Exploratory Evaluation of Biomarkers Associated With Treatment Response to Cosentyx (Secukinumab) in Psoriasis Patients

NCT03149900 | Completed

• 1 other identifier: CAIN457ADE02T
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

To identify possible genetic associations of clinical response to anti-IL-17A (Secukinumab) treatment in psoriasis using a combined gene association study and gene expression analysis. To investigate the influence of IL-17A on the cutaneous microbial flora and to analyse cutaneous antimicrobial peptide expression in the skin of patients with psoriasis prior to, and during, treatment with Secukinumab to determine the extent to which the microbial flora is associated with response to treatment, as determined by the PASI75, PASI90, PGA- and DLQI improvement.

Conditions

Psoriasis Vulgaris

Outcome Measures

Primary Outcomes (3)

• Change in skin microbiome composition

  Investigation of skin microbiome composition associated with treatment response in psoriasis patients treated with Secukinumab

  from baseline to week 24

• Change in antimicrobial peptide composition

  Investigation of antimicrobial peptide composition associated with treatment response in psoriasis patients treated with Secukinumab

  from baseline to week 24

• Change in gene expression

  Investigation of gene expression in RNA and DNA associated with treatment response in psoriasis patients treated with Secukinumab

  from baseline to week 24

Study Arms (1)

Secukinumab

Patients will be recruited in the Comprehensive Center for Inflammation Medicine. The study population will consist of 40 subjects (both male and female), aged 18 years and older, in whom treatment with Secukinumab is clinically indicated and according to the licensed product specifications. The study drug will be prescribed by a doctor who is independent of this study. Visit 1 will be carried out prior to the first injection of Secukinumab. All patients will receive a number and the data will be recorded in a pseudo-anonymised form. No blinding is necessary for investigators or patients (open study), as all patients receive the same treatment (marketed product).

Drug: Secukinumab

Interventions

Secukinumab DRUG

See Arm Description

Also known as: Cosentyx

Secukinumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of 40 subjects (both male and female), aged 18 years and older, in whom treatment with Secukinumab is clinically indicated and according to the licensed product specifications. The study drug will be prescribed by a doctor who is independent of this study. Visit 1 will be carried out prior to the first injection of Secukinumab. All patients will receive a number and the data will be recorded in a pseudo-anonymised form. No blinding is necessary for investigators or patients (open study), as all patients receive the same treatment (marketed product).

You may qualify if:

• Subjects must be able to understand and communicate with the investigator and comply with the requirements of the study and must give written, signed and dated informed consent before any study related activity is performed.
• Chronic moderate to severe plaque type psoriasis for at least 6 months prior to baseline with a PASI score ≥ 10 and BSA ≥ 10 as per German guidelines.
• Subjects must be at least 18 years of age at time of enrollment
• Patients starting treatment with Secukinumab and for whom the clinical decision has been made prior to participation in the study.
• Initiation of Secukinumab therapy, in patients who are not biologic naïve will be carried out according to a published consensus paper (Mrowietz et al. 2014)

You may not qualify if:

• Patients incapable of giving full informed consent.
• Forms of psoriasis other than chronic plaque-type at enrollment
• Oral or topical antibiotic therapy within the month prior to enrollment
• Phototherapy (UVB/PUVA) within the month prior to enrollment
• Allergy to local anaesthetic or latex
• Pregnancy/Lactation

Sponsors & Collaborators

• Diamant Thaci: lead
• Novartis: collaborator

Study Sites (1)

University Clinic Schleswig-Holstein

Lübeck, Schleswig-Holstein, 23538, Germany

Location

Related Publications (21)

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  PMID: 15872205 BACKGROUND

• Johnson-Huang LM, Lowes MA, Krueger JG. Putting together the psoriasis puzzle: an update on developing targeted therapies. Dis Model Mech. 2012 Jul;5(4):423-33. doi: 10.1242/dmm.009092.

  PMID: 22730473 BACKGROUND

• Langley RG, Elewski BE, Lebwohl M, Reich K, Griffiths CE, Papp K, Puig L, Nakagawa H, Spelman L, Sigurgeirsson B, Rivas E, Tsai TF, Wasel N, Tyring S, Salko T, Hampele I, Notter M, Karpov A, Helou S, Papavassilis C; ERASURE Study Group; FIXTURE Study Group. Secukinumab in plaque psoriasis--results of two phase 3 trials. N Engl J Med. 2014 Jul 24;371(4):326-38. doi: 10.1056/NEJMoa1314258. Epub 2014 Jul 9.

  PMID: 25007392 BACKGROUND

• Tsoi LC, Spain SL, Knight J, Ellinghaus E, Stuart PE, Capon F, Ding J, Li Y, Tejasvi T, Gudjonsson JE, Kang HM, Allen MH, McManus R, Novelli G, Samuelsson L, Schalkwijk J, Stahle M, Burden AD, Smith CH, Cork MJ, Estivill X, Bowcock AM, Krueger GG, Weger W, Worthington J, Tazi-Ahnini R, Nestle FO, Hayday A, Hoffmann P, Winkelmann J, Wijmenga C, Langford C, Edkins S, Andrews R, Blackburn H, Strange A, Band G, Pearson RD, Vukcevic D, Spencer CC, Deloukas P, Mrowietz U, Schreiber S, Weidinger S, Koks S, Kingo K, Esko T, Metspalu A, Lim HW, Voorhees JJ, Weichenthal M, Wichmann HE, Chandran V, Rosen CF, Rahman P, Gladman DD, Griffiths CE, Reis A, Kere J; Collaborative Association Study of Psoriasis (CASP); Genetic Analysis of Psoriasis Consortium; Psoriasis Association Genetics Extension; Wellcome Trust Case Control Consortium 2; Nair RP, Franke A, Barker JN, Abecasis GR, Elder JT, Trembath RC. Identification of 15 new psoriasis susceptibility loci highlights the role of innate immunity. Nat Genet. 2012 Dec;44(12):1341-8. doi: 10.1038/ng.2467. Epub 2012 Nov 11.

  PMID: 23143594 BACKGROUND

• Nair RP, Duffin KC, Helms C, Ding J, Stuart PE, Goldgar D, Gudjonsson JE, Li Y, Tejasvi T, Feng BJ, Ruether A, Schreiber S, Weichenthal M, Gladman D, Rahman P, Schrodi SJ, Prahalad S, Guthery SL, Fischer J, Liao W, Kwok PY, Menter A, Lathrop GM, Wise CA, Begovich AB, Voorhees JJ, Elder JT, Krueger GG, Bowcock AM, Abecasis GR; Collaborative Association Study of Psoriasis. Genome-wide scan reveals association of psoriasis with IL-23 and NF-kappaB pathways. Nat Genet. 2009 Feb;41(2):199-204. doi: 10.1038/ng.311. Epub 2009 Jan 25.

  PMID: 19169254 BACKGROUND

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  PMID: 23879815 BACKGROUND

• Rich P, Sigurgeirsson B, Thaci D, Ortonne JP, Paul C, Schopf RE, Morita A, Roseau K, Harfst E, Guettner A, Machacek M, Papavassilis C. Secukinumab induction and maintenance therapy in moderate-to-severe plaque psoriasis: a randomized, double-blind, placebo-controlled, phase II regimen-finding study. Br J Dermatol. 2013 Feb;168(2):402-11. doi: 10.1111/bjd.12112.

  PMID: 23362969 BACKGROUND

• Thaci D, Blauvelt A, Reich K, Tsai TF, Vanaclocha F, Kingo K, Ziv M, Pinter A, Hugot S, You R, Milutinovic M. Secukinumab is superior to ustekinumab in clearing skin of subjects with moderate to severe plaque psoriasis: CLEAR, a randomized controlled trial. J Am Acad Dermatol. 2015 Sep;73(3):400-9. doi: 10.1016/j.jaad.2015.05.013. Epub 2015 Jun 17.

  PMID: 26092291 BACKGROUND

• Batycka-Baran A, Maj J, Wolf R, Szepietowski JC. The new insight into the role of antimicrobial proteins-alarmins in the immunopathogenesis of psoriasis. J Immunol Res. 2014;2014:628289. doi: 10.1155/2014/628289. Epub 2014 May 8.

  PMID: 24901012 BACKGROUND

• Chen YE, Tsao H. The skin microbiome: current perspectives and future challenges. J Am Acad Dermatol. 2013 Jul;69(1):143-55. doi: 10.1016/j.jaad.2013.01.016. Epub 2013 Mar 13.

  PMID: 23489584 BACKGROUND

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  PMID: 24042968 BACKGROUND

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  PMID: 15568027 BACKGROUND

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  PMID: 19016697 BACKGROUND

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  PMID: 23437792 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Interventions

secukinumab

Study Officials

• Diamant Thaci, Prof. Dr.

  University of Luebeck

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: November 30, 2016
• First Posted: May 11, 2017
• Study Start: October 1, 2016
• Primary Completion: July 25, 2019
• Study Completion: July 25, 2019
• Last Updated: August 16, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)