Trial Outcomes & Findings for Rimegepant in Moderate Plaque-type Psoriasis (NCT NCT04629950)
NCT ID: NCT04629950
Last Updated: 2025-07-17
Results Overview
Total score of Psoriasis Area and Severity Index ranges from 0 to 72. Change = (Week 16 score - Baseline score) for the placebo-controlled phase and (Week 15 score-Visit 12 score) for the extension phase. A low score means less severe disease while a high score reflects more severe disease. A score of 0 means no psoriasis. A PASI score of 5 to 10 is considered moderate disease and a score over 10 is considered severe. A score over 40 is rare. The primary outcome measure is the mean percent change in PASI score from baseline to week 16 in the placebo-controlled phase. For the extension phase, it is particularly interesting if a change is noted in the group that received placebo prior to the extension phase.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
41 participants
Primary outcome timeframe
Baseline and Week 16 for placebo controlled trial. For Extension Phase, Visit 11/12 (Day 1) to Visit 15 (Week 12).
Results posted on
2025-07-17
Participant Flow
Participants were recruited from the dermatology practices of the Weill Cornell Medical College Department of Dermatology and the practice of Neil Sadick, M.D., a voluntary faculty member of the department.
Ninety-six subjects were screened, 41 met criteria for entry. Five subjects withdrew or were withdrawn before being assigned to a group.
Participant milestones
| Measure |
Rimegepant
Participants receive a rimegepant 75 mg tablet orally every other day for 16 weeks.
Rimegepant: Active Agent
|
Placebo
Participants receive a placebo tablet matching rimegepant orally every other day for 16 weeks.
Placebo: Placebo Comparator
|
Rimegepant Extension-Previously Received Rimegepant-Open Label
Participants who previously received rimegepant receive a rimegepant 75 mg tablet orally every other day for an additional 12 weeks.
Rimegepant: Active Agent
|
Rimegepant Extension-Previously Received Placebo-Open Label
Participants who previously received placebo receive a rimegepant 75 mg tablet orally every other day for an additional 12 weeks.
Rimegepant: Active Agent
|
|---|---|---|---|---|
|
Double-Blind Placebo Controlled Trial
STARTED
|
18
|
18
|
0
|
0
|
|
Double-Blind Placebo Controlled Trial
COMPLETED
|
17
|
13
|
0
|
0
|
|
Double-Blind Placebo Controlled Trial
NOT COMPLETED
|
1
|
5
|
0
|
0
|
|
Extension Study
STARTED
|
0
|
0
|
12
|
6
|
|
Extension Study
COMPLETED
|
0
|
0
|
11
|
5
|
|
Extension Study
NOT COMPLETED
|
0
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
Rimegepant
Participants receive a rimegepant 75 mg tablet orally every other day for 16 weeks.
Rimegepant: Active Agent
|
Placebo
Participants receive a placebo tablet matching rimegepant orally every other day for 16 weeks.
Placebo: Placebo Comparator
|
Rimegepant Extension-Previously Received Rimegepant-Open Label
Participants who previously received rimegepant receive a rimegepant 75 mg tablet orally every other day for an additional 12 weeks.
Rimegepant: Active Agent
|
Rimegepant Extension-Previously Received Placebo-Open Label
Participants who previously received placebo receive a rimegepant 75 mg tablet orally every other day for an additional 12 weeks.
Rimegepant: Active Agent
|
|---|---|---|---|---|
|
Double-Blind Placebo Controlled Trial
Lost to Follow-up
|
1
|
1
|
0
|
0
|
|
Double-Blind Placebo Controlled Trial
Withdrawal by Subject
|
0
|
2
|
0
|
0
|
|
Double-Blind Placebo Controlled Trial
Adverse Event
|
0
|
2
|
0
|
0
|
|
Extension Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
|
Extension Study
Adverse Event
|
0
|
0
|
0
|
1
|
Baseline Characteristics
The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study.
Baseline characteristics by cohort
| Measure |
Rimegepant
n=18 Participants
Participants receive a rimegepant 75 mg tablet orally every other day for 16 weeks.
Rimegepant: Active Agent
|
Placebo
n=18 Participants
Participants receive a placebo tablet matching rimegepant orally every other day for 16 weeks.
Placebo: Placebo Comparator
|
Rimegepant Extension-Previously Received Rimegepant-Open Label
n=12 Participants
Participants who previously received rimegepant receive a rimegepant 75 mg tablet orally every other day for an additional 12 weeks.
Rimegepant: Active Agent
|
Rimegepant Extension-Previously Received Placebo-Open Label
n=6 Participants
Participants who previously received placebo receive a rimegepant 75 mg tablet orally every other day for an additional 12 weeks.
Rimegepant: Active Agent
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
Double-Blind Controlled Trial
|
47.72 years
STANDARD_DEVIATION 14.85 • n=18 Participants • The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study.
|
50.94 years
STANDARD_DEVIATION 14.09 • n=18 Participants • The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study.
|
—
|
—
|
49.29 years
STANDARD_DEVIATION 14.37 • n=36 Participants • The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study.
|
|
Age, Continuous
Open Label Extension
|
—
|
—
|
48.42 years
STANDARD_DEVIATION 15.29 • n=12 Participants • The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study.
|
46.33 years
STANDARD_DEVIATION 13.49 • n=6 Participants • The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study.
|
47.72 years
STANDARD_DEVIATION 14.34 • n=18 Participants • The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study.
|
|
Sex: Female, Male
Double-Blind Controlled Trial · Female
|
6 Participants
n=18 Participants • The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study.
|
6 Participants
n=18 Participants • The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study.
|
—
|
—
|
12 Participants
n=36 Participants • The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study.
|
|
Sex: Female, Male
Double-Blind Controlled Trial · Male
|
12 Participants
n=18 Participants • The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study.
|
12 Participants
n=18 Participants • The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study.
|
—
|
—
|
24 Participants
n=36 Participants • The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study.
|
|
Sex: Female, Male
Open Label Extension · Female
|
—
|
—
|
3 Participants
n=12 Participants • The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study.
|
3 Participants
n=6 Participants • The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study.
|
6 Participants
n=18 Participants • The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study.
|
|
Sex: Female, Male
Open Label Extension · Male
|
—
|
—
|
9 Participants
n=12 Participants • The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study.
|
3 Participants
n=6 Participants • The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study.
|
12 Participants
n=18 Participants • The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study.
|
|
Ethnicity (NIH/OMB)
Double-Blind Controlled Trial · Hispanic or Latino
|
6 Participants
n=18 Participants • The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study.
|
7 Participants
n=18 Participants • The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study.
|
—
|
—
|
13 Participants
n=36 Participants • The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study.
|
|
Ethnicity (NIH/OMB)
Double-Blind Controlled Trial · Not Hispanic or Latino
|
12 Participants
n=18 Participants • The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study.
|
10 Participants
n=18 Participants • The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study.
|
—
|
—
|
22 Participants
n=36 Participants • The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study.
|
|
Ethnicity (NIH/OMB)
Double-Blind Controlled Trial · Unknown or Not Reported
|
0 Participants
n=18 Participants • The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study.
|
1 Participants
n=18 Participants • The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study.
|
—
|
—
|
1 Participants
n=36 Participants • The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study.
|
|
Ethnicity (NIH/OMB)
Open Label Extension · Hispanic or Latino
|
—
|
—
|
3 Participants
n=12 Participants • The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study.
|
2 Participants
n=6 Participants • The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study.
|
5 Participants
n=18 Participants • The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study.
|
|
Ethnicity (NIH/OMB)
Open Label Extension · Not Hispanic or Latino
|
—
|
—
|
9 Participants
n=12 Participants • The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study.
|
4 Participants
n=6 Participants • The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study.
|
13 Participants
n=18 Participants • The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study.
|
|
Ethnicity (NIH/OMB)
Open Label Extension · Unknown or Not Reported
|
—
|
—
|
0 Participants
n=12 Participants • The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study.
|
0 Participants
n=6 Participants • The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study.
|
0 Participants
n=18 Participants • The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study.
|
|
Race (NIH/OMB)
Double-Blind Controlled Trial · American Indian or Alaska Native
|
0 Participants
n=18 Participants • The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study.
|
0 Participants
n=18 Participants • The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study.
|
—
|
—
|
0 Participants
n=36 Participants • The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study.
|
|
Race (NIH/OMB)
Double-Blind Controlled Trial · Asian
|
1 Participants
n=18 Participants • The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study.
|
2 Participants
n=18 Participants • The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study.
|
—
|
—
|
3 Participants
n=36 Participants • The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study.
|
|
Race (NIH/OMB)
Double-Blind Controlled Trial · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=18 Participants • The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study.
|
0 Participants
n=18 Participants • The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study.
|
—
|
—
|
0 Participants
n=36 Participants • The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study.
|
|
Race (NIH/OMB)
Double-Blind Controlled Trial · Black or African American
|
1 Participants
n=18 Participants • The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study.
|
1 Participants
n=18 Participants • The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study.
|
—
|
—
|
2 Participants
n=36 Participants • The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study.
|
|
Race (NIH/OMB)
Double-Blind Controlled Trial · White
|
11 Participants
n=18 Participants • The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study.
|
10 Participants
n=18 Participants • The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study.
|
—
|
—
|
21 Participants
n=36 Participants • The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study.
|
|
Race (NIH/OMB)
Double-Blind Controlled Trial · More than one race
|
0 Participants
n=18 Participants • The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study.
|
0 Participants
n=18 Participants • The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study.
|
—
|
—
|
0 Participants
n=36 Participants • The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study.
|
|
Race (NIH/OMB)
Double-Blind Controlled Trial · Unknown or Not Reported
|
5 Participants
n=18 Participants • The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study.
|
5 Participants
n=18 Participants • The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study.
|
—
|
—
|
10 Participants
n=36 Participants • The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study.
|
|
Race (NIH/OMB)
Open Label Extension · American Indian or Alaska Native
|
—
|
—
|
0 Participants
n=12 Participants • The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study.
|
0 Participants
n=6 Participants • The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study.
|
0 Participants
n=18 Participants • The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study.
|
|
Race (NIH/OMB)
Open Label Extension · Asian
|
—
|
—
|
1 Participants
n=12 Participants • The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study.
|
1 Participants
n=6 Participants • The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study.
|
2 Participants
n=18 Participants • The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study.
|
|
Race (NIH/OMB)
Open Label Extension · Native Hawaiian or Other Pacific Islander
|
—
|
—
|
0 Participants
n=12 Participants • The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study.
|
0 Participants
n=6 Participants • The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study.
|
0 Participants
n=18 Participants • The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study.
|
|
Race (NIH/OMB)
Open Label Extension · Black or African American
|
—
|
—
|
0 Participants
n=12 Participants • The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study.
|
1 Participants
n=6 Participants • The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study.
|
1 Participants
n=18 Participants • The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study.
|
|
Race (NIH/OMB)
Open Label Extension · White
|
—
|
—
|
7 Participants
n=12 Participants • The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study.
|
4 Participants
n=6 Participants • The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study.
|
11 Participants
n=18 Participants • The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study.
|
|
Race (NIH/OMB)
Open Label Extension · More than one race
|
—
|
—
|
0 Participants
n=12 Participants • The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study.
|
0 Participants
n=6 Participants • The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study.
|
0 Participants
n=18 Participants • The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study.
|
|
Race (NIH/OMB)
Open Label Extension · Unknown or Not Reported
|
—
|
—
|
4 Participants
n=12 Participants • The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study.
|
0 Participants
n=6 Participants • The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study.
|
4 Participants
n=18 Participants • The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study.
|
|
Region of Enrollment
United States
|
18 participants
n=18 Participants • The number of subjects in the double-blind, placebo controlled phase of the study is reported here.
|
18 participants
n=18 Participants • The number of subjects in the double-blind, placebo controlled phase of the study is reported here.
|
12 participants
n=12 Participants • The number of subjects in the extension phase of the study is reported here.
|
6 participants
n=6 Participants • The number of subjects in the extension phase of the study is reported here.
|
18 participants
n=18 Participants • The number of subjects in the extension phase of the study is reported here.
|
PRIMARY outcome
Timeframe: Baseline and Week 16 for placebo controlled trial. For Extension Phase, Visit 11/12 (Day 1) to Visit 15 (Week 12).Population: The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study. Furthermore, one subject assigned to the placebo group was not included in the analysis due to having an adverse reaction (very severe insect bite reaction) prior to the first scheduled evaluation. Thus, the total number of analyzed subjects in the placebo-controlled phase was 35.
Total score of Psoriasis Area and Severity Index ranges from 0 to 72. Change = (Week 16 score - Baseline score) for the placebo-controlled phase and (Week 15 score-Visit 12 score) for the extension phase. A low score means less severe disease while a high score reflects more severe disease. A score of 0 means no psoriasis. A PASI score of 5 to 10 is considered moderate disease and a score over 10 is considered severe. A score over 40 is rare. The primary outcome measure is the mean percent change in PASI score from baseline to week 16 in the placebo-controlled phase. For the extension phase, it is particularly interesting if a change is noted in the group that received placebo prior to the extension phase.
Outcome measures
| Measure |
Rimegepant
n=18 Participants
Participants receive a rimegepant 75 mg tablet orally every other day for 16 weeks.
Rimegepant: Active Agent
|
Placebo
n=17 Participants
Participants receive a placebo tablet matching rimegepant orally every other day for 16 weeks.
Placebo: Placebo Comparator
|
Rimegepant Extension-Previously Received Rimegepant-Open Label
n=12 Participants
Participants who previously received rimegepant receive a rimegepant 75 mg tablet orally every other day for an additional 12 weeks.
Rimegepant: Active Agent
|
Rimegepant Extension-Previously Received Placebo-Open Label
n=6 Participants
Participants who previously received placebo receive a rimegepant 75 mg tablet orally every other day for an additional 12 weeks.
Rimegepant: Active Agent
|
|---|---|---|---|---|
|
Change in Severity of Psoriasis as Measured by Percentage Change in the Psoriasis Area and Severity Index (PASI) Instrument
|
17.29 Percent change in PASI score
Standard Deviation 34.43
|
27.06 Percent change in PASI score
Standard Deviation 32.58
|
7.07 Percent change in PASI score
Standard Deviation 31.68
|
20.02 Percent change in PASI score
Standard Deviation 28.78
|
SECONDARY outcome
Timeframe: Baseline and Week 16 for placebo controlled trial. For Extension Phase, Visit 11/12 (Day 1) to Visit 15 (Week 12).Population: The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study. Furthermore, one subject assigned to the placebo group was not included in the analysis due to having an adverse reaction (very severe insect bite reaction) prior to the first scheduled evaluation. Thus, the total number of analyzed subjects in the placebo-controlled phase was 35.
To record the number of subjects whose PASI Score Improves by at least 50% by week 16 (Week 16 average score - Baseline average score) for the placebo-controled phase and the change from Visit 12 (Day 1) to Visit 15 (Week 12) for the extension phase. PASI range is 0-72 although PASI must be at least 5 for entry into the study. A score of 0 means no psoriasis. A PASI score of 5 to 10 is considered moderate disease and a score over 10 is considered severe. A score over 40 is rare.
Outcome measures
| Measure |
Rimegepant
n=18 Participants
Participants receive a rimegepant 75 mg tablet orally every other day for 16 weeks.
Rimegepant: Active Agent
|
Placebo
n=17 Participants
Participants receive a placebo tablet matching rimegepant orally every other day for 16 weeks.
Placebo: Placebo Comparator
|
Rimegepant Extension-Previously Received Rimegepant-Open Label
n=12 Participants
Participants who previously received rimegepant receive a rimegepant 75 mg tablet orally every other day for an additional 12 weeks.
Rimegepant: Active Agent
|
Rimegepant Extension-Previously Received Placebo-Open Label
n=6 Participants
Participants who previously received placebo receive a rimegepant 75 mg tablet orally every other day for an additional 12 weeks.
Rimegepant: Active Agent
|
|---|---|---|---|---|
|
Number of Subjects Who Had a 50% or Greater Reduction in Psoriasis Area and Severity Index Instrument Score
|
3 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 16 for placebo controlled trial. For Extension Phase, Visit 11/12 (Day 1) to Week 12.Population: The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study. Furthermore, one subject assigned to the placebo group was not included in the analysis due to having an adverse reaction (very severe insect bite reaction) prior to the first scheduled evaluation. Thus, the total number of analyzed subjects in the placebo-controlled phase was 35.
Score of the Investigator's Global Assessment instrument ranges from 0 to 5. Three parameters (erythema, induration and scaling, each is scored on a scale of 0 to 5. Erythema: 0 to 5 is the scale of intensity of erythema with 5 being the highest. Induration: 0 to 5 reflects the degree of elevation of the lesion with 5 being the most elevated. Scaling: 0 to 5 is the abundance of scale as well as the thickness and tenacious character of the scale with 5 being the most abundant, thick and tenacious scale) were each measured and averaged to obtain a score averaged to the nearest integer. The change from baseline to week 16 for each subject was calculated for the placebo-controlled phase and the change from Visit 12 to Visit 15 for the extension phase and the mean difference +/- standard deviation between groups was compared. For the extension phase, it is particularly interesting if a change is noted in the group that received placebo prior to the extension phase.
Outcome measures
| Measure |
Rimegepant
n=18 Participants
Participants receive a rimegepant 75 mg tablet orally every other day for 16 weeks.
Rimegepant: Active Agent
|
Placebo
n=17 Participants
Participants receive a placebo tablet matching rimegepant orally every other day for 16 weeks.
Placebo: Placebo Comparator
|
Rimegepant Extension-Previously Received Rimegepant-Open Label
n=12 Participants
Participants who previously received rimegepant receive a rimegepant 75 mg tablet orally every other day for an additional 12 weeks.
Rimegepant: Active Agent
|
Rimegepant Extension-Previously Received Placebo-Open Label
n=6 Participants
Participants who previously received placebo receive a rimegepant 75 mg tablet orally every other day for an additional 12 weeks.
Rimegepant: Active Agent
|
|---|---|---|---|---|
|
Change in Severity of Psoriasis as Assessed by the Investigator's Global Assessment Instrument
|
0.39 score on a scale
Standard Deviation 0.98
|
0.47 score on a scale
Standard Deviation 0.51
|
0.18 score on a scale
Standard Deviation 0.40
|
0.5 score on a scale
Standard Deviation 0.55
|
SECONDARY outcome
Timeframe: Baseline and Week 16 for placebo controlled trial. For Extension Phase, Visit 11/12 (Day 1) to Visit 15 (Week 12).Population: The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study. Furthermore, one subject assigned to the placebo group was not included in the analysis due to having an adverse reaction (very severe insect bite reaction) prior to the first scheduled evaluation. Thus, the total number of analyzed subjects in the placebo-controlled phase was 35.
Dermatology Quality of Life Index score ranges from 0-30. Average Change in Score of Each Group= (Week 16 average score - Baseline average score) for the placebo-controlled phase and (Visit 15 average score-Visit 12 average score) for the extension phase. 0 - 1 no effect at all on patient's life, 2 - 5 small effect on patient's life, 6 - 10 moderate effect on patient's life, 11 - 20 very large effect on patient's life, 21 - 30 extremely large effect on patient's life. For the extension phase, it is particularly interesting if a change is noted in the group that received placebo prior to the extension phase.
Outcome measures
| Measure |
Rimegepant
n=18 Participants
Participants receive a rimegepant 75 mg tablet orally every other day for 16 weeks.
Rimegepant: Active Agent
|
Placebo
n=17 Participants
Participants receive a placebo tablet matching rimegepant orally every other day for 16 weeks.
Placebo: Placebo Comparator
|
Rimegepant Extension-Previously Received Rimegepant-Open Label
n=12 Participants
Participants who previously received rimegepant receive a rimegepant 75 mg tablet orally every other day for an additional 12 weeks.
Rimegepant: Active Agent
|
Rimegepant Extension-Previously Received Placebo-Open Label
n=6 Participants
Participants who previously received placebo receive a rimegepant 75 mg tablet orally every other day for an additional 12 weeks.
Rimegepant: Active Agent
|
|---|---|---|---|---|
|
Change in Dermatology Quality of Life Index
|
2.22 score on a scale
Standard Deviation 5.15
|
4.65 score on a scale
Standard Deviation 8.4
|
1.45 score on a scale
Standard Deviation 5.28
|
0.5 score on a scale
Standard Deviation 2.07
|
SECONDARY outcome
Timeframe: Baseline and Week 16 for placebo controlled trial. For Extension Phase, Visit 11/12 (Day 1) to Week 12.Population: The number of subjects in each arm of the extension phase of our study are a subset of the subjects treated in the double blind, placebo controlled initial phase of the study. Furthermore, one subject assigned to the placebo group was not included in the analysis due to having an adverse reaction (very severe insect bite reaction) prior to the first scheduled evaluation. Thus, the total number of analyzed subjects in the placebo-controlled phase was 35.
The Visual Analogue Scale ranges from 0 to 10. 0= no pruritus, \< 3= mild pruritus, ≥ 3-\<7= moderate pruritus, ≥ 7-\<9 = severe pruritus, ≥ 9= very severe pruritus. We separately measured the reduction in average itch over the preceding 3 days and the reduction in maximum itch over the previous 7 days for each subject. For the extension phase, it is particularly interesting if a change is noted in the group that received placebo prior to the extension phase.
Outcome measures
| Measure |
Rimegepant
n=18 Participants
Participants receive a rimegepant 75 mg tablet orally every other day for 16 weeks.
Rimegepant: Active Agent
|
Placebo
n=17 Participants
Participants receive a placebo tablet matching rimegepant orally every other day for 16 weeks.
Placebo: Placebo Comparator
|
Rimegepant Extension-Previously Received Rimegepant-Open Label
n=12 Participants
Participants who previously received rimegepant receive a rimegepant 75 mg tablet orally every other day for an additional 12 weeks.
Rimegepant: Active Agent
|
Rimegepant Extension-Previously Received Placebo-Open Label
n=6 Participants
Participants who previously received placebo receive a rimegepant 75 mg tablet orally every other day for an additional 12 weeks.
Rimegepant: Active Agent
|
|---|---|---|---|---|
|
Change in Degree of Itching Assessed by the Visual Analogue Scale
Mean reduction in average itch
|
0.76 score on a scale
Standard Deviation 2.64
|
2.05 score on a scale
Standard Deviation 3.06
|
0.58 score on a scale
Standard Deviation 2.01
|
-0.07 score on a scale
Standard Deviation 1.02
|
|
Change in Degree of Itching Assessed by the Visual Analogue Scale
Mean reduction max itch
|
0.93 score on a scale
Standard Deviation 2.97
|
1.86 score on a scale
Standard Deviation 2.81
|
0.43 score on a scale
Standard Deviation 2.08
|
-0.02 score on a scale
Standard Deviation 1.09
|
POST_HOC outcome
Timeframe: Visit 11/12 (Day 1) to Visit 15 (Week 12).Total score of Psoriasis Area and Severity Index ranges from 0 to 72. A low score means less severe disease while a high score reflects more severe disease. A score of 0 means no psoriasis. A PASI score of 5 to 10 is considered moderate disease and a score over 10 is considered severe. A score over 40 is rare. Change = (Week 15 score-Visit 12 score) for the extension phase was examined.
Outcome measures
| Measure |
Rimegepant
n=12 Participants
Participants receive a rimegepant 75 mg tablet orally every other day for 16 weeks.
Rimegepant: Active Agent
|
Placebo
Participants receive a placebo tablet matching rimegepant orally every other day for 16 weeks.
Placebo: Placebo Comparator
|
Rimegepant Extension-Previously Received Rimegepant-Open Label
Participants who previously received rimegepant receive a rimegepant 75 mg tablet orally every other day for an additional 12 weeks.
Rimegepant: Active Agent
|
Rimegepant Extension-Previously Received Placebo-Open Label
Participants who previously received placebo receive a rimegepant 75 mg tablet orally every other day for an additional 12 weeks.
Rimegepant: Active Agent
|
|---|---|---|---|---|
|
Median Change in the Psoriasis Area and Severity Index (PASI) Instrument Score From Visit 11/12 to Visit 15 in the Extension Phase - Previously Received Rimegepant Group
|
0.9 score on a scale
Interval -3.0 to 5.2
|
—
|
—
|
—
|
POST_HOC outcome
Timeframe: Visit 11/12 (Day 1) to Visit 15 (Week 12).Total score of Psoriasis Area and Severity Index ranges from 0 to 72. A low score means less severe disease while a high score reflects more severe disease. A score of 0 means no psoriasis. A PASI score of 5 to 10 is considered moderate disease and a score over 10 is considered severe. A score over 40 is rare. Change = (Week 15 score-Visit 12 score) for the extension phase was examined.
Outcome measures
| Measure |
Rimegepant
n=6 Participants
Participants receive a rimegepant 75 mg tablet orally every other day for 16 weeks.
Rimegepant: Active Agent
|
Placebo
Participants receive a placebo tablet matching rimegepant orally every other day for 16 weeks.
Placebo: Placebo Comparator
|
Rimegepant Extension-Previously Received Rimegepant-Open Label
Participants who previously received rimegepant receive a rimegepant 75 mg tablet orally every other day for an additional 12 weeks.
Rimegepant: Active Agent
|
Rimegepant Extension-Previously Received Placebo-Open Label
Participants who previously received placebo receive a rimegepant 75 mg tablet orally every other day for an additional 12 weeks.
Rimegepant: Active Agent
|
|---|---|---|---|---|
|
Median Change in the Psoriasis Area and Severity Index (PASI) Instrument Score From Visit 11/12 to Visit 15 in the Extension Phase - Previously Received Placebo Group
|
1.35 score on a scale
Interval -1.69 to 5.8
|
—
|
—
|
—
|
POST_HOC outcome
Timeframe: Visit 11/12 (Day 1) to Visit 15 (Week 12).Dermatology Quality of Life Index score ranges from 0-30. . 0 - 1 no effect at all on patient's life, 2 - 5 small effect on patient's life, 6 - 10 moderate effect on patient's life, 11 - 20 very large effect on patient's life, 21 - 30 extremely large effect on patient's life. Change in Median Score of Each Group = (Visit 15 median score-Visit 11/12 median score) for the extension phase was examined
Outcome measures
| Measure |
Rimegepant
n=12 Participants
Participants receive a rimegepant 75 mg tablet orally every other day for 16 weeks.
Rimegepant: Active Agent
|
Placebo
Participants receive a placebo tablet matching rimegepant orally every other day for 16 weeks.
Placebo: Placebo Comparator
|
Rimegepant Extension-Previously Received Rimegepant-Open Label
Participants who previously received rimegepant receive a rimegepant 75 mg tablet orally every other day for an additional 12 weeks.
Rimegepant: Active Agent
|
Rimegepant Extension-Previously Received Placebo-Open Label
Participants who previously received placebo receive a rimegepant 75 mg tablet orally every other day for an additional 12 weeks.
Rimegepant: Active Agent
|
|---|---|---|---|---|
|
Median Change in the Dermatology Life Quality Index (DLQI) Instrument Score From Visit 11/12 to Visit 15 in the Extension Phase - Previously Received Rimegepant Group
|
0 score on a scale
Interval -6.0 to 14.0
|
—
|
—
|
—
|
POST_HOC outcome
Timeframe: Visit 11/12 (Day 1) to Visit 15 (Week 12).Dermatology Quality of Life Index score ranges from 0-30. . 0 - 1 no effect at all on patient's life, 2 - 5 small effect on patient's life, 6 - 10 moderate effect on patient's life, 11 - 20 very large effect on patient's life, 21 - 30 extremely large effect on patient's life. Change in Median Score of Each Group = (Visit 15 median score-Visit 11/12 median score) for the extension phase was examined
Outcome measures
| Measure |
Rimegepant
n=6 Participants
Participants receive a rimegepant 75 mg tablet orally every other day for 16 weeks.
Rimegepant: Active Agent
|
Placebo
Participants receive a placebo tablet matching rimegepant orally every other day for 16 weeks.
Placebo: Placebo Comparator
|
Rimegepant Extension-Previously Received Rimegepant-Open Label
Participants who previously received rimegepant receive a rimegepant 75 mg tablet orally every other day for an additional 12 weeks.
Rimegepant: Active Agent
|
Rimegepant Extension-Previously Received Placebo-Open Label
Participants who previously received placebo receive a rimegepant 75 mg tablet orally every other day for an additional 12 weeks.
Rimegepant: Active Agent
|
|---|---|---|---|---|
|
Median Change in the Dermatology Life Quality Index (DLQI) Instrument Score From Visit 11/12 to Visit 15 in the Extension Phase - Previously Received Placebo Group
|
0.5 score on a scale
Interval -3.0 to 3.0
|
—
|
—
|
—
|
POST_HOC outcome
Timeframe: Visit 11/12 (Day 1) to Visit 15 (Week 12).Score of the Investigator's Global Assessment instrument ranges from 0 to 5. Three parameters (erythema, induration and scaling, each is scored on a scale of 0 to 5. Erythema: 0 to 5 is the scale of intensity of erythema with 5 being the highest. Induration: 0 to 5 reflects the degree of elevation of the lesion with 5 being the most elevated. Scaling: 0 to 5 is the abundance of scale as well as the thickness and tenacious character of the scale with 5 being the most abundant, thick and tenacious scale) were each measured and averaged to obtain a score averaged to the nearest integer. The change from Visit 11/12 to Visit 15 for the extension phase was examined.
Outcome measures
| Measure |
Rimegepant
n=12 Participants
Participants receive a rimegepant 75 mg tablet orally every other day for 16 weeks.
Rimegepant: Active Agent
|
Placebo
Participants receive a placebo tablet matching rimegepant orally every other day for 16 weeks.
Placebo: Placebo Comparator
|
Rimegepant Extension-Previously Received Rimegepant-Open Label
Participants who previously received rimegepant receive a rimegepant 75 mg tablet orally every other day for an additional 12 weeks.
Rimegepant: Active Agent
|
Rimegepant Extension-Previously Received Placebo-Open Label
Participants who previously received placebo receive a rimegepant 75 mg tablet orally every other day for an additional 12 weeks.
Rimegepant: Active Agent
|
|---|---|---|---|---|
|
Change in Severity of Psoriasis as Assessed by the Investigator's Global Assessment Instrument From Visit 11/12 to Visit 15 in the Extension Phase - Previously Received Rimegepant Group
|
0 score on a scale
Interval 0.0 to 1.0
|
—
|
—
|
—
|
POST_HOC outcome
Timeframe: Visit 11/12 (Day 1) to Visit 15 (Week 12).Score of the Investigator's Global Assessment instrument ranges from 0 to 5. Three parameters (erythema, induration and scaling, each is scored on a scale of 0 to 5. Erythema: 0 to 5 is the scale of intensity of erythema with 5 being the highest. Induration: 0 to 5 reflects the degree of elevation of the lesion with 5 being the most elevated. Scaling: 0 to 5 is the abundance of scale as well as the thickness and tenacious character of the scale with 5 being the most abundant, thick and tenacious scale) were each measured and averaged to obtain a score averaged to the nearest integer. The change from Visit 11/12 to Visit 15 for the extension phase was examined.
Outcome measures
| Measure |
Rimegepant
n=6 Participants
Participants receive a rimegepant 75 mg tablet orally every other day for 16 weeks.
Rimegepant: Active Agent
|
Placebo
Participants receive a placebo tablet matching rimegepant orally every other day for 16 weeks.
Placebo: Placebo Comparator
|
Rimegepant Extension-Previously Received Rimegepant-Open Label
Participants who previously received rimegepant receive a rimegepant 75 mg tablet orally every other day for an additional 12 weeks.
Rimegepant: Active Agent
|
Rimegepant Extension-Previously Received Placebo-Open Label
Participants who previously received placebo receive a rimegepant 75 mg tablet orally every other day for an additional 12 weeks.
Rimegepant: Active Agent
|
|---|---|---|---|---|
|
Change in Severity of Psoriasis as Assessed by the Investigator's Global Assessment Instrument From Visit 11/12 to Visit 15 in the Extension Phase - Previously Received Placebo Group
|
0.5 score on a scale
Interval 0.0 to 1.0
|
—
|
—
|
—
|
POST_HOC outcome
Timeframe: Visit 11/12 (Day 1) to Visit 15 (Week 12).The Visual Analogue Scale ranges from 0 to 10. 0= no pruritus, \< 3= mild pruritus, ≥ 3-\<7= moderate pruritus, ≥ 7-\<9 = severe pruritus, ≥ 9= very severe pruritus. We separately measured the reduction in average itch over the preceding 3 days and the reduction in maximum itch over the previous 7 days for each subject. Have examined the change in each score from visit 11/12 to visit 15 in the extension phase.
Outcome measures
| Measure |
Rimegepant
n=12 Participants
Participants receive a rimegepant 75 mg tablet orally every other day for 16 weeks.
Rimegepant: Active Agent
|
Placebo
Participants receive a placebo tablet matching rimegepant orally every other day for 16 weeks.
Placebo: Placebo Comparator
|
Rimegepant Extension-Previously Received Rimegepant-Open Label
Participants who previously received rimegepant receive a rimegepant 75 mg tablet orally every other day for an additional 12 weeks.
Rimegepant: Active Agent
|
Rimegepant Extension-Previously Received Placebo-Open Label
Participants who previously received placebo receive a rimegepant 75 mg tablet orally every other day for an additional 12 weeks.
Rimegepant: Active Agent
|
|---|---|---|---|---|
|
Change in Degree of Itching Assessed by the Visual Analogue Scale From Visit 11/12 to Visit 15 in the Extension Phase - Previously Received Rimegepant Group
Average Itch Preceding 3 Days
|
0.6 score on a scale
Interval -3.6 to 4.5
|
—
|
—
|
—
|
|
Change in Degree of Itching Assessed by the Visual Analogue Scale From Visit 11/12 to Visit 15 in the Extension Phase - Previously Received Rimegepant Group
Maximum Itch Within the Preceding 7 days
|
0.4 score on a scale
Interval -4.5 to 3.5
|
—
|
—
|
—
|
POST_HOC outcome
Timeframe: Visit 11/12 (Day 1) to Visit 15 (Week 12).The Visual Analogue Scale ranges from 0 to 10. 0= no pruritus, \< 3= mild pruritus, ≥ 3-\<7= moderate pruritus, ≥ 7-\<9 = severe pruritus, ≥ 9= very severe pruritus. We separately measured the reduction in average itch over the preceding 3 days and the reduction in maximum itch over the previous 7 days for each subject. Have examined the change in each score from visit 11/12 to visit 15 in the extension phase.
Outcome measures
| Measure |
Rimegepant
n=6 Participants
Participants receive a rimegepant 75 mg tablet orally every other day for 16 weeks.
Rimegepant: Active Agent
|
Placebo
Participants receive a placebo tablet matching rimegepant orally every other day for 16 weeks.
Placebo: Placebo Comparator
|
Rimegepant Extension-Previously Received Rimegepant-Open Label
Participants who previously received rimegepant receive a rimegepant 75 mg tablet orally every other day for an additional 12 weeks.
Rimegepant: Active Agent
|
Rimegepant Extension-Previously Received Placebo-Open Label
Participants who previously received placebo receive a rimegepant 75 mg tablet orally every other day for an additional 12 weeks.
Rimegepant: Active Agent
|
|---|---|---|---|---|
|
Change in Degree of Itching Assessed by the Visual Analogue Scale From Visit 11/12 to Visit 15 in the Extension Phase - Previously Received Placebo Group
Average Itch Preceding 3 Days
|
0.05 score on a scale
Interval -1.7 to 1.4
|
—
|
—
|
—
|
|
Change in Degree of Itching Assessed by the Visual Analogue Scale From Visit 11/12 to Visit 15 in the Extension Phase - Previously Received Placebo Group
Maximum Itch Within the Preceding 7 Days
|
0 score on a scale
Interval -1.7 to 1.7
|
—
|
—
|
—
|
Adverse Events
Rimegepant
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Rimegepant Extension-Previously Received Rimegepant-Open Label
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Rimegepant Extension-Previously Received Placebo-Open Label
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Rimegepant
n=18 participants at risk
Participants receive a rimegepant 75 mg tablet orally every other day for 16 weeks.
Rimegepant: Active Agent
|
Placebo
n=18 participants at risk
Participants receive a placebo tablet matching rimegepant orally every other day for 16 weeks.
Placebo: Placebo Comparator
|
Rimegepant Extension-Previously Received Rimegepant-Open Label
n=12 participants at risk
Participants who previously received rimegepant receive a rimegepant 75 mg tablet orally every other day for an additional 12 weeks.
Rimegepant: Active Agent
|
Rimegepant Extension-Previously Received Placebo-Open Label
n=6 participants at risk
Participants who previously received placebo receive a rimegepant 75 mg tablet orally every other day for an additional 12 weeks.
Rimegepant: Active Agent
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Acid Reflux
|
0.00%
0/18 • 20 weeks for the placebo-controlled phase for subjects that complete that phase and up to 34 weeks for subjects that enter the extension phase and completed it.
One subject was withdrawn from the placebo group between the baseline visit and visit 1 due to an adverse reaction to bug bites. Therefore, the subject received IP and would be at risk for an AE but was not included in the analysis as we did not collect visit 1 data. Thus, for purposes of adverse events all 18 subjects assigned to the placebo group were included in the adverse events tables while only 17 subjects were included in the placebo-controlled phase in the outcome measures data tables.
|
0.00%
0/18 • 20 weeks for the placebo-controlled phase for subjects that complete that phase and up to 34 weeks for subjects that enter the extension phase and completed it.
One subject was withdrawn from the placebo group between the baseline visit and visit 1 due to an adverse reaction to bug bites. Therefore, the subject received IP and would be at risk for an AE but was not included in the analysis as we did not collect visit 1 data. Thus, for purposes of adverse events all 18 subjects assigned to the placebo group were included in the adverse events tables while only 17 subjects were included in the placebo-controlled phase in the outcome measures data tables.
|
0.00%
0/12 • 20 weeks for the placebo-controlled phase for subjects that complete that phase and up to 34 weeks for subjects that enter the extension phase and completed it.
One subject was withdrawn from the placebo group between the baseline visit and visit 1 due to an adverse reaction to bug bites. Therefore, the subject received IP and would be at risk for an AE but was not included in the analysis as we did not collect visit 1 data. Thus, for purposes of adverse events all 18 subjects assigned to the placebo group were included in the adverse events tables while only 17 subjects were included in the placebo-controlled phase in the outcome measures data tables.
|
16.7%
1/6 • Number of events 1 • 20 weeks for the placebo-controlled phase for subjects that complete that phase and up to 34 weeks for subjects that enter the extension phase and completed it.
One subject was withdrawn from the placebo group between the baseline visit and visit 1 due to an adverse reaction to bug bites. Therefore, the subject received IP and would be at risk for an AE but was not included in the analysis as we did not collect visit 1 data. Thus, for purposes of adverse events all 18 subjects assigned to the placebo group were included in the adverse events tables while only 17 subjects were included in the placebo-controlled phase in the outcome measures data tables.
|
|
Eye disorders
Blurry Vision
|
5.6%
1/18 • Number of events 1 • 20 weeks for the placebo-controlled phase for subjects that complete that phase and up to 34 weeks for subjects that enter the extension phase and completed it.
One subject was withdrawn from the placebo group between the baseline visit and visit 1 due to an adverse reaction to bug bites. Therefore, the subject received IP and would be at risk for an AE but was not included in the analysis as we did not collect visit 1 data. Thus, for purposes of adverse events all 18 subjects assigned to the placebo group were included in the adverse events tables while only 17 subjects were included in the placebo-controlled phase in the outcome measures data tables.
|
0.00%
0/18 • 20 weeks for the placebo-controlled phase for subjects that complete that phase and up to 34 weeks for subjects that enter the extension phase and completed it.
One subject was withdrawn from the placebo group between the baseline visit and visit 1 due to an adverse reaction to bug bites. Therefore, the subject received IP and would be at risk for an AE but was not included in the analysis as we did not collect visit 1 data. Thus, for purposes of adverse events all 18 subjects assigned to the placebo group were included in the adverse events tables while only 17 subjects were included in the placebo-controlled phase in the outcome measures data tables.
|
0.00%
0/12 • 20 weeks for the placebo-controlled phase for subjects that complete that phase and up to 34 weeks for subjects that enter the extension phase and completed it.
One subject was withdrawn from the placebo group between the baseline visit and visit 1 due to an adverse reaction to bug bites. Therefore, the subject received IP and would be at risk for an AE but was not included in the analysis as we did not collect visit 1 data. Thus, for purposes of adverse events all 18 subjects assigned to the placebo group were included in the adverse events tables while only 17 subjects were included in the placebo-controlled phase in the outcome measures data tables.
|
0.00%
0/6 • 20 weeks for the placebo-controlled phase for subjects that complete that phase and up to 34 weeks for subjects that enter the extension phase and completed it.
One subject was withdrawn from the placebo group between the baseline visit and visit 1 due to an adverse reaction to bug bites. Therefore, the subject received IP and would be at risk for an AE but was not included in the analysis as we did not collect visit 1 data. Thus, for purposes of adverse events all 18 subjects assigned to the placebo group were included in the adverse events tables while only 17 subjects were included in the placebo-controlled phase in the outcome measures data tables.
|
|
General disorders
Light Headedness Upon Standing
|
0.00%
0/18 • 20 weeks for the placebo-controlled phase for subjects that complete that phase and up to 34 weeks for subjects that enter the extension phase and completed it.
One subject was withdrawn from the placebo group between the baseline visit and visit 1 due to an adverse reaction to bug bites. Therefore, the subject received IP and would be at risk for an AE but was not included in the analysis as we did not collect visit 1 data. Thus, for purposes of adverse events all 18 subjects assigned to the placebo group were included in the adverse events tables while only 17 subjects were included in the placebo-controlled phase in the outcome measures data tables.
|
5.6%
1/18 • Number of events 1 • 20 weeks for the placebo-controlled phase for subjects that complete that phase and up to 34 weeks for subjects that enter the extension phase and completed it.
One subject was withdrawn from the placebo group between the baseline visit and visit 1 due to an adverse reaction to bug bites. Therefore, the subject received IP and would be at risk for an AE but was not included in the analysis as we did not collect visit 1 data. Thus, for purposes of adverse events all 18 subjects assigned to the placebo group were included in the adverse events tables while only 17 subjects were included in the placebo-controlled phase in the outcome measures data tables.
|
0.00%
0/12 • 20 weeks for the placebo-controlled phase for subjects that complete that phase and up to 34 weeks for subjects that enter the extension phase and completed it.
One subject was withdrawn from the placebo group between the baseline visit and visit 1 due to an adverse reaction to bug bites. Therefore, the subject received IP and would be at risk for an AE but was not included in the analysis as we did not collect visit 1 data. Thus, for purposes of adverse events all 18 subjects assigned to the placebo group were included in the adverse events tables while only 17 subjects were included in the placebo-controlled phase in the outcome measures data tables.
|
0.00%
0/6 • 20 weeks for the placebo-controlled phase for subjects that complete that phase and up to 34 weeks for subjects that enter the extension phase and completed it.
One subject was withdrawn from the placebo group between the baseline visit and visit 1 due to an adverse reaction to bug bites. Therefore, the subject received IP and would be at risk for an AE but was not included in the analysis as we did not collect visit 1 data. Thus, for purposes of adverse events all 18 subjects assigned to the placebo group were included in the adverse events tables while only 17 subjects were included in the placebo-controlled phase in the outcome measures data tables.
|
|
Musculoskeletal and connective tissue disorders
Muscle Cramps
|
0.00%
0/18 • 20 weeks for the placebo-controlled phase for subjects that complete that phase and up to 34 weeks for subjects that enter the extension phase and completed it.
One subject was withdrawn from the placebo group between the baseline visit and visit 1 due to an adverse reaction to bug bites. Therefore, the subject received IP and would be at risk for an AE but was not included in the analysis as we did not collect visit 1 data. Thus, for purposes of adverse events all 18 subjects assigned to the placebo group were included in the adverse events tables while only 17 subjects were included in the placebo-controlled phase in the outcome measures data tables.
|
0.00%
0/18 • 20 weeks for the placebo-controlled phase for subjects that complete that phase and up to 34 weeks for subjects that enter the extension phase and completed it.
One subject was withdrawn from the placebo group between the baseline visit and visit 1 due to an adverse reaction to bug bites. Therefore, the subject received IP and would be at risk for an AE but was not included in the analysis as we did not collect visit 1 data. Thus, for purposes of adverse events all 18 subjects assigned to the placebo group were included in the adverse events tables while only 17 subjects were included in the placebo-controlled phase in the outcome measures data tables.
|
0.00%
0/12 • 20 weeks for the placebo-controlled phase for subjects that complete that phase and up to 34 weeks for subjects that enter the extension phase and completed it.
One subject was withdrawn from the placebo group between the baseline visit and visit 1 due to an adverse reaction to bug bites. Therefore, the subject received IP and would be at risk for an AE but was not included in the analysis as we did not collect visit 1 data. Thus, for purposes of adverse events all 18 subjects assigned to the placebo group were included in the adverse events tables while only 17 subjects were included in the placebo-controlled phase in the outcome measures data tables.
|
16.7%
1/6 • Number of events 1 • 20 weeks for the placebo-controlled phase for subjects that complete that phase and up to 34 weeks for subjects that enter the extension phase and completed it.
One subject was withdrawn from the placebo group between the baseline visit and visit 1 due to an adverse reaction to bug bites. Therefore, the subject received IP and would be at risk for an AE but was not included in the analysis as we did not collect visit 1 data. Thus, for purposes of adverse events all 18 subjects assigned to the placebo group were included in the adverse events tables while only 17 subjects were included in the placebo-controlled phase in the outcome measures data tables.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/18 • 20 weeks for the placebo-controlled phase for subjects that complete that phase and up to 34 weeks for subjects that enter the extension phase and completed it.
One subject was withdrawn from the placebo group between the baseline visit and visit 1 due to an adverse reaction to bug bites. Therefore, the subject received IP and would be at risk for an AE but was not included in the analysis as we did not collect visit 1 data. Thus, for purposes of adverse events all 18 subjects assigned to the placebo group were included in the adverse events tables while only 17 subjects were included in the placebo-controlled phase in the outcome measures data tables.
|
11.1%
2/18 • Number of events 2 • 20 weeks for the placebo-controlled phase for subjects that complete that phase and up to 34 weeks for subjects that enter the extension phase and completed it.
One subject was withdrawn from the placebo group between the baseline visit and visit 1 due to an adverse reaction to bug bites. Therefore, the subject received IP and would be at risk for an AE but was not included in the analysis as we did not collect visit 1 data. Thus, for purposes of adverse events all 18 subjects assigned to the placebo group were included in the adverse events tables while only 17 subjects were included in the placebo-controlled phase in the outcome measures data tables.
|
0.00%
0/12 • 20 weeks for the placebo-controlled phase for subjects that complete that phase and up to 34 weeks for subjects that enter the extension phase and completed it.
One subject was withdrawn from the placebo group between the baseline visit and visit 1 due to an adverse reaction to bug bites. Therefore, the subject received IP and would be at risk for an AE but was not included in the analysis as we did not collect visit 1 data. Thus, for purposes of adverse events all 18 subjects assigned to the placebo group were included in the adverse events tables while only 17 subjects were included in the placebo-controlled phase in the outcome measures data tables.
|
0.00%
0/6 • 20 weeks for the placebo-controlled phase for subjects that complete that phase and up to 34 weeks for subjects that enter the extension phase and completed it.
One subject was withdrawn from the placebo group between the baseline visit and visit 1 due to an adverse reaction to bug bites. Therefore, the subject received IP and would be at risk for an AE but was not included in the analysis as we did not collect visit 1 data. Thus, for purposes of adverse events all 18 subjects assigned to the placebo group were included in the adverse events tables while only 17 subjects were included in the placebo-controlled phase in the outcome measures data tables.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/18 • 20 weeks for the placebo-controlled phase for subjects that complete that phase and up to 34 weeks for subjects that enter the extension phase and completed it.
One subject was withdrawn from the placebo group between the baseline visit and visit 1 due to an adverse reaction to bug bites. Therefore, the subject received IP and would be at risk for an AE but was not included in the analysis as we did not collect visit 1 data. Thus, for purposes of adverse events all 18 subjects assigned to the placebo group were included in the adverse events tables while only 17 subjects were included in the placebo-controlled phase in the outcome measures data tables.
|
5.6%
1/18 • Number of events 1 • 20 weeks for the placebo-controlled phase for subjects that complete that phase and up to 34 weeks for subjects that enter the extension phase and completed it.
One subject was withdrawn from the placebo group between the baseline visit and visit 1 due to an adverse reaction to bug bites. Therefore, the subject received IP and would be at risk for an AE but was not included in the analysis as we did not collect visit 1 data. Thus, for purposes of adverse events all 18 subjects assigned to the placebo group were included in the adverse events tables while only 17 subjects were included in the placebo-controlled phase in the outcome measures data tables.
|
0.00%
0/12 • 20 weeks for the placebo-controlled phase for subjects that complete that phase and up to 34 weeks for subjects that enter the extension phase and completed it.
One subject was withdrawn from the placebo group between the baseline visit and visit 1 due to an adverse reaction to bug bites. Therefore, the subject received IP and would be at risk for an AE but was not included in the analysis as we did not collect visit 1 data. Thus, for purposes of adverse events all 18 subjects assigned to the placebo group were included in the adverse events tables while only 17 subjects were included in the placebo-controlled phase in the outcome measures data tables.
|
0.00%
0/6 • 20 weeks for the placebo-controlled phase for subjects that complete that phase and up to 34 weeks for subjects that enter the extension phase and completed it.
One subject was withdrawn from the placebo group between the baseline visit and visit 1 due to an adverse reaction to bug bites. Therefore, the subject received IP and would be at risk for an AE but was not included in the analysis as we did not collect visit 1 data. Thus, for purposes of adverse events all 18 subjects assigned to the placebo group were included in the adverse events tables while only 17 subjects were included in the placebo-controlled phase in the outcome measures data tables.
|
|
General disorders
Dizziness
|
0.00%
0/18 • 20 weeks for the placebo-controlled phase for subjects that complete that phase and up to 34 weeks for subjects that enter the extension phase and completed it.
One subject was withdrawn from the placebo group between the baseline visit and visit 1 due to an adverse reaction to bug bites. Therefore, the subject received IP and would be at risk for an AE but was not included in the analysis as we did not collect visit 1 data. Thus, for purposes of adverse events all 18 subjects assigned to the placebo group were included in the adverse events tables while only 17 subjects were included in the placebo-controlled phase in the outcome measures data tables.
|
5.6%
1/18 • Number of events 1 • 20 weeks for the placebo-controlled phase for subjects that complete that phase and up to 34 weeks for subjects that enter the extension phase and completed it.
One subject was withdrawn from the placebo group between the baseline visit and visit 1 due to an adverse reaction to bug bites. Therefore, the subject received IP and would be at risk for an AE but was not included in the analysis as we did not collect visit 1 data. Thus, for purposes of adverse events all 18 subjects assigned to the placebo group were included in the adverse events tables while only 17 subjects were included in the placebo-controlled phase in the outcome measures data tables.
|
0.00%
0/12 • 20 weeks for the placebo-controlled phase for subjects that complete that phase and up to 34 weeks for subjects that enter the extension phase and completed it.
One subject was withdrawn from the placebo group between the baseline visit and visit 1 due to an adverse reaction to bug bites. Therefore, the subject received IP and would be at risk for an AE but was not included in the analysis as we did not collect visit 1 data. Thus, for purposes of adverse events all 18 subjects assigned to the placebo group were included in the adverse events tables while only 17 subjects were included in the placebo-controlled phase in the outcome measures data tables.
|
0.00%
0/6 • 20 weeks for the placebo-controlled phase for subjects that complete that phase and up to 34 weeks for subjects that enter the extension phase and completed it.
One subject was withdrawn from the placebo group between the baseline visit and visit 1 due to an adverse reaction to bug bites. Therefore, the subject received IP and would be at risk for an AE but was not included in the analysis as we did not collect visit 1 data. Thus, for purposes of adverse events all 18 subjects assigned to the placebo group were included in the adverse events tables while only 17 subjects were included in the placebo-controlled phase in the outcome measures data tables.
|
|
Immune system disorders
Exaggerated Reaction to Insect Bites
|
0.00%
0/18 • 20 weeks for the placebo-controlled phase for subjects that complete that phase and up to 34 weeks for subjects that enter the extension phase and completed it.
One subject was withdrawn from the placebo group between the baseline visit and visit 1 due to an adverse reaction to bug bites. Therefore, the subject received IP and would be at risk for an AE but was not included in the analysis as we did not collect visit 1 data. Thus, for purposes of adverse events all 18 subjects assigned to the placebo group were included in the adverse events tables while only 17 subjects were included in the placebo-controlled phase in the outcome measures data tables.
|
5.6%
1/18 • Number of events 1 • 20 weeks for the placebo-controlled phase for subjects that complete that phase and up to 34 weeks for subjects that enter the extension phase and completed it.
One subject was withdrawn from the placebo group between the baseline visit and visit 1 due to an adverse reaction to bug bites. Therefore, the subject received IP and would be at risk for an AE but was not included in the analysis as we did not collect visit 1 data. Thus, for purposes of adverse events all 18 subjects assigned to the placebo group were included in the adverse events tables while only 17 subjects were included in the placebo-controlled phase in the outcome measures data tables.
|
0.00%
0/12 • 20 weeks for the placebo-controlled phase for subjects that complete that phase and up to 34 weeks for subjects that enter the extension phase and completed it.
One subject was withdrawn from the placebo group between the baseline visit and visit 1 due to an adverse reaction to bug bites. Therefore, the subject received IP and would be at risk for an AE but was not included in the analysis as we did not collect visit 1 data. Thus, for purposes of adverse events all 18 subjects assigned to the placebo group were included in the adverse events tables while only 17 subjects were included in the placebo-controlled phase in the outcome measures data tables.
|
0.00%
0/6 • 20 weeks for the placebo-controlled phase for subjects that complete that phase and up to 34 weeks for subjects that enter the extension phase and completed it.
One subject was withdrawn from the placebo group between the baseline visit and visit 1 due to an adverse reaction to bug bites. Therefore, the subject received IP and would be at risk for an AE but was not included in the analysis as we did not collect visit 1 data. Thus, for purposes of adverse events all 18 subjects assigned to the placebo group were included in the adverse events tables while only 17 subjects were included in the placebo-controlled phase in the outcome measures data tables.
|
|
Endocrine disorders
Irregular Menses
|
0.00%
0/18 • 20 weeks for the placebo-controlled phase for subjects that complete that phase and up to 34 weeks for subjects that enter the extension phase and completed it.
One subject was withdrawn from the placebo group between the baseline visit and visit 1 due to an adverse reaction to bug bites. Therefore, the subject received IP and would be at risk for an AE but was not included in the analysis as we did not collect visit 1 data. Thus, for purposes of adverse events all 18 subjects assigned to the placebo group were included in the adverse events tables while only 17 subjects were included in the placebo-controlled phase in the outcome measures data tables.
|
0.00%
0/18 • 20 weeks for the placebo-controlled phase for subjects that complete that phase and up to 34 weeks for subjects that enter the extension phase and completed it.
One subject was withdrawn from the placebo group between the baseline visit and visit 1 due to an adverse reaction to bug bites. Therefore, the subject received IP and would be at risk for an AE but was not included in the analysis as we did not collect visit 1 data. Thus, for purposes of adverse events all 18 subjects assigned to the placebo group were included in the adverse events tables while only 17 subjects were included in the placebo-controlled phase in the outcome measures data tables.
|
8.3%
1/12 • Number of events 1 • 20 weeks for the placebo-controlled phase for subjects that complete that phase and up to 34 weeks for subjects that enter the extension phase and completed it.
One subject was withdrawn from the placebo group between the baseline visit and visit 1 due to an adverse reaction to bug bites. Therefore, the subject received IP and would be at risk for an AE but was not included in the analysis as we did not collect visit 1 data. Thus, for purposes of adverse events all 18 subjects assigned to the placebo group were included in the adverse events tables while only 17 subjects were included in the placebo-controlled phase in the outcome measures data tables.
|
0.00%
0/6 • 20 weeks for the placebo-controlled phase for subjects that complete that phase and up to 34 weeks for subjects that enter the extension phase and completed it.
One subject was withdrawn from the placebo group between the baseline visit and visit 1 due to an adverse reaction to bug bites. Therefore, the subject received IP and would be at risk for an AE but was not included in the analysis as we did not collect visit 1 data. Thus, for purposes of adverse events all 18 subjects assigned to the placebo group were included in the adverse events tables while only 17 subjects were included in the placebo-controlled phase in the outcome measures data tables.
|
Additional Information
Dr. Richard D. Granstein
Department of Dermatology, Weill Cornell Medicine
Phone: (646) 962-7546
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place