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

Sponsor
Novartis Pharmaceuticals
Study ID
NCT03020199
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Secukinumab — BIOLOGICAL
    Secukinumab (AIN457) 300 mg was administered in an open-label fashion according to label as 2 s.c. injections of secukinumab 150 mg (1-mL liquid formulation in a pre-filled syringe). Each 300-mg dose was provided as 2 pre-filled syringes of 150-mg secukinumab in a single box. Each syringe was labeled as AIN457 150 mg/1 mL.
  • nb-UVB — RADIATION
    Narrow-band UVB applied in 1 or 2 cycles, each comprising a period of 12 weeks with 2 to 3 treatment sessions per week totaling 24 to 36 sessions per cycle. The application was performed according to the investigational site's protocol, taking into account the patient's skin type. A maximum dose of 3 J/cm2 on the body and 1 J/cm2 on the face was recommended

Study Details

The purpose of this study was 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).

Key Dates

Start date
Mar 27, 2017
Status verified
Jan 2025
Primary completion
Nov 30, 2021
Completion
Jun 16, 2023

Study Design

Enrollment
196 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Secukinumab 300 mg
    In the Main Study, 80 new-onset psoriasis patients in Arm A1 (68 in Arm A1a, 12 in Arm A1b) received 300 mg secukinumab injections weekly for the first month, then every 4 weeks until Week 48 (52-week treatment). Arm A1b patients also joined the Mechanistic Sub-study. In the Mechanistic Sub-study, 12 new-onset psoriasis patients (Arm A2) and 24 chronic plaque psoriasis patients (12 each in Arms C1 and C2) received similar secukinumab treatment. Arm A2 and C2 patients continued until Week 100 (104-week treatment), while Arm C1 ended at Week 48 (52-week treatment).
  • Active Comparator: Narrow-band ultraviolet B (nb-UVB)
    In the Main Study, 80 new-onset psoriasis patients in Arm B1 (68 in Arm B1a and 12 in Arm B1b) received 1 or 2 cycles of nb UVB of 12 weeks each with a maximum break of 28 weeks between cycles (patients with PASI 90 at Week 40 did not receive a second treatment cycle) (treatment duration = 52 weeks). Patients from Arm B1b participated also in the Mechanistic Sub-study.

Primary Outcome Measure

Number of Participants Who Achieved Pain Assessment Severity Index (PASI) 90 at Week 52. [ Time Frame: Baseline, Week 52 ]

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