Trial results for rimegepant in a Phase 2 study (NCT04629950) for moderate plaque-type psoriasis were posted on ClinicalTrials.gov on 2025-07-17. The study found no statistically significant difference between rimegepant and placebo in the percentage change in Psoriasis Area and Severity Index (PASI) score, with rimegepant showing a mean change of 17.29% compared to 27.06% for placebo.
Background
Rimegepant is an orally administered small molecule competitive inhibitor of the calcitonin gene-related peptide (CGRP) receptor. It is approved by the FDA under the trade name Nurtec ODT for the treatment of acute migraine. This study investigated rimegepant for the treatment of moderate plaque-type psoriasis, an investigational indication for which it has not been previously studied.
Trial design
The study (NCT04629950) was a Phase 2 trial that enrolled 41 participants. The investigation focused on the use of rimegepant for individuals diagnosed with psoriasis. Participants received either rimegepant or placebo as interventions.
Key results
The trial evaluated several outcomes related to psoriasis severity:
- Change in Severity of Psoriasis as Measured by Percentage Change in the Psoriasis Area and Severity Index (PASI) Instrument:
- For the Rimegepant group, the mean percentage change in PASI score was 17.29% (Standard Deviation: 34.43).
- For the Placebo group, the mean percentage change in PASI score was 27.06% (Standard Deviation: 32.58).
- An analysis using a t-test (2 sided) yielded a p-value of 0.395 when comparing rimegepant to placebo.
- In the open-label extension phase, participants who previously received Rimegepant showed a mean change of 7.07% (Standard Deviation: 31.68), while those who previously received Placebo showed a mean change of 20.02% (Standard Deviation: 28.78).
- Number of Subjects Who Had a 50% or Greater Reduction in Psoriasis Area and Severity Index Instrument Score:
- In the Rimegepant group, 3 participants achieved a 50% or greater reduction.
- In the Placebo group, 4 participants achieved a 50% or greater reduction.
- A Fisher Exact analysis yielded a p-value of 0.691 when comparing rimegepant to placebo.
- In the open-label extension phase, 1 participant who previously received Rimegepant achieved this reduction, while 0 participants who previously received Placebo did.
- Change in Severity of Psoriasis as Assessed by the Investigator's Global Assessment Instrument:
- For the Rimegepant group, the mean change was 0.39 (Standard Deviation: 0.98).
- For the Placebo group, the mean change was 0.47 (Standard Deviation: 0.51).
- An analysis using a t-test (2 sided) yielded a p-value of 0.758 when comparing rimegepant to placebo.
- In the open-label extension phase, participants who previously received Rimegepant showed a mean change of 0.18 (Standard Deviation: 0.40), while those who previously received Placebo showed a mean change of 0.5 (Standard Deviation: 0.55).
What this means
The results from this Phase 2 trial indicate that rimegepant did not demonstrate a statistically significant improvement over placebo in treating moderate plaque-type psoriasis. Across key efficacy measures such as percentage change in PASI score, the number of responders with a 50% PASI reduction, and Investigator's Global Assessment scores, the differences between the rimegepant and placebo groups were not statistically significant, with p-values consistently above 0.2. Numerically, placebo showed a greater mean percentage change in PASI score and a higher number of responders compared to rimegepant in the initial phase.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT04629950, titled "Rimegepant in Moderate Plaque-type Psoriasis," were posted on 2025-07-17 on clinicaltrials.gov.