Study of the Efficacy of Early Intervention With Secukinumab 300 mg s.c. Compared to Narrow-band UVB in Patients With New-onset Moderate to Severe Plaque Psoriasis (STEPin)

  • STATUS
    Recruiting
  • End date
    Aug 30, 2024
  • participants needed
    196
  • sponsor
    Novartis Pharmaceuticals
Updated on 4 October 2022
secukinumab
betamethasone
phototherapy
calcipotriene

Summary

The purpose of this study is to determine whether early intervention with subcutaneous (s.c.) secukinumab 300 mg in patients with new-onset moderate to severe plaque psoriasis may lead to prolonged symptom free periods by preventing reactivation of old lesions or ultimately totally hindering the occurrence of new lesions, i.e., changing the natural course of the disease (Main Study).

Description

The overall study population (Main Study and Mechanistic Sub-study) will consist of a total of 205 male and female patients aged between 18 and 40 years inclusive.

Main Study The Main Study will be conducted in patients with new-onset moderate to severe plaque psoriasis not previously treated with any systemic treatment or phototherapy. A total of 160 patients will be randomized to Arm A1 or Arm B1 in approximately 50 sites worldwide. Since a maximum screening failure rate of 20% is expected, approximately 200 patients will be screened.

Mechanistic Sub-study Any patient who consents can participate in the Mechanistic Sub-study. Patients with new-onset plaque psoriasis will be randomized to Arm A1b, Arm A2, or Arm B1b, those with chronic plaque psoriasis will be randomized to Arm C1 and Arm C2 (15 patients each). For Arm A1b or Arm B1b, the first 15 patients will be included on a first come first serve basis.

Safety assessments :Physical examination, Vital signs, Height and body weight, Laboratory evaluations (hematology, clinical chemistry, high-sensitivity C-reactive protein), Electrocardiogram, Pregnancy, Adverse events

Data Analysis The primary efficacy variable is the proportion of patients who achieve PASI 90 at Week 52. The analysis for the primary objective will be based on the full analysis set. For the primary analysis, the following hypothesis testing will be performed: H01: psec = pnbUVB versus HA1: psec ≠ pnbUVB The primary analysis method for PASI 90 response at Week 52 will use an exact logistic regression model with treatment as an explanatory variable and baseline PASI score as covariate. The key secondary variable is the proportion of all randomized patients who achieve PASI 90 at Week 104. In order to reduce selection bias, all patients who do not achieve PASI 90 at Week 52 will also be included in the analysis at Week 104 using the PASI improvement obtained at Week 104 only.

For the key secondary analysis, the following hypothesis testing will be performed:

H02: psec = pnbUVB versus HA2: psec ≠ pnbUVB

Details
Condition Plaque Psoriasis
Treatment Secukinumab, nbUVB, Calcipotriol, Betamethasone, Betamethasone
Clinical Study IdentifierNCT03020199
SponsorNovartis Pharmaceuticals
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Able to understand and communicate with the investigator, willing and capable to comply with all study procedures, and provide written signed and dated informed consent (personally or by a witness) before any assessment is performed
Aged 18 to 40 years inclusive
New-onset plaque psoriasis with appearance of the first psoriasis plaques within the last 12 months before randomization and naïve to any systemic treatment and phototherapy (Arms A1, A2 and Arm B1)
Chronic plaque psoriasis with appearance of the first psoriasis symptoms 5 years or longer and intolerance or inadequate response to phototherapy or any systemic treatment including biologicals, except for IL-17A inhibitors (Arm C1 and Arm C2)
Moderate to severe plaque psoriasis defined at screening and baseline by PASI ≥ 10, and body surface area (BSA) ≥ 10%, and investigator's global assessment (IGA mod 2011) ≥ 3

Exclusion Criteria

Forms of psoriasis other than plaque-type (e.g., pustular, erythrodermic, guttate, light sensitive, and drug induced)
Ongoing use of prohibited treatments
Previous treatment with phototherapy or any systemic treatment
Pregnant or nursing (lactating) women
Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during the Treatment Epoch or longer if required by locally-approved prescribing information (e.g., 20 weeks in the EU)
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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