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

NCT ID: NCT03020199

Last Updated: 2025-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 196 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-27
• Study Completion Date: 2023-06-16

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.

Conditions

Plaque Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Secukinumab

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

nb-UVB

Intervention Type: 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

Interventions

Secukinumab

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.

Intervention Type: BIOLOGICAL

nb-UVB

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

Intervention Type: RADIATION

Other Intervention Names

AIN457

Eligibility Criteria

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.

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Investigative Site

Ciudad Autonoma de Bs As, Buenos Aires, Argentina

Novartis Investigative Site

Buenos Aires, , Argentina

Novartis Investigative Site

Pleven, , Bulgaria

Novartis Investigative Site

Plovdiv, , Bulgaria

Novartis Investigative Site

Sofia, , Bulgaria

Novartis Investigative Site

Sofia, , Bulgaria

Novartis Investigative Site

Sofia, , Bulgaria

Novartis Investigative Site

Greater Sudbury, Ontario, Canada

Novartis Investigative Site

Markham, Ontario, Canada

Novartis Investigative Site

Aarhus N, , Denmark

Novartis Investigative Site

Tallinn, , Estonia

Novartis Investigative Site

Tallinn, , Estonia

Novartis Investigative Site

Tartu, , Estonia

Novartis Investigative Site

Tampere, , Finland

Novartis Investigative Site

Turku, , Finland

Novartis Investigative Site

Berlin, , Germany

Novartis Investigative Site

Berlin, , Germany

Novartis Investigative Site

Erlangen, , Germany

Novartis Investigative Site

Frankfurt, , Germany

Novartis Investigative Site

Nyíregyháza, , Hungary

Novartis Investigative Site

Szolnok, , Hungary

Novartis Investigative Site

Bialystok, , Poland

Novartis Investigative Site

Bydgoszcz, , Poland

Novartis Investigative Site

Gdansk, , Poland

Novartis Investigative Site

Krakow, , Poland

Novartis Investigative Site

Lodz, , Poland

Novartis Investigative Site

Lodz, , Poland

Novartis Investigative Site

Badalona, Catalonia, Spain

Novartis Investigative Site

Barcelona, Catalonia, Spain

Novartis Investigative Site

Barcelona, Catalonia, Spain

Novartis Investigative Site

Alcorcón, Madrid, Spain

Novartis Investigative Site

Alicante, Valencia, Spain

Novartis Investigative Site

Valencia, Valencia, Spain

Novartis Investigative Site

Las Palmas de Gran Canaria, , Spain

Novartis Investigative Site

Madrid, , Spain

Novartis Investigative Site

Madrid, , Spain

Novartis Investigative Site

Madrid, , Spain

Novartis Investigative Site

Gothenburg, , Sweden

Novartis Investigative Site

Malmo, , Sweden

Novartis Investigative Site

Lausanne, , Switzerland

Novartis Investigative Site

Bradford, West Yorkshire, United Kingdom

Novartis Investigative Site

Leeds, West Yorkshire, United Kingdom

Novartis Investigative Site

London, , United Kingdom

Novartis Investigative Site

Salford, , United Kingdom

Countries

Argentina; Bulgaria; Canada; Denmark; Estonia; Finland; Germany; Hungary; Poland; Spain; Sweden; Switzerland; United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2015-002423-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CAIN457A2322

Identifier Type: -

Identifier Source: org_study_id