drugset / Trial / NCT03442088
Monocyte Biomarkers in Moderate to Severe Plaque Psoriasis Subjects Treated With Apremilast
NaSingle-groupOpen-labelTreatment
Summary
This is an open label pilot study of the impact of treatment with standard dosing of Otezla for 16 weeks on AM-endotype psoriasis patients, identified by elevated (\>150% of normal): 1.) Intermediate (CD14++CD16+) monocytes, or 2.) circulating monocyte doublets, or 3.) circulating monocyte-platelet aggregates (MPA). Approximately 25 psoriasis patients with the AM-endotype will be followed during treatment over 16 weeks with 4 monthly individual blood draws will be enrolled. All treated psoriasis subjects will receive apremilast through Week 16.
Timeline
- Start
- 2018-06-01
- Primary completion
- 2021-09-30
- Completion
- 2021-09-30
Publications
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- Background Garcia-Rodriguez S, Arias-Santiago S, Perandres-Lopez R, Castellote L, Zumaquero E, Navarro P, Buendia-Eisman A, Ruiz JC, Orgaz-Molina J, Sancho J, M Zubiaur. Increased gene expression of Toll-like receptor 4 on peripheral blood mononuclear cells in patients with psoriasis. J Eur Acad Dermatol Venereol. 2013 Feb;27(2):242-50. doi: 10.1111/j.1468-3083.2011.04372.x.
- Background Benoit S, Toksoy A, Ahlmann M, Schmidt M, Sunderkotter C, Foell D, Pasparakis M, Roth J, Goebeler M. Elevated serum levels of calcium-binding S100 proteins A8 and A9 reflect disease activity and abnormal differentiation of keratinocytes in psoriasis. Br J Dermatol. 2006 Jul;155(1):62-6. doi: 10.1111/j.1365-2133.2006.07198.x.
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- Background Moniuszko M, Bodzenta-Lukaszyk A, Kowal K, Lenczewska D, Dabrowska M. Enhanced frequencies of CD14++CD16+, but not CD14+CD16+, peripheral blood monocytes in severe asthmatic patients. Clin Immunol. 2009 Mar;130(3):338-46. doi: 10.1016/j.clim.2008.09.011. Epub 2008 Oct 25.
- Background Mysliwska J, Smardzewski M, Marek-Trzonkowska N, Mysliwiec M, Raczynska K. Expansion of CD14+CD16+ monocytes producing TNF-alpha in complication-free diabetes type 1 juvenile onset patients. Cytokine. 2012 Oct;60(1):309-17. doi: 10.1016/j.cyto.2012.03.010. Epub 2012 Apr 7.
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- Background Schlitt A, Heine GH, Blankenberg S, Espinola-Klein C, Dopheide JF, Bickel C, Lackner KJ, Iz M, Meyer J, Darius H, Rupprecht HJ. CD14+CD16+ monocytes in coronary artery disease and their relationship to serum TNF-alpha levels. Thromb Haemost. 2004 Aug;92(2):419-24. doi: 10.1160/TH04-02-0095.
- Background Rogacev KS, Cremers B, Zawada AM, Seiler S, Binder N, Ege P, Grosse-Dunker G, Heisel I, Hornof F, Jeken J, Rebling NM, Ulrich C, Scheller B, Bohm M, Fliser D, Heine GH. CD14++CD16+ monocytes independently predict cardiovascular events: a cohort study of 951 patients referred for elective coronary angiography. J Am Coll Cardiol. 2012 Oct 16;60(16):1512-20. doi: 10.1016/j.jacc.2012.07.019. Epub 2012 Sep 19.
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- Background Golden JB, Groft SG, Squeri MV, Debanne SM, Ward NL, McCormick TS, Cooper KD. Chronic Psoriatic Skin Inflammation Leads to Increased Monocyte Adhesion and Aggregation. J Immunol. 2015 Sep 1;195(5):2006-18. doi: 10.4049/jimmunol.1402307. Epub 2015 Jul 29.
- Background Schafer PH, Parton A, Gandhi AK, Capone L, Adams M, Wu L, Bartlett JB, Loveland MA, Gilhar A, Cheung YF, Baillie GS, Houslay MD, Man HW, Muller GW, Stirling DI. Apremilast, a cAMP phosphodiesterase-4 inhibitor, demonstrates anti-inflammatory activity in vitro and in a model of psoriasis. Br J Pharmacol. 2010 Feb;159(4):842-55. doi: 10.1111/j.1476-5381.2009.00559.x. Epub 2009 Dec 24.
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Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Apremilast | Small molecule | 30 mg | Oral |