on Days 1, 29, and 57.
|
|---|---|---|---|
|
Overall Study
STARTED
|
42
|
40
|
41
|
|
Overall Study
Safety Analysis Set
|
41
|
39
|
41
|
|
Overall Study
COMPLETED
|
34
|
34
|
37
|
|
Overall Study
NOT COMPLETED
|
8
|
6
|
4
|
Reasons for withdrawal
| Measure |
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.
|
Imsidolimab 200/100 mg
Participants received imsidolimab 200 mg by SC injection on Day 1, followed by 100 mg on Days 29 and 57.
|
Placebo
Participants received imsidolimab matching placebo by SC injection on Days 1, 29, and 57.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
3
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
1
|
|
Overall Study
Used of Prohibited Medication or Treatment
|
0
|
1
|
2
|
|
Overall Study
Other
|
1
|
1
|
0
|
Baseline Characteristics
A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Participants With Acne Vulgaris
Baseline characteristics by cohort
| Measure |
Imsidolimab 400/200 mg
n=42 Participants
Participants received imsidolimab 400 mg by SC injection on Day 1, followed by 200 mg on Days 29 and 57.
|
Imsidolimab 200/100 mg
n=40 Participants
Participants received imsidolimab 200 mg by SC injection on Day 1, followed by 100 mg on Days 29 and 57.
|
Placebo
n=41 Participants
Participants received imsidolimab matching placebo by SC injection on Days 1, 29, and 57.
|
Total
n=123 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
19.3 years
STANDARD_DEVIATION 5.58 • n=5 Participants
|
20.7 years
STANDARD_DEVIATION 7.39 • n=7 Participants
|
21.0 years
STANDARD_DEVIATION 7.62 • n=5 Participants
|
20.3 years
STANDARD_DEVIATION 6.89 • n=4 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
80 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
17 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
82 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
34 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
93 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Facial inflammatory Lesion Count
|
29.5 lesions
STANDARD_DEVIATION 8.12 • n=5 Participants
|
29.0 lesions
STANDARD_DEVIATION 12.34 • n=7 Participants
|
26.9 lesions
STANDARD_DEVIATION 7.11 • n=5 Participants
|
28.5 lesions
STANDARD_DEVIATION 9.42 • n=4 Participants
|
|
Facial Investigator's Global Assessment (IGA) score
|
3.1 units on a scale
STANDARD_DEVIATION 0.35 • n=5 Participants
|
3.1 units on a scale
STANDARD_DEVIATION 0.27 • n=7 Participants
|
3.1 units on a scale
STANDARD_DEVIATION 0.33 • n=5 Participants
|
3.1 units on a scale
STANDARD_DEVIATION 0.32 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: Participants in ITT Analysis Set with available data were analyzed.
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.
Outcome measures
| Measure |
Imsidolimab 400/200 mg
n=34 Participants
Participants received imsidolimab 400 mg by SC injection on Day 1, followed by 200 mg on Days 29 and 57.
|
Imsidolimab 200/100 mg
n=35 Participants
Participants received imsidolimab 200 mg by SC injection on Day 1, followed by 100 mg on Days 29 and 57.
|
Placebo
n=36 Participants
Participants received imsidolimab matching placebo by SC injection on Days 1, 29, and 57.
|
|---|---|---|---|
|
Change From Baseline in Facial Inflammatory Lesion Counts at Week 12
|
-6.8 lesions
Standard Deviation 13.63
|
-7.4 lesions
Standard Deviation 16.38
|
-9.6 lesions
Standard Deviation 10.66
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, and 20Population: Participants in the ITT Analysis Set with available data were analyzed.
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.
Outcome measures
| Measure |
Imsidolimab 400/200 mg
n=40 Participants
Participants received imsidolimab 400 mg by SC injection on Day 1, followed by 200 mg on Days 29 and 57.
|
Imsidolimab 200/100 mg
n=38 Participants
Participants received imsidolimab 200 mg by SC injection on Day 1, followed by 100 mg on Days 29 and 57.
|
Placebo
n=39 Participants
Participants received imsidolimab matching placebo by SC injection on Days 1, 29, and 57.
|
|---|---|---|---|
|
Change From Baseline in Facial Inflammatory Lesion Counts at Weeks 2, 4, 8, and 20
Change at Week 2
|
-1.9 lesions
Standard Deviation 7.87
|
-0.5 lesions
Standard Deviation 7.30
|
-3.8 lesions
Standard Deviation 7.04
|
|
Change From Baseline in Facial Inflammatory Lesion Counts at Weeks 2, 4, 8, and 20
Change at Week 4
|
-0.3 lesions
Standard Deviation 15.21
|
-4.4 lesions
Standard Deviation 9.87
|
-8.0 lesions
Standard Deviation 9.64
|
|
Change From Baseline in Facial Inflammatory Lesion Counts at Weeks 2, 4, 8, and 20
Change at Week 8
|
-5.5 lesions
Standard Deviation 10.75
|
-6.2 lesions
Standard Deviation 12.43
|
-7.8 lesions
Standard Deviation 12.40
|
|
Change From Baseline in Facial Inflammatory Lesion Counts at Weeks 2, 4, 8, and 20
Change at Week 20
|
-8.7 lesions
Standard Deviation 11.42
|
-12.0 lesions
Standard Deviation 16.58
|
-11.7 lesions
Standard Deviation 9.00
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12 and 20Population: Participants in the ITT Analysis Set with available data were analyzed.
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.
Outcome measures
| Measure |
Imsidolimab 400/200 mg
n=40 Participants
Participants received imsidolimab 400 mg by SC injection on Day 1, followed by 200 mg on Days 29 and 57.
|
Imsidolimab 200/100 mg
n=38 Participants
Participants received imsidolimab 200 mg by SC injection on Day 1, followed by 100 mg on Days 29 and 57.
|
Placebo
n=39 Participants
Participants received imsidolimab matching placebo by SC injection on Days 1, 29, and 57.
|
|---|---|---|---|
|
Percent Change From Baseline in Facial Inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20
Percent Change at Week 2
|
-6.6 percent change
Standard Deviation 27.87
|
-1.9 percent change
Standard Deviation 27.37
|
-13.6 percent change
Standard Deviation 25.76
|
|
Percent Change From Baseline in Facial Inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20
Percent Change at Week 4
|
-2.9 percent change
Standard Deviation 44.00
|
-14.1 percent change
Standard Deviation 31.98
|
-29.3 percent change
Standard Deviation 33.39
|
|
Percent Change From Baseline in Facial Inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20
Percent Change at Week 8
|
-21.50 percent change
Standard Deviation 33.89
|
-19.6 percent change
Standard Deviation 39.15
|
-28.4 percent change
Standard Deviation 42.87
|
|
Percent Change From Baseline in Facial Inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20
Percent Change at Week 12
|
-26.8 percent change
Standard Deviation 42.68
|
-20.5 percent change
Standard Deviation 53.96
|
-37.6 percent change
Standard Deviation 40.73
|
|
Percent Change From Baseline in Facial Inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20
Percent Change at Week 20
|
-34.3 percent change
Standard Deviation 37.50
|
-36.4 percent change
Standard Deviation 48.53
|
-46.9 percent change
Standard Deviation 32.95
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12, and 20Population: Participants in the ITT Analysis Set with available data were analyzed.
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.
Outcome measures
| Measure |
Imsidolimab 400/200 mg
n=40 Participants
Participants received imsidolimab 400 mg by SC injection on Day 1, followed by 200 mg on Days 29 and 57.
|
Imsidolimab 200/100 mg
n=38 Participants
Participants received imsidolimab 200 mg by SC injection on Day 1, followed by 100 mg on Days 29 and 57.
|
Placebo
n=39 Participants
Participants received imsidolimab matching placebo by SC injection on Days 1, 29, and 57.
|
|---|---|---|---|
|
Change From Baseline in Facial Non-inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20
Change at Week 2
|
-2.2 lesions
Standard Deviation 11.28
|
-0.9 lesions
Standard Deviation 9.95
|
-3.2 lesions
Standard Deviation 14.07
|
|
Change From Baseline in Facial Non-inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20
Change at Week 4
|
-4.7 lesions
Standard Deviation 11.87
|
-4.3 lesions
Standard Deviation 10.15
|
-6.4 lesions
Standard Deviation 14.98
|
|
Change From Baseline in Facial Non-inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20
Change at Week 8
|
-6.5 lesions
Standard Deviation 21.57
|
-2.2 lesions
Standard Deviation 16.65
|
-8.1 lesions
Standard Deviation 15.30
|
|
Change From Baseline in Facial Non-inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20
Change at Week 12
|
-6.6 lesions
Standard Deviation 20.18
|
-4.5 lesions
Standard Deviation 17.89
|
-9.4 lesions
Standard Deviation 16.96
|
|
Change From Baseline in Facial Non-inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20
Change at Week 20
|
-9.9 lesions
Standard Deviation 15.31
|
-4.0 lesions
Standard Deviation 20.90
|
-11.0 lesions
Standard Deviation 15.01
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12, and 20Population: Participants in the ITT Analysis Set with available data were analyzed.
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.
Outcome measures
| Measure |
Imsidolimab 400/200 mg
n=40 Participants
Participants received imsidolimab 400 mg by SC injection on Day 1, followed by 200 mg on Days 29 and 57.
|
Imsidolimab 200/100 mg
n=38 Participants
Participants received imsidolimab 200 mg by SC injection on Day 1, followed by 100 mg on Days 29 and 57.
|
Placebo
n=39 Participants
Participants received imsidolimab matching placebo by SC injection on Days 1, 29, and 57.
|
|---|---|---|---|
|
Percent Change From Baseline in Facial Non-Inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20
Percent Change at Week 2
|
-1.0 percent change
Standard Deviation 37.86
|
1.0 percent change
Standard Deviation 49.80
|
1.1 percent change
Standard Deviation 67.11
|
|
Percent Change From Baseline in Facial Non-Inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20
Percent Change at Week 4
|
-6.8 percent change
Standard Deviation 37.46
|
-8.7 percent change
Standard Deviation 45.48
|
-12.7 percent change
Standard Deviation 45.88
|
|
Percent Change From Baseline in Facial Non-Inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20
Percent Change at Week 8
|
-7.7 percent change
Standard Deviation 84.17
|
11.4 percent change
Standard Deviation 117.96
|
-18.1 percent change
Standard Deviation 32.73
|
|
Percent Change From Baseline in Facial Non-Inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20
Percent Change at Week 12
|
-2.4 percent change
Standard Deviation 68.07
|
8.8 percent change
Standard Deviation 114.44
|
-22.1 percent change
Standard Deviation 40.26
|
|
Percent Change From Baseline in Facial Non-Inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20
Percent Change at Week 20
|
-21.1 percent change
Standard Deviation 46.59
|
-0.9 percent change
Standard Deviation 95.05
|
-31.4 percent change
Standard Deviation 50.91
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12, and 20Population: Participants in the ITT Analysis Set with available data were analyzed.
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.
Outcome measures
| Measure |
Imsidolimab 400/200 mg
n=40 Participants
Participants received imsidolimab 400 mg by SC injection on Day 1, followed by 200 mg on Days 29 and 57.
|
Imsidolimab 200/100 mg
n=38 Participants
Participants received imsidolimab 200 mg by SC injection on Day 1, followed by 100 mg on Days 29 and 57.
|
Placebo
n=39 Participants
Participants received imsidolimab matching placebo by SC injection on Days 1, 29, and 57.
|
|---|---|---|---|
|
Change From Baseline in Total Facial Lesion (Inflammatory and Non-inflammatory Lesions) Counts at Weeks 2, 4, 8, 12, and 20
Change at Week 2
|
-4.1 lesions
Standard Deviation 15.03
|
-1.3 lesions
Standard Deviation 11.95
|
-7.0 lesions
Standard Deviation 12.36
|
|
Change From Baseline in Total Facial Lesion (Inflammatory and Non-inflammatory Lesions) Counts at Weeks 2, 4, 8, 12, and 20
Change at Week 4
|
-5.0 lesions
Standard Deviation 21.03
|
-8.7 lesions
Standard Deviation 16.32
|
-14.4 lesions
Standard Deviation 15.22
|
|
Change From Baseline in Total Facial Lesion (Inflammatory and Non-inflammatory Lesions) Counts at Weeks 2, 4, 8, 12, and 20
Change at Week 8
|
-12.0 lesions
Standard Deviation 28.0
|
-8.4 lesions
Standard Deviation 23.85
|
-15.9 lesions
Standard Deviation 19.50
|
|
Change From Baseline in Total Facial Lesion (Inflammatory and Non-inflammatory Lesions) Counts at Weeks 2, 4, 8, 12, and 20
Change at Week 12
|
-13.4 lesions
Standard Deviation 26.82
|
-11.9 lesions
Standard Deviation 29.06
|
-19.0 lesions
Standard Deviation 21.24
|
|
Change From Baseline in Total Facial Lesion (Inflammatory and Non-inflammatory Lesions) Counts at Weeks 2, 4, 8, 12, and 20
Change at Week 20
|
-18.6 lesions
Standard Deviation 22.01
|
-16.0 lesions
Standard Deviation 31.82
|
-22.7 lesions
Standard Deviation 18.65
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12, and 20Population: Participants in the ITT Analysis Set with available data were analyzed.
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.
Outcome measures
| Measure |
Imsidolimab 400/200 mg
n=40 Participants
Participants received imsidolimab 400 mg by SC injection on Day 1, followed by 200 mg on Days 29 and 57.
|
Imsidolimab 200/100 mg
n=38 Participants
Participants received imsidolimab 200 mg by SC injection on Day 1, followed by 100 mg on Days 29 and 57.
|
Placebo
n=39 Participants
Participants received imsidolimab matching placebo by SC injection on Days 1, 29, and 57.
|
|---|---|---|---|
|
Percent Change From Baseline in Total Facial Lesion (Inflammatory and Non-inflammatory Lesions) Counts at Weeks 2, 4, 8, 12, and 20
Percent Change at Week 2
|
-6.9 percent change
Standard Deviation 21.26
|
-1.9 percent change
Standard Deviation 21.62
|
-10.7 percent change
Standard Deviation 22.27
|
|
Percent Change From Baseline in Total Facial Lesion (Inflammatory and Non-inflammatory Lesions) Counts at Weeks 2, 4, 8, 12, and 20
Percent Change at Week 4
|
-7.7 percent change
Standard Deviation 29.10
|
-13.5 percent change
Standard Deviation 22.61
|
-23.2 percent change
Standard Deviation 23.87
|
|
Percent Change From Baseline in Total Facial Lesion (Inflammatory and Non-inflammatory Lesions) Counts at Weeks 2, 4, 8, 12, and 20
Percent Change at Week 8
|
-18.9 percent change
Standard Deviation 40.88
|
-12.7 percent change
Standard Deviation 31.36
|
-24.0 percent change
Standard Deviation 27.82
|
|
Percent Change From Baseline in Total Facial Lesion (Inflammatory and Non-inflammatory Lesions) Counts at Weeks 2, 4, 8, 12, and 20
Percent Change at Week 12
|
-18.9 percent change
Standard Deviation 39.18
|
-15.4 percent change
Standard Deviation 44.85
|
-31.2 percent change
Standard Deviation 31.88
|
|
Percent Change From Baseline in Total Facial Lesion (Inflammatory and Non-inflammatory Lesions) Counts at Weeks 2, 4, 8, 12, and 20
Percent Change at Week 20
|
-28.6 percent change
Standard Deviation 33.69
|
-23.0 percent change
Standard Deviation 56.30
|
-38.7 percent change
Standard Deviation 30.00
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12, and 20Population: Participants in the ITT Analysis Set with available data were analyzed.
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.
Outcome measures
| Measure |
Imsidolimab 400/200 mg
n=40 Participants
Participants received imsidolimab 400 mg by SC injection on Day 1, followed by 200 mg on Days 29 and 57.
|
Imsidolimab 200/100 mg
n=38 Participants
Participants received imsidolimab 200 mg by SC injection on Day 1, followed by 100 mg on Days 29 and 57.
|
Placebo
n=39 Participants
Participants received imsidolimab matching placebo by SC injection on Days 1, 29, and 57.
|
|---|---|---|---|
|
Change From Baseline in Facial Investigator's Global Assessment (IGA) at Weeks 2, 4, 8, 12, and 20
Change at Week 2
|
-0.2 units on a scale
Standard Deviation 0.46
|
-0.0 units on a scale
Standard Deviation 0.16
|
-0.2 units on a scale
Standard Deviation 0.43
|
|
Change From Baseline in Facial Investigator's Global Assessment (IGA) at Weeks 2, 4, 8, 12, and 20
Change at Week 4
|
-0.2 units on a scale
Standard Deviation 0.49
|
-0.1 units on a scale
Standard Deviation 0.42
|
-0.5 units on a scale
Standard Deviation 0.60
|
|
Change From Baseline in Facial Investigator's Global Assessment (IGA) at Weeks 2, 4, 8, 12, and 20
Change at Week 8
|
-0.4 units on a scale
Standard Deviation 0.62
|
-0.3 units on a scale
Standard Deviation 0.53
|
-0.6 units on a scale
Standard Deviation 0.60
|
|
Change From Baseline in Facial Investigator's Global Assessment (IGA) at Weeks 2, 4, 8, 12, and 20
Change at Week 12
|
-0.6 units on a scale
Standard Deviation 0.78
|
-0.3 units on a scale
Standard Deviation 0.54
|
-0.8 units on a scale
Standard Deviation 0.83
|
|
Change From Baseline in Facial Investigator's Global Assessment (IGA) at Weeks 2, 4, 8, 12, and 20
Change at Week 20
|
-0.7 units on a scale
Standard Deviation 0.91
|
-0.7 units on a scale
Standard Deviation 0.80
|
-0.9 units on a scale
Standard Deviation 0.71
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12, and 20Population: Participants in the ITT Analysis Set with available data were analyzed.
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.
Outcome measures
| Measure |
Imsidolimab 400/200 mg
n=40 Participants
Participants received imsidolimab 400 mg by SC injection on Day 1, followed by 200 mg on Days 29 and 57.
|
Imsidolimab 200/100 mg
n=38 Participants
Participants received imsidolimab 200 mg by SC injection on Day 1, followed by 100 mg on Days 29 and 57.
|
Placebo
n=39 Participants
Participants received imsidolimab matching placebo by SC injection on Days 1, 29, and 57.
|
|---|---|---|---|
|
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
Week 2
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
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
Week 4
|
0 percentage of participants
|
0 percentage of participants
|
2.6 percentage of participants
|
|
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
Week 8
|
2.5 percentage of participants
|
0 percentage of participants
|
2.6 percentage of participants
|
|
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
Week 12
|
11.8 percentage of participants
|
0 percentage of participants
|
13.9 percentage of participants
|
|
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
Week 20
|
14.3 percentage of participants
|
8.6 percentage of participants
|
18.9 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12, and 20Population: Participants in the ITT Analysis Set with available data were analyzed.
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.
Outcome measures
| Measure |
Imsidolimab 400/200 mg
n=40 Participants
Participants received imsidolimab 400 mg by SC injection on Day 1, followed by 200 mg on Days 29 and 57.
|
Imsidolimab 200/100 mg
n=38 Participants
Participants received imsidolimab 200 mg by SC injection on Day 1, followed by 100 mg on Days 29 and 57.
|
Placebo
n=39 Participants
Participants received imsidolimab matching placebo by SC injection on Days 1, 29, and 57.
|
|---|---|---|---|
|
Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20
Week 8: Severe
|
10.0 percentage of participants
|
5.7 percentage of participants
|
7.9 percentage of participants
|
|
Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20
Week 12: Mild
|
41.2 percentage of participants
|
42.9 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20
Week 12: Moderate
|
44.1 percentage of participants
|
51.4 percentage of participants
|
47.2 percentage of participants
|
|
Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20
Week 12: Severe
|
8.8 percentage of participants
|
5.7 percentage of participants
|
2.8 percentage of participants
|
|
Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20
Week 20: Clear Skin
|
2.9 percentage of participants
|
2.9 percentage of participants
|
2.6 percentage of participants
|
|
Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20
Week 20: Mild
|
54.3 percentage of participants
|
57.1 percentage of participants
|
63.2 percentage of participants
|
|
Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20
Week 20: Moderate
|
34.3 percentage of participants
|
34.3 percentage of participants
|
28.9 percentage of participants
|
|
Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20
Week 20: Severe
|
8.6 percentage of participants
|
5.7 percentage of participants
|
5.3 percentage of participants
|
|
Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20
Week 12: Clear Skin
|
5.9 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20
Week 2: Clear Skin
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20
Week 2: Mild
|
25.0 percentage of participants
|
23.7 percentage of participants
|
21.1 percentage of participants
|
|
Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20
Week 2: Moderate
|
55.0 percentage of participants
|
63.2 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20
Week 2: Severe
|
20.0 percentage of participants
|
13.2 percentage of participants
|
28.9 percentage of participants
|
|
Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20
Week 4: Clear Skin
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20
Week 4: Mild
|
26.3 percentage of participants
|
21.6 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20
Week 4: Moderate
|
63.2 percentage of participants
|
70.3 percentage of participants
|
48.7 percentage of participants
|
|
Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20
Week 4: Severe
|
10.5 percentage of participants
|
8.1 percentage of participants
|
17.9 percentage of participants
|
|
Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20
Week 8: Clear Skin
|
2.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20
Week 8: Mild
|
27.5 percentage of participants
|
48.6 percentage of participants
|
44.7 percentage of participants
|
|
Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20
Week 8: Moderate
|
60.0 percentage of participants
|
45.7 percentage of participants
|
47.4 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12, and 20Population: Participants in the ITT Analysis Set with available data were analyzed.
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.
Outcome measures
| Measure |
Imsidolimab 400/200 mg
n=40 Participants
Participants received imsidolimab 400 mg by SC injection on Day 1, followed by 200 mg on Days 29 and 57.
|
Imsidolimab 200/100 mg
n=38 Participants
Participants received imsidolimab 200 mg by SC injection on Day 1, followed by 100 mg on Days 29 and 57.
|
Placebo
n=39 Participants
Participants received imsidolimab matching placebo by SC injection on Days 1, 29, and 57.
|
|---|---|---|---|
|
Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20
Week 2: A little better
|
55.0 percentage of participants
|
50.0 percentage of participants
|
52.6 percentage of participants
|
|
Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20
Week 2: No change
|
20.0 percentage of participants
|
18.4 percentage of participants
|
34.2 percentage of participants
|
|
Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20
Week 2: Very much better
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20
Week 2: Much better
|
5.0 percentage of participants
|
2.6 percentage of participants
|
2.6 percentage of participants
|
|
Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20
Week 2: A little worse
|
15.0 percentage of participants
|
18.4 percentage of participants
|
10.5 percentage of participants
|
|
Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20
Week 2: Much worse
|
5.0 percentage of participants
|
10.5 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20
Week 2: Very much worse
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20
Week 4: Very much better
|
0 percentage of participants
|
2.7 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20
Week 4: Much better
|
7.9 percentage of participants
|
13.5 percentage of participants
|
15.4 percentage of participants
|
|
Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20
Week 4: A little better
|
47.4 percentage of participants
|
37.8 percentage of participants
|
56.4 percentage of participants
|
|
Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20
Week 4: No change
|
26.3 percentage of participants
|
18.9 percentage of participants
|
15.4 percentage of participants
|
|
Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20
Week 4: A little worse
|
13.2 percentage of participants
|
16.2 percentage of participants
|
12.8 percentage of participants
|
|
Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20
Week 4: Much worse
|
2.6 percentage of participants
|
8.1 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20
Week 4: Very much worse
|
2.6 percentage of participants
|
2.7 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20
Week 8: Very much better
|
5.0 percentage of participants
|
2.9 percentage of participants
|
2.6 percentage of participants
|
|
Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20
Week 8: Much better
|
17.5 percentage of participants
|
14.3 percentage of participants
|
31.6 percentage of participants
|
|
Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20
Week 8: A little better
|
47.5 percentage of participants
|
40.0 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20
Week 8: No change
|
15.0 percentage of participants
|
22.9 percentage of participants
|
13.2 percentage of participants
|
|
Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20
Week 8: A little worse
|
7.5 percentage of participants
|
17.1 percentage of participants
|
2.6 percentage of participants
|
|
Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20
Week 8: Much worse
|
2.5 percentage of participants
|
2.9 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20
Week 8: Very much worse
|
5.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20
Week 12: Very much better
|
5.9 percentage of participants
|
2.9 percentage of participants
|
5.6 percentage of participants
|
|
Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20
Week 12: Much better
|
20.6 percentage of participants
|
22.9 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20
Week 12: A little better
|
47.1 percentage of participants
|
31.4 percentage of participants
|
47.2 percentage of participants
|
|
Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20
Week 12: No change
|
14.7 percentage of participants
|
17.1 percentage of participants
|
16.7 percentage of participants
|
|
Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20
Week 12: A little worse
|
5.9 percentage of participants
|
14.3 percentage of participants
|
2.8 percentage of participants
|
|
Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20
Week 12: Much worse
|
2.9 percentage of participants
|
8.6 percentage of participants
|
2.8 percentage of participants
|
|
Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20
Week 12: Very much worse
|
2.9 percentage of participants
|
2.9 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20
Week 20: Very much better
|
2.9 percentage of participants
|
11.4 percentage of participants
|
10.5 percentage of participants
|
|
Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20
Week 20: Much better
|
28.6 percentage of participants
|
17.1 percentage of participants
|
34.2 percentage of participants
|
|
Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20
Week 20: A little better
|
40.0 percentage of participants
|
40.0 percentage of participants
|
28.9 percentage of participants
|
|
Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20
Week 20: No change
|
20.0 percentage of participants
|
20.0 percentage of participants
|
15.8 percentage of participants
|
|
Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20
Week 20: A little worse
|
8.6 percentage of participants
|
8.6 percentage of participants
|
10.5 percentage of participants
|
|
Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20
Week 20: Much worse
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20
Week 20: Very much worse
|
0 percentage of participants
|
2.9 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12, and 20Population: Participants in the ITT Analysis Set with available data were analyzed.
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.
Outcome measures
| Measure |
Imsidolimab 400/200 mg
n=27 Participants
Participants received imsidolimab 400 mg by SC injection on Day 1, followed by 200 mg on Days 29 and 57.
|
Imsidolimab 200/100 mg
n=26 Participants
Participants received imsidolimab 200 mg by SC injection on Day 1, followed by 100 mg on Days 29 and 57.
|
Placebo
n=24 Participants
Participants received imsidolimab matching placebo by SC injection on Days 1, 29, and 57.
|
|---|---|---|---|
|
Change From Baseline in Dermatology Life Quality Index Questionnaire (DLQI) Total Score at Weeks 2, 4, 8, 12, and 20
Change at Week 2
|
-1.6 units on a scale
Standard Deviation 4.53
|
-1.9 units on a scale
Standard Deviation 5.28
|
-2.0 units on a scale
Standard Deviation 3.37
|
|
Change From Baseline in Dermatology Life Quality Index Questionnaire (DLQI) Total Score at Weeks 2, 4, 8, 12, and 20
Change at Week 4
|
-2.6 units on a scale
Standard Deviation 5.01
|
-3.6 units on a scale
Standard Deviation 5.20
|
-2.3 units on a scale
Standard Deviation 4.19
|
|
Change From Baseline in Dermatology Life Quality Index Questionnaire (DLQI) Total Score at Weeks 2, 4, 8, 12, and 20
Change at Week 8
|
-3.4 units on a scale
Standard Deviation 5.28
|
-4.0 units on a scale
Standard Deviation 6.26
|
-4.3 units on a scale
Standard Deviation 4.93
|
|
Change From Baseline in Dermatology Life Quality Index Questionnaire (DLQI) Total Score at Weeks 2, 4, 8, 12, and 20
Change at Week 12
|
-4.2 units on a scale
Standard Deviation 4.71
|
-2.9 units on a scale
Standard Deviation 5.14
|
-4.0 units on a scale
Standard Deviation 4.98
|
|
Change From Baseline in Dermatology Life Quality Index Questionnaire (DLQI) Total Score at Weeks 2, 4, 8, 12, and 20
Change at Week 20
|
-1.8 units on a scale
Standard Deviation 5.75
|
-3.7 units on a scale
Standard Deviation 4.11
|
-4.7 units on a scale
Standard Deviation 5.69
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12, and 20Population: Participants in the ITT Analysis Set with available data were analyzed.
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.
Outcome measures
| Measure |
Imsidolimab 400/200 mg
n=12 Participants
Participants received imsidolimab 400 mg by SC injection on Day 1, followed by 200 mg on Days 29 and 57.
|
Imsidolimab 200/100 mg
n=12 Participants
Participants received imsidolimab 200 mg by SC injection on Day 1, followed by 100 mg on Days 29 and 57.
|
Placebo
n=14 Participants
Participants received imsidolimab matching placebo by SC injection on Days 1, 29, and 57.
|
|---|---|---|---|
|
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score at Weeks 2, 4, 8, 12, and 20
Change at Week 2
|
-1.6 units on a scale
Standard Deviation 3.70
|
-0.7 units on a scale
Standard Deviation 9.00
|
-2.0 units on a scale
Standard Deviation 5.07
|
|
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score at Weeks 2, 4, 8, 12, and 20
Change at Week 4
|
-0.3 units on a scale
Standard Deviation 2.90
|
-2.7 units on a scale
Standard Deviation 6.31
|
-2.6 units on a scale
Standard Deviation 4.69
|
|
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score at Weeks 2, 4, 8, 12, and 20
Change at Week 8
|
-1.8 units on a scale
Standard Deviation 4.52
|
-2.2 units on a scale
Standard Deviation 6.48
|
-2.9 units on a scale
Standard Deviation 4.85
|
|
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score at Weeks 2, 4, 8, 12, and 20
Change at Week 12
|
-2.3 units on a scale
Standard Deviation 4.46
|
-1.1 units on a scale
Standard Deviation 7.20
|
-3.2 units on a scale
Standard Deviation 4.67
|
|
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score at Weeks 2, 4, 8, 12, and 20
Change at Week 20
|
-3.1 units on a scale
Standard Deviation 4.44
|
-3.5 units on a scale
Standard Deviation 7.33
|
-2.8 units on a scale
Standard Deviation 4.71
|
SECONDARY outcome
Timeframe: First dose of study drug until end of study (up to 20 weeks)Population: Safety Analysis Set.
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.
Outcome measures
| Measure |
Imsidolimab 400/200 mg
n=41 Participants
Participants received imsidolimab 400 mg by SC injection on Day 1, followed by 200 mg on Days 29 and 57.
|
Imsidolimab 200/100 mg
n=39 Participants
Participants received imsidolimab 200 mg by SC injection on Day 1, followed by 100 mg on Days 29 and 57.
|
Placebo
n=41 Participants
Participants received imsidolimab matching placebo by SC injection on Days 1, 29, and 57.
|
|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Any TEAEs
|
18 participants
|
10 participants
|
11 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Serious TEAEs
|
1 participants
|
0 participants
|
0 participants
|
Adverse Events
Imsidolimab 400/200 mg
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Imsidolimab 200/100 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Imsidolimab 400/200 mg
n=41 participants at risk
Participants received imsidolimab 400 mg by SC injection on Day 1, followed by 200 mg on Days 29 and 57.
|
Imsidolimab 200/100 mg
n=39 participants at risk
Participants received imsidolimab 200 mg by SC injection on Day 1, followed by 100 mg on Days 29 and 57.
|
Placebo
n=41 participants at risk
Participants received imsidolimab matching placebo by SC injection on Days 1, 29, and 57.
|
|---|---|---|---|
|
Reproductive system and breast disorders
Fallopian tube cyst
|
2.4%
1/41 • 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)
All-cause mortality: ITT Analysis Set Adverse events: Safety Analysis Set
|
0.00%
0/39 • 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)
All-cause mortality: ITT Analysis Set Adverse events: Safety Analysis Set
|
0.00%
0/41 • 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)
All-cause mortality: ITT Analysis Set Adverse events: Safety Analysis Set
|
Other adverse events
| Measure |
Imsidolimab 400/200 mg
n=41 participants at risk
Participants received imsidolimab 400 mg by SC injection on Day 1, followed by 200 mg on Days 29 and 57.
|
Imsidolimab 200/100 mg
n=39 participants at risk
Participants received imsidolimab 200 mg by SC injection on Day 1, followed by 100 mg on Days 29 and 57.
|
Placebo
n=41 participants at risk
Participants received imsidolimab matching placebo by SC injection on Days 1, 29, and 57.
|
|---|---|---|---|
|
Infections and infestations
COVID-19
|
7.3%
3/41 • 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)
All-cause mortality: ITT Analysis Set Adverse events: Safety Analysis Set
|
2.6%
1/39 • 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)
All-cause mortality: ITT Analysis Set Adverse events: Safety Analysis Set
|
12.2%
5/41 • 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)
All-cause mortality: ITT Analysis Set Adverse events: Safety Analysis Set
|
|
Infections and infestations
Upper respiratory tract infection
|
7.3%
3/41 • 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)
All-cause mortality: ITT Analysis Set Adverse events: Safety Analysis Set
|
2.6%
1/39 • 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)
All-cause mortality: ITT Analysis Set Adverse events: Safety Analysis Set
|
2.4%
1/41 • 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)
All-cause mortality: ITT Analysis Set Adverse events: Safety Analysis Set
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/41 • 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)
All-cause mortality: ITT Analysis Set Adverse events: Safety Analysis Set
|
5.1%
2/39 • 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)
All-cause mortality: ITT Analysis Set Adverse events: Safety Analysis Set
|
2.4%
1/41 • 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)
All-cause mortality: ITT Analysis Set Adverse events: Safety Analysis Set
|
|
Nervous system disorders
Headache
|
7.3%
3/41 • 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)
All-cause mortality: ITT Analysis Set Adverse events: Safety Analysis Set
|
0.00%
0/39 • 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)
All-cause mortality: ITT Analysis Set Adverse events: Safety Analysis Set
|
0.00%
0/41 • 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)
All-cause mortality: ITT Analysis Set Adverse events: Safety Analysis Set
|
|
Nervous system disorders
Migraine
|
0.00%
0/41 • 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)
All-cause mortality: ITT Analysis Set Adverse events: Safety Analysis Set
|
5.1%
2/39 • 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)
All-cause mortality: ITT Analysis Set Adverse events: Safety Analysis Set
|
0.00%
0/41 • 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)
All-cause mortality: ITT Analysis Set Adverse events: Safety Analysis Set
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER