Multiple-dose Regimen Study to Assess Effect of 12 Months of Secukinumab Treatment on Skin Response and Biomarkers in Psoriasis Patients

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Novartis

Status and phase

Completed
Phase 2

Conditions

Psoriasis, Plaque-type Psoriasis

Treatments

Drug: secukinumab
Drug: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01537432
CAIN457A2223

Details and patient eligibility

About

This study is designed to evaluate the proportion of patients achieving reversal of chronic plaque psoriasis at week 4 and 12 following multiple doses of secukinumab administered subcutaneously (sc) compared to placebo. Starting from week 13, all patients will receive multiple doses of secukinumab up to week 52 to study long term effects of secukinumab. Clinical endpoints including biomarker assessments, PASI, IGA and DLQI will be compared to better understand, why secukinumab may be effective in psoriasis patients.

Enrollment

36 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Chronic plaque-type psoriasis diagnosed for at least 6 months
  • Moderate to severe psoriasis as defined by: PASI score of ≥12, IGA score of ≥3, BSA (body surface area) affected by plaque-type psoriasis of ≥10%
  • Chronic plaque-type psoriasis considered inadequately controlled by: topical treatment and/or; phototherapy and/or previous systemic therapy

Exclusion criteria

  • Forms of psoriasis other than chronic plaque-type
  • Evidence of skin conditions at the time of the screening visit (e.g., eczema) that would interfere with evaluations of the effect of the investigational product on psoriasis
  • History or evidence of active tuberculosis or evidence of latent tuberculosis (or other infections like Hepatitis-C/B), malignancy; active or known use of other immunosuppressive drugs (for eg: AIDs, RA, organ rejection etc.) at the screening visit
  • Pregnant or nursing (lactating) women

Trial design

36 participants in 2 patient groups, including a placebo group

placebo
Placebo Comparator group
Description:
placebo
Treatment:
Drug: placebo
secukinumab
Experimental group
Description:
secukinumab
Treatment:
Drug: secukinumab

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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