drugset / Trial / NCT04629950
Rimegepant in Moderate Plaque-type Psoriasis
RandomizedParallel-groupTriple-blindTreatment
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.
Timeline
- Start
- 2021-01-19
- Primary completion
- 2024-08-20
- Completion
- 2024-11-18
Publications
- Background 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rimegepant | Small molecule | 75 mg | Oral |