Rimegepant in Moderate Plaque-type Psoriasis

NCT04629950 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 20-07022368
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• Change in Severity of Psoriasis as Measured by Percentage Change in the Psoriasis Area and Severity Index (PASI) Instrument

  Total score of Psoriasis Area and Severity Index ranges from 0 to 72. Change = (Week 16 score - Baseline score) for the placebo-controlled phase and (Week 15 score-Visit 12 score) for the extension phase. A low score means less severe disease while a high score reflects more severe disease. A score of 0 means no psoriasis. A PASI score of 5 to 10 is considered moderate disease and a score over 10 is considered severe. A score over 40 is rare. The primary outcome measure is the mean percent change in PASI score from baseline to week 16 in the placebo-controlled phase. For the extension phase, it is particularly interesting if a change is noted in the group that received placebo prior to the extension phase.

  Baseline and Week 16 for placebo controlled trial. For Extension Phase, Visit 11/12 (Day 1) to Visit 15 (Week 12).

Secondary Outcomes (4)

• Number of Subjects Who Had a 50% or Greater Reduction in Psoriasis Area and Severity Index Instrument Score

  Baseline and Week 16 for placebo controlled trial. For Extension Phase, Visit 11/12 (Day 1) to Visit 15 (Week 12).

• Change in Severity of Psoriasis as Assessed by the Investigator's Global Assessment Instrument

  Baseline and Week 16 for placebo controlled trial. For Extension Phase, Visit 11/12 (Day 1) to Week 12.

• Change in Dermatology Quality of Life Index

  Baseline and Week 16 for placebo controlled trial. For Extension Phase, Visit 11/12 (Day 1) to Visit 15 (Week 12).

• Change in Degree of Itching Assessed by the Visual Analogue Scale

  Baseline and Week 16 for placebo controlled trial. For Extension Phase, Visit 11/12 (Day 1) to Week 12.

Study Arms (4)

Rimegepant

EXPERIMENTAL

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

Drug: Rimegepant

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Rimegepant Extension-Previously Received Rimegepant-Open Label

EXPERIMENTAL

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

Drug: Rimegepant

Rimegepant Extension-Previously Received Placebo-Open Label

EXPERIMENTAL

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

Drug: Rimegepant

Interventions

Rimegepant DRUG

Active Agent

Also known as: Nurtec

Rimegepant; Rimegepant Extension-Previously Received Placebo-Open Label; Rimegepant Extension-Previously Received Rimegepant-Open Label

Placebo DRUG

Placebo Comparator

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients with at least 3% body surface are involved with psoriasis and a PASI score \>5.
• Between 18 and 75 years of age.
• Documentation of a definite diagnosis of psoriasis by a dermatologist or biopsy.
• For women of childbearing potential, a negative urine pregnancy test within 48 hours of randomization. Female subjects should not have attempted to become pregnant in the month prior to exposure to rimegepant and agree not to attempt to become pregnant for 8 weeks after exposure to rimegepant.
• A valid form of contraception must be documented for men and women of child-bearing potential.
• The two methods for women of childbearing potential should include:
• One barrier method (for example, Diaphragm with spermicidal gel, condom with spermicidal gel, cervical caps or intrauterine devices placed for at least four weeks before sexual intercourse); AND
• One additional method. The other method could include hormonal contraceptives, or second barrier method as listed above.
• The two options for men of childbearing potential should include:
• Simultaneous use of male condom, and for the female partner, hormonal contraceptives (for example, birth control pills, implants, patch, depot injection, used since at least 4 weeks) or intra-uterine contraceptive device (placed since at least 4 weeks) before sexual intercourse; OR simultaneous use of male condom, and for the female partner, diaphragm with intravaginally applied spermicide.

You may not qualify if:

• Any ongoing medical illness or condition that places the participant at higher risk for adverse outcomes or inability to complete study procedures in the opinion of the study investigator.
• Pregnancy or breastfeeding.
• Known autoimmune disorders other than psoriasis.
• Current use of corticosteroids or immunosuppressive medications (for any reason).
• Immunodeficiency diseases.
• Use of any biologic agent/monoclonal antibody within 5 half-lifes prior to baseline.
• Ultraviolet light treatment, cyclosporine, oral corticosteroids, methotrexate, oral retinoids, mycophenolate mofetil, thioguanine, hydroxyurea, sirolimus or azathioprine within the 4 weeks prior to baseline or had topical psoriasis treatment within the previous 2 weeks prior to baseline.
• Participation in another clinical trial involving an investigational drug within the last 30 days prior to baseline.
• Inability for woman of child-bearing potential to use an effective form of contraception if sexually active.
• Use of any medication that is a strong or moderate inhibitor of CYP3A, a strong or moderate inducer of CYP3A, or an inhibitor of glycoprotein (P-gp) or Breast Cancer Resistance Protein (BCRP). Please see Section 7.8 for more information.
• Subject history with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. Subjects with myocardial infarction (MI), acute coronary syndrome (ACS), percutaneous coronary intervention (PCI), cardiac surgery, stroke or transient ischemic attack (TIA) during 6 months (24 weeks) prior to screening.
• Subjects with an active episode of major depressive episode within the last 6 months are ineligible. Subjects with major depressive disorder or any anxiety disorder are eligible only if they are on stable medication for each disorder for at least 3 months prior to the Screening visit.
• Subject has a history or diagnosis of Gilbert's Syndrome or any other active hepatic or biliary disorder
• Hematologic or solid malignancy diagnosis within 5 years prior to screening. Subjects with a history of localized basal cell or squamous cell skin cancer are eligible for the study if they are cancer-free prior to the screening visit in this study.
• Subject has current diagnosis of major depressive disorder requiring treatment with atypical antipsychotics, schizophrenia, bipolar disorder, or borderline personality disorder.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Pfizer: collaborator

Study Sites (2)

Weill Cornell Medicine

New York, New York, 10021, United States

Location

Sadick Dermatology

New York, New York, 10075, United States

Location

Related Publications (15)

• Rajguru JP, Maya D, Kumar D, Suri P, Bhardwaj S, Patel ND. Update on psoriasis: A review. J Family Med Prim Care. 2020 Jan 28;9(1):20-24. doi: 10.4103/jfmpc.jfmpc_689_19. eCollection 2020 Jan.

  PMID: 32110559 BACKGROUND

• Takeshita J, Grewal S, Langan SM, Mehta NN, Ogdie A, Van Voorhees AS, Gelfand JM. Psoriasis and comorbid diseases: Implications for management. J Am Acad Dermatol. 2017 Mar;76(3):393-403. doi: 10.1016/j.jaad.2016.07.065.

  PMID: 28212760 BACKGROUND

• Greb JE, Goldminz AM, Elder JT, Lebwohl MG, Gladman DD, Wu JJ, Mehta NN, Finlay AY, Gottlieb AB. Psoriasis. Nat Rev Dis Primers. 2016 Nov 24;2:16082. doi: 10.1038/nrdp.2016.82.

  PMID: 27883001 BACKGROUND

• Kaushik SB, Lebwohl MG. Review of safety and efficacy of approved systemic psoriasis therapies. Int J Dermatol. 2019 Jun;58(6):649-658. doi: 10.1111/ijd.14246. Epub 2018 Sep 23.

  PMID: 30246393 BACKGROUND

• Racz E, Prens EP. Phototherapy of Psoriasis, a Chronic Inflammatory Skin Disease. Adv Exp Med Biol. 2017;996:287-294. doi: 10.1007/978-3-319-56017-5_24.

  PMID: 29124709 BACKGROUND

• Farber EM, Lanigan SW, Boer J. The role of cutaneous sensory nerves in the maintenance of psoriasis. Int J Dermatol. 1990 Jul-Aug;29(6):418-20. doi: 10.1111/j.1365-4362.1990.tb03825.x.

  PMID: 2397964 BACKGROUND

• Zhu TH, Nakamura M, Farahnik B, Abrouk M, Lee K, Singh R, Gevorgyan A, Koo J, Bhutani T. The Role of the Nervous System in the Pathophysiology of Psoriasis: A Review of Cases of Psoriasis Remission or Improvement Following Denervation Injury. Am J Clin Dermatol. 2016 Jun;17(3):257-63. doi: 10.1007/s40257-016-0183-7.

  PMID: 26935938 BACKGROUND

• Perlman HH. Remission of psoriasis vulgaris from the use of nerve-blocking agents. Arch Dermatol. 1972 Jan;105(1):128-9. doi: 10.1001/archderm.1972.01620040088028. No abstract available.

  PMID: 5009614 BACKGROUND

• Aschenbeck KA, Hordinsky MK, Kennedy WR, Wendelschafer-Crabb G, Ericson ME, Kavand S, Bertin A, Dykstra DD, Panoutsopoulou IG. Neuromodulatory treatment of recalcitrant plaque psoriasis with onabotulinumtoxinA. J Am Acad Dermatol. 2018 Dec;79(6):1156-1159. doi: 10.1016/j.jaad.2018.07.058. No abstract available.

  PMID: 30420008 BACKGROUND

• Ostrowski SM, Belkadi A, Loyd CM, Diaconu D, Ward NL. Cutaneous denervation of psoriasiform mouse skin improves acanthosis and inflammation in a sensory neuropeptide-dependent manner. J Invest Dermatol. 2011 Jul;131(7):1530-8. doi: 10.1038/jid.2011.60. Epub 2011 Apr 7.

  PMID: 21471984 BACKGROUND

• Reich A, Orda A, Wisnicka B, Szepietowski JC. Plasma concentration of selected neuropeptides in patients suffering from psoriasis. Exp Dermatol. 2007 May;16(5):421-8. doi: 10.1111/j.1600-0625.2007.00544.x.

  PMID: 17437485 BACKGROUND

• He Y, Ding G, Wang X, Zhu T, Fan S. Calcitonin gene-related peptide in Langerhans cells in psoriatic plaque lesions. Chin Med J (Engl). 2000 Aug;113(8):747-51.

  PMID: 11776062 BACKGROUND

• Riol-Blanco L, Ordovas-Montanes J, Perro M, Naval E, Thiriot A, Alvarez D, Paust S, Wood JN, von Andrian UH. Nociceptive sensory neurons drive interleukin-23-mediated psoriasiform skin inflammation. Nature. 2014 Jun 5;510(7503):157-61. doi: 10.1038/nature13199. Epub 2014 Apr 23.

  PMID: 24759321 BACKGROUND

• Kashem SW, Riedl MS, Yao C, Honda CN, Vulchanova L, Kaplan DH. Nociceptive Sensory Fibers Drive Interleukin-23 Production from CD301b+ Dermal Dendritic Cells and Drive Protective Cutaneous Immunity. Immunity. 2015 Sep 15;43(3):515-26. doi: 10.1016/j.immuni.2015.08.016.

  PMID: 26377898 BACKGROUND

• Ding W, Stohl LL, Xu L, Zhou XK, Manni M, Wagner JA, Granstein RD. Calcitonin Gene-Related Peptide-Exposed Endothelial Cells Bias Antigen Presentation to CD4+ T Cells toward a Th17 Response. J Immunol. 2016 Mar 1;196(5):2181-94. doi: 10.4049/jimmunol.1500303. Epub 2016 Feb 1.

  PMID: 26829986 BACKGROUND

MeSH Terms

Conditions

Psoriasis

Interventions

rimegepant sulfate

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

A relatively high number of subjects withdrew or were withdrawn. The were a relatively small number of subjects in the extension phase.

Results Point of Contact

• Title: Dr. Richard D. Granstein
• Organization: Department of Dermatology, Weill Cornell Medicine

rdgranst@med.cornell.edu

(646) 962-7546

Study Officials

• Richard D Granstein, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2020
• First Posted: November 16, 2020
• Study Start: January 19, 2021
• Primary Completion: August 20, 2024
• Study Completion: November 18, 2024
• Last Updated: July 17, 2025
• Results First Posted: July 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)