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

Phase 4

Completed

Brief Summary: 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).

Detailed Description: This was and open label, parallel group, multicenter, randomized study with 3 clinical periods: Screening period, Treatment period, and Follow-up period.

The design consisted of the Main Study and a Mechanistic Sub study:

1. The Main Study had 2-treatment-arm secukinumab and nb-UVB).

2. The Mechanistic Sub-study had 4 arms treated with secukinumab and one arm with nb-UVB arm. The outcome measures were all exploratory, i.e. no results presented. Not all participants of the Mechanistic Sub-study participated in the Main Study, these participants are only reported for the safety analyses, but not for the primary and secondary outcome measures.

Recruitment & Eligibility

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 50 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 (Arm A1, Arm A2, and Arm B1). Episodes of mild psoriasis, which occurred at least 3 years before screening and resolved spontaneously within 6 months will be accepted.
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 IGA mod 2011 >= 3.

Key

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 period or longer if required by locally approved prescribing information (e.g., 20 weeks in the EU and countries where applicable for secukinumab).

Arm && Interventions

Group	Intervention	Description
Narrow-band ultraviolet B (nb-UVB)	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.
Secukinumab 300 mg	Secukinumab	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).

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Achieved Pain Assessment Severity Index (PASI) 90 at Week 52.	Baseline, Week 52	The PASI quantifies the severity of a participant's psoriasis based on both "lesion severity" and the "percent of Body Surface Area (BSA)" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI composite score varies in increments of 0.1 and range from 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. PASI 90 response is a binary measure defined as at least a 90% improvement in PASI score at Week 52, relative to baseline PASI score.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Achieved PASI 90 at Week 104	Baseline, Week 104	The PASI quantifies the severity of a participant's psoriasis based on both "lesion severity" and the "percent of Body Surface Area (BSA)" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI composite score varies in increments of 0.1 and range from 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. PASI 90 response is a binary measure defined as at least a 90% improvement in PASI score at Week 104, relative to baseline PASI score.
Number of Participants With IGA Mod 2011 0/1 Response at Week 52	Baseline, Week 52	Investigators assessed the disease using the validated Investigator Global Assessment (IGA) mod 2011 and rated the disease from a score of 0 (clear skin) to 4 (severe disease). Response is defined as a score of 0 or 1 at Week 52.