The purpose of this study is to examine the use of a new investigational medication for the treatment of moderate plaque-type psoriasis. The study medication is rimegepant, an orally administered small molecule competitive inhibitor of the calcitonin gene-related peptide (CGRP) receptor. This medication, rimegepant, has been approved by the FDA under the trade name Nurtec for the treatment of acute migraine. However, rimegepant has not been studied in the treatment of moderate plaque-type psoriasis and is investigational for this indication.
This is a randomized, double-blind, placebo-controlled study of rimegepant 75 mg dosed every other day for the treatment of mild to moderate psoriasis. Subjects must have at 3% body surface area involvement before entry into the study. Psoriasis Area and Severity Index (PASI) and Investigator's Global Assessment (IGA) scores will be calculated and subjects will each complete the Dermatology Life Quality Index (DLQI) instrument as well an itch assessments. These assessments will be performed at baseline and every 2 weeks in follow-up. Areas of psoriasis in each subject will be photographed at baseline and two very similar appearing lesions identified for biopsy of one on day 1 and the other at the end of week 16. Patients will also repeat the DLQI at each visit. Subjects will also be photographed at each visit. Subjects will discontinue medications after the end of week 16. Subjects who complete the 20-week protocol will have the option of entering a 3-month, open-label extension of the study in which they will take 75 mg of rimegepant every other day for an additional 12 weeks. Eligible subjects have 2 weeks past visit 11 to enroll in the extension. For those rolling over before visit 11, visits 11 and 12 can be combined. They will have the same 7 assessments as in the previous portion of the study every 4 Protocol #20-07022368 Version Date 5/10/24 weeks including an EKG. The inclusion and exclusion criteria remain the same.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
41
Active Agent
Placebo Comparator
Weill Cornell Medicine
New York, New York, United States
Sadick Dermatology
New York, New York, United States
Change in Severity of Psoriasis as Measured by Percentage Change in the Psoriasis Area and Severity Index (PASI) Instrument
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.
Time frame: Baseline and Week 16 for placebo controlled trial. For Extension Phase, Visit 11/12 (Day 1) to Visit 15 (Week 12).
Number of Subjects Who Had a 50% or Greater Reduction in Psoriasis Area and Severity Index Instrument Score
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.
Time frame: Baseline and Week 16 for placebo controlled trial. For Extension Phase, Visit 11/12 (Day 1) to Visit 15 (Week 12).
Change in Severity of Psoriasis as Assessed by the Investigator's Global Assessment Instrument
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.
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Time frame: Baseline and Week 16 for placebo controlled trial. For Extension Phase, Visit 11/12 (Day 1) to Week 12.
Change in Dermatology Quality of Life Index
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.
Time frame: Baseline and Week 16 for placebo controlled trial. For Extension Phase, Visit 11/12 (Day 1) to Visit 15 (Week 12).
Change in Degree of Itching Assessed by the Visual Analogue Scale
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.
Time frame: Baseline and Week 16 for placebo controlled trial. For Extension Phase, Visit 11/12 (Day 1) to Week 12.