Trial Outcomes & Findings for Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of EP262 in Subjects With Chronic Spontaneous Urticaria (NCT NCT06077773)
NCT ID: NCT06077773
Last Updated: 2025-12-19
Results Overview
The UAS is a chronic spontaneous urticaria (CSU)-specific, 24-hour self-evaluation, patient-reported outcome measure based on the assessment of key CSU symptoms: intensity of itch (assessed as the Itch Severity Score \[ISS\]) and number of wheals (assessed as the Hive Severity Score \[HSS\]). The UAS scales for both itch and wheal assessment are recorded as a score from 0 to 3, with 0 representing no itch/hives to 3 representing intense itch/hives. ISS and HSS scores are summed over 7 consecutive days to create the ISS7 and HSS7 scores, which range from 0 to 21. Higher scores indicate greater disease severity. The UAS score is the sum of the ISS and HSS scores. Daily UAS scores are summed over 7 consecutive days to create the UAS7 score, which ranges from 0 to 42. Higher scores indicate greater disease severity. The 7 daily UAS/ISS/HSS scores prior to or on the nominal Visit 4 (Week 6) date (including the nominal Week 6 visit date UAS/ISS/HSS score) were summed.
TERMINATED
PHASE2
113 participants
Baseline; Week 6
2025-12-19
Participant Flow
This study was conducted at 33 study sites in the United States, Germany, Canada, Poland, Spain, and the Netherlands. The study was terminated following the completion of Part 1 due to business reasons; Part 2 was not enrolled.
Participant milestones
| Measure |
Placebo
Participants received matching placebo once daily for 6 weeks.
|
EP262 50 mg
Participants received oral EP262 50 milligrams (mg) once daily for 6 weeks.
|
EP262 150 mg
Participants received oral EP262 150 mg once daily for 6 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
38
|
37
|
38
|
|
Overall Study
COMPLETED
|
37
|
36
|
35
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
3
|
Reasons for withdrawal
| Measure |
Placebo
Participants received matching placebo once daily for 6 weeks.
|
EP262 50 mg
Participants received oral EP262 50 milligrams (mg) once daily for 6 weeks.
|
EP262 150 mg
Participants received oral EP262 150 mg once daily for 6 weeks.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
2
|
Baseline Characteristics
Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of EP262 in Subjects With Chronic Spontaneous Urticaria
Baseline characteristics by cohort
| Measure |
Placebo
n=38 Participants
Participants received matching placebo once daily for 6 weeks.
|
EP262 50 mg
n=37 Participants
Participants received oral EP262 50 milligrams (mg) once daily for 6 weeks.
|
EP262 150 mg
n=38 Participants
Participants received oral EP262 150 mg once daily for 6 weeks.
|
Total
n=113 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
44.8 years
STANDARD_DEVIATION 16.1 • n=8 Participants
|
43.6 years
STANDARD_DEVIATION 14.2 • n=6 Participants
|
45.4 years
STANDARD_DEVIATION 14.6 • n=6 Participants
|
44.6 years
STANDARD_DEVIATION 14.9 • n=9 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=8 Participants
|
31 Participants
n=6 Participants
|
34 Participants
n=6 Participants
|
98 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=8 Participants
|
6 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
15 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=8 Participants
|
6 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
16 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=8 Participants
|
31 Participants
n=6 Participants
|
33 Participants
n=6 Participants
|
97 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
White
|
32 Participants
n=8 Participants
|
25 Participants
n=6 Participants
|
25 Participants
n=6 Participants
|
82 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 Participants
n=8 Participants
|
9 Participants
n=6 Participants
|
8 Participants
n=6 Participants
|
21 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=8 Participants
|
1 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
5 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Brazilian
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
0 Participants
n=8 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native/Black or African American/White
|
1 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native/White
|
1 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Middle Eastern
|
0 Participants
n=8 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
|
Urticaria Activity Score over a 7-day period
|
29.52 scores on a scale
STANDARD_DEVIATION 8.081 • n=8 Participants
|
25.88 scores on a scale
STANDARD_DEVIATION 7.129 • n=6 Participants
|
25.95 scores on a scale
STANDARD_DEVIATION 8.399 • n=6 Participants
|
27.13 scores on a scale
STANDARD_DEVIATION 8.009 • n=9 Participants
|
PRIMARY outcome
Timeframe: Baseline; Week 6Population: Full Analysis Set: all randomized participants who took ≥1 dose of randomized study drug. Participants were analyzed according to randomized treatment assignment. Only participants with available data were analyzed. Mixed model for repeated measures (MMRM) included fixed effects for treatment group, week, treatment group by week interaction, prior omalizumab use, and the Baseline score as a covariate. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
The UAS is a chronic spontaneous urticaria (CSU)-specific, 24-hour self-evaluation, patient-reported outcome measure based on the assessment of key CSU symptoms: intensity of itch (assessed as the Itch Severity Score \[ISS\]) and number of wheals (assessed as the Hive Severity Score \[HSS\]). The UAS scales for both itch and wheal assessment are recorded as a score from 0 to 3, with 0 representing no itch/hives to 3 representing intense itch/hives. ISS and HSS scores are summed over 7 consecutive days to create the ISS7 and HSS7 scores, which range from 0 to 21. Higher scores indicate greater disease severity. The UAS score is the sum of the ISS and HSS scores. Daily UAS scores are summed over 7 consecutive days to create the UAS7 score, which ranges from 0 to 42. Higher scores indicate greater disease severity. The 7 daily UAS/ISS/HSS scores prior to or on the nominal Visit 4 (Week 6) date (including the nominal Week 6 visit date UAS/ISS/HSS score) were summed.
Outcome measures
| Measure |
Placebo
n=35 Participants
Participants received matching placebo once daily for 6 weeks.
|
EP262 50 mg
n=36 Participants
Participants received oral EP262 50 milligrams (mg) once daily for 6 weeks.
|
EP262 150 mg
n=34 Participants
Participants received oral EP262 150 mg once daily for 6 weeks.
|
|---|---|---|---|
|
Change From Baseline to Visit 4 (Week 6) in the Urticaria Activity Score Over a 7-day Period (UAS7)
|
-10.41 scores on a scale
Standard Error 1.863
|
-8.43 scores on a scale
Standard Error 1.844
|
-11.95 scores on a scale
Standard Error 1.827
|
SECONDARY outcome
Timeframe: up to 81 daysPopulation: Safety Analysis Set: all participants who were randomized and took at least 1 dose of randomized study drug. Safety analyses were based upon treatment actually received.
An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore have been any unfavorable or unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product. Medical conditions present at baseline that worsened in severity or frequency after exposure to study drug were considered TEAEs. A TEAE was any condition that was not present prior to treatment with the study drug but appeared following treatment, was present at treatment initiation but worsened during treatment, or was present at treatment initiation but resolved and then reappeared while the individual was on treatment (regardless of the intensity of the AE when the treatment was initiated).
Outcome measures
| Measure |
Placebo
n=38 Participants
Participants received matching placebo once daily for 6 weeks.
|
EP262 50 mg
n=37 Participants
Participants received oral EP262 50 milligrams (mg) once daily for 6 weeks.
|
EP262 150 mg
n=38 Participants
Participants received oral EP262 150 mg once daily for 6 weeks.
|
|---|---|---|---|
|
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
|
12 Participants
|
15 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: up to 81 daysPopulation: Safety Analysis Set
An AE was any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore have been any unfavorable or unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product. Medical conditions present at baseline that worsened in severity or frequency after exposure to study drug were considered TEAEs. TEAEs were graded for severity (i.e., intensity) using Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. Grade 1: mild; asymptomatic or mild symptoms; intervention not indicated. Grade 2: moderate; minimal, local or noninvasive intervention indicated. Grade 3: severe or medically significant, but not immediately life-threatening. Grade 4: life-threatening consequences; urgent intervention indicated. Grade 5: death related to TEAE.
Outcome measures
| Measure |
Placebo
n=38 Participants
Participants received matching placebo once daily for 6 weeks.
|
EP262 50 mg
n=37 Participants
Participants received oral EP262 50 milligrams (mg) once daily for 6 weeks.
|
EP262 150 mg
n=38 Participants
Participants received oral EP262 150 mg once daily for 6 weeks.
|
|---|---|---|---|
|
Number of Participants With Any ≥Grade 3 TEAE
|
1 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: up to 81 daysPopulation: Safety Analysis Set
Clinically meaningful changes were determined by the investigator.
Outcome measures
| Measure |
Placebo
n=38 Participants
Participants received matching placebo once daily for 6 weeks.
|
EP262 50 mg
n=37 Participants
Participants received oral EP262 50 milligrams (mg) once daily for 6 weeks.
|
EP262 150 mg
n=38 Participants
Participants received oral EP262 150 mg once daily for 6 weeks.
|
|---|---|---|---|
|
Number of Participants With Any Clinically Meaningful Change From Baseline in Electrocardiogram Parameters
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: up to 81 daysPopulation: Safety Analysis Set
Clinically meaningful changes were determined by the investigator.
Outcome measures
| Measure |
Placebo
n=38 Participants
Participants received matching placebo once daily for 6 weeks.
|
EP262 50 mg
n=37 Participants
Participants received oral EP262 50 milligrams (mg) once daily for 6 weeks.
|
EP262 150 mg
n=38 Participants
Participants received oral EP262 150 mg once daily for 6 weeks.
|
|---|---|---|---|
|
Number of Participants With Any Clinically Meaningful Change From Baseline in Vital Sign Measurements
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: up to 81 daysPopulation: Safety Analysis Set
Clinically meaningful changes were determined by the investigator.
Outcome measures
| Measure |
Placebo
n=38 Participants
Participants received matching placebo once daily for 6 weeks.
|
EP262 50 mg
n=37 Participants
Participants received oral EP262 50 milligrams (mg) once daily for 6 weeks.
|
EP262 150 mg
n=38 Participants
Participants received oral EP262 150 mg once daily for 6 weeks.
|
|---|---|---|---|
|
Number of Participants With Any Clinically Meaningful Change From Baseline in Clinical Laboratory Test Results
|
4 Participants
|
4 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Baseline; Week 6Population: Full Analysis Set. Only participants with available data were analyzed.
The ISS is part of the UAS, a CSU-specific, 24-hour self-evaluation, patient-reported outcome measure based on the assessment of key CSU symptoms: intensity of itch (assessed as the ISS) and number of wheals (assessed as the HSS). The UAS scale for itch is recorded as a score from 0 to 3, with 0 representing no itch to 3 representing intense itch. ISS scores are summed over 7 consecutive days to create the ISS7 score, which ranges from 0 to 21. Higher scores indicate greater disease severity. The 7 daily ISS scores prior to or on the nominal Visit 4 (Week 6) date (including the nominal Week 6 visit date ISS score) were summed. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Outcome measures
| Measure |
Placebo
n=38 Participants
Participants received matching placebo once daily for 6 weeks.
|
EP262 50 mg
n=37 Participants
Participants received oral EP262 50 milligrams (mg) once daily for 6 weeks.
|
EP262 150 mg
n=38 Participants
Participants received oral EP262 150 mg once daily for 6 weeks.
|
|---|---|---|---|
|
Change From Baseline to Visit 4 (Week 6) in the Itch Severity Score Over a 7-day Period (ISS7)
Baseline
|
15.57 scores on a scale
Standard Deviation 3.918
|
13.55 scores on a scale
Standard Deviation 3.483
|
13.91 scores on a scale
Standard Deviation 4.016
|
|
Change From Baseline to Visit 4 (Week 6) in the Itch Severity Score Over a 7-day Period (ISS7)
Change from Baseline at Week 6
|
-7.12 scores on a scale
Standard Deviation 6.058
|
-4.89 scores on a scale
Standard Deviation 5.895
|
-7.19 scores on a scale
Standard Deviation 5.631
|
SECONDARY outcome
Timeframe: Baseline; Week 6Population: Full Analysis Set. Only participants with available data were analyzed.
The HSS is part of the UAS, a CSU-specific, 24-hour self-evaluation, patient-reported outcome measure based on the assessment of key CSU symptoms: intensity of itch (assessed as the ISS) and number of wheals (assessed as the HSS). The UAS scale for wheal assessment is recorded as a score from 0 to 3, with 0 representing no hives to 3 representing intense hives. HSS scores are summed over 7 consecutive days to create the HSS7 score, which ranges from 0 to 21. Higher scores indicate greater disease severity. The 7 daily HSS scores prior to or on the nominal Visit 4 (Week 6) date (including the nominal Week 6 visit date HSS score) were summed. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Outcome measures
| Measure |
Placebo
n=38 Participants
Participants received matching placebo once daily for 6 weeks.
|
EP262 50 mg
n=37 Participants
Participants received oral EP262 50 milligrams (mg) once daily for 6 weeks.
|
EP262 150 mg
n=38 Participants
Participants received oral EP262 150 mg once daily for 6 weeks.
|
|---|---|---|---|
|
Change From Baseline to Visit 4 (Week 6) in the Hive Severity Score Over a 7-day Period (HSS7)
Baseline
|
13.95 scores on a scale
Standard Deviation 4.620
|
12.33 scores on a scale
Standard Deviation 4.331
|
12.04 scores on a scale
Standard Deviation 5.295
|
|
Change From Baseline to Visit 4 (Week 6) in the Hive Severity Score Over a 7-day Period (HSS7)
Change from Baseline at Week 6
|
-5.71 scores on a scale
Standard Deviation 5.355
|
-4.45 scores on a scale
Standard Deviation 5.584
|
-5.66 scores on a scale
Standard Deviation 4.998
|
Adverse Events
Placebo
EP262 Pooled
EP262 50 mg
EP262 150 mg
Total
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=38 participants at risk
Participants received matching placebo once daily for 6 weeks.
|
EP262 Pooled
n=75 participants at risk
Participants received oral EP262 50 milligrams (mg) or 150 mg once daily for 6 weeks.
|
EP262 50 mg
n=37 participants at risk
Participants received oral EP262 50 mg once daily for 6 weeks.
|
EP262 150 mg
n=38 participants at risk
Participants received oral EP262 150 mg once daily for 6 weeks.
|
Total
n=113 participants at risk
Total
|
|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
5.3%
2/38 • Number of events 3 • up to 81 days
Adverse events have been reported for the Safety Analysis Set, comprised of all participants who were randomized and took at least 1 dose of randomized study drug.
|
4.0%
3/75 • Number of events 3 • up to 81 days
Adverse events have been reported for the Safety Analysis Set, comprised of all participants who were randomized and took at least 1 dose of randomized study drug.
|
5.4%
2/37 • Number of events 2 • up to 81 days
Adverse events have been reported for the Safety Analysis Set, comprised of all participants who were randomized and took at least 1 dose of randomized study drug.
|
2.6%
1/38 • Number of events 1 • up to 81 days
Adverse events have been reported for the Safety Analysis Set, comprised of all participants who were randomized and took at least 1 dose of randomized study drug.
|
4.4%
5/113 • Number of events 6 • up to 81 days
Adverse events have been reported for the Safety Analysis Set, comprised of all participants who were randomized and took at least 1 dose of randomized study drug.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/38 • up to 81 days
Adverse events have been reported for the Safety Analysis Set, comprised of all participants who were randomized and took at least 1 dose of randomized study drug.
|
2.7%
2/75 • Number of events 2 • up to 81 days
Adverse events have been reported for the Safety Analysis Set, comprised of all participants who were randomized and took at least 1 dose of randomized study drug.
|
0.00%
0/37 • up to 81 days
Adverse events have been reported for the Safety Analysis Set, comprised of all participants who were randomized and took at least 1 dose of randomized study drug.
|
5.3%
2/38 • Number of events 2 • up to 81 days
Adverse events have been reported for the Safety Analysis Set, comprised of all participants who were randomized and took at least 1 dose of randomized study drug.
|
1.8%
2/113 • Number of events 2 • up to 81 days
Adverse events have been reported for the Safety Analysis Set, comprised of all participants who were randomized and took at least 1 dose of randomized study drug.
|
|
Investigations
Blood creatine phosphokinase increased
|
7.9%
3/38 • Number of events 3 • up to 81 days
Adverse events have been reported for the Safety Analysis Set, comprised of all participants who were randomized and took at least 1 dose of randomized study drug.
|
2.7%
2/75 • Number of events 2 • up to 81 days
Adverse events have been reported for the Safety Analysis Set, comprised of all participants who were randomized and took at least 1 dose of randomized study drug.
|
5.4%
2/37 • Number of events 2 • up to 81 days
Adverse events have been reported for the Safety Analysis Set, comprised of all participants who were randomized and took at least 1 dose of randomized study drug.
|
0.00%
0/38 • up to 81 days
Adverse events have been reported for the Safety Analysis Set, comprised of all participants who were randomized and took at least 1 dose of randomized study drug.
|
4.4%
5/113 • Number of events 5 • up to 81 days
Adverse events have been reported for the Safety Analysis Set, comprised of all participants who were randomized and took at least 1 dose of randomized study drug.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/38 • up to 81 days
Adverse events have been reported for the Safety Analysis Set, comprised of all participants who were randomized and took at least 1 dose of randomized study drug.
|
4.0%
3/75 • Number of events 3 • up to 81 days
Adverse events have been reported for the Safety Analysis Set, comprised of all participants who were randomized and took at least 1 dose of randomized study drug.
|
2.7%
1/37 • Number of events 1 • up to 81 days
Adverse events have been reported for the Safety Analysis Set, comprised of all participants who were randomized and took at least 1 dose of randomized study drug.
|
5.3%
2/38 • Number of events 2 • up to 81 days
Adverse events have been reported for the Safety Analysis Set, comprised of all participants who were randomized and took at least 1 dose of randomized study drug.
|
2.7%
3/113 • Number of events 3 • up to 81 days
Adverse events have been reported for the Safety Analysis Set, comprised of all participants who were randomized and took at least 1 dose of randomized study drug.
|
|
Infections and infestations
Nasopharyngitis
|
2.6%
1/38 • Number of events 1 • up to 81 days
Adverse events have been reported for the Safety Analysis Set, comprised of all participants who were randomized and took at least 1 dose of randomized study drug.
|
4.0%
3/75 • Number of events 4 • up to 81 days
Adverse events have been reported for the Safety Analysis Set, comprised of all participants who were randomized and took at least 1 dose of randomized study drug.
|
2.7%
1/37 • Number of events 2 • up to 81 days
Adverse events have been reported for the Safety Analysis Set, comprised of all participants who were randomized and took at least 1 dose of randomized study drug.
|
5.3%
2/38 • Number of events 2 • up to 81 days
Adverse events have been reported for the Safety Analysis Set, comprised of all participants who were randomized and took at least 1 dose of randomized study drug.
|
3.5%
4/113 • Number of events 5 • up to 81 days
Adverse events have been reported for the Safety Analysis Set, comprised of all participants who were randomized and took at least 1 dose of randomized study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/38 • up to 81 days
Adverse events have been reported for the Safety Analysis Set, comprised of all participants who were randomized and took at least 1 dose of randomized study drug.
|
2.7%
2/75 • Number of events 2 • up to 81 days
Adverse events have been reported for the Safety Analysis Set, comprised of all participants who were randomized and took at least 1 dose of randomized study drug.
|
0.00%
0/37 • up to 81 days
Adverse events have been reported for the Safety Analysis Set, comprised of all participants who were randomized and took at least 1 dose of randomized study drug.
|
5.3%
2/38 • Number of events 2 • up to 81 days
Adverse events have been reported for the Safety Analysis Set, comprised of all participants who were randomized and took at least 1 dose of randomized study drug.
|
1.8%
2/113 • Number of events 2 • up to 81 days
Adverse events have been reported for the Safety Analysis Set, comprised of all participants who were randomized and took at least 1 dose of randomized study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/38 • up to 81 days
Adverse events have been reported for the Safety Analysis Set, comprised of all participants who were randomized and took at least 1 dose of randomized study drug.
|
2.7%
2/75 • Number of events 2 • up to 81 days
Adverse events have been reported for the Safety Analysis Set, comprised of all participants who were randomized and took at least 1 dose of randomized study drug.
|
5.4%
2/37 • Number of events 2 • up to 81 days
Adverse events have been reported for the Safety Analysis Set, comprised of all participants who were randomized and took at least 1 dose of randomized study drug.
|
0.00%
0/38 • up to 81 days
Adverse events have been reported for the Safety Analysis Set, comprised of all participants who were randomized and took at least 1 dose of randomized study drug.
|
1.8%
2/113 • Number of events 2 • up to 81 days
Adverse events have been reported for the Safety Analysis Set, comprised of all participants who were randomized and took at least 1 dose of randomized study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/38 • up to 81 days
Adverse events have been reported for the Safety Analysis Set, comprised of all participants who were randomized and took at least 1 dose of randomized study drug.
|
2.7%
2/75 • Number of events 3 • up to 81 days
Adverse events have been reported for the Safety Analysis Set, comprised of all participants who were randomized and took at least 1 dose of randomized study drug.
|
0.00%
0/37 • up to 81 days
Adverse events have been reported for the Safety Analysis Set, comprised of all participants who were randomized and took at least 1 dose of randomized study drug.
|
5.3%
2/38 • Number of events 3 • up to 81 days
Adverse events have been reported for the Safety Analysis Set, comprised of all participants who were randomized and took at least 1 dose of randomized study drug.
|
1.8%
2/113 • Number of events 3 • up to 81 days
Adverse events have been reported for the Safety Analysis Set, comprised of all participants who were randomized and took at least 1 dose of randomized study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER