Rimegepant for Psoriasis

No longer recruiting at 1 trial location

Overseen By Jennifer T Vu, BS

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Weill Medical College of Cornell University

Must not be taking: Corticosteroids, Immunosuppressives, Atypical antipsychotics, others

Disqualifiers: Autoimmune disorders, Immunodeficiency, Cardiovascular disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a medication called rimegepant to determine its effectiveness in treating moderate plaque-type psoriasis, a skin condition that causes red, scaly patches. While rimegepant is already used for migraines, its use for psoriasis is new. Participants will receive either rimegepant or a placebo (a pill with no active medicine) to compare effects. Candidates for this trial include those with psoriasis covering at least 3% of their body and a confirmed diagnosis from a doctor. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

Yes, you may need to stop taking certain medications. The trial excludes participants using corticosteroids, immunosuppressive medications, certain biologic agents, and specific drugs like atypical antipsychotics and some migraine medications. It's best to discuss your current medications with the study team to see if any changes are needed.

Is there any evidence suggesting that rimegepant is likely to be safe for humans?

Research has shown that rimegepant is generally safe and well-tolerated. In past studies on migraine treatment, participants took 75 mg of rimegepant either daily or as needed for up to a year. These studies did not find any major safety issues, such as liver damage, suggesting that rimegepant is safe for treating migraines in humans.

The FDA has approved rimegepant for treating sudden migraine attacks, further supporting its safety. While researchers are now testing it for psoriasis, its safety is well-established for migraines.

Overall, current evidence indicates that rimegepant is likely safe for humans. However, since researchers are studying it for a new use, they will continue to monitor its safety for this purpose. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for psoriasis?

Rimegepant is unique because it offers a potential new way to tackle psoriasis by acting as a calcitonin gene-related peptide (CGRP) receptor antagonist. While most psoriasis treatments, like topical steroids or biologics, target the immune system to reduce inflammation, Rimegepant works differently by blocking CGRP, which plays a role in inflammation and pain. Researchers are excited because this novel mechanism might lead to fewer side effects compared to traditional therapies and could offer a new option for patients who don't respond well to existing treatments.

What evidence suggests that rimegepant might be an effective treatment for psoriasis?

Research has shown that rimegepant effectively treats sudden migraine attacks, outperforming a placebo. Although approved for migraines, researchers are investigating its use for moderate plaque-type psoriasis. In this trial, participants will receive either rimegepant or a placebo to assess its effectiveness for psoriasis. Rimegepant blocks a specific receptor that may reduce inflammation, potentially benefiting psoriasis. While data on its use for psoriasis remains limited, its mechanism suggests it might help with skin inflammation. Early studies are underway to evaluate its effectiveness for this condition. ^{2 3 6 7 8}

Who Is on the Research Team?

Richard D Granstein, MD

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

I am a woman who can have children and have a recent negative pregnancy test.

You have been diagnosed with psoriasis by a dermatologist or through a skin biopsy.

Exclusion Criteria

Pregnancy or breastfeeding

I was diagnosed with cancer within the last 5 years.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a rimegepant 75 mg tablet orally every other day for 16 weeks or a matching placebo

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Rimegepant

Trial Overview 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.

How Is the Trial Designed?

Group I: Rimegepant Extension-Previously Received Rimegepant-Open Label Experimental Treatment 1 Intervention

Participants who previously received rimegepant receive a rimegepant 75 mg tablet orally every other day for an additional 12 weeks. Rimegepant: Active Agent

Group II: Rimegepant Extension-Previously Received Placebo-Open Label Experimental Treatment 1 Intervention

Participants who previously received placebo receive a rimegepant 75 mg tablet orally every other day for an additional 12 weeks. Rimegepant: Active Agent

Group III: Rimegepant Experimental Treatment 1 Intervention

Participants receive a rimegepant 75 mg tablet orally every other day for 16 weeks.

Group IV: Placebo Placebo Group 1 Intervention

Participants receive a placebo tablet matching rimegepant orally every other day for 16 weeks.

Rimegepant is already approved in United States, European Union, Canada, United Kingdom for the following indications:

Approved in United States as Nurtec ODT for:

• Acute treatment of migraine with or without aura in adults
• Preventative treatment of episodic migraine in adults

Approved in European Union as Vydura for:

• Prophylaxis and acute treatment of migraine in adults

Approved in Canada as Nurtec ODT for:

• Acute treatment of migraine with or without aura in adults
• Preventative treatment of episodic migraine in adults

Approved in United Kingdom as Vydura for:

• Prophylaxis and acute treatment of migraine in adults

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Pfizer

Industry Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Biohaven Pharmaceuticals, Inc.

Industry Sponsor

Trials

49

Recruited

30,100+

Published Research Related to This Trial

In a pooled analysis of 1104 patients with mild to severe psoriasis, Calcipotriene 0.005% and betamethasone dipropionate 0.064% aerosol foam demonstrated a treatment success rate of 51% after 4 weeks, outperforming all other treatment groups.

The aerosol foam not only provided a greater reduction in psoriasis severity (72% decrease in mPASI) but also significantly alleviated itch within the first week, showing its efficacy across various body areas and regardless of initial disease severity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aerosol Foam Formulation of Fixed Combination Calcipotriene Plus Betamethasone Dipropionate is Highly Efficacious in Patients With Psoriasis Vulgaris: Pooled Data From Three Randomized Controlled Studies. Stein Gold, L., Lebwohl, M., Menter, A., et al.[2017]

In a long-term study of 1184 psoriasis patients treated with apremilast for up to 156 weeks, the medication showed a consistent safety profile with no new adverse events reported after the first year.

Common side effects included diarrhea and nausea, but serious adverse events and rates of major cardiac events, malignancies, and depression did not increase over time, indicating that apremilast is well tolerated for extended use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term safety and tolerability of apremilast in patients with psoriasis: Pooled safety analysis for ≥156 weeks from 2 phase 3, randomized, controlled trials (ESTEEM 1 and 2). Crowley, J., Thaçi, D., Joly, P., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04629950

Rimegepant in Moderate Plaque-type Psoriasis This is a randomized, double-blind, placebo-controlled study of rimegepant 75 mg dosed every other day for the treatment of mild to moderate psoriasis. ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10299922/

Rimegepant: A Review in the Acute Treatment and ... A single 75 mg dose of rimegepant ODT provided superior efficacy to placebo for the acute treatment of migraine [25]. At 2 h post-dose, a ...

3. jcto.weill.cornell.edu jcto.weill.cornell.edu/open_clinical_trials/a-pilot-study-of-rimegepant-in-moderate-plaque-type-psoriasis

A Pilot Study of Rimegepant in Moderate Plaque-type ... The purpose of this study is to examine the use of a new investigational medication for the treatment of moderate plaque-type psoriasis.

4. pharmaceutical-technology.com pharmaceutical-technology.com/data-insights/rimegepant-sulfate-odt-pfizer-plaque-psoriasis-psoriasis-vulgaris-likelihood-of-approval/

Rimegepant sulfate ODT by Pfizer for Plaque Psoriasis ... According to GlobalData, Phase II drugs for Plaque Psoriasis (Psoriasis Vulgaris) have a 47% phase transition success rate (PTSR) indication ...

5. prnewswire.com prnewswire.com/news-releases/biohaven-pharmaceuticals-and-weill-cornell-medicine-collaborate-to-initiate-proof-of-concept-trial-with-cgrp-receptor-antagonist-in-plaque-psoriasis-301173222.html

Biohaven Pharmaceuticals And Weill Cornell Medicine ... The investigator-led clinical trial will explore whether treatment with one of Biohaven's CGRP-receptor antagonists will reduce the severity of disease.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38659334/

Rimegepant Safety Study for Migraine Treatment Conclusions: Rimegepant 75 mg up to once per day as EOD + PRN for 12 weeks or PRN for up to 52 weeks was safe and well tolerated. No signal of hepatotoxicity, ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03732638

NCT03732638 | Efficacy and Safety Trial of Rimegepant for ... The purpose of this is study is to compare the efficacy of BHV-3000 (rimegepant) to placebo as a preventive treatment for migraine, as measured by the ...

8. thejournalofheadacheandpain.biomedcentral.com thejournalofheadacheandpain.biomedcentral.com/articles/10.1186/s10194-021-01378-5

post hoc results from an open label safety study (BHV3000 ... Overall, rimegepant use was associated with a 2.0 MMD reduction from baseline over the 52-week period, and an estimated benefit of 0.08 QALYs.