Trial Outcomes & Findings for A Study of Baricitinib (LY3009104) in Patients With Moderate to Severe Atopic Dermatitis (NCT NCT03334396)
NCT ID: NCT03334396
Last Updated: 2020-08-18
Results Overview
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.
COMPLETED
PHASE3
660 participants
16 Weeks
2020-08-18
Participant Flow
Participants who completed double blind treatment phase had option to enter extension study I4V-MC-JAHN (NCT03334435).
Participant milestones
| Measure |
Placebo
Placebo administered orally once daily.
|
1 mg Baricitinib
1 mg Baricitinib administered orally once daily.
|
2 mg Baricitinib
2 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
4 mg Baricitinib administered orally once daily.
|
Placebo Maximum Extended Enrollment (MEE)
Placebo administered orally once daily.
|
1 mg Baricitinib MEE
1 mg Baricitinib administered orally once daily.
|
2 mg Baricitinib MEE
2 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib MEE
4 mg Baricitinib administered orally once daily.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
249
|
127
|
123
|
125
|
15
|
5
|
8
|
8
|
|
Overall Study
Received at Least One Dose of Study Drug
|
249
|
127
|
123
|
125
|
15
|
5
|
8
|
8
|
|
Overall Study
COMPLETED
|
226
|
116
|
113
|
120
|
12
|
4
|
5
|
7
|
|
Overall Study
NOT COMPLETED
|
23
|
11
|
10
|
5
|
3
|
1
|
3
|
1
|
Reasons for withdrawal
| Measure |
Placebo
Placebo administered orally once daily.
|
1 mg Baricitinib
1 mg Baricitinib administered orally once daily.
|
2 mg Baricitinib
2 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
4 mg Baricitinib administered orally once daily.
|
Placebo Maximum Extended Enrollment (MEE)
Placebo administered orally once daily.
|
1 mg Baricitinib MEE
1 mg Baricitinib administered orally once daily.
|
2 mg Baricitinib MEE
2 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib MEE
4 mg Baricitinib administered orally once daily.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Lack of Efficacy
|
10
|
4
|
1
|
3
|
1
|
0
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
10
|
5
|
7
|
2
|
2
|
1
|
2
|
0
|
|
Overall Study
Pregnancy
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Ineligible
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Started New Job
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Study of Baricitinib (LY3009104) in Patients With Moderate to Severe Atopic Dermatitis
Baseline characteristics by cohort
| Measure |
Placebo
n=249 Participants
Placebo administered orally once daily.
|
1 mg Baricitinib
n=127 Participants
1 mg Baricitinib administered orally once daily.
|
2 mg Baricitinib
n=123 Participants
2 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
n=125 Participants
4 mg Baricitinib administered orally once daily.
|
Placebo Maximum Extended Enrollment (MEE)
n=15 Participants
Placebo administered orally once daily.
|
1 mg Baricitinib MEE
n=5 Participants
1 mg Baricitinib administered orally once daily. .
|
2 mg Baricitinib MEE
n=8 Participants
2 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib MEE
n=8 Participants
4 mg Baricitinib administered orally once daily.
|
Total
n=660 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Race (NIH/OMB)
White
|
147 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
70 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
366 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
13 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
34 Participants
n=6 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
242 Participants
n=5 Participants
|
127 Participants
n=7 Participants
|
118 Participants
n=5 Participants
|
121 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
8 Participants
n=6 Participants
|
642 Participants
n=6 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
17 Participants
n=6 Participants
|
|
Sex: Female, Male
Female
|
101 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
243 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
148 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
83 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
8 Participants
n=115 Participants
|
6 Participants
n=6 Participants
|
417 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
14 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
30 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
73 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
8 Participants
n=115 Participants
|
8 Participants
n=6 Participants
|
225 Participants
n=6 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
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
|
Region of Enrollment
Czechia
|
36 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
76 Participants
n=6 Participants
|
|
Region of Enrollment
Japan
|
45 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
111 Participants
n=6 Participants
|
|
Region of Enrollment
Taiwan
|
25 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
63 Participants
n=6 Participants
|
|
Region of Enrollment
Italy
|
17 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
44 Participants
n=6 Participants
|
|
Region of Enrollment
Mexico
|
32 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
73 Participants
n=6 Participants
|
|
Region of Enrollment
France
|
15 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
39 Participants
n=6 Participants
|
|
Region of Enrollment
Germany
|
67 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
178 Participants
n=6 Participants
|
|
Region of Enrollment
India
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
8 Participants
n=115 Participants
|
8 Participants
n=6 Participants
|
46 Participants
n=6 Participants
|
|
Region of Enrollment
Russia
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
30 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: 16 WeeksPopulation: All participants randomized to placebo, 2 mg, or 4 mg of study drug. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (MEE) arms/groups but only for the main global study arms/groups.
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.
Outcome measures
| Measure |
Placebo
n=249 Participants
Placebo administered orally once daily.
|
2 mg Baricitinib
n=123 Participants
2 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
n=125 Participants
4 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
4 mg Baricitinib administered orally once daily.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 With a ≥ 2 Point Improvement (Placebo, 2 mg, or 4 mg Baricitinib)
|
4.8 percentage of participants
|
11.4 percentage of participants
|
16.8 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 16 WeeksPopulation: All participants randomized to placebo or 1 mg of study drug. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (MEE) arms/groups but only for the main global study arms/groups.
The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.
Outcome measures
| Measure |
Placebo
n=249 Participants
Placebo administered orally once daily.
|
2 mg Baricitinib
n=127 Participants
2 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
4 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
4 mg Baricitinib administered orally once daily.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving IGA of 0 or 1 With a ≥ 2 Point Improvement (Placebo, 1 mg Baricitinib)
|
4.8 percentage of participants
|
11.8 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 16 WeeksPopulation: All randomized participants. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (MEE) arms/groups but only for the main global study arms/groups.
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score.
Outcome measures
| Measure |
Placebo
n=249 Participants
Placebo administered orally once daily.
|
2 mg Baricitinib
n=127 Participants
2 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
n=123 Participants
4 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
n=125 Participants
4 mg Baricitinib administered orally once daily.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI75)
|
8.8 percentage of participants
|
17.3 percentage of participants
|
18.7 percentage of participants
|
24.8 percentage of participants
|
SECONDARY outcome
Timeframe: 16 WeeksPopulation: All randomized participants. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (MEE) arms/groups but only for the main global study arms/groups.
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI90 is defined as a ≥ 90% improvement from baseline in the EASI score.
Outcome measures
| Measure |
Placebo
n=249 Participants
Placebo administered orally once daily.
|
2 mg Baricitinib
n=127 Participants
2 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
n=123 Participants
4 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
n=125 Participants
4 mg Baricitinib administered orally once daily.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving EASI90
|
4.8 percentage of participants
|
8.7 percentage of participants
|
10.6 percentage of participants
|
16.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, 16 WeeksPopulation: All randomized participants who had Week 16 EASI data. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (MEE) arms/groups but only for the main global study arms/groups.
The EASI assesses objective physician estimates of 2 dimensions of AD - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). Least Square (LS) Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effect
Outcome measures
| Measure |
Placebo
n=71 Participants
Placebo administered orally once daily.
|
2 mg Baricitinib
n=52 Participants
2 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
n=52 Participants
4 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
n=70 Participants
4 mg Baricitinib administered orally once daily.
|
|---|---|---|---|---|
|
Percent Change From Baseline in EASI Score
|
-34.82 percent change
Standard Error 3.64
|
-48.22 percent change
Standard Error 4.52
|
-51.89 percent change
Standard Error 4.29
|
-59.36 percent change
Standard Error 3.84
|
SECONDARY outcome
Timeframe: 16 WeeksPopulation: All randomized participants. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (MEE) arms/groups but only for the main global study arms/groups.
The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with visual analog scale (VAS) where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), \& subjective symptoms (C: 0-20) combine using A/5 + 7\*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. The SCORAD75 responder is defined as a participant who achieves a ≥ 75% improvement from baseline in the SCORAD score.
Outcome measures
| Measure |
Placebo
n=249 Participants
Placebo administered orally once daily.
|
2 mg Baricitinib
n=127 Participants
2 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
n=123 Participants
4 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
n=125 Participants
4 mg Baricitinib administered orally once daily.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving SCORing Atopic Dermatitis 75 (SCORAD75)
|
1.2 percentage of participants
|
5.5 percentage of participants
|
7.3 percentage of participants
|
10.4 percentage of participants
|
SECONDARY outcome
Timeframe: 16 WeeksPopulation: All randomized participants with a Baseline Itch NRS score \>=4. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (MEE) arms/groups but only for the main global study arms/groups.
The Itch Numeric Rating Scale (NRS) is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participants itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours.
Outcome measures
| Measure |
Placebo
n=222 Participants
Placebo administered orally once daily.
|
2 mg Baricitinib
n=105 Participants
2 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
n=100 Participants
4 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
n=107 Participants
4 mg Baricitinib administered orally once daily.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving a 4-Point Improvement in Itch Numeric Rating Scale (NRS)
|
7.2 percentage of participants
|
10.5 percentage of participants
|
12.0 percentage of participants
|
21.5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, 16 WeeksPopulation: All randomized participants with Week 16 ADSS Item 2 (frequency of waking) data. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (MEE) arms/groups but only for the main global study arms/groups.
Atopic Dermatitis Sleep Scale (ADSS) is a 3-item, participant-administered questionnaire developed to assess the impact of itch on sleep including difficulty falling asleep, frequency of waking, and difficulty getting back to sleep last night. Item 2, frequency of waking last night is reported by selecting the number of times they woke up each night, ranging from 0 to 29 times,where the higher a number indicates a worse outcome. The ADSS is designed to be completed daily, using a daily diary, with respondents thinking about sleep "last night." Each item is scored individually. LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by- visit-interaction as fixed continuous effects.
Outcome measures
| Measure |
Placebo
n=68 Participants
Placebo administered orally once daily.
|
2 mg Baricitinib
n=52 Participants
2 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
n=50 Participants
4 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
n=68 Participants
4 mg Baricitinib administered orally once daily.
|
|---|---|---|---|---|
|
Change From Baseline in the Score of Item 2 of the Atopic Dermatitis Sleep Scale (ADSS)
|
-0.84 units on a scale
Standard Error 0.15
|
-1.21 units on a scale
Standard Error 0.18
|
-1.04 units on a scale
Standard Error 0.17
|
-1.42 units on a scale
Standard Error 0.16
|
SECONDARY outcome
Timeframe: Baseline, 16 WeeksPopulation: All randomized participants with Week 16 Skin Pain NRS data. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (MEE) arms/groups but only for the main global study arms/groups.
Skin Pain NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no pain" and 10 representing "worst pain imaginable." Overall severity of a participant's skin pain is indicated by selecting the number, using a daily diary, that best describes the worst level of skin pain in the past 24 hours. LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
Outcome measures
| Measure |
Placebo
n=68 Participants
Placebo administered orally once daily.
|
2 mg Baricitinib
n=52 Participants
2 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
n=50 Participants
4 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
n=68 Participants
4 mg Baricitinib administered orally once daily.
|
|---|---|---|---|---|
|
Change From Baseline in the Skin Pain Numeric Rating Scale (NRS)
|
-0.84 units on a scale
Standard Error 0.24
|
-1.92 units on a scale
Standard Error 0.30
|
-1.58 units on a scale
Standard Error 0.29
|
-1.93 units on a scale
Standard Error 0.26
|
SECONDARY outcome
Timeframe: 16 WeeksPopulation: All randomized participants. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (MEE) arms/groups but only for the main global study arms/groups.
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100%) and the severity of 4 clinical signs (erythema, edema/papulation, excoriation, and lichenification) each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head and neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2 and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI50 is defined as a ≥ 50% improvement from baseline in EASI score.
Outcome measures
| Measure |
Placebo
n=249 Participants
Placebo administered orally once daily.
|
2 mg Baricitinib
n=127 Participants
2 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
n=123 Participants
4 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
n=125 Participants
4 mg Baricitinib administered orally once daily.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving EASI50
|
15.3 percentage of participants
|
26.0 percentage of participants
|
30.1 percentage of participants
|
41.6 percentage of participants
|
SECONDARY outcome
Timeframe: 16 WeeksPopulation: All randomized participants. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (MEE) arms/groups but only for the main global study arms/groups.
The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.
Outcome measures
| Measure |
Placebo
n=249 Participants
Placebo administered orally once daily.
|
2 mg Baricitinib
n=127 Participants
2 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
n=123 Participants
4 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
n=125 Participants
4 mg Baricitinib administered orally once daily.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving IGA of 0
|
0.8 percentage of participants
|
1.6 percentage of participants
|
2.4 percentage of participants
|
1.6 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, 16 WeeksPopulation: All randomized participants with Week 16 SCORAD data. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (MEE) arms/groups but only for the main global study arms/groups.
The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with VAS where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), \& subjective symptoms (C: 0-20) combine using A/5 + 7\*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
Outcome measures
| Measure |
Placebo
n=71 Participants
Placebo administered orally once daily.
|
2 mg Baricitinib
n=52 Participants
2 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
n=52 Participants
4 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
n=70 Participants
4 mg Baricitinib administered orally once daily.
|
|---|---|---|---|---|
|
Change From Baseline in SCORAD
|
-13.51 units on a scale
Standard Error 2.00
|
-18.85 units on a scale
Standard Error 2.48
|
-21.47 units on a scale
Standard Error 2.36
|
-28.30 units on a scale
Standard Error 2.10
|
SECONDARY outcome
Timeframe: 16 WeeksPopulation: All randomized participants. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (MEE) arms/groups but only for the main global study arms/groups.
The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with VAS where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), \& subjective symptoms (C: 0-20) combine using A/5 + 7\*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. SCORAD90 is defined as a ≥ 90% improvement from baseline in the SCORAD score.
Outcome measures
| Measure |
Placebo
n=249 Participants
Placebo administered orally once daily.
|
2 mg Baricitinib
n=127 Participants
2 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
n=123 Participants
4 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
n=125 Participants
4 mg Baricitinib administered orally once daily.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving SCORAD90
|
0.8 percentage of participants
|
0.8 percentage of participants
|
2.4 percentage of participants
|
2.4 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, 16 WeeksPopulation: All randomized participants with Week 16 BSA data. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (MEE) arms/groups but only for the main global study arms/groups.
Body surface area affected by AD will be assessed for 4 separate body regions and is collected as part of the EASI assessment: head and neck, trunk (including genital region), upper extremities, and lower extremities (including the buttocks). Each body region will be assessed for disease extent ranging from 0% to 100% involvement. The overall total percentage will be reported based off of all 4 body regions combined, after applying specific multipliers to the different body regions to account for the percent of the total BSA represented by each of the 4 regions. Use the percentage of skin affected for each region (0 to 100%) in EASI as follows: BSA Total = 0.1\*BSAhead and neck + 0.3\*BSAtrunk + 0.2\* BSAupper limbs + 0.4\*BSAlower limbs. LS Means were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
Outcome measures
| Measure |
Placebo
n=71 Participants
Placebo administered orally once daily.
|
2 mg Baricitinib
n=52 Participants
2 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
n=52 Participants
4 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
n=70 Participants
4 mg Baricitinib administered orally once daily.
|
|---|---|---|---|---|
|
Change From Baseline in Body Surface Area (BSA) Affected
|
-14.80 units on a scale
Standard Error 1.82
|
-20.79 units on a scale
Standard Error 2.26
|
-20.14 units on a scale
Standard Error 2.16
|
-25.96 units on a scale
Standard Error 1.93
|
SECONDARY outcome
Timeframe: 16 WeeksPopulation: All randomized participants. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (MEE) arms/groups but only for the main global study arms/groups.
Percentage of participants developing skin infections requiring antibiotic treatment.
Outcome measures
| Measure |
Placebo
n=249 Participants
Placebo administered orally once daily.
|
2 mg Baricitinib
n=127 Participants
2 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
n=123 Participants
4 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
n=125 Participants
4 mg Baricitinib administered orally once daily.
|
|---|---|---|---|---|
|
Percentage of Participants Developing Skin Infections Requiring Antibiotic Treatment
|
4.4 percentage of participants
|
0.8 percentage of participants
|
4.9 percentage of participants
|
3.2 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, 16 WeeksPopulation: All randomized participants with Week 16 Itch NRS data. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (MEE) arms/groups but only for the main global study arms/groups.
The Itch NRS is a participant-administered, 11-point horizontal scale, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participant's itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours. LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
Outcome measures
| Measure |
Placebo
n=68 Participants
Placebo administered orally once daily.
|
2 mg Baricitinib
n=52 Participants
2 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
n=50 Participants
4 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
n=68 Participants
4 mg Baricitinib administered orally once daily.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Itch NRS
|
-12.04 Percent Change
Standard Error 4.65
|
-31.30 Percent Change
Standard Error 5.70
|
-29.43 Percent Change
Standard Error 5.45
|
-36.55 Percent Change
Standard Error 4.88
|
SECONDARY outcome
Timeframe: Baseline, 16 WeeksPopulation: All randomized participants with Week 16 POEM data. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (MEE) arms/groups but only for the main global study arms/groups.
The POEM is a 7-item self-assessment questionnaire that assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) on a scale ranging from 0-4 (0 = no days, 1 = 1-2 days, 2 = 3-4 days, 3 = 5-6 days, 4 = everyday). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (severe disease). High scores are indicative of more severe disease and poor quality of life. LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
Outcome measures
| Measure |
Placebo
n=72 Participants
Placebo administered orally once daily.
|
2 mg Baricitinib
n=53 Participants
2 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
n=52 Participants
4 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
n=70 Participants
4 mg Baricitinib administered orally once daily.
|
|---|---|---|---|---|
|
Change From Baseline in the Total Score of the Patient Oriented Eczema Measure (POEM)
|
-2.68 units on a scale
Standard Error 0.76
|
-5.32 units on a scale
Standard Error 0.93
|
-6.26 units on a scale
Standard Error 0.91
|
-7.84 units on a scale
Standard Error 0.80
|
SECONDARY outcome
Timeframe: Baseline, 16 WeeksPopulation: All randomized participants with Week 16 PGI-S-AD data. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (MEE) arms/groups but only for the main global study arms/groups.
The PGI-S-AD asked the participant to evaluate the severity of the disease at that point in time on a single-item, 5-point scale, using a daily diary. The same category labels used in the Physician's Global Assessment were used for the PGI-S-AD, i.e., "(0) no symptoms", "(1) very mild", "(2) mild" "(3) moderate", and "(4) severe." LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
Outcome measures
| Measure |
Placebo
n=68 Participants
Placebo administered orally once daily.
|
2 mg Baricitinib
n=52 Participants
2 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
n=50 Participants
4 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
n=68 Participants
4 mg Baricitinib administered orally once daily.
|
|---|---|---|---|---|
|
Change From Baseline in the Patient Global Impression of Severity-Atopic Dermatitis (PGI-S-AD) Score
|
-0.31 units on a scale
Standard Error 0.09
|
-0.58 units on a scale
Standard Error 0.12
|
-0.58 units on a scale
Standard Error 0.11
|
-0.77 units on a scale
Standard Error 0.10
|
SECONDARY outcome
Timeframe: Baseline, 16 WeeksPopulation: All randomized participants with Week 16 HADS data. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (MEE) arms/groups but only for the main global study arms/groups.
The HADS is a participant-rated instrument used to assess both anxiety and depression. This instrument consists of 14 item questionnaire, each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.' LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
Outcome measures
| Measure |
Placebo
n=71 Participants
Placebo administered orally once daily.
|
2 mg Baricitinib
n=51 Participants
2 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
n=52 Participants
4 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
n=70 Participants
4 mg Baricitinib administered orally once daily.
|
|---|---|---|---|---|
|
Change From Baseline on the Hospital Anxiety and Depression Scale (HADS)
Anxiety
|
-0.90 units on a scale
Standard Error 0.28
|
-1.35 units on a scale
Standard Error 0.34
|
-1.83 units on a scale
Standard Error 0.33
|
-2.05 units on a scale
Standard Error 0.30
|
|
Change From Baseline on the Hospital Anxiety and Depression Scale (HADS)
Depression
|
-0.37 units on a scale
Standard Error 0.27
|
-1.04 units on a scale
Standard Error 0.34
|
-1.40 units on a scale
Standard Error 0.32
|
-1.50 units on a scale
Standard Error 0.29
|
SECONDARY outcome
Timeframe: Baseline, 16 WeeksPopulation: All randomized participants with Week 16 DLQI data. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (MEE) arms/groups but only for the main global study arms/groups.
The DLQI is a simple, participant-administered,10 question, validated, quality-of-life questionnaire that covers 6 domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. The recall period of this scale is over the last "week." Response categories include "not at all," "a lot," and "very much," with corresponding scores of 1, 2, and 3, respectively, and at unanswered ("not relevant") responses scored as "0." Scores range from 0 to 30 (less to more impairment), and a 4-point change from baseline is considered as the minimal clinically important difference threshold. LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
Outcome measures
| Measure |
Placebo
n=71 Participants
Placebo administered orally once daily.
|
2 mg Baricitinib
n=52 Participants
2 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
n=52 Participants
4 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
n=70 Participants
4 mg Baricitinib administered orally once daily.
|
|---|---|---|---|---|
|
Change From Baseline in the Dermatology Life Quality Index (DLQI)
|
-2.46 units on a scale
Standard Error 0.57
|
-4.64 units on a scale
Standard Error 0.70
|
-4.30 units on a scale
Standard Error 0.68
|
-6.76 units on a scale
Standard Error 0.60
|
SECONDARY outcome
Timeframe: Baseline, 16 WeeksPopulation: All randomized participants with Week 16 WPAI-AD data. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (MEE) arms/groups but only for the main global study arms/groups.
The WPAI-AD participant questionnaire was developed to measure the effect of general health and symptom severity on work productivity and regular activities in the 7 days prior to the visit. The WPAI-AD consists of 6 items grouped in 4 domains: absenteeism (work time missed), presenteeism (impairment at work/reduced on-the-job effectiveness), work productivity loss (overall work impairment/absenteeism plus presenteeism), and activity impairment, that range from 0% to 100%, with higher values indicating greater impairment. LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
Outcome measures
| Measure |
Placebo
n=70 Participants
Placebo administered orally once daily.
|
2 mg Baricitinib
n=51 Participants
2 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
n=52 Participants
4 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
n=70 Participants
4 mg Baricitinib administered orally once daily.
|
|---|---|---|---|---|
|
Change From Baseline on the Work Productivity and Activity Impairment - Atopic Dermatitis (WPAI-AD) Questionnaire
Absenteeism
|
-0.49 units on a scale
Standard Error 1.68
|
-4.54 units on a scale
Standard Error 2.15
|
-0.84 units on a scale
Standard Error 2.23
|
-3.89 units on a scale
Standard Error 1.88
|
|
Change From Baseline on the Work Productivity and Activity Impairment - Atopic Dermatitis (WPAI-AD) Questionnaire
Presenteeism
|
-2.89 units on a scale
Standard Error 2.60
|
-9.75 units on a scale
Standard Error 3.37
|
-11.53 units on a scale
Standard Error 3.44
|
-15.17 units on a scale
Standard Error 2.95
|
|
Change From Baseline on the Work Productivity and Activity Impairment - Atopic Dermatitis (WPAI-AD) Questionnaire
Work Productivity Loss
|
-2.57 units on a scale
Standard Error 2.89
|
-11.23 units on a scale
Standard Error 3.75
|
-9.06 units on a scale
Standard Error 3.83
|
-13.85 units on a scale
Standard Error 3.29
|
|
Change From Baseline on the Work Productivity and Activity Impairment - Atopic Dermatitis (WPAI-AD) Questionnaire
Activity Impairment
|
-5.67 units on a scale
Standard Error 2.16
|
-12.98 units on a scale
Standard Error 2.63
|
-10.80 units on a scale
Standard Error 2.57
|
-22.20 units on a scale
Standard Error 2.30
|
SECONDARY outcome
Timeframe: Baseline, 16 WeeksPopulation: All randomized participants with Week 16 EQ-5D-5L Health State Index US and UK data. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (MEE) arms/groups but only for the main global study arms/groups.
EQ-5D-5L is a 2-part measurement. The first part is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1, with higher score indicating better health state. LS Means were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
Outcome measures
| Measure |
Placebo
n=70 Participants
Placebo administered orally once daily.
|
2 mg Baricitinib
n=51 Participants
2 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
n=52 Participants
4 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
n=70 Participants
4 mg Baricitinib administered orally once daily.
|
|---|---|---|---|---|
|
Change From Baseline on the European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L) Index Score United States and United Kingdom Algorithm
Health State Index Score (US Algorithm)
|
0.01 units on a scale
Standard Error 0.01
|
0.05 units on a scale
Standard Error 0.02
|
0.05 units on a scale
Standard Error 0.02
|
0.09 units on a scale
Standard Error 0.01
|
|
Change From Baseline on the European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L) Index Score United States and United Kingdom Algorithm
Health State Index Score (UK Algorithm)
|
0.01 units on a scale
Standard Error 0.02
|
0.07 units on a scale
Standard Error 0.02
|
0.07 units on a scale
Standard Error 0.02
|
0.13 units on a scale
Standard Error 0.02
|
SECONDARY outcome
Timeframe: Baseline, 16 WeeksPopulation: All randomized participants with Week 16 EQ-5D-5L VAS data. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (MEE) arms/groups but only for the main global study arms/groups.
EQ-5D-5L is a 2-part measurement. The second part is assessed using a visual analog scale (VAS) that ranged from 0 to 100 millimeter (mm), where 0 is the worst health you can imagine and 100 is the best health you can imagine. LS Means were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
Outcome measures
| Measure |
Placebo
n=70 Participants
Placebo administered orally once daily.
|
2 mg Baricitinib
n=51 Participants
2 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
n=52 Participants
4 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
n=70 Participants
4 mg Baricitinib administered orally once daily.
|
|---|---|---|---|---|
|
Change From Baseline on the European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L) Visual Analog Score (VAS)
|
2.00 millimeters
Standard Error 2.04
|
4.97 millimeters
Standard Error 2.53
|
3.35 millimeters
Standard Error 2.41
|
9.05 millimeters
Standard Error 2.17
|
SECONDARY outcome
Timeframe: 4 WeeksPopulation: All randomized participants. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (MEE) arms/groups but only for the main global study arms/groups.
The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.
Outcome measures
| Measure |
Placebo
n=249 Participants
Placebo administered orally once daily.
|
2 mg Baricitinib
n=127 Participants
2 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
n=123 Participants
4 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
n=125 Participants
4 mg Baricitinib administered orally once daily.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 With a ≥ 2 Point Improvement
|
2.4 percentage of participants
|
3.1 percentage of participants
|
8.9 percentage of participants
|
10.4 percentage of participants
|
Adverse Events
Placebo
1 mg Baricitinib
2 mg Baricitinib
4 mg Baricitinib
Placebo Maximum Extended Enrollment
1 mg Baricitinib Maximum Extended Enrollment
2 mg Baricitinib Maximum Extended Enrollment
4 mg Baricitinib Maximum Extended Enrollment
Serious adverse events
| Measure |
Placebo
n=249 participants at risk
Placebo administered orally once daily.
|
1 mg Baricitinib
n=127 participants at risk
1 mg Baricitinib administered orally once daily.
|
2 mg Baricitinib
n=123 participants at risk
2 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
n=125 participants at risk
4 mg Baricitinib administered orally once daily.
|
Placebo Maximum Extended Enrollment
n=15 participants at risk
Placebo administered orally once daily.
|
1 mg Baricitinib Maximum Extended Enrollment
n=5 participants at risk
1 mg Baricitinib administered orally once daily.
|
2 mg Baricitinib Maximum Extended Enrollment
n=8 participants at risk
2 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib Maximum Extended Enrollment
n=8 participants at risk
4 mg Baricitinib administered orally once daily.
|
|---|---|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/249 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/127 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/123 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.80%
1/125 • Number of events 1 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/15 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.40%
1/249 • Number of events 1 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/127 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/123 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/125 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/15 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.40%
1/249 • Number of events 1 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/127 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/123 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/125 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/15 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.40%
1/249 • Number of events 1 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/127 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/123 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/125 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/15 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.40%
1/249 • Number of events 1 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/127 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/123 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/125 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/15 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Suicide attempt
|
0.40%
1/249 • Number of events 1 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/127 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/123 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/125 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/15 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.80%
2/249 • Number of events 2 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.79%
1/127 • Number of events 1 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/123 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.80%
1/125 • Number of events 1 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/15 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
Placebo
n=249 participants at risk
Placebo administered orally once daily.
|
1 mg Baricitinib
n=127 participants at risk
1 mg Baricitinib administered orally once daily.
|
2 mg Baricitinib
n=123 participants at risk
2 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
n=125 participants at risk
4 mg Baricitinib administered orally once daily.
|
Placebo Maximum Extended Enrollment
n=15 participants at risk
Placebo administered orally once daily.
|
1 mg Baricitinib Maximum Extended Enrollment
n=5 participants at risk
1 mg Baricitinib administered orally once daily.
|
2 mg Baricitinib Maximum Extended Enrollment
n=8 participants at risk
2 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib Maximum Extended Enrollment
n=8 participants at risk
4 mg Baricitinib administered orally once daily.
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.40%
1/249 • Number of events 1 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/127 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/123 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.80%
1/125 • Number of events 1 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
6.7%
1/15 • Number of events 1 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/249 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/127 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/123 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/125 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
6.7%
1/15 • Number of events 1 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/249 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/127 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.81%
1/123 • Number of events 1 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.80%
1/125 • Number of events 1 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
6.7%
1/15 • Number of events 1 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.40%
1/249 • Number of events 1 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/127 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/123 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/125 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
6.7%
1/15 • Number of events 1 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.40%
1/249 • Number of events 1 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
1.6%
2/127 • Number of events 2 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
2.4%
3/123 • Number of events 4 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/125 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/15 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.8%
7/249 • Number of events 8 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
7.1%
9/127 • Number of events 9 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/123 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
3.2%
4/125 • Number of events 4 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
6.7%
1/15 • Number of events 1 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.80%
2/249 • Number of events 2 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.79%
1/127 • Number of events 1 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.81%
1/123 • Number of events 1 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.80%
1/125 • Number of events 1 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/15 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Oedema
|
0.40%
1/249 • Number of events 1 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/127 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/123 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/125 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
6.7%
1/15 • Number of events 1 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Oedema peripheral
|
0.40%
1/249 • Number of events 1 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/127 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/123 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/125 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/15 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/249 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.79%
1/127 • Number of events 1 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
2.4%
3/123 • Number of events 3 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.80%
1/125 • Number of events 1 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/15 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
10.4%
26/249 • Number of events 28 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
17.3%
22/127 • Number of events 25 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
9.8%
12/123 • Number of events 14 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
9.6%
12/125 • Number of events 17 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/15 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/249 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
2.4%
3/127 • Number of events 4 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
1.6%
2/123 • Number of events 2 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
1.6%
2/125 • Number of events 2 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
6.7%
1/15 • Number of events 1 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Skin infection
|
0.40%
1/249 • Number of events 1 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/127 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.81%
1/123 • Number of events 1 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/125 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/15 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 3 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
1.6%
4/249 • Number of events 4 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.79%
1/127 • Number of events 1 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
1.6%
2/123 • Number of events 2 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
3.2%
4/125 • Number of events 7 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/15 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.99%
1/101 • Number of events 1 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
—
0/0 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Weight decreased
|
0.00%
0/249 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/127 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/123 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/125 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
6.7%
1/15 • Number of events 1 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.40%
1/249 • Number of events 1 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
1.6%
2/127 • Number of events 2 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.81%
1/123 • Number of events 1 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/125 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
6.7%
1/15 • Number of events 1 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
6.4%
16/249 • Number of events 17 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
5.5%
7/127 • Number of events 8 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
11.4%
14/123 • Number of events 15 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
8.0%
10/125 • Number of events 11 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/15 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.80%
2/249 • Number of events 2 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/127 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/123 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
3.2%
4/125 • Number of events 4 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
6.7%
1/15 • Number of events 1 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60