Skip to main content
Top
Published in: Dermatology and Therapy 12/2022

Open Access 01-11-2022 | Generalized Pustular Psoriasis | Review

A Review of the Clinical Trial Landscape in Psoriasis: An Update for Clinicians

Authors: Anastasia Drakos, Ronald Vender

Published in: Dermatology and Therapy | Issue 12/2022

Login to get access

Abstract

As our understanding of the pathogenesis of psoriasis has evolved over the past two decades, so has the number of treatment options. The introduction of biologic agents targeting specific cytokines in the interleukin (IL)-23/IL-17 pathway has proven successful in promoting skin clearance among patients. However, their use is often limited owing to cost, parenteral administration, and possible reduced efficacy over time. Topical therapies have also seen limited advancement, with agents such as corticosteroids and vitamin D derivatives remaining the mainstay of treatment, despite side effects limiting their long-term use. New therapeutic agents are needed to improve disease management for patients. In this review, we summarize pipeline and recently approved therapies undergoing clinical trials for psoriasis during a 12-month search period (30 June 2021 to 30 June 2022) using ClinicalTrials.gov. New-generation biologics and oral small molecules in phase II or III development were included, and pivotal data identified through various search modalities (PubMed, conference presentations, etc.) evaluating each drug candidate will be discussed. Topical therapies will also be discussed in line with recent US Food and Drug Administration approvals. As new therapies continue to enter the treatment landscape, long-term data and comparative trials will be needed to better understand their place among existing therapeutic agents.
Literature
1.
go back to reference Armstrong AW, Read C. Pathophysiology, clinical presentation, and treatment of psoriasis: a review. JAMA. 2020;323(19):1945–60.PubMedCrossRef Armstrong AW, Read C. Pathophysiology, clinical presentation, and treatment of psoriasis: a review. JAMA. 2020;323(19):1945–60.PubMedCrossRef
2.
go back to reference Puig L, Thom H, Mollon P, Tian H, Ramakrishna GS. Clear or almost clear skin improves the quality of life in patients with moderate-to-severe psoriasis: a systematic review and meta-analysis. J Eur Acad Dermatol Venereol. 2017;31(2):213–20.PubMedCrossRef Puig L, Thom H, Mollon P, Tian H, Ramakrishna GS. Clear or almost clear skin improves the quality of life in patients with moderate-to-severe psoriasis: a systematic review and meta-analysis. J Eur Acad Dermatol Venereol. 2017;31(2):213–20.PubMedCrossRef
4.
go back to reference Sewerin P, Brinks R, Schneider M, Haase I, Vordenbäumen S. Prevalence and incidence of psoriasis and psoriatic arthritis. Ann Rheum Dis. 2019;78(2):286–7.PubMedCrossRef Sewerin P, Brinks R, Schneider M, Haase I, Vordenbäumen S. Prevalence and incidence of psoriasis and psoriatic arthritis. Ann Rheum Dis. 2019;78(2):286–7.PubMedCrossRef
5.
go back to reference Hawkes JE, Chan TC, Krueger JG. Psoriasis pathogenesis and the development of novel targeted immune therapies. J Allergy Clin Immunol. 2017;140(3):645–53.PubMedPubMedCentralCrossRef Hawkes JE, Chan TC, Krueger JG. Psoriasis pathogenesis and the development of novel targeted immune therapies. J Allergy Clin Immunol. 2017;140(3):645–53.PubMedPubMedCentralCrossRef
6.
go back to reference Singh R, Koppu S, Perche PO, Feldman SR. The cytokine mediated molecular pathophysiology of psoriasis and its clinical implications. Int J Mol Sci. 2021;22(23):12793.PubMedPubMedCentralCrossRef Singh R, Koppu S, Perche PO, Feldman SR. The cytokine mediated molecular pathophysiology of psoriasis and its clinical implications. Int J Mol Sci. 2021;22(23):12793.PubMedPubMedCentralCrossRef
7.
go back to reference Girolomoni G, Strohal R, Puig L, et al. The role of IL-23 and the IL-23/Th17 immune axis in the pathogenesis and treatment of psoriasis. J Eur Acad Dermatol Venereol. 2017;31(10):1616–26.PubMedPubMedCentralCrossRef Girolomoni G, Strohal R, Puig L, et al. The role of IL-23 and the IL-23/Th17 immune axis in the pathogenesis and treatment of psoriasis. J Eur Acad Dermatol Venereol. 2017;31(10):1616–26.PubMedPubMedCentralCrossRef
8.
go back to reference Sbidian E, Chaimani A, Garcia-Doval I, et al. Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis. Cochrane Database Syst Rev. 2022; 5(5):CD011535. Sbidian E, Chaimani A, Garcia-Doval I, et al. Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis. Cochrane Database Syst Rev. 2022; 5(5):CD011535.
9.
go back to reference Dommasch ED, Kim SC, Lee MP, Gagne JJ. Risk of serious infection in patients receiving systemic medications for the treatment of psoriasis. JAMA Dermatol. 2019;155(10):1142–52.PubMedPubMedCentralCrossRef Dommasch ED, Kim SC, Lee MP, Gagne JJ. Risk of serious infection in patients receiving systemic medications for the treatment of psoriasis. JAMA Dermatol. 2019;155(10):1142–52.PubMedPubMedCentralCrossRef
10.
go back to reference Puig L. PASI90 response: the new standard in therapeutic efficacy for psoriasis. J Eur Acad Dermatol Venereol. 2015;29(4):645–8.PubMedCrossRef Puig L. PASI90 response: the new standard in therapeutic efficacy for psoriasis. J Eur Acad Dermatol Venereol. 2015;29(4):645–8.PubMedCrossRef
11.
go back to reference Elberdín L, Fernández-Torres RM, Paradela S, et al. Biologic therapy for moderate to severe psoriasis. Real-world follow-up of patients who initiated biologic therapy at least 10 years ago. Dermatol Ther (Heidelb). 2022; 12(3):761–770. Elberdín L, Fernández-Torres RM, Paradela S, et al. Biologic therapy for moderate to severe psoriasis. Real-world follow-up of patients who initiated biologic therapy at least 10 years ago. Dermatol Ther (Heidelb). 2022; 12(3):761–770.
12.
go back to reference Curmin R, Guillo S, De Rycke Y, et al. Switches between biologics in patients with moderate-to-severe psoriasis: results from the French cohort PSOBIOTEQ. J Eur Acad Dermatol Venereol. 2022. Curmin R, Guillo S, De Rycke Y, et al. Switches between biologics in patients with moderate-to-severe psoriasis: results from the French cohort PSOBIOTEQ. J Eur Acad Dermatol Venereol. 2022.
13.
go back to reference Aleshaki JS, Cardwell LA, Muse ME, Feldman SR. Adherence and resource use among psoriasis patients treated with biologics. Expert Rev Pharmacoecon Outcomes Res. 2018;18(6):609–17.PubMedCrossRef Aleshaki JS, Cardwell LA, Muse ME, Feldman SR. Adherence and resource use among psoriasis patients treated with biologics. Expert Rev Pharmacoecon Outcomes Res. 2018;18(6):609–17.PubMedCrossRef
14.
15.
go back to reference Lupardus PJ, Garcia KC. The structure of interleukin-23 reveals the molecular basis of p40 subunit sharing with interleukin-12. J Mol Biol. 2008;382(4):931–41.PubMedPubMedCentralCrossRef Lupardus PJ, Garcia KC. The structure of interleukin-23 reveals the molecular basis of p40 subunit sharing with interleukin-12. J Mol Biol. 2008;382(4):931–41.PubMedPubMedCentralCrossRef
16.
go back to reference Hawkes JE, Yan BY, Chan TC, Krueger JG. Discovery of the IL-23/IL-17 signalling pathway and the treatment of psoriasis. J Immunol. 2018;201(6):1605–13.PubMedCrossRef Hawkes JE, Yan BY, Chan TC, Krueger JG. Discovery of the IL-23/IL-17 signalling pathway and the treatment of psoriasis. J Immunol. 2018;201(6):1605–13.PubMedCrossRef
17.
go back to reference Chan TC, Hawkes JE, Krueger JG. Interleukin 23 in the skin: role in psoriasis pathogenesis and selective interleukin 23 blockade as treatment. Ther Adv Chronic Dis. 2018;9(5):111–9.PubMedPubMedCentralCrossRef Chan TC, Hawkes JE, Krueger JG. Interleukin 23 in the skin: role in psoriasis pathogenesis and selective interleukin 23 blockade as treatment. Ther Adv Chronic Dis. 2018;9(5):111–9.PubMedPubMedCentralCrossRef
18.
go back to reference Fotiadou C, Lazaridou E, Sotiriou E, Ioannides D. Targeting IL-23 in psoriasis: current perspectives. Psoriasis (Auckl). 2018;8:1–5. Fotiadou C, Lazaridou E, Sotiriou E, Ioannides D. Targeting IL-23 in psoriasis: current perspectives. Psoriasis (Auckl). 2018;8:1–5.
19.
go back to reference Yang K, Oak ASW, Elewski BE. Use of IL-23 inhibitors for the treatment of plaque psoriasis and psoriatic arthritis: a comprehensive review. Am J Clin Dermatol. 2021;22(2):173–92.PubMedCrossRef Yang K, Oak ASW, Elewski BE. Use of IL-23 inhibitors for the treatment of plaque psoriasis and psoriatic arthritis: a comprehensive review. Am J Clin Dermatol. 2021;22(2):173–92.PubMedCrossRef
20.
go back to reference Li L, Wu Z, Wu M, et al. IBI112, a selective anti-IL23p19 monoclonal antibody, displays high efficacy in IL-23-induced psoriasiform dermatitis. Int Immunopharmacol. 2020;89(Pt B): 107008.PubMedCrossRef Li L, Wu Z, Wu M, et al. IBI112, a selective anti-IL23p19 monoclonal antibody, displays high efficacy in IL-23-induced psoriasiform dermatitis. Int Immunopharmacol. 2020;89(Pt B): 107008.PubMedCrossRef
23.
go back to reference Soderstrom C, Berstein G, Zhang W, et al. Ultra-sensitive measurement of IL-17A and IL-17F in psoriasis patient serum and skin. AAPS J. 2017;19(4):1218–22.PubMedCrossRef Soderstrom C, Berstein G, Zhang W, et al. Ultra-sensitive measurement of IL-17A and IL-17F in psoriasis patient serum and skin. AAPS J. 2017;19(4):1218–22.PubMedCrossRef
24.
go back to reference Tollenaere MAX, Hebsgaard J, Ewald DA, et al. Signalling of multiple interleukin (IL)-17 family cytokines via IL-17 receptor A drives psoriasis-related inflammatory pathways. Br J Dermatol. 2021;185(3):585–94.PubMedPubMedCentralCrossRef Tollenaere MAX, Hebsgaard J, Ewald DA, et al. Signalling of multiple interleukin (IL)-17 family cytokines via IL-17 receptor A drives psoriasis-related inflammatory pathways. Br J Dermatol. 2021;185(3):585–94.PubMedPubMedCentralCrossRef
25.
go back to reference AbuHilal M, Walsh S, Shear N. The role of IL-17 in the pathogenesis of psoriasis and update on IL-17 inhibitors for the treatment of plaque psoriasis. J Cutan Med Surg. 2016;20(6):509–16.PubMedCrossRef AbuHilal M, Walsh S, Shear N. The role of IL-17 in the pathogenesis of psoriasis and update on IL-17 inhibitors for the treatment of plaque psoriasis. J Cutan Med Surg. 2016;20(6):509–16.PubMedCrossRef
26.
go back to reference Blauvelt A, Chiricozzi A. The immunologic role of IL-17 in psoriasis and psoriatic arthritis pathogenesis. Clin Rev Allergy Immunol. 2018;55(3):379–90.PubMedPubMedCentralCrossRef Blauvelt A, Chiricozzi A. The immunologic role of IL-17 in psoriasis and psoriatic arthritis pathogenesis. Clin Rev Allergy Immunol. 2018;55(3):379–90.PubMedPubMedCentralCrossRef
27.
go back to reference Von Stebut E, Boehncke W-H, Ghoreschi K, et al. IL-17A in psoriasis and beyond: cardiovascular and metabolic implications. Front Immunol. 2020;10:3096.CrossRef Von Stebut E, Boehncke W-H, Ghoreschi K, et al. IL-17A in psoriasis and beyond: cardiovascular and metabolic implications. Front Immunol. 2020;10:3096.CrossRef
28.
go back to reference Hohenberger M, Cardwell LA, Oussedik E, Feldman SR. Interleukin-17 inhibition: role in psoriasis and inflammatory bowel disease. J Dermatol Treat. 2018;29(1):13–8.CrossRef Hohenberger M, Cardwell LA, Oussedik E, Feldman SR. Interleukin-17 inhibition: role in psoriasis and inflammatory bowel disease. J Dermatol Treat. 2018;29(1):13–8.CrossRef
29.
go back to reference Gisondi P, Geat D, Pizzolato M, Girolomoni G. State of the art and pharmacological pipeline of biologics for chronic plaque psoriasis. Curr Opin Pharmacol. 2019;46:90–9.PubMedCrossRef Gisondi P, Geat D, Pizzolato M, Girolomoni G. State of the art and pharmacological pipeline of biologics for chronic plaque psoriasis. Curr Opin Pharmacol. 2019;46:90–9.PubMedCrossRef
30.
go back to reference Korotaeva T, Gaydukova I, Mazurov V, et al. POS1043 Netakimab reduces psoriatic arthritis activity in patients with or without axial disease: subanalysis of the PATERA study. Ann Rheum Dis. 2021;80:796–7.CrossRef Korotaeva T, Gaydukova I, Mazurov V, et al. POS1043 Netakimab reduces psoriatic arthritis activity in patients with or without axial disease: subanalysis of the PATERA study. Ann Rheum Dis. 2021;80:796–7.CrossRef
31.
go back to reference Puig L, Bakulev AL, Kokhan MM, et al. Efficacy and safety of netakimab, a novel Anti-IL-17 monoclonal antibody, in patients with moderate to severe plaque psoriasis. Results of a 54-week randomized double-blind placebo-controlled PLANETA clinical trial. Dermatol Ther (Heidelb). 2021; 11(4):1319–1332. Puig L, Bakulev AL, Kokhan MM, et al. Efficacy and safety of netakimab, a novel Anti-IL-17 monoclonal antibody, in patients with moderate to severe plaque psoriasis. Results of a 54-week randomized double-blind placebo-controlled PLANETA clinical trial. Dermatol Ther (Heidelb). 2021; 11(4):1319–1332.
32.
go back to reference Samtsov AV, Khairutdinov VR, Bakulev AL, Kubanov AA, Karamova AE, Artem’eva AV, Korotaeva TV: Efficacy and safety of BCD-085, a novel interleukin-17 inhibitor. Results of phase II clinical trial in patients with moderate-to-severe plaque psoriasis. Vestnik Dermatologii i Venerologii 2017:52–63. Samtsov AV, Khairutdinov VR, Bakulev AL, Kubanov AA, Karamova AE, Artem’eva AV, Korotaeva TV: Efficacy and safety of BCD-085, a novel interleukin-17 inhibitor. Results of phase II clinical trial in patients with moderate-to-severe plaque psoriasis. Vestnik Dermatologii i Venerologii 2017:52–63.
34.
go back to reference Zhang C, Yan K, Diao Q, et al. A multicenter, randomized, double-blinded, placebo-controlled, dose-ranging study evaluating the efficacy and safety of vunakizumab in patients with moderate-to-severe plaque psoriasis. J Am Acad Dermatol. 2022;87(1):95–102.PubMedCrossRef Zhang C, Yan K, Diao Q, et al. A multicenter, randomized, double-blinded, placebo-controlled, dose-ranging study evaluating the efficacy and safety of vunakizumab in patients with moderate-to-severe plaque psoriasis. J Am Acad Dermatol. 2022;87(1):95–102.PubMedCrossRef
35.
go back to reference Gooderham MJ, Van Voorhees AS, Lebwohl MG. An update on generalized pustular psoriasis. Expert Review Clin Immunol. 2019;15(9):907–19.CrossRef Gooderham MJ, Van Voorhees AS, Lebwohl MG. An update on generalized pustular psoriasis. Expert Review Clin Immunol. 2019;15(9):907–19.CrossRef
36.
go back to reference Johnston A, Xing X, Wolterink L, et al. IL-1 and IL-36 are dominant cytokines in generalized pustular psoriasis. J Allergy Clin Immunol. 2017;140(1):109–20.PubMedCrossRef Johnston A, Xing X, Wolterink L, et al. IL-1 and IL-36 are dominant cytokines in generalized pustular psoriasis. J Allergy Clin Immunol. 2017;140(1):109–20.PubMedCrossRef
38.
39.
41.
go back to reference Gudjonsson J RA, Barker J, Pink A, et al. Imsidolimab, an anti-IL-36 receptor monoclonal antibody, in the treatment of generalized pustular psoriasis; results from a phase 2 trial. 30th EADV Congress; 29 September–2 October 2021. Gudjonsson J RA, Barker J, Pink A, et al. Imsidolimab, an anti-IL-36 receptor monoclonal antibody, in the treatment of generalized pustular psoriasis; results from a phase 2 trial. 30th EADV Congress; 29 September–2 October 2021.
43.
go back to reference Bachelez H, Choon S-E, Marrakchi S, et al. Trial of spesolimab for generalized pustular psoriasis. N Engl J Med. 2021;385(26):2431–40.PubMedCrossRef Bachelez H, Choon S-E, Marrakchi S, et al. Trial of spesolimab for generalized pustular psoriasis. N Engl J Med. 2021;385(26):2431–40.PubMedCrossRef
44.
go back to reference Mrowietz U, Burden AD, Pinter A. Spesolimab, an anti-interleukin-36 receptor antibody, in patients with palmoplantar pustulosis: results of a phase iia, multicenter, double-blind, randomized placebo-controlled pilot study. Dermatol Ther (Heidelb). 2021;11(2):571–85.CrossRef Mrowietz U, Burden AD, Pinter A. Spesolimab, an anti-interleukin-36 receptor antibody, in patients with palmoplantar pustulosis: results of a phase iia, multicenter, double-blind, randomized placebo-controlled pilot study. Dermatol Ther (Heidelb). 2021;11(2):571–85.CrossRef
46.
go back to reference Gerlo S, Kooijman R, Beck IM, Kolmus K, Spooren A, Haegeman G. Cyclic AMP: a selective modulator of NF-kB action. Cell Mol Life Sci. 2011;68(23):3823–41.PubMedCrossRef Gerlo S, Kooijman R, Beck IM, Kolmus K, Spooren A, Haegeman G. Cyclic AMP: a selective modulator of NF-kB action. Cell Mol Life Sci. 2011;68(23):3823–41.PubMedCrossRef
47.
go back to reference Wittmann M, Helliwell PS. Phosphodiesterase 4 inhibition in the treatment of psoriasis, psoriatic arthritis and other chronic inflammatory diseases. Dermatol Ther (Heidelb). 2013;3(1):1–15.CrossRef Wittmann M, Helliwell PS. Phosphodiesterase 4 inhibition in the treatment of psoriasis, psoriatic arthritis and other chronic inflammatory diseases. Dermatol Ther (Heidelb). 2013;3(1):1–15.CrossRef
48.
go back to reference Milakovic M, Gooderham MJ. Phosphodiesterase-4 inhibition in psoriasis. Psoriasis (Auckl). 2021;11:21–9. Milakovic M, Gooderham MJ. Phosphodiesterase-4 inhibition in psoriasis. Psoriasis (Auckl). 2021;11:21–9.
50.
go back to reference Hashim PW, Chima M, Kim HJ, et al. Crisaborole 2% ointment for the treatment of intertriginous, anogenital, and facial psoriasis: a double-blind, randomized, vehicle-controlled trial. J Am Acad Dermatol. 2020;82(2):360–5.PubMedCrossRef Hashim PW, Chima M, Kim HJ, et al. Crisaborole 2% ointment for the treatment of intertriginous, anogenital, and facial psoriasis: a double-blind, randomized, vehicle-controlled trial. J Am Acad Dermatol. 2020;82(2):360–5.PubMedCrossRef
52.
go back to reference Lebwohl MG, Papp KA, Stein Gold L, et al. Trial of roflumilast cream for chronic plaque psoriasis. N Eng J Med. 2020;383(3):229–39.CrossRef Lebwohl MG, Papp KA, Stein Gold L, et al. Trial of roflumilast cream for chronic plaque psoriasis. N Eng J Med. 2020;383(3):229–39.CrossRef
54.
go back to reference Lebwohl M, Kircik LH, Moore AY, et al. Safety and efficacy of once-daily roflumilast Cream 0.3%, a potent phosphodiesterase-4 inhibitor for the treatment of psoriasis in the DERMIS-1 and DERMIS-2 phase 3 trials. Poster presented at: 30th EADV Congress, Sept 29–Oct 2, 2021; virtual. Lebwohl M, Kircik LH, Moore AY, et al. Safety and efficacy of once-daily roflumilast Cream 0.3%, a potent phosphodiesterase-4 inhibitor for the treatment of psoriasis in the DERMIS-1 and DERMIS-2 phase 3 trials. Poster presented at: 30th EADV Congress, Sept 29–Oct 2, 2021; virtual.
55.
go back to reference Słuczanowska-Głąbowska S, Ziegler-Krawczyk A, Szumilas K, Pawlik A. Role of Janus kinase inhibitors in therapy of psoriasis. J Clin Med. 2021;10(19):4307.PubMedPubMedCentralCrossRef Słuczanowska-Głąbowska S, Ziegler-Krawczyk A, Szumilas K, Pawlik A. Role of Janus kinase inhibitors in therapy of psoriasis. J Clin Med. 2021;10(19):4307.PubMedPubMedCentralCrossRef
57.
go back to reference Gómez-García F, Gómez-Arias PJ, Montilla-López A, et al. A scoping review on use of drugs targeting the JAK/STAT pathway in psoriasis. Front Med (Lausanne). 2022;9: 754116.CrossRef Gómez-García F, Gómez-Arias PJ, Montilla-López A, et al. A scoping review on use of drugs targeting the JAK/STAT pathway in psoriasis. Front Med (Lausanne). 2022;9: 754116.CrossRef
58.
go back to reference Chimalakonda A, Burke J, Cheng L, et al. Selectivity profile of the tyrosine kinase 2 inhibitor deucravacitinib compared with Janus kinase 1/2/3 inhibitors. Dermatol Ther (Heidelb). 2021;11(5):1763–76.CrossRef Chimalakonda A, Burke J, Cheng L, et al. Selectivity profile of the tyrosine kinase 2 inhibitor deucravacitinib compared with Janus kinase 1/2/3 inhibitors. Dermatol Ther (Heidelb). 2021;11(5):1763–76.CrossRef
59.
go back to reference Armstrong AW, Gooderham M, Warren RB, et al. Deucravacitinib versus placebo and apremilast in moderate to severe plaque psoriasis: efficacy and safety results from the 52-week, randomized, double-blinded, placebo-controlled phase 3 POETYK PSO-1 trial. J Am Acad Dermatol. 2022;S0190–9622(22):02256–63. Armstrong AW, Gooderham M, Warren RB, et al. Deucravacitinib versus placebo and apremilast in moderate to severe plaque psoriasis: efficacy and safety results from the 52-week, randomized, double-blinded, placebo-controlled phase 3 POETYK PSO-1 trial. J Am Acad Dermatol. 2022;S0190–9622(22):02256–63.
60.
go back to reference Strober B, Thaçi D, Sofen H, et al. Deucravacitinib versus placebo and apremilast in moderate to severe plaque psoriasis: efficacy and safety results from the 52-week, randomized, double-blinded, phase 3 POETYK PSO-2 trial. J Am Acad Dermatol. 2022;S0190–9622(22):02643–53. Strober B, Thaçi D, Sofen H, et al. Deucravacitinib versus placebo and apremilast in moderate to severe plaque psoriasis: efficacy and safety results from the 52-week, randomized, double-blinded, phase 3 POETYK PSO-2 trial. J Am Acad Dermatol. 2022;S0190–9622(22):02643–53.
61.
go back to reference Liu J, Lv B, Yin H, Zhu X, Wei H, Ding Y. A phase I, randomized, double-blind, placebo-controlled, single ascending dose, multiple ascending dose and food effect study to evaluate the tolerance, pharmacokinetics of Jaktinib, a new selective Janus kinase inhibitor in healthy Chinese volunteers. Front Pharmacol. 2020;11: 604314.PubMedPubMedCentralCrossRef Liu J, Lv B, Yin H, Zhu X, Wei H, Ding Y. A phase I, randomized, double-blind, placebo-controlled, single ascending dose, multiple ascending dose and food effect study to evaluate the tolerance, pharmacokinetics of Jaktinib, a new selective Janus kinase inhibitor in healthy Chinese volunteers. Front Pharmacol. 2020;11: 604314.PubMedPubMedCentralCrossRef
62.
go back to reference Gangolli EA, Carreiro S, Leit S, et al. Characterization of pharmacokinetics, pharmacodynamics, tolerability and clinical activity in phase I studies of the novel allosteric tyrosine kinase 2 (TYK2) inhibitor NDI-034858. Presented at: 2022 SID Annual Meeting, May 18 - 21, 2022; Portland, Oregon. Gangolli EA, Carreiro S, Leit S, et al. Characterization of pharmacokinetics, pharmacodynamics, tolerability and clinical activity in phase I studies of the novel allosteric tyrosine kinase 2 (TYK2) inhibitor NDI-034858. Presented at: 2022 SID Annual Meeting, May 18 - 21, 2022; Portland, Oregon.
63.
go back to reference McElwee JJ, Garcet S, Li X, et al. Analysis of histologic, molecular and clinical improvement in moderate-to-severe psoriasis: results from a phase 1b trial of the novel allosteric TYK2 inhibitor NDI-034858. Presented at: 2022 AAD Annual Meeting, March 25–29, 2022; Boston, Massachusetts. McElwee JJ, Garcet S, Li X, et al. Analysis of histologic, molecular and clinical improvement in moderate-to-severe psoriasis: results from a phase 1b trial of the novel allosteric TYK2 inhibitor NDI-034858. Presented at: 2022 AAD Annual Meeting, March 25–29, 2022; Boston, Massachusetts.
64.
go back to reference Ivanov II, McKenzie BS, Zhou L, et al. The orphan nuclear receptor RORgammat directs the differentiation program of proinflammatory IL-17+ T helper cells. Cell. 2006;126(6):1121–33.PubMedCrossRef Ivanov II, McKenzie BS, Zhou L, et al. The orphan nuclear receptor RORgammat directs the differentiation program of proinflammatory IL-17+ T helper cells. Cell. 2006;126(6):1121–33.PubMedCrossRef
65.
go back to reference Gege C. Retinoic acid-related orphan receptor gamma t (RORyt) inverse agonists/antagonists for the treatment of inflammatory diseases – where are we presently? Expert Opin Drug Discov. 2021;16(12):1517–35.PubMedCrossRef Gege C. Retinoic acid-related orphan receptor gamma t (RORyt) inverse agonists/antagonists for the treatment of inflammatory diseases – where are we presently? Expert Opin Drug Discov. 2021;16(12):1517–35.PubMedCrossRef
66.
go back to reference Mandavia D, Farinola N, Ramachandra M, et al. Safety, tolerability, pharmacokinetics and pharmacodynamics of AUR101, an RORγt inhibitor, in normal healthy volunteers. Presented at: EAACI Congress 2019, June 1–5, 2019; Lisbon, Portugal. Mandavia D, Farinola N, Ramachandra M, et al. Safety, tolerability, pharmacokinetics and pharmacodynamics of AUR101, an RORγt inhibitor, in normal healthy volunteers. Presented at: EAACI Congress 2019, June 1–5, 2019; Lisbon, Portugal.
67.
go back to reference Duan X, Liu X, Liu N, et al. Inhibition of keratinocyte necroptosis mediated by RIPK1/RIPK3/MLKL provides a protective effect against psoriatic inflammation. Cell Death Dis. 2020;11(2):134.PubMedPubMedCentralCrossRef Duan X, Liu X, Liu N, et al. Inhibition of keratinocyte necroptosis mediated by RIPK1/RIPK3/MLKL provides a protective effect against psoriatic inflammation. Cell Death Dis. 2020;11(2):134.PubMedPubMedCentralCrossRef
68.
go back to reference Weisel K, Berger S, Papp K, et al. Response to inhibition of receptor-interacting protein kinase 1 (RIPK1) in active plaque psoriasis: a randomized placebo-controlled study. Clin Pharmacol Ther. 2020;108(4):808–16.PubMedPubMedCentralCrossRef Weisel K, Berger S, Papp K, et al. Response to inhibition of receptor-interacting protein kinase 1 (RIPK1) in active plaque psoriasis: a randomized placebo-controlled study. Clin Pharmacol Ther. 2020;108(4):808–16.PubMedPubMedCentralCrossRef
69.
go back to reference Harris PA, Berger SB, Jeong JU, et al. Discovery of a first-in-class receptor interacting protein 1 (RIP1) kinase specific clinical candidate (GSK2982772) for the treatment of inflammatory diseases. J Med Chem. 2017;60(4):1247–61.PubMedCrossRef Harris PA, Berger SB, Jeong JU, et al. Discovery of a first-in-class receptor interacting protein 1 (RIP1) kinase specific clinical candidate (GSK2982772) for the treatment of inflammatory diseases. J Med Chem. 2017;60(4):1247–61.PubMedCrossRef
70.
go back to reference Weisel K, Berger S, Papp K, et al. Response to inhibition of receptor-interacting protein kinase 1 (RIPK1) in active plaque psoriasis: a randomized placebo-controlled study. Clin Pharmacol Ther. 2020;1–8(4):808–16.CrossRef Weisel K, Berger S, Papp K, et al. Response to inhibition of receptor-interacting protein kinase 1 (RIPK1) in active plaque psoriasis: a randomized placebo-controlled study. Clin Pharmacol Ther. 2020;1–8(4):808–16.CrossRef
71.
go back to reference Tompson D, Whitaker M, Pan R, et al. Development of a once-daily modified-release formulation for the short half-life RIPK1 inhibitor GSK2982772 using DiffCORE technology. Pharm Res. 2022;39(1):153–65.PubMedPubMedCentralCrossRef Tompson D, Whitaker M, Pan R, et al. Development of a once-daily modified-release formulation for the short half-life RIPK1 inhibitor GSK2982772 using DiffCORE technology. Pharm Res. 2022;39(1):153–65.PubMedPubMedCentralCrossRef
72.
go back to reference Tompson DJ, Whitaker M, Pan R, et al. Development of a prototype, once-daily, modified-release formulation for the short half-life RIPK1 inhibitor GSK2982772. Pharm Res. 2021;38(7):1235–45.PubMedPubMedCentralCrossRef Tompson DJ, Whitaker M, Pan R, et al. Development of a prototype, once-daily, modified-release formulation for the short half-life RIPK1 inhibitor GSK2982772. Pharm Res. 2021;38(7):1235–45.PubMedPubMedCentralCrossRef
74.
go back to reference David M, Ackerman L, Ziv M. Treatment of plaque-type psoriasis with oral CF101: data from an exploratory randomized phase 2 clinical trial. J Eur Acad Dermatol Venereol. 2012;26(3):361–7.PubMedCrossRef David M, Ackerman L, Ziv M. Treatment of plaque-type psoriasis with oral CF101: data from an exploratory randomized phase 2 clinical trial. J Eur Acad Dermatol Venereol. 2012;26(3):361–7.PubMedCrossRef
75.
go back to reference Misiak-Galazka M, Zozula J, Rudnicka L. Palmoplantar pustulosis: recent advances in etiopathogenesis and emerging treatments. Am J Clin Dermatol. 2020;21(3):355–70.PubMedPubMedCentralCrossRef Misiak-Galazka M, Zozula J, Rudnicka L. Palmoplantar pustulosis: recent advances in etiopathogenesis and emerging treatments. Am J Clin Dermatol. 2020;21(3):355–70.PubMedPubMedCentralCrossRef
76.
go back to reference Bissonnette R, Maari C, Tsianakas A, et al. A randomized, double-blind, placebo-controlled, phase 2a study to evaluate the efficacy and safety of RIST4721 in subjects with palmoplantar pustulosis. Dermatol Ther (Heidelb). 2021;11(6):2179–93.CrossRef Bissonnette R, Maari C, Tsianakas A, et al. A randomized, double-blind, placebo-controlled, phase 2a study to evaluate the efficacy and safety of RIST4721 in subjects with palmoplantar pustulosis. Dermatol Ther (Heidelb). 2021;11(6):2179–93.CrossRef
77.
go back to reference Napolitano M, Fabbrocini G, Martora F, Picone V, Morelli P, Patruno C. Role of aryl hydrocarbon receptor activation in inflammatory chronic skin diseases. Cells. 2021;10(12):3559.PubMedPubMedCentralCrossRef Napolitano M, Fabbrocini G, Martora F, Picone V, Morelli P, Patruno C. Role of aryl hydrocarbon receptor activation in inflammatory chronic skin diseases. Cells. 2021;10(12):3559.PubMedPubMedCentralCrossRef
78.
80.
go back to reference Lebwohl MG, Stein Gold L, Strober B, et al. Phase 3 trials of tapinarof cream for plaque psoriasis. N Engl J Med. 2021;385(24):2219–29.PubMedCrossRef Lebwohl MG, Stein Gold L, Strober B, et al. Phase 3 trials of tapinarof cream for plaque psoriasis. N Engl J Med. 2021;385(24):2219–29.PubMedCrossRef
81.
go back to reference Strober B, Stein Gold L, Bissonnette R, et al. One-year safety and efficacy of tapinarof cream for the treatment of plaque psoriasis: results from the PSOARING 3 trial. J Am Acad Dermatol. 2022;S0190–9622(22):02219–28. Strober B, Stein Gold L, Bissonnette R, et al. One-year safety and efficacy of tapinarof cream for the treatment of plaque psoriasis: results from the PSOARING 3 trial. J Am Acad Dermatol. 2022;S0190–9622(22):02219–28.
84.
go back to reference Croop R, Lipton RB, Kudrow D, et al. Oral rimegepant for preventative treatment of migraine: a phase 2/3, randomised, double-blind, placebo-controlled trial. Lancet. 2021;397(10268):51–60.PubMedCrossRef Croop R, Lipton RB, Kudrow D, et al. Oral rimegepant for preventative treatment of migraine: a phase 2/3, randomised, double-blind, placebo-controlled trial. Lancet. 2021;397(10268):51–60.PubMedCrossRef
85.
go back to reference Kim YJ, Granstein RD. Roles of calcitonin gene-related peptide in the skin, and other physiological and pathophysiological funcitons. Brain Behav Immune Health. 2021;18: 100361.CrossRef Kim YJ, Granstein RD. Roles of calcitonin gene-related peptide in the skin, and other physiological and pathophysiological funcitons. Brain Behav Immune Health. 2021;18: 100361.CrossRef
87.
go back to reference Liu L, Wang J, Li H-J, et al. Sphingosine-1-Phosphate and its signal modulators alleviate psoriasis-like dermatitis: preclinical and clinical evidence and possible mechanisms. Front Immunol. 2021;12: 759276.PubMedPubMedCentralCrossRef Liu L, Wang J, Li H-J, et al. Sphingosine-1-Phosphate and its signal modulators alleviate psoriasis-like dermatitis: preclinical and clinical evidence and possible mechanisms. Front Immunol. 2021;12: 759276.PubMedPubMedCentralCrossRef
Metadata
Title
A Review of the Clinical Trial Landscape in Psoriasis: An Update for Clinicians
Authors
Anastasia Drakos
Ronald Vender
Publication date
01-11-2022
Publisher
Springer Healthcare
Published in
Dermatology and Therapy / Issue 12/2022
Print ISSN: 2193-8210
Electronic ISSN: 2190-9172
DOI
https://doi.org/10.1007/s13555-022-00840-9

Other articles of this Issue 12/2022

Dermatology and Therapy 12/2022 Go to the issue
Obesity Clinical Trial Summary

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.

Developed by: Springer Medicine

Highlights from the ACC 2024 Congress

Year in Review: Pediatric cardiology

Watch Dr. Anne Marie Valente present the last year's highlights in pediatric and congenital heart disease in the official ACC.24 Year in Review session.

Year in Review: Pulmonary vascular disease

The last year's highlights in pulmonary vascular disease are presented by Dr. Jane Leopold in this official video from ACC.24.

Year in Review: Valvular heart disease

Watch Prof. William Zoghbi present the last year's highlights in valvular heart disease from the official ACC.24 Year in Review session.

Year in Review: Heart failure and cardiomyopathies

Watch this official video from ACC.24. Dr. Biykem Bozkurt discusses last year's major advances in heart failure and cardiomyopathies.