Trial Outcomes & Findings for Study to Evaluate EP547 in Subjects With Cholestatic Pruritus Due to Primary Biliary Cholangitis or Primary Sclerosing Cholangitis (NCT NCT05525520)
NCT ID: NCT05525520
Last Updated: 2025-07-31
Results Overview
Participants were asked to rate the severity of their worst level of itching in the past 24 hours using the daily WI-NRS, an 11-point scale ranging from 0 (no itching) to 10 (worst itching imaginable). Itching severity scores collected via the WI-NRS have been categorized in the as mild (\<4), moderate (≥4 to \<7), or severe (≥7). The average WI-NRS score using the daily values from the week before the first dose of study drug (including the WI-NRS score captured on Study Day 1 of dosing) served as the Baseline score. A weekly score was determined based on the average of all available daily scores of the week. Change from Baseline was calculated as the post-Baseline score minus the Baseline score.
COMPLETED
PHASE2
62 participants
Baseline; up to Week 6
2025-07-31
Participant Flow
Participants were enrolled at 29 study sites across the United States, United Kingdom, France, Spain, Canada, Israel, Belgium, and the Netherlands.
Participant milestones
| Measure |
Placebo 100 mg QD; EP547 100 mg QD
Participants were randomized to receive oral placebo 100 mg QD for 6 weeks in the Double-Blind (DB) Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug switched to oral EP547 100 mg QD for 6 weeks in the Open-Label Extension Period.
|
EP547 100 mg QD; EP547 100 mg QD
Participants were randomized to receive oral EP547 100 milligrams (mg) once daily (QD) for 6 weeks in the Double-Blind Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug received oral EP547 100 mg QD for an additional 6 weeks in the Open-Label Extension Period.
|
|---|---|---|
|
DB Treatment Period (Weeks 1-6)
STARTED
|
30
|
32
|
|
DB Treatment Period (Weeks 1-6)
COMPLETED
|
29
|
29
|
|
DB Treatment Period (Weeks 1-6)
NOT COMPLETED
|
1
|
3
|
|
Open-label Extension Period (Weeks 7-12)
STARTED
|
29
|
29
|
|
Open-label Extension Period (Weeks 7-12)
COMPLETED
|
29
|
29
|
|
Open-label Extension Period (Weeks 7-12)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Placebo 100 mg QD; EP547 100 mg QD
Participants were randomized to receive oral placebo 100 mg QD for 6 weeks in the Double-Blind (DB) Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug switched to oral EP547 100 mg QD for 6 weeks in the Open-Label Extension Period.
|
EP547 100 mg QD; EP547 100 mg QD
Participants were randomized to receive oral EP547 100 milligrams (mg) once daily (QD) for 6 weeks in the Double-Blind Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug received oral EP547 100 mg QD for an additional 6 weeks in the Open-Label Extension Period.
|
|---|---|---|
|
DB Treatment Period (Weeks 1-6)
Withdrawal by Subject
|
0
|
2
|
|
DB Treatment Period (Weeks 1-6)
Protocol Violation
|
1
|
1
|
Baseline Characteristics
Study to Evaluate EP547 in Subjects With Cholestatic Pruritus Due to Primary Biliary Cholangitis or Primary Sclerosing Cholangitis
Baseline characteristics by cohort
| Measure |
Placebo 100 mg QD; EP547 100 mg QD
n=30 Participants
Participants were randomized to receive oral placebo 100 mg QD for 6 weeks in the Double-Blind (DB) Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug switched to oral EP547 100 mg QD for 6 weeks in the Open-Label Extension Period.
|
EP547 100 mg QD; EP547 100 mg QD
n=31 Participants
Participants were randomized to receive oral EP547 100 milligrams (mg) once daily (QD) for 6 weeks in the Double-Blind Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug received oral EP547 100 mg QD for an additional 6 weeks in the Open-Label Extension Period.
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.6 years
STANDARD_DEVIATION 12.99 • n=5 Participants
|
51.6 years
STANDARD_DEVIATION 12.88 • n=7 Participants
|
51.1 years
STANDARD_DEVIATION 12.83 • n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
26 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian/White
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native/White
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
North African (Morocco)
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline; up to Week 6Population: Full Analysis Set: all participants who were randomized and took at least 1 dose of randomized study drug. Participants were analyzed according to randomized treatment assignment. Only participants with available data were analyzed. MMRM=mixed effects model for repeated measures.
Participants were asked to rate the severity of their worst level of itching in the past 24 hours using the daily WI-NRS, an 11-point scale ranging from 0 (no itching) to 10 (worst itching imaginable). Itching severity scores collected via the WI-NRS have been categorized in the as mild (\<4), moderate (≥4 to \<7), or severe (≥7). The average WI-NRS score using the daily values from the week before the first dose of study drug (including the WI-NRS score captured on Study Day 1 of dosing) served as the Baseline score. A weekly score was determined based on the average of all available daily scores of the week. Change from Baseline was calculated as the post-Baseline score minus the Baseline score.
Outcome measures
| Measure |
Placebo 100 mg QD; EP547 100 mg QD
n=27 Participants
Participants were randomized to receive oral placebo 100 mg QD for 6 weeks in the Double-Blind (DB) Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug switched to oral EP547 100 mg QD for 6 weeks in the Open-Label Extension Period.
|
EP547 100 mg QD; EP547 100 mg QD
n=30 Participants
Participants were randomized to receive oral EP547 100 milligrams (mg) once daily (QD) for 6 weeks in the Double-Blind Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug received oral EP547 100 mg QD for an additional 6 weeks in the Open-Label Extension Period.
|
|---|---|---|
|
Change From Baseline in the Worst Itch Numeric Rating Scale (WI-NRS) Score up to Week 6
|
-2.20 scores on a scale
Standard Error 0.445
|
-1.75 scores on a scale
Standard Error 0.430
|
SECONDARY outcome
Timeframe: Baseline; Week 6Population: Full Analysis Set. Only participants with available data were analyzed. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
The 5-D Itch Scale is a multidimensional (degree, duration, direction, disability, and distribution) questionnaire measuring changes in pruritis. The duration, degree, and direction domain scores range from 1 (no pruritus) to 5 (most severe pruritus). The disability domain includes 4 items assessing itching impact on daily activities: sleep, leisure/social activities, housework/errands, and work/school. Disability domain score=highest score on any of the 4 categories (1 \[no pruritis\] to 5 \[most severe pruritis\]). For the distribution domain, 16 body parts are listed to determine the distribution of itching over the last 2 weeks; the number of affected body parts is tallied (potential sum=0-16); the sum is sorted into 5 thresholds: 0-2 is assigned a score of 1; 3-5, a score of 2; 6-10, a score of 3; 11-13, a score of 4; 14-16, a score of 5. Higher scores indicate more severe pruritis. The 5 domain scores are summed to get a total 5-D score: 5 (no pruritus) to 25 (most severe pruritus).
Outcome measures
| Measure |
Placebo 100 mg QD; EP547 100 mg QD
n=27 Participants
Participants were randomized to receive oral placebo 100 mg QD for 6 weeks in the Double-Blind (DB) Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug switched to oral EP547 100 mg QD for 6 weeks in the Open-Label Extension Period.
|
EP547 100 mg QD; EP547 100 mg QD
n=25 Participants
Participants were randomized to receive oral EP547 100 milligrams (mg) once daily (QD) for 6 weeks in the Double-Blind Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug received oral EP547 100 mg QD for an additional 6 weeks in the Open-Label Extension Period.
|
|---|---|---|
|
Change From Baseline in the 5-D Itch Scale Total Score at Week 6
|
-3.7 scores on a scale
Standard Error 0.78
|
-3.8 scores on a scale
Standard Error 0.82
|
SECONDARY outcome
Timeframe: Baseline; Week 6Population: Full Analysis Set. Only participants with available data were analyzed. Exact binomial (Clopper-Pearson) confidence intervals have been reported.
Participants were asked to rate their impression of overall change in pruritus in the past 7 days compared to before they started taking study drug using the PGI-C, a 7-point scale ranging from "much improved" to "much worse," with higher scores indicating less improvement in pruritus. Participants that reported a change in their itch of "minimally improved" or better were considered to be responders in terms of "improvement in pruritus."
Outcome measures
| Measure |
Placebo 100 mg QD; EP547 100 mg QD
n=27 Participants
Participants were randomized to receive oral placebo 100 mg QD for 6 weeks in the Double-Blind (DB) Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug switched to oral EP547 100 mg QD for 6 weeks in the Open-Label Extension Period.
|
EP547 100 mg QD; EP547 100 mg QD
n=28 Participants
Participants were randomized to receive oral EP547 100 milligrams (mg) once daily (QD) for 6 weeks in the Double-Blind Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug received oral EP547 100 mg QD for an additional 6 weeks in the Open-Label Extension Period.
|
|---|---|---|
|
Percentage of Participants With Improvement in Pruritus as Defined by Patient Global Impression of Change (PGI-C) at Week 6
|
55.6 percentage of participants
Interval 35.3 to 74.5
|
60.7 percentage of participants
Interval 40.6 to 78.5
|
SECONDARY outcome
Timeframe: Baseline; Week 6Population: Full Analysis Set. Only participants with available data were analyzed. Exact binomial (Clopper-Pearson) confidence intervals have been reported.
Participants were asked to rate the severity of their pruritus in the past 7 days using the PGI-S, a 4-point scale ranging from "none" to "severe." Participants that reported a positive shift in their categorical assessment of itch compared to their Baseline level (e.g., "severe" at Visit 2 \[Day 1\] with a shift to "moderate" at Visit 6 \[Week 6\]) were considered to be responders in terms of "improvement in pruritus."
Outcome measures
| Measure |
Placebo 100 mg QD; EP547 100 mg QD
n=27 Participants
Participants were randomized to receive oral placebo 100 mg QD for 6 weeks in the Double-Blind (DB) Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug switched to oral EP547 100 mg QD for 6 weeks in the Open-Label Extension Period.
|
EP547 100 mg QD; EP547 100 mg QD
n=28 Participants
Participants were randomized to receive oral EP547 100 milligrams (mg) once daily (QD) for 6 weeks in the Double-Blind Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug received oral EP547 100 mg QD for an additional 6 weeks in the Open-Label Extension Period.
|
|---|---|---|
|
Percentage of Participants With Improvement in Pruritus Severity From Baseline as Defined by Change in Patient Global Impress of Severity (PGI-S) at Week 6
|
56.0 percentage of participants
Interval 34.9 to 75.6
|
52.0 percentage of participants
Interval 31.3 to 72.2
|
SECONDARY outcome
Timeframe: Baseline; Week 6Population: Full Analysis Set. Only participants with available data were analyzed. Exact binomial (Clopper-Pearson) confidence intervals have been reported.
Participants were asked to rate the severity of their worst level of itching in the past 24 hours using the daily WI-NRS, an 11-point scale ranging from 0 (no itching) to 10 (worst itching imaginable). Itching severity scores collected via the WI-NRS have been categorized in the as mild (\<4), moderate (≥4 to \<7), or severe (≥7). The average WI-NRS score using the daily values from the week before the first dose of study drug (including the WI-NRS score captured on Study Day 1 of dosing) served as the Baseline score. A weekly score was determined based on the average of all available daily scores of the week.
Outcome measures
| Measure |
Placebo 100 mg QD; EP547 100 mg QD
n=28 Participants
Participants were randomized to receive oral placebo 100 mg QD for 6 weeks in the Double-Blind (DB) Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug switched to oral EP547 100 mg QD for 6 weeks in the Open-Label Extension Period.
|
EP547 100 mg QD; EP547 100 mg QD
n=28 Participants
Participants were randomized to receive oral EP547 100 milligrams (mg) once daily (QD) for 6 weeks in the Double-Blind Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug received oral EP547 100 mg QD for an additional 6 weeks in the Open-Label Extension Period.
|
|---|---|---|
|
Percentage of Participants With a Reduction in WI-NRS Score ≥2 From Baseline at Week 6
|
44.4 percentage of participants
Interval 25.5 to 64.7
|
35.7 percentage of participants
Interval 18.6 to 55.9
|
SECONDARY outcome
Timeframe: Baseline; Week 6Population: Full Analysis Set. Only participants with available data were analyzed. Exact binomial (Clopper-Pearson) confidence intervals have been reported.
Participants were asked to rate the severity of their worst level of itching in the past 24 hours using the daily WI-NRS, an 11-point scale ranging from 0 (no itching) to 10 (worst itching imaginable). Itching severity scores collected via the WI-NRS have been categorized in the as mild (\<4), moderate (≥4 to \<7), or severe (≥7). The average WI-NRS score using the daily values from the week before the first dose of study drug (including the WI-NRS score captured on Study Day 1 of dosing) served as the Baseline score. A weekly score was determined based on the average of all available daily scores of the week.
Outcome measures
| Measure |
Placebo 100 mg QD; EP547 100 mg QD
n=28 Participants
Participants were randomized to receive oral placebo 100 mg QD for 6 weeks in the Double-Blind (DB) Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug switched to oral EP547 100 mg QD for 6 weeks in the Open-Label Extension Period.
|
EP547 100 mg QD; EP547 100 mg QD
n=28 Participants
Participants were randomized to receive oral EP547 100 milligrams (mg) once daily (QD) for 6 weeks in the Double-Blind Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug received oral EP547 100 mg QD for an additional 6 weeks in the Open-Label Extension Period.
|
|---|---|---|
|
Percentage of Participants With a Reduction in WI-NRS Score ≥3 From Baseline at Week 6
|
37.0 percentage of participants
Interval 19.4 to 57.6
|
25.0 percentage of participants
Interval 10.7 to 44.9
|
SECONDARY outcome
Timeframe: Baseline; Week 6Population: Full Analysis Set. Only participants with available data were analyzed. Exact binomial (Clopper-Pearson) confidence intervals have been reported.
Participants were asked to rate the severity of their worst level of itching in the past 24 hours using the daily WI-NRS, an 11-point scale ranging from 0 (no itching) to 10 (worst itching imaginable). Itching severity scores collected via the WI-NRS have been categorized in the as mild (\<4), moderate (≥4 to \<7), or severe (≥7). The average WI-NRS score using the daily values from the week before the first dose of study drug (including the WI-NRS score captured on Study Day 1 of dosing) served as the Baseline score. A weekly score was determined based on the average of all available daily scores of the week.
Outcome measures
| Measure |
Placebo 100 mg QD; EP547 100 mg QD
n=28 Participants
Participants were randomized to receive oral placebo 100 mg QD for 6 weeks in the Double-Blind (DB) Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug switched to oral EP547 100 mg QD for 6 weeks in the Open-Label Extension Period.
|
EP547 100 mg QD; EP547 100 mg QD
n=28 Participants
Participants were randomized to receive oral EP547 100 milligrams (mg) once daily (QD) for 6 weeks in the Double-Blind Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug received oral EP547 100 mg QD for an additional 6 weeks in the Open-Label Extension Period.
|
|---|---|---|
|
Percentage of Participants With a Reduction in WI-NRS Score ≥4 From Baseline at Week 6
|
37.0 percentage of participants
Interval 19.4 to 57.6
|
17.9 percentage of participants
Interval 6.1 to 36.9
|
SECONDARY outcome
Timeframe: Baseline; Week 6Population: Full Analysis Set. Only participants with available data were analyzed. Exact binomial (Clopper-Pearson) confidence intervals have been reported.
Participants were asked to rate the severity of their worst level of itching in the past 24 hours using the daily WI-NRS, an 11-point scale ranging from 0 (no itching) to 10 (worst itching imaginable). Itching severity scores collected via the WI-NRS have been categorized in the as mild (\<4), moderate (≥4 to \<7), or severe (≥7). The average WI-NRS score using the daily values from the week before the first dose of study drug (including the WI-NRS score captured on Study Day 1 of dosing) served as the Baseline score. A weekly score was determined based on the average of all available daily scores of the week.
Outcome measures
| Measure |
Placebo 100 mg QD; EP547 100 mg QD
n=28 Participants
Participants were randomized to receive oral placebo 100 mg QD for 6 weeks in the Double-Blind (DB) Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug switched to oral EP547 100 mg QD for 6 weeks in the Open-Label Extension Period.
|
EP547 100 mg QD; EP547 100 mg QD
n=28 Participants
Participants were randomized to receive oral EP547 100 milligrams (mg) once daily (QD) for 6 weeks in the Double-Blind Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug received oral EP547 100 mg QD for an additional 6 weeks in the Open-Label Extension Period.
|
|---|---|---|
|
Percentage of Participants With a WI-NRS Score <4 at Week 6
|
42.9 percentage of participants
Interval 24.5 to 62.8
|
35.7 percentage of participants
Interval 18.6 to 55.9
|
SECONDARY outcome
Timeframe: up to the end of Week 6Population: Safety Analysis Set: All participants who were randomized and took at least 1 dose of randomized study drug. Analysis was based on the treatment actually received.
An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be 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. TEAEs are AEs with an onset after the first dose of study drug or existing events that worsened after the first dose during the study. TEAEs were graded for severity (mild \[Grade 1\], moderate \[Grade 2\], severe \[Grade 3\], life threatening \[Grade 4\], death \[Grade 5\]) using Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. The investigator assessed whether the TEAEs were related or unrelated to the study drug.
Outcome measures
| Measure |
Placebo 100 mg QD; EP547 100 mg QD
n=30 Participants
Participants were randomized to receive oral placebo 100 mg QD for 6 weeks in the Double-Blind (DB) Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug switched to oral EP547 100 mg QD for 6 weeks in the Open-Label Extension Period.
|
EP547 100 mg QD; EP547 100 mg QD
n=31 Participants
Participants were randomized to receive oral EP547 100 milligrams (mg) once daily (QD) for 6 weeks in the Double-Blind Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug received oral EP547 100 mg QD for an additional 6 weeks in the Open-Label Extension Period.
|
|---|---|---|
|
Double-blind Treatment Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Any ≥Grade 3 TEAE, Any Related TEAE, and Any TEAE That Led to Discontinuation of Study Drug
Any TEAE
|
15 Participants
|
18 Participants
|
|
Double-blind Treatment Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Any ≥Grade 3 TEAE, Any Related TEAE, and Any TEAE That Led to Discontinuation of Study Drug
Any ≥Grade 3 TEAE
|
0 Participants
|
0 Participants
|
|
Double-blind Treatment Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Any ≥Grade 3 TEAE, Any Related TEAE, and Any TEAE That Led to Discontinuation of Study Drug
Any related TEAE
|
5 Participants
|
5 Participants
|
|
Double-blind Treatment Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Any ≥Grade 3 TEAE, Any Related TEAE, and Any TEAE That Led to Discontinuation of Study Drug
Any TEAE that led to discontinuation of study drug
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: from the beginning of Week 7 up to Week 12Population: Open-label Extension Analysis Set: all participants who completed the Double-Blind Treatment Period and received at least 1 dose of study drug in the Open-Label Extension Period
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be 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. TEAEs are AEs with an onset after the first dose of study drug or existing events that worsened after the first dose during the study. TEAEs were graded for severity (mild \[Grade 1\], moderate \[Grade 2\], severe \[Grade 3\], life threatening \[Grade 4\], death \[Grade 5\]) using CTCAE, version 5.0. The investigator assessed whether the TEAEs were related or unrelated to the study drug.
Outcome measures
| Measure |
Placebo 100 mg QD; EP547 100 mg QD
n=29 Participants
Participants were randomized to receive oral placebo 100 mg QD for 6 weeks in the Double-Blind (DB) Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug switched to oral EP547 100 mg QD for 6 weeks in the Open-Label Extension Period.
|
EP547 100 mg QD; EP547 100 mg QD
n=29 Participants
Participants were randomized to receive oral EP547 100 milligrams (mg) once daily (QD) for 6 weeks in the Double-Blind Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug received oral EP547 100 mg QD for an additional 6 weeks in the Open-Label Extension Period.
|
|---|---|---|
|
Open-label Extension Period: Number of Participants With Any TEAE, Any ≥Grade 3 TEAE, Any Related TEAE, and Any TEAE That Led to Discontinuation of Study Drug
Any TEAE
|
16 Participants
|
15 Participants
|
|
Open-label Extension Period: Number of Participants With Any TEAE, Any ≥Grade 3 TEAE, Any Related TEAE, and Any TEAE That Led to Discontinuation of Study Drug
Any ≥Grade 3 TEAE
|
2 Participants
|
0 Participants
|
|
Open-label Extension Period: Number of Participants With Any TEAE, Any ≥Grade 3 TEAE, Any Related TEAE, and Any TEAE That Led to Discontinuation of Study Drug
Any related TEAE
|
5 Participants
|
2 Participants
|
|
Open-label Extension Period: Number of Participants With Any TEAE, Any ≥Grade 3 TEAE, Any Related TEAE, and Any TEAE That Led to Discontinuation of Study Drug
Any TEAE that led to discontinuation of study drug
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: up to the end of Week 6Population: Safety Analysis Set
TEAEs are AEs with an onset after the first dose of study drug or existing events that worsened after the first dose during the study. A serious TEAE is any untoward medical occurrence, that at any dose: results in death; is life threatening; requires hospital admission or prolongs hospitalization; results in persistent or significant disability or incapacity; is a congenital anomaly/birth defect; or is a medically significant event that, based on appropriate medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent one of the previously listed outcomes. Serious TEAEs were graded for severity (mild \[Grade 1\], moderate \[Grade 2\], severe \[Grade 3\], life threatening \[Grade 4\], death \[Grade 5\]) using CTCAE, version 5.0. The investigator assessed whether the serious TEAEs were related or unrelated to the study drug.
Outcome measures
| Measure |
Placebo 100 mg QD; EP547 100 mg QD
n=30 Participants
Participants were randomized to receive oral placebo 100 mg QD for 6 weeks in the Double-Blind (DB) Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug switched to oral EP547 100 mg QD for 6 weeks in the Open-Label Extension Period.
|
EP547 100 mg QD; EP547 100 mg QD
n=31 Participants
Participants were randomized to receive oral EP547 100 milligrams (mg) once daily (QD) for 6 weeks in the Double-Blind Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug received oral EP547 100 mg QD for an additional 6 weeks in the Open-Label Extension Period.
|
|---|---|---|
|
Double-blind Treatment Period: Number of Participants With Any Serious TEAE, Any ≥Grade 3 Serious TEAE, Any Related Serious TEAE, and Any Serious TEAE That Led to Discontinuation of Study Drug
Any serious TEAE
|
0 Participants
|
0 Participants
|
|
Double-blind Treatment Period: Number of Participants With Any Serious TEAE, Any ≥Grade 3 Serious TEAE, Any Related Serious TEAE, and Any Serious TEAE That Led to Discontinuation of Study Drug
Any ≥Grade 3 serious TEAE
|
0 Participants
|
0 Participants
|
|
Double-blind Treatment Period: Number of Participants With Any Serious TEAE, Any ≥Grade 3 Serious TEAE, Any Related Serious TEAE, and Any Serious TEAE That Led to Discontinuation of Study Drug
Any related serious TEAE
|
0 Participants
|
0 Participants
|
|
Double-blind Treatment Period: Number of Participants With Any Serious TEAE, Any ≥Grade 3 Serious TEAE, Any Related Serious TEAE, and Any Serious TEAE That Led to Discontinuation of Study Drug
Any serious TEAE that led to discontinuation of study drug
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: from the beginning of Week 7 up to Week 12Population: Open-label Extension Analysis Set
TEAEs are AEs with an onset after the first dose of study drug or existing events that worsened after the first dose during the study. A serious TEAE is any untoward medical occurrence, that at any dose: results in death; is life threatening; requires hospital admission or prolongs hospitalization; results in persistent or significant disability or incapacity; is a congenital anomaly/birth defect; or is a medically significant event that, based on appropriate medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent one of the previously listed outcomes. Serious TEAEs were graded for severity (mild \[Grade 1\], moderate \[Grade 2\], severe \[Grade 3\], life threatening \[Grade 4\], death \[Grade 5\]) using CTCAE, version 5.0. The investigator assessed whether the serious TEAEs were related or unrelated to the study drug.
Outcome measures
| Measure |
Placebo 100 mg QD; EP547 100 mg QD
n=29 Participants
Participants were randomized to receive oral placebo 100 mg QD for 6 weeks in the Double-Blind (DB) Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug switched to oral EP547 100 mg QD for 6 weeks in the Open-Label Extension Period.
|
EP547 100 mg QD; EP547 100 mg QD
n=29 Participants
Participants were randomized to receive oral EP547 100 milligrams (mg) once daily (QD) for 6 weeks in the Double-Blind Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug received oral EP547 100 mg QD for an additional 6 weeks in the Open-Label Extension Period.
|
|---|---|---|
|
Open-label Extension Period: Number of Participants With Any Serious TEAE, Any ≥Grade 3 Serious TEAE, Any Related Serious TEAE, and Any Serious TEAE That Led to Discontinuation of Study Drug
Any serious TEAE
|
1 Participants
|
0 Participants
|
|
Open-label Extension Period: Number of Participants With Any Serious TEAE, Any ≥Grade 3 Serious TEAE, Any Related Serious TEAE, and Any Serious TEAE That Led to Discontinuation of Study Drug
Any ≥Grade 3 serious TEAE
|
1 Participants
|
0 Participants
|
|
Open-label Extension Period: Number of Participants With Any Serious TEAE, Any ≥Grade 3 Serious TEAE, Any Related Serious TEAE, and Any Serious TEAE That Led to Discontinuation of Study Drug
Any related serious TEAE
|
0 Participants
|
0 Participants
|
|
Open-label Extension Period: Number of Participants With Any Serious TEAE, Any ≥Grade 3 Serious TEAE, Any Related Serious TEAE, and Any Serious TEAE That Led to Discontinuation of Study Drug
Any serious TEAE that led to discontinuation of study drug
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: up to the end of Week 6Population: Safety Analysis Set
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. TEAEs are AEs with an onset after the first dose of study drug or existing events that worsened after the first dose during the study. AESI were considered to be any clinically meaningful new, worsening from Baseline, or abnormal laboratory findings or symptoms suggestive of acute kidney injury (AKI) (e.g., "blood urea increased" or "protein urine present" AEs as identified by the Standardized Medical Dictionary for Regulatory Activities \[MedDRA\] Query \[SMQ\] "Acute renal failure"). TE AESIs were graded for severity (mild \[Grade 1\], moderate \[Grade 2\], severe \[Grade 3\], life threatening \[Grade 4\], death \[Grade 5\]) using CTCAE, version 5.0. The investigator assessed whether the AE AESIs were related or unrelated to the study drug.
Outcome measures
| Measure |
Placebo 100 mg QD; EP547 100 mg QD
n=30 Participants
Participants were randomized to receive oral placebo 100 mg QD for 6 weeks in the Double-Blind (DB) Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug switched to oral EP547 100 mg QD for 6 weeks in the Open-Label Extension Period.
|
EP547 100 mg QD; EP547 100 mg QD
n=31 Participants
Participants were randomized to receive oral EP547 100 milligrams (mg) once daily (QD) for 6 weeks in the Double-Blind Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug received oral EP547 100 mg QD for an additional 6 weeks in the Open-Label Extension Period.
|
|---|---|---|
|
Double-blind Treatment Period: Number of Participants With Any Treatment-emergent (TE) Adverse Event of Special Interest (AESI), Any ≥Grade 3 TE AESI, Any Related TE AESI, and Any TE AESI That Led to Discontinuation of Study Drug
Any treatment-emergent (TE) AESI
|
0 Participants
|
0 Participants
|
|
Double-blind Treatment Period: Number of Participants With Any Treatment-emergent (TE) Adverse Event of Special Interest (AESI), Any ≥Grade 3 TE AESI, Any Related TE AESI, and Any TE AESI That Led to Discontinuation of Study Drug
Any ≥Grade 3 TE AESI
|
0 Participants
|
0 Participants
|
|
Double-blind Treatment Period: Number of Participants With Any Treatment-emergent (TE) Adverse Event of Special Interest (AESI), Any ≥Grade 3 TE AESI, Any Related TE AESI, and Any TE AESI That Led to Discontinuation of Study Drug
Any related TE AESI
|
0 Participants
|
0 Participants
|
|
Double-blind Treatment Period: Number of Participants With Any Treatment-emergent (TE) Adverse Event of Special Interest (AESI), Any ≥Grade 3 TE AESI, Any Related TE AESI, and Any TE AESI That Led to Discontinuation of Study Drug
Any TE AESI that led to discontinuation of study drug
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: from the beginning of Week 7 up to Week 12Population: Open-label Extension Analysis Set
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. TEAEs are AEs with an onset after the first dose of study drug or existing events that worsened after the first dose during the study. AESI were considered to be any clinically meaningful new, worsening from Baseline, or abnormal laboratory findings or symptoms suggestive of acute kidney injury (AKI) (e.g., "blood urea increased" or "protein urine present" AEs as identified by the Standardized Medical Dictionary for Regulatory Activities \[MedDRA\] Query \[SMQ\] "Acute renal failure"). TE AESIs were graded for severity (mild \[Grade 1\], moderate \[Grade 2\], severe \[Grade 3\], life threatening \[Grade 4\], death \[Grade 5\]) using CTCAE, version 5.0. The investigator assessed whether the AE AESIs were related or unrelated to the study drug.
Outcome measures
| Measure |
Placebo 100 mg QD; EP547 100 mg QD
n=29 Participants
Participants were randomized to receive oral placebo 100 mg QD for 6 weeks in the Double-Blind (DB) Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug switched to oral EP547 100 mg QD for 6 weeks in the Open-Label Extension Period.
|
EP547 100 mg QD; EP547 100 mg QD
n=29 Participants
Participants were randomized to receive oral EP547 100 milligrams (mg) once daily (QD) for 6 weeks in the Double-Blind Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug received oral EP547 100 mg QD for an additional 6 weeks in the Open-Label Extension Period.
|
|---|---|---|
|
Open-label Extension Period: Number of Participants With Any Treatment-emergent (TE) AESI, Any ≥Grade 3 TE AESI, Any Related TE AESI, and Any TE AESI That Led to Discontinuation of Study Drug
Any TE AESI
|
0 Participants
|
0 Participants
|
|
Open-label Extension Period: Number of Participants With Any Treatment-emergent (TE) AESI, Any ≥Grade 3 TE AESI, Any Related TE AESI, and Any TE AESI That Led to Discontinuation of Study Drug
Any ≥Grade 3 TE AESI
|
0 Participants
|
0 Participants
|
|
Open-label Extension Period: Number of Participants With Any Treatment-emergent (TE) AESI, Any ≥Grade 3 TE AESI, Any Related TE AESI, and Any TE AESI That Led to Discontinuation of Study Drug
Any related TE AESI
|
0 Participants
|
0 Participants
|
|
Open-label Extension Period: Number of Participants With Any Treatment-emergent (TE) AESI, Any ≥Grade 3 TE AESI, Any Related TE AESI, and Any TE AESI That Led to Discontinuation of Study Drug
Any TE AESI that led to discontinuation of study drug
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: up to the end of Week 12Population: Safety Analysis Set
Clinical laboratory test results included results for clinical hematology, chemistry, coagulation, and thyroid function parameters . The investigator determined if changes were clinically meaningful.
Outcome measures
| Measure |
Placebo 100 mg QD; EP547 100 mg QD
n=30 Participants
Participants were randomized to receive oral placebo 100 mg QD for 6 weeks in the Double-Blind (DB) Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug switched to oral EP547 100 mg QD for 6 weeks in the Open-Label Extension Period.
|
EP547 100 mg QD; EP547 100 mg QD
n=31 Participants
Participants were randomized to receive oral EP547 100 milligrams (mg) once daily (QD) for 6 weeks in the Double-Blind Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug received oral EP547 100 mg QD for an additional 6 weeks in the Open-Label Extension Period.
|
|---|---|---|
|
Number of Participants With Any Clinically Meaningful Changes From Baseline in Clinically Meaningful in Clinical Laboratory Test Results
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: up to the end of Week 12Population: Safety Analysis Set
Vital sign measurements included measurements for blood pressure, pulse rate, oxygen saturation, body temperature, and respiratory rate. The investigator determined if changes were clinically meaningful.
Outcome measures
| Measure |
Placebo 100 mg QD; EP547 100 mg QD
n=30 Participants
Participants were randomized to receive oral placebo 100 mg QD for 6 weeks in the Double-Blind (DB) Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug switched to oral EP547 100 mg QD for 6 weeks in the Open-Label Extension Period.
|
EP547 100 mg QD; EP547 100 mg QD
n=31 Participants
Participants were randomized to receive oral EP547 100 milligrams (mg) once daily (QD) for 6 weeks in the Double-Blind Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug received oral EP547 100 mg QD for an additional 6 weeks in the Open-Label Extension Period.
|
|---|---|---|
|
Number of Participants With Any Clinically Meaningful Changes From Baseline in Vital Sign Measurements
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: up to the end of Week 12Population: Safety Analysis Set
ECG parameters included heart rate, RR interval, PR interval, QRS duration, or QT interval. The investigator determined if changes were clinically significant.
Outcome measures
| Measure |
Placebo 100 mg QD; EP547 100 mg QD
n=30 Participants
Participants were randomized to receive oral placebo 100 mg QD for 6 weeks in the Double-Blind (DB) Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug switched to oral EP547 100 mg QD for 6 weeks in the Open-Label Extension Period.
|
EP547 100 mg QD; EP547 100 mg QD
n=31 Participants
Participants were randomized to receive oral EP547 100 milligrams (mg) once daily (QD) for 6 weeks in the Double-Blind Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug received oral EP547 100 mg QD for an additional 6 weeks in the Open-Label Extension Period.
|
|---|---|---|
|
Number of Participants With Any Clinically Significant Changes From Baseline in Electrocardiogram (ECG) Parameters
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1, 2, and 3 hours postdose on Day 1 and Week 3; predose on Weeks 1, 2, and 6Population: Pharmokinetic Set: all participants who received at least 1 dose of EP547 and provided adequate blood samples for bioanalysis
The lower level of quantitation = 0.01 micrograms per milliliter (µg/mL) for EP547 and 0.005 μg/mL for EP3583.
Outcome measures
| Measure |
Placebo 100 mg QD; EP547 100 mg QD
Participants were randomized to receive oral placebo 100 mg QD for 6 weeks in the Double-Blind (DB) Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug switched to oral EP547 100 mg QD for 6 weeks in the Open-Label Extension Period.
|
EP547 100 mg QD; EP547 100 mg QD
n=31 Participants
Participants were randomized to receive oral EP547 100 milligrams (mg) once daily (QD) for 6 weeks in the Double-Blind Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug received oral EP547 100 mg QD for an additional 6 weeks in the Open-Label Extension Period.
|
|---|---|---|
|
Plasma Concentration of EP547 and Metabolites
EP547: Week 3, predose
|
—
|
6617.4 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 49.06
|
|
Plasma Concentration of EP547 and Metabolites
EP547: Week 3, 1 hour postdose
|
—
|
11709.4 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 39.25
|
|
Plasma Concentration of EP547 and Metabolites
EP547: Day 1, 1 hour postdose
|
—
|
2661.0 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 159.42
|
|
Plasma Concentration of EP547 and Metabolites
EP547: Day 1, 2 hours postdose
|
—
|
5197.7 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 93.75
|
|
Plasma Concentration of EP547 and Metabolites
EP547: Day 1, 3 hours postdose
|
—
|
5698.4 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 75.27
|
|
Plasma Concentration of EP547 and Metabolites
EP547: Week 1, predose
|
—
|
6267.9 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 51.54
|
|
Plasma Concentration of EP547 and Metabolites
EP547: Week 2, predose
|
—
|
5786.5 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 56.27
|
|
Plasma Concentration of EP547 and Metabolites
EP547: Week 3, 2 hours postdose
|
—
|
12012.7 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 30.98
|
|
Plasma Concentration of EP547 and Metabolites
EP547: Week 3, 3 hours postdose
|
—
|
11909.4 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 49.76
|
|
Plasma Concentration of EP547 and Metabolites
EP547: Week 6, predose
|
—
|
4947.6 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 91.61
|
|
Plasma Concentration of EP547 and Metabolites
EP3583: Day 1, 1 hour postdose
|
—
|
308.5 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 160.23
|
|
Plasma Concentration of EP547 and Metabolites
EP3583: : Day 1, 2 hours postdose
|
—
|
796.1 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 104.08
|
|
Plasma Concentration of EP547 and Metabolites
EP3583: : Day 1, 3 hours postdose
|
—
|
910.6 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 90.22
|
|
Plasma Concentration of EP547 and Metabolites
EP3583: Week 1, predose
|
—
|
952.1 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 56.10
|
|
Plasma Concentration of EP547 and Metabolites
EP3583: Week 2, predose
|
—
|
948.2 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 61.73
|
|
Plasma Concentration of EP547 and Metabolites
EP3583: Week 3, predose
|
—
|
1028.9 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 64.53
|
|
Plasma Concentration of EP547 and Metabolites
EP3583: Week 3, 1 hour postdose
|
—
|
1625.4 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 54.57
|
|
Plasma Concentration of EP547 and Metabolites
EP3583: Week 3, 2 hours postdose
|
—
|
1898.0 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 47.98
|
|
Plasma Concentration of EP547 and Metabolites
EP3583: Week 3, 3 hours postdose
|
—
|
1836.0 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 62.20
|
|
Plasma Concentration of EP547 and Metabolites
EP3583: Week 6, predose
|
—
|
801.8 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 103.25
|
Adverse Events
Placebo
EP547
Serious adverse events
| Measure |
Placebo
n=30 participants at risk
Participants were randomized to receive oral placebo 100 milligrams (mg) once daily (QD) for 6 weeks in the Double-Blind (DB) Treatment Period.
|
EP547
n=60 participants at risk
Participants were randomized to receive oral EP547 100 mg QD for 6 weeks in the DB Treatment Period and for 6 weeks in the Open-Label Extension Period. Participants who were randomized to receive oral placebo 100 mg QD for 6 weeks during the DB Treatment Period received EP547 100 mg QD for 6 weeks in the Open-Label Extension Period.
|
|---|---|---|
|
Psychiatric disorders
Depression
|
0.00%
0/30 • 12 weeks
For participants who received placebo up to Week 6 and then switched to EP547, adverse events are presented by the treatment they were on at onset of the event.
|
1.7%
1/60 • Number of events 1 • 12 weeks
For participants who received placebo up to Week 6 and then switched to EP547, adverse events are presented by the treatment they were on at onset of the event.
|
|
Injury, poisoning and procedural complications
Gun shot wound
|
0.00%
0/30 • 12 weeks
For participants who received placebo up to Week 6 and then switched to EP547, adverse events are presented by the treatment they were on at onset of the event.
|
1.7%
1/60 • Number of events 1 • 12 weeks
For participants who received placebo up to Week 6 and then switched to EP547, adverse events are presented by the treatment they were on at onset of the event.
|
Other adverse events
| Measure |
Placebo
n=30 participants at risk
Participants were randomized to receive oral placebo 100 milligrams (mg) once daily (QD) for 6 weeks in the Double-Blind (DB) Treatment Period.
|
EP547
n=60 participants at risk
Participants were randomized to receive oral EP547 100 mg QD for 6 weeks in the DB Treatment Period and for 6 weeks in the Open-Label Extension Period. Participants who were randomized to receive oral placebo 100 mg QD for 6 weeks during the DB Treatment Period received EP547 100 mg QD for 6 weeks in the Open-Label Extension Period.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/30 • 12 weeks
For participants who received placebo up to Week 6 and then switched to EP547, adverse events are presented by the treatment they were on at onset of the event.
|
5.0%
3/60 • Number of events 3 • 12 weeks
For participants who received placebo up to Week 6 and then switched to EP547, adverse events are presented by the treatment they were on at onset of the event.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/30 • 12 weeks
For participants who received placebo up to Week 6 and then switched to EP547, adverse events are presented by the treatment they were on at onset of the event.
|
5.0%
3/60 • Number of events 3 • 12 weeks
For participants who received placebo up to Week 6 and then switched to EP547, adverse events are presented by the treatment they were on at onset of the event.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/30 • 12 weeks
For participants who received placebo up to Week 6 and then switched to EP547, adverse events are presented by the treatment they were on at onset of the event.
|
5.0%
3/60 • Number of events 4 • 12 weeks
For participants who received placebo up to Week 6 and then switched to EP547, adverse events are presented by the treatment they were on at onset of the event.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/30 • 12 weeks
For participants who received placebo up to Week 6 and then switched to EP547, adverse events are presented by the treatment they were on at onset of the event.
|
10.0%
6/60 • Number of events 6 • 12 weeks
For participants who received placebo up to Week 6 and then switched to EP547, adverse events are presented by the treatment they were on at onset of the event.
|
|
Nervous system disorders
Headache
|
10.0%
3/30 • Number of events 3 • 12 weeks
For participants who received placebo up to Week 6 and then switched to EP547, adverse events are presented by the treatment they were on at onset of the event.
|
10.0%
6/60 • Number of events 15 • 12 weeks
For participants who received placebo up to Week 6 and then switched to EP547, adverse events are presented by the treatment they were on at onset of the event.
|
|
Infections and infestations
Nasopharyngitis
|
6.7%
2/30 • Number of events 2 • 12 weeks
For participants who received placebo up to Week 6 and then switched to EP547, adverse events are presented by the treatment they were on at onset of the event.
|
0.00%
0/60 • 12 weeks
For participants who received placebo up to Week 6 and then switched to EP547, adverse events are presented by the treatment they were on at onset of the event.
|
|
Gastrointestinal disorders
Nausea
|
3.3%
1/30 • Number of events 1 • 12 weeks
For participants who received placebo up to Week 6 and then switched to EP547, adverse events are presented by the treatment they were on at onset of the event.
|
5.0%
3/60 • Number of events 3 • 12 weeks
For participants who received placebo up to Week 6 and then switched to EP547, adverse events are presented by the treatment they were on at onset of the event.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.0%
3/30 • Number of events 3 • 12 weeks
For participants who received placebo up to Week 6 and then switched to EP547, adverse events are presented by the treatment they were on at onset of the event.
|
6.7%
4/60 • Number of events 5 • 12 weeks
For participants who received placebo up to Week 6 and then switched to EP547, adverse events are presented by the treatment they were on at onset of the event.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/30 • 12 weeks
For participants who received placebo up to Week 6 and then switched to EP547, adverse events are presented by the treatment they were on at onset of the event.
|
6.7%
4/60 • Number of events 4 • 12 weeks
For participants who received placebo up to Week 6 and then switched to EP547, adverse events are presented by the treatment they were on at onset of the event.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/30 • 12 weeks
For participants who received placebo up to Week 6 and then switched to EP547, adverse events are presented by the treatment they were on at onset of the event.
|
10.0%
6/60 • Number of events 6 • 12 weeks
For participants who received placebo up to Week 6 and then switched to EP547, adverse events are presented by the treatment they were on at onset of the event.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60