NCT04629950

Rimegepant in Moderate Plaque-type Psoriasis

Completed Phase 2 Results posted Last updated 17 July 2025

What this trial tests

Phase 2 trial testing Rimegepant in Psoriasis in 41 participants. Completed in 18 November 2024.

Timeline

19 January 2021

Primary endpoint
20 August 2024

18 November 2024

Quick facts

Lead sponsor	Weill Medical College of Cornell University
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	41
Start date	19 January 2021
Primary completion	20 August 2024
Estimated completion	18 November 2024
Sites	2 locations across United States

Drugs / interventions tested

• Rimegepant (rimegepant) — full drug profile →
• Placebo

Conditions studied

• Psoriasis — all drugs for Psoriasis →

Sponsor

Weill Medical College of Cornell University

Who can join

Adults 18 to 75, any sex, with Psoriasis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Severity of Psoriasis as Measured by Percentage Change in the Psoriasis Area and Severity Index (PASI) Instrument Primary · Baseline and Week 16 for placebo controlled trial. For Extension Phase, Visit 11/12 (Day 1) to Visit 15 (Week 12).

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,

Group	Value	95% CI
Rimegepant	17.29	± 34.43
Placebo	27.06	± 32.58
Rimegepant Extension-Previously Received Rimegepant-Open Label	7.07	± 31.68
Rimegepant Extension-Previously Received Placebo-Open Label	20.02	± 28.78

Number of Subjects Who Had a 50% or Greater Reduction in Psoriasis Area and Severity Index Instrument Score Secondary · Baseline and Week 16 for placebo controlled trial. For Extension Phase, Visit 11/12 (Day 1) to Visit 15 (Week 12).

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.

Group	Value	95% CI
Rimegepant	3
Placebo	4
Rimegepant Extension-Previously Received Rimegepant-Open Label	1
Rimegepant Extension-Previously Received Placebo-Open Label	0

Change in Severity of Psoriasis as Assessed by the Investigator's Global Assessment Instrument Secondary · Baseline and Week 16 for placebo controlled trial. For Extension Phase, Visit 11/12 (Day 1) to 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 chan

Group	Value	95% CI
Rimegepant	0.39	± 0.98
Placebo	0.47	± 0.51
Rimegepant Extension-Previously Received Rimegepant-Open Label	0.18	± 0.40
Rimegepant Extension-Previously Received Placebo-Open Label	0.5	± 0.55

Change in Dermatology Quality of Life Index Secondary · Baseline and Week 16 for placebo controlled trial. For Extension Phase, Visit 11/12 (Day 1) to Visit 15 (Week 12).

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 e

Group	Value	95% CI
Rimegepant	2.22	± 5.15
Placebo	4.65	± 8.4
Rimegepant Extension-Previously Received Rimegepant-Open Label	1.45	± 5.28
Rimegepant Extension-Previously Received Placebo-Open Label	0.5	± 2.07

Change in Degree of Itching Assessed by the Visual Analogue Scale Secondary · Baseline and Week 16 for placebo controlled trial. For Extension Phase, Visit 11/12 (Day 1) to 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. For the extension phase, it is particularly interesting if a change is noted in the group that received placebo prior to the extension phase.

Mean reduction in average itch

Group	Value	95% CI
Rimegepant	0.76	± 2.64
Placebo	2.05	± 3.06
Rimegepant Extension-Previously Received Rimegepant-Open Label	0.58	± 2.01
Rimegepant Extension-Previously Received Placebo-Open Label	-0.07	± 1.02

Mean reduction max itch

Group	Value	95% CI
Rimegepant	0.93	± 2.97
Placebo	1.86	± 2.81
Rimegepant Extension-Previously Received Rimegepant-Open Label	0.43	± 2.08
Rimegepant Extension-Previously Received Placebo-Open Label	-0.02	± 1.09

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 Secondary · 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.

Group	Value	95% CI
Rimegepant Extension-Previously Received Rimegepant-Open Label	0.9	-3.0 – 5.2

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 Secondary · 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.

Group	Value	95% CI
Rimegepant Extension-Previously Received Placebo-Open Label	1.35	-1.69 – 5.8

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 Secondary · 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

Group	Value	95% CI
Rimegepant Extension-Previously Received Rimegepant-Open Label	0	-6 – 14

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 Secondary · 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

Group	Value	95% CI
Rimegepant Extension-Previously Received Placebo-Open Label	0.5	-3 – 3

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 Secondary · 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 chan

Group	Value	95% CI
Rimegepant Extension-Previously Received Rimegepant-Open Label	0	0 – 1

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 Secondary · 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 chan

Group	Value	95% CI
Rimegepant Extension-Previously Received Placebo-Open Label	0.5	0 – 1

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 Secondary · 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.

Average Itch Preceding 3 Days

Group	Value	95% CI
Rimegepant Extension-Previously Received Rimegepant-Open Label	0.6	-3.6 – 4.5

Maximum Itch Within the Preceding 7 days

Group	Value	95% CI
Rimegepant Extension-Previously Received Rimegepant-Open Label	0.4	-4.5 – 3.5

Adverse events — posted to ClinicalTrials.gov

Time frame: 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.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Rimegepant

Serious: 0/18 (0%)

Deaths: 0/18

Placebo

Serious: 0/18 (0%)

Deaths: 0/18

Rimegepant Extension-Previously Received Rimegepant-Open Label

Serious: 0/12 (0%)

Deaths: 0/12

Rimegepant Extension-Previously Received Placebo-Open Label

Serious: 0/6 (0%)

Deaths: 0/6

Other adverse events (9 terms — click to expand)

Reaction	System	Rimegepant	Placebo	Rimegepant Extension-Previ…	Rimegepant Extension-Previ…
Nausea	Gastrointestinal disorders	—	—	—	—
Acid Reflux	Gastrointestinal disorders	—	—	—	—
Blurry Vision	Eye disorders	—	—	—	—
Light Headedness Upon Standing	General disorders	—	—	—	—
Muscle Cramps	Musculoskeletal and connective tissue disorders	—	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—	—
Dizziness	General disorders	—	—	—	—
Exaggerated Reaction to Insect Bites	Immune system disorders	—	—	—	—
Irregular Menses	Endocrine disorders	—	—	—	—

Data from ClinicalTrials.gov NCT04629950 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Gepants - a long way to cure: a narrative review.
   Altamura C, Brunelli N, Marcosano M, Fofi L, et al · · 2022 · cited 32× · PMID 35650458 · DOI 10.1007/s10072-022-06184-8
2. A Review of the Clinical Trial Landscape in Psoriasis: An Update for Clinicians.
   Drakos A, Vender R. · · 2022 · cited 15× · PMID 36319883 · DOI 10.1007/s13555-022-00840-9