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

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ClinicalTrials.gov Identifier: NCT03149900
Recruitment Status : Active, not recruiting
First Posted : May 11, 2017
Last Update Posted : April 17, 2019
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Diamant Thaci, University of Luebeck

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.


Condition or disease Intervention/treatment
Psoriasis Vulgaris Drug: Secukinumab

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Exploratory Evaluation of Biomarkers Associated With Treatment Response to Cosentyx (Secukinumab) in Psoriasis Patients
Study Start Date : October 2016
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Secukinumab

Group/Cohort Intervention/treatment
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
See Arm Description
Other Name: Cosentyx




Primary Outcome Measures :
  1. Change in skin microbiome composition [ Time Frame: from baseline to week 24 ]
    Investigation of skin microbiome composition associated with treatment response in psoriasis patients treated with Secukinumab

  2. Change in antimicrobial peptide composition [ Time Frame: from baseline to week 24 ]
    Investigation of antimicrobial peptide composition associated with treatment response in psoriasis patients treated with Secukinumab

  3. Change in gene expression [ Time Frame: from baseline to week 24 ]
    Investigation of gene expression in RNA and DNA associated with treatment response in psoriasis patients treated with Secukinumab


Biospecimen Retention:   Samples With DNA
Blood samples


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Criteria

Inclusion Criteria:

  1. 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.
  2. 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.
  3. Subjects must be at least 18 years of age at time of enrollment
  4. Patients starting treatment with Secukinumab and for whom the clinical decision has been made prior to participation in the study.
  5. 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)

Exclusion Criteria:

  1. Exclusion criteria will comply with the licensed product specifications for Cosentyx (Secukinumab)
  2. Patients incapable of giving full informed consent.
  3. Forms of psoriasis other than chronic plaque-type at enrollment
  4. Oral or topical antibiotic therapy within the month prior to enrollment
  5. Phototherapy (UVB/PUVA) within the month prior to enrollment
  6. Allergy to local anaesthetic or latex
  7. Pregnancy/Lactation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03149900


Locations
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Germany
University Clinic Schleswig-Holstein
Lubeck, Schleswig-Holstein, Germany, 23538
Sponsors and Collaborators
Diamant Thaci
Novartis
Investigators
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Principal Investigator: Diamant Thaci, Prof. Dr. University of Luebeck

Publications:
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, Ståhle 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.

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Responsible Party: Diamant Thaci, Prof. Dr. med., University of Luebeck
ClinicalTrials.gov Identifier: NCT03149900     History of Changes
Other Study ID Numbers: CAIN457ADE02T
First Posted: May 11, 2017    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs