Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Plaque Psoriasis (NCT NCT05600036)
NCT ID: NCT05600036
Last Updated: 2025-06-18
Results Overview
Proportion of patients with moderate to severe psoriasis achieving ≥75% reduction in PASI score
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
228 participants
Primary outcome timeframe
12 weeks
Results posted on
2025-06-18
Participant Flow
Participant milestones
| Measure |
ESK-001 10mg QD
ESK-001 10mg tablet once a day
|
ESK-001 20mg QD
ESK-001 20mg tablet once a day
|
ESK-001 40mg QD
ESK-001 40mg tablet once a day
|
ESK-001 20mg BID
ESK-001 20mg tablet twice a day
|
ESK-001 40mg BID
ESK-001 40mg tablet twice a day
|
Placebo
Placebo tablet
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
36
|
36
|
39
|
40
|
39
|
38
|
|
Overall Study
COMPLETED
|
36
|
30
|
33
|
37
|
35
|
33
|
|
Overall Study
NOT COMPLETED
|
0
|
6
|
6
|
3
|
4
|
5
|
Reasons for withdrawal
| Measure |
ESK-001 10mg QD
ESK-001 10mg tablet once a day
|
ESK-001 20mg QD
ESK-001 20mg tablet once a day
|
ESK-001 40mg QD
ESK-001 40mg tablet once a day
|
ESK-001 20mg BID
ESK-001 20mg tablet twice a day
|
ESK-001 40mg BID
ESK-001 40mg tablet twice a day
|
Placebo
Placebo tablet
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
1
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
1
|
1
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
2
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
2
|
0
|
3
|
5
|
|
Overall Study
Discontinued Prior to Dosing Due to the Blood Sample Logistics
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Subject Can't Continue With Week 16 Visit
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
The Patient was Terminated From The Study Due to Sponsor Requirements
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Plaque Psoriasis
Baseline characteristics by cohort
| Measure |
ESK-001 10mg QD
n=36 Participants
ESK-001 10mg tablet once a day
|
ESK-001 20mg QD
n=36 Participants
ESK-001 20mg tablet once a day
|
ESK-001 40mg QD
n=39 Participants
ESK-001 40mg tablet once a day
|
ESK-001 20mg BID
n=40 Participants
ESK-001 20mg tablet twice a day
|
ESK-001 40mg BID
n=39 Participants
ESK-001 40mg tablet twice a day
|
Placebo
n=38 Participants
Placebo tablet
|
Total
n=228 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
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
|
0 Participants
n=115 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
33 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
33 Participants
n=21 Participants
|
35 Participants
n=10 Participants
|
206 Participants
n=115 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
22 Participants
n=115 Participants
|
|
Age, Continuous
|
48.8 years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
43.9 years
STANDARD_DEVIATION 11.99 • n=7 Participants
|
49.5 years
STANDARD_DEVIATION 10.45 • n=5 Participants
|
47.7 years
STANDARD_DEVIATION 12.52 • n=4 Participants
|
47.9 years
STANDARD_DEVIATION 14.17 • n=21 Participants
|
49.1 years
STANDARD_DEVIATION 11.67 • n=10 Participants
|
47.8 years
STANDARD_DEVIATION 12.3 • n=115 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
74 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
31 Participants
n=10 Participants
|
154 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
13 Participants
n=10 Participants
|
65 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
24 Participants
n=10 Participants
|
161 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
13 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
10 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
White
|
30 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
33 Participants
n=21 Participants
|
27 Participants
n=10 Participants
|
188 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
10 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: All Randomized and Treated Participants
Proportion of patients with moderate to severe psoriasis achieving ≥75% reduction in PASI score
Outcome measures
| Measure |
ESK-001 10mg QD
n=36 Participants
ESK-001 10mg tablet once a day
|
ESK-001 20mg QD
n=36 Participants
ESK-001 20mg tablet once a day
|
ESK-001 40mg QD
n=39 Participants
ESK-001 40mg tablet once a day
|
ESK-001 20mg BID
n=39 Participants
ESK-001 20mg tablet twice a day
|
ESK-001 40mg BID
n=39 Participants
ESK-001 40mg tablet twice a day
|
Placebo
n=38 Participants
Placebo tablet
|
|---|---|---|---|---|---|---|
|
To Compare the Psoriasis Area and Severity Index (PASI-75) Between Doses of ESK-001 and Placebo
|
19.4 Percentage
Interval 8.2 to 36.0
|
33.3 Percentage
Interval 18.6 to 51.0
|
56.4 Percentage
Interval 39.6 to 72.2
|
56.4 Percentage
Interval 36.6 to 72.2
|
64.1 Percentage
Interval 47.2 to 78.8
|
0 Percentage
Interval 0.0 to 9.3
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Safety Analysis Set
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs). See Adverse Events section.
Outcome measures
| Measure |
ESK-001 10mg QD
n=36 Participants
ESK-001 10mg tablet once a day
|
ESK-001 20mg QD
n=36 Participants
ESK-001 20mg tablet once a day
|
ESK-001 40mg QD
n=39 Participants
ESK-001 40mg tablet once a day
|
ESK-001 20mg BID
n=39 Participants
ESK-001 20mg tablet twice a day
|
ESK-001 40mg BID
n=39 Participants
ESK-001 40mg tablet twice a day
|
Placebo
n=38 Participants
Placebo tablet
|
|---|---|---|---|---|---|---|
|
To Assess the Safety and Tolerability of ESK-001 Dose in Moderate to Severe Psoriasis Patients
|
19 Participants
|
14 Participants
|
19 Participants
|
18 Participants
|
25 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: mITT population
Proportion of patients achieving an sPGA score of "0" ("cleared") or "1" ("minimal")
Outcome measures
| Measure |
ESK-001 10mg QD
n=36 Participants
ESK-001 10mg tablet once a day
|
ESK-001 20mg QD
n=36 Participants
ESK-001 20mg tablet once a day
|
ESK-001 40mg QD
n=39 Participants
ESK-001 40mg tablet once a day
|
ESK-001 20mg BID
n=39 Participants
ESK-001 20mg tablet twice a day
|
ESK-001 40mg BID
n=39 Participants
ESK-001 40mg tablet twice a day
|
Placebo
n=38 Participants
Placebo tablet
|
|---|---|---|---|---|---|---|
|
To Assess the Response Rate in Static Physician's Global Assessment (sPGA) Score
|
6 Participants
|
14 Participants
|
21 Participants
|
19 Participants
|
23 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 14 weeksPopulation: PK Analysis Set
Plasma concentrations and PK parameters of ESK-001.
Outcome measures
| Measure |
ESK-001 10mg QD
n=36 Participants
ESK-001 10mg tablet once a day
|
ESK-001 20mg QD
n=36 Participants
ESK-001 20mg tablet once a day
|
ESK-001 40mg QD
n=39 Participants
ESK-001 40mg tablet once a day
|
ESK-001 20mg BID
n=39 Participants
ESK-001 20mg tablet twice a day
|
ESK-001 40mg BID
n=39 Participants
ESK-001 40mg tablet twice a day
|
Placebo
n=38 Participants
Placebo tablet
|
|---|---|---|---|---|---|---|
|
To Characterize the Pharmacokinetics (PK) of ESK-001
|
11.9 ng/ml
Standard Deviation 12.4
|
33.0 ng/ml
Standard Deviation 49.9
|
50.7 ng/ml
Standard Deviation 44.8
|
63.9 ng/ml
Standard Deviation 44.8
|
174.0 ng/ml
Standard Deviation 125.0
|
2.9 ng/ml
Standard Deviation 10.5
|
Adverse Events
ESK-001 10mg QD
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
ESK-001 20mg QD
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
ESK-001 40mg QD
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
ESK-001 20mg BID
Serious events: 3 serious events
Other events: 18 other events
Deaths: 0 deaths
ESK-001 40mg BID
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ESK-001 10mg QD
n=36 participants at risk
ESK-001 10mg tablet once a day
|
ESK-001 20mg QD
n=36 participants at risk
ESK-001 20mg tablet once a day
|
ESK-001 40mg QD
n=39 participants at risk
ESK-001 40mg tablet once a day
|
ESK-001 20mg BID
n=39 participants at risk
ESK-001 20mg tablet twice a day
|
ESK-001 40mg BID
n=39 participants at risk
ESK-001 40mg tablet twice a day
|
Placebo
n=38 participants at risk
Placebo tablet
|
|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
2.8%
1/36 • Adverse Event data was collected from Screening through end of study (Week 16).
|
0.00%
0/36 • Adverse Event data was collected from Screening through end of study (Week 16).
|
0.00%
0/39 • Adverse Event data was collected from Screening through end of study (Week 16).
|
0.00%
0/39 • Adverse Event data was collected from Screening through end of study (Week 16).
|
0.00%
0/39 • Adverse Event data was collected from Screening through end of study (Week 16).
|
0.00%
0/38 • Adverse Event data was collected from Screening through end of study (Week 16).
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/36 • Adverse Event data was collected from Screening through end of study (Week 16).
|
0.00%
0/36 • Adverse Event data was collected from Screening through end of study (Week 16).
|
0.00%
0/39 • Adverse Event data was collected from Screening through end of study (Week 16).
|
2.6%
1/39 • Adverse Event data was collected from Screening through end of study (Week 16).
|
0.00%
0/39 • Adverse Event data was collected from Screening through end of study (Week 16).
|
0.00%
0/38 • Adverse Event data was collected from Screening through end of study (Week 16).
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/36 • Adverse Event data was collected from Screening through end of study (Week 16).
|
0.00%
0/36 • Adverse Event data was collected from Screening through end of study (Week 16).
|
0.00%
0/39 • Adverse Event data was collected from Screening through end of study (Week 16).
|
2.6%
1/39 • Adverse Event data was collected from Screening through end of study (Week 16).
|
0.00%
0/39 • Adverse Event data was collected from Screening through end of study (Week 16).
|
0.00%
0/38 • Adverse Event data was collected from Screening through end of study (Week 16).
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/36 • Adverse Event data was collected from Screening through end of study (Week 16).
|
0.00%
0/36 • Adverse Event data was collected from Screening through end of study (Week 16).
|
0.00%
0/39 • Adverse Event data was collected from Screening through end of study (Week 16).
|
2.6%
1/39 • Adverse Event data was collected from Screening through end of study (Week 16).
|
0.00%
0/39 • Adverse Event data was collected from Screening through end of study (Week 16).
|
0.00%
0/38 • Adverse Event data was collected from Screening through end of study (Week 16).
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/36 • Adverse Event data was collected from Screening through end of study (Week 16).
|
0.00%
0/36 • Adverse Event data was collected from Screening through end of study (Week 16).
|
0.00%
0/39 • Adverse Event data was collected from Screening through end of study (Week 16).
|
2.6%
1/39 • Adverse Event data was collected from Screening through end of study (Week 16).
|
0.00%
0/39 • Adverse Event data was collected from Screening through end of study (Week 16).
|
0.00%
0/38 • Adverse Event data was collected from Screening through end of study (Week 16).
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/36 • Adverse Event data was collected from Screening through end of study (Week 16).
|
0.00%
0/36 • Adverse Event data was collected from Screening through end of study (Week 16).
|
2.6%
1/39 • Adverse Event data was collected from Screening through end of study (Week 16).
|
0.00%
0/39 • Adverse Event data was collected from Screening through end of study (Week 16).
|
0.00%
0/39 • Adverse Event data was collected from Screening through end of study (Week 16).
|
0.00%
0/38 • Adverse Event data was collected from Screening through end of study (Week 16).
|
Other adverse events
| Measure |
ESK-001 10mg QD
n=36 participants at risk
ESK-001 10mg tablet once a day
|
ESK-001 20mg QD
n=36 participants at risk
ESK-001 20mg tablet once a day
|
ESK-001 40mg QD
n=39 participants at risk
ESK-001 40mg tablet once a day
|
ESK-001 20mg BID
n=39 participants at risk
ESK-001 20mg tablet twice a day
|
ESK-001 40mg BID
n=39 participants at risk
ESK-001 40mg tablet twice a day
|
Placebo
n=38 participants at risk
Placebo tablet
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
5.6%
2/36 • Adverse Event data was collected from Screening through end of study (Week 16).
|
5.6%
2/36 • Adverse Event data was collected from Screening through end of study (Week 16).
|
5.1%
2/39 • Adverse Event data was collected from Screening through end of study (Week 16).
|
2.6%
1/39 • Adverse Event data was collected from Screening through end of study (Week 16).
|
7.7%
3/39 • Adverse Event data was collected from Screening through end of study (Week 16).
|
0.00%
0/38 • Adverse Event data was collected from Screening through end of study (Week 16).
|
|
Infections and infestations
Nasopharyngitis
|
5.6%
2/36 • Adverse Event data was collected from Screening through end of study (Week 16).
|
0.00%
0/36 • Adverse Event data was collected from Screening through end of study (Week 16).
|
2.6%
1/39 • Adverse Event data was collected from Screening through end of study (Week 16).
|
2.6%
1/39 • Adverse Event data was collected from Screening through end of study (Week 16).
|
7.7%
3/39 • Adverse Event data was collected from Screening through end of study (Week 16).
|
7.9%
3/38 • Adverse Event data was collected from Screening through end of study (Week 16).
|
|
Infections and infestations
COVID-19
|
0.00%
0/36 • Adverse Event data was collected from Screening through end of study (Week 16).
|
0.00%
0/36 • Adverse Event data was collected from Screening through end of study (Week 16).
|
0.00%
0/39 • Adverse Event data was collected from Screening through end of study (Week 16).
|
2.6%
1/39 • Adverse Event data was collected from Screening through end of study (Week 16).
|
2.6%
1/39 • Adverse Event data was collected from Screening through end of study (Week 16).
|
7.9%
3/38 • Adverse Event data was collected from Screening through end of study (Week 16).
|
|
Nervous system disorders
Headache
|
0.00%
0/36 • Adverse Event data was collected from Screening through end of study (Week 16).
|
5.6%
2/36 • Adverse Event data was collected from Screening through end of study (Week 16).
|
10.3%
4/39 • Adverse Event data was collected from Screening through end of study (Week 16).
|
7.7%
3/39 • Adverse Event data was collected from Screening through end of study (Week 16).
|
7.7%
3/39 • Adverse Event data was collected from Screening through end of study (Week 16).
|
5.3%
2/38 • Adverse Event data was collected from Screening through end of study (Week 16).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/36 • Adverse Event data was collected from Screening through end of study (Week 16).
|
0.00%
0/36 • Adverse Event data was collected from Screening through end of study (Week 16).
|
2.6%
1/39 • Adverse Event data was collected from Screening through end of study (Week 16).
|
5.1%
2/39 • Adverse Event data was collected from Screening through end of study (Week 16).
|
0.00%
0/39 • Adverse Event data was collected from Screening through end of study (Week 16).
|
0.00%
0/38 • Adverse Event data was collected from Screening through end of study (Week 16).
|
|
Gastrointestinal disorders
Diarrhea
|
2.8%
1/36 • Adverse Event data was collected from Screening through end of study (Week 16).
|
0.00%
0/36 • Adverse Event data was collected from Screening through end of study (Week 16).
|
2.6%
1/39 • Adverse Event data was collected from Screening through end of study (Week 16).
|
5.1%
2/39 • Adverse Event data was collected from Screening through end of study (Week 16).
|
0.00%
0/39 • Adverse Event data was collected from Screening through end of study (Week 16).
|
0.00%
0/38 • Adverse Event data was collected from Screening through end of study (Week 16).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/36 • Adverse Event data was collected from Screening through end of study (Week 16).
|
0.00%
0/36 • Adverse Event data was collected from Screening through end of study (Week 16).
|
0.00%
0/39 • Adverse Event data was collected from Screening through end of study (Week 16).
|
5.1%
2/39 • Adverse Event data was collected from Screening through end of study (Week 16).
|
0.00%
0/39 • Adverse Event data was collected from Screening through end of study (Week 16).
|
0.00%
0/38 • Adverse Event data was collected from Screening through end of study (Week 16).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/36 • Adverse Event data was collected from Screening through end of study (Week 16).
|
0.00%
0/36 • Adverse Event data was collected from Screening through end of study (Week 16).
|
0.00%
0/39 • Adverse Event data was collected from Screening through end of study (Week 16).
|
5.1%
2/39 • Adverse Event data was collected from Screening through end of study (Week 16).
|
0.00%
0/39 • Adverse Event data was collected from Screening through end of study (Week 16).
|
2.6%
1/38 • Adverse Event data was collected from Screening through end of study (Week 16).
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/36 • Adverse Event data was collected from Screening through end of study (Week 16).
|
0.00%
0/36 • Adverse Event data was collected from Screening through end of study (Week 16).
|
5.1%
2/39 • Adverse Event data was collected from Screening through end of study (Week 16).
|
0.00%
0/39 • Adverse Event data was collected from Screening through end of study (Week 16).
|
5.1%
2/39 • Adverse Event data was collected from Screening through end of study (Week 16).
|
0.00%
0/38 • Adverse Event data was collected from Screening through end of study (Week 16).
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
2.8%
1/36 • Adverse Event data was collected from Screening through end of study (Week 16).
|
0.00%
0/36 • Adverse Event data was collected from Screening through end of study (Week 16).
|
0.00%
0/39 • Adverse Event data was collected from Screening through end of study (Week 16).
|
0.00%
0/39 • Adverse Event data was collected from Screening through end of study (Week 16).
|
5.1%
2/39 • Adverse Event data was collected from Screening through end of study (Week 16).
|
0.00%
0/38 • Adverse Event data was collected from Screening through end of study (Week 16).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/36 • Adverse Event data was collected from Screening through end of study (Week 16).
|
0.00%
0/36 • Adverse Event data was collected from Screening through end of study (Week 16).
|
0.00%
0/39 • Adverse Event data was collected from Screening through end of study (Week 16).
|
5.1%
2/39 • Adverse Event data was collected from Screening through end of study (Week 16).
|
5.1%
2/39 • Adverse Event data was collected from Screening through end of study (Week 16).
|
0.00%
0/38 • Adverse Event data was collected from Screening through end of study (Week 16).
|
|
General disorders
Pyrexia
|
0.00%
0/36 • Adverse Event data was collected from Screening through end of study (Week 16).
|
0.00%
0/36 • Adverse Event data was collected from Screening through end of study (Week 16).
|
0.00%
0/39 • Adverse Event data was collected from Screening through end of study (Week 16).
|
2.6%
1/39 • Adverse Event data was collected from Screening through end of study (Week 16).
|
5.1%
2/39 • Adverse Event data was collected from Screening through end of study (Week 16).
|
0.00%
0/38 • Adverse Event data was collected from Screening through end of study (Week 16).
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
5.6%
2/36 • Adverse Event data was collected from Screening through end of study (Week 16).
|
0.00%
0/36 • Adverse Event data was collected from Screening through end of study (Week 16).
|
0.00%
0/39 • Adverse Event data was collected from Screening through end of study (Week 16).
|
2.6%
1/39 • Adverse Event data was collected from Screening through end of study (Week 16).
|
0.00%
0/39 • Adverse Event data was collected from Screening through end of study (Week 16).
|
0.00%
0/38 • Adverse Event data was collected from Screening through end of study (Week 16).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Investigator may publish after the earlier of: publication of the final multicenter publication or 24 months after completion of the Study. Investigator will provide to Sponsor a copy of any publication at least 60 days prior to submission. Sponsor may delete any confidential or proprietary information of Sponsor from the publication. Investigator will delay any publication an additional 90 days if requested to enable Sponsor to secure patent protection.
- Publication restrictions are in place
Restriction type: OTHER