What side effects are associated with this type of intervention?

Common treatments for psoriasis that are similar to Rimegepant include biologics like ustekinumab, which targets specific components of the immune system. Known side effects of ustekinumab include serious infections, nonfatal strokes, myocardial infarctions, and other serious adverse events. These treatments are generally effective but carry risks of significant side effects, particularly related to infections and cardiovascular events.

What prior FDA approvals exist?

The FDA has approved several treatments for psoriasis, including biologic agents and small molecule inhibitors. Biologic agents such as TNF-alpha inhibitors (e.g., infliximab, adalimumab), IL-12/23 inhibitors (e.g., ustekinumab), IL-17 inhibitors (e.g., secukinumab, ixekizumab), and IL-23 inhibitors (e.g., guselkumab, tildrakizumab, risankizumab) have shown efficacy in treating moderate to severe plaque psoriasis. Small molecule inhibitors like apremilast, which targets phosphodiesterase 4, have also been approved. While Rimegepant, a CGRP receptor inhibitor, is being studied for psoriasis, it is currently FDA-approved for acute migraine treatment under the trade name Nurtec.

What other types of research exist?

Promising novel alternatives to Rimegepant for psoriasis patients include Ustekinumab and Secukinumab. Ustekinumab has shown efficacy in improving nail disease in patients with moderate-to-severe psoriasis, while Secukinumab has demonstrated positive results in clinical trials for plaque psoriasis and psoriatic arthritis.

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Small Molecule

Rimegepant for Psoriasis

Phase 2

Waitlist Available

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

Must not have

History or diagnosis of Gilbert's Syndrome or any other active hepatic or biliary disorder

History of major depressive episode, major depressive disorder, anxiety disorder, or specific psychiatric disorders

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and week 16

Summary

This trial is testing rimegepant, a pill that blocks a protein, to see if it helps people with moderate plaque-type psoriasis. This medicine is already used for migraines but hasn't been tried for psoriasis before.

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.

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.

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

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I am between 18 and 75 years old.

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I have psoriasis affecting more than 3% of my body and a PASI score over 5.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have Gilbert's Syndrome or another liver/bile duct condition.

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I have a history of major depression or anxiety.

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I am not taking medications that affect certain enzymes or proteins.

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I have a history of heart disease, high blood pressure, or diabetes that is not well-controlled.

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I haven't taken any biologic drugs or monoclonal antibodies recently.

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I have a condition that weakens my immune system.

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I am currently taking corticosteroids or immunosuppressive medications.

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I have had gallstones in the past.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and week 16

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Severity of Psoriasis as Measured with the Psoriasis Area and Severity Index (PASI) Instrument

Secondary study objectives

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

Side effects data

From 2023 Phase 4 trial • 580 Patients • NCT05127486

Covid-19

Nasopharyngitis

Sinusitis

Nausea

Injection site pain

Fatigue

Migraine

Influenza

100%

80%

60%

40%

20%

Study treatment Arm

Rimegepant

Galcanezumab

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

~12660

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Psoriasis treatments often target specific pathways involved in the inflammatory process. Rimegepant, a competitive inhibitor of the CGRP receptor, is being studied for its potential in treating psoriasis by blocking the CGRP pathway, which is involved in inflammation. Other common treatments include TNF-alpha inhibitors (e.g., infliximab, adalimumab) that block tumor necrosis factor-alpha, a cytokine that promotes inflammation. IL-17 and IL-23 inhibitors (e.g., secukinumab, ustekinumab) target interleukins involved in the inflammatory cascade. These treatments are crucial for psoriasis patients as they help reduce inflammation, control symptoms, and prevent disease progression, thereby improving quality of life.