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Small Molecule

Rimegepant for Psoriasis

Phase 2
Recruiting
Led By Richard D Granstein, MD
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Between 18 and 75 years of age
Male or female patients with at least 3% body surface area involved with psoriasis and a PASI score >5
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and week 16
Awards & highlights

Study Summary

This trial is testing a new migraine medication to see if it also works for plaque psoriasis.

Who is the study for?
Adults aged 18-75 with moderate plaque-type psoriasis, covering at least 3% of their body and a PASI score over 5. Participants must use effective contraception if applicable and have no major psychiatric disorders, immune deficiencies, liver or biliary diseases, uncontrolled hypertension or diabetes, recent malignancies, or be on certain medications.Check my eligibility
What is being tested?
The trial is testing Rimegepant's effectiveness for treating moderate plaque-type psoriasis compared to a placebo. Rimegepant is an oral medication already approved for migraines but not yet for psoriasis. Participants will randomly receive either the study drug or a placebo.See study design
What are the potential side effects?
Potential side effects are not detailed in the provided information but may be similar to those experienced by migraine patients taking Rimegepant: nausea, stomach pain, indigestion; however specific side effects related to psoriasis treatment are unknown.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 75 years old.
Select...
I have psoriasis affecting more than 3% of my body and a PASI score over 5.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and week 16
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and week 16 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Severity of Psoriasis as Measured with the Psoriasis Area and Severity Index (PASI) Instrument
Secondary outcome measures
Average Change in Psoriasis Area and Severity Index Instrument Score
Change in Degree of Itching Assessed by the Visual Analogue Scale
Change in Dermatology Quality of Life Index
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: RimegepantExperimental Treatment1 Intervention
Participants receive a rimegepant 75 mg tablet orally every other day for 16 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Participants receive a placebo tablet matching rimegepant orally every other day for 16 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rimegepant
2021
Completed Phase 4
~12670

Find a Location

Who is running the clinical trial?

PfizerIndustry Sponsor
4,570 Previous Clinical Trials
10,910,410 Total Patients Enrolled
67 Trials studying Psoriasis
172,547 Patients Enrolled for Psoriasis
Weill Medical College of Cornell UniversityLead Sponsor
1,054 Previous Clinical Trials
1,316,279 Total Patients Enrolled
2 Trials studying Psoriasis
40 Patients Enrolled for Psoriasis
Biohaven Pharmaceuticals, Inc.Industry Sponsor
47 Previous Clinical Trials
37,105 Total Patients Enrolled

Media Library

Rimegepant (Small Molecule) Clinical Trial Eligibility Overview. Trial Name: NCT04629950 — Phase 2
Psoriasis Clinical Trial 2023: Rimegepant Highlights & Side Effects. Trial Name: NCT04629950 — Phase 2
Rimegepant (Small Molecule) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04629950 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA granted clearance to Rimegepant?

"Rimegepant's safety has been partially validated in a Phase 2 trial, so it was given an assessment of 2. Unfortunately, there are no clinical data supporting its efficacy yet."

Answered by AI

Are there particular demographics that would be beneficial to include in this clinical investigation?

"The qualifications for this medical trial necessitate that participants have psoriasis and be between the ages of 18-75. However, only 30 individuals will ultimately comprise its sample size."

Answered by AI

How many participants are being enrolled for this trial at its maximum capacity?

"Affirmative. The clinicaltrial.gov database specifies that this trial, which was originally shared on January 19th 2021 is actively recruiting participants from a single site and needs 30 people to complete the study."

Answered by AI

Are there still openings to participate in this experiment?

"Affirmative. Information available on clinicaltrials.gov clarifies that this research study, initially posted in January 2021, is currently enrolling volunteers for the trial. 30 individuals need to be sourced from a single site."

Answered by AI

Is this research unprecedented in its scope?

"Since its initial study in 2019, sponsored by Biohaven Pharmaceuticals, Inc., Rimegepant has been actively researched. This drug received Phase 2 approval following the first trial and now there are 6 ongoing studies spanning 9 countries and 251 cities."

Answered by AI

What additional medical experiments have been conducted with Rimegepant?

"Currently, 6 clinical trials dedicated to the study of Rimegepant are in progress with 3 reaching Phase 3. While the primary research site is located in Gilbert Arizona, there are 499 other medical centres conducting related studies."

Answered by AI

Does this research endeavor offer enrollment to senior citizens?

"The requisites for enrolment in this clinical trial demand that potential participants are between 18-75 years old."

Answered by AI
~2 spots leftby Aug 2024