Rimegepant for Psoriasis

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

41 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

How is the drug Rimegepant unique for treating psoriasis?

Rimegepant is unique for psoriasis treatment as it is primarily known for treating migraines, and its use for psoriasis is novel, unlike traditional topical treatments like calcipotriene and betamethasone dipropionate. ^{1 2 3 4 5}

Research Team

Richard D Granstein, MD

Principal Investigator

Weill Medical College of Cornell University

Eligibility Criteria

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 am between 18 and 75 years old.

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.

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

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

Treatment Details

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.

Participant Groups

Group I: Rimegepant Experimental Treatment 1 Intervention

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

Group II: 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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Superior efficacy of calcipotriene and betamethasone dipropionate aerosol foam versus ointment in patients with psoriasis vulgaris--A randomized phase II study. [2022]

2. United States 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. [2017]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Aerosol Foam Compared with Betamethasone 17-Valerate-Medicated Plaster for the Treatment of Psoriasis. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Efficacy, Safety, and Potency of Betamethasone Dipropionate Spray 0.05%: A Treatment for Adults with Mild-to-moderate Plaque Psoriasis. [2020]

5. United States 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). [2022]