Rimegepant in Moderate Plaque-type Psoriasis

Part of paid clinical trials in New York, New York.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT04629950
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Rimegepant — DRUG
    Active Agent
  • Placebo — DRUG
    Placebo Comparator

Study Details

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.

Key Dates

Start date
Jan 19, 2021
Status verified
Jun 2025
Primary completion
Aug 20, 2024
Completion
Nov 18, 2024

Study Design

Enrollment
41 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Rimegepant
    Participants receive a rimegepant 75 mg tablet orally every other day for 16 weeks.
  • Placebo Comparator: Placebo
    Participants receive a placebo tablet matching rimegepant orally every other day for 16 weeks.
  • Experimental: 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
  • Experimental: 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

Primary Outcome Measure

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

Locations (2)

FacilityCityStateZIPSite coordinators
Sadick DermatologyNew YorkNew York10075-
Weill Cornell MedicineNew YorkNew York10021-

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