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

NCT03020199 | Completed Phase 4 Results

• 2 other identifiers: CAIN457A23222015-002423-26
• Study Type: interventional
• Target: 196
• Locations: 12 countries
• Sites: 41

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).

Conditions

Plaque Psoriasis

Keywords

Psoriasis; interleukin (IL) 17A; IL-17A; secukinumab; AIN457; Narrow-band ultraviolet light B; nb-UVB; Psoriasis area and severity index; PASI

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Achieved Pain Assessment Severity Index (PASI) 90 at 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.

  Baseline, Week 52

Secondary Outcomes (2)

• Number of Participants Who Achieved PASI 90 at Week 104

  Baseline, Week 104

• Number of Participants With IGA Mod 2011 0/1 Response at Week 52

  Baseline, Week 52

Study Arms (2)

Secukinumab 300 mg

EXPERIMENTAL

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).

Biological: Secukinumab

Narrow-band ultraviolet B (nb-UVB)

ACTIVE COMPARATOR

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.

Radiation: nb-UVB

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.

Also known as: AIN457

Secukinumab 300 mg

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

Narrow-band ultraviolet B (nb-UVB)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (44)

Novartis Investigative Site

Ciudad Autonoma de Bs As, Buenos Aires, 1181, Argentina

Location

Novartis Investigative Site

Buenos Aires, C1425DKG, Argentina

Location

Novartis Investigative Site

Pleven, 5800, Bulgaria

Location

Novartis Investigative Site

Plovdiv, 4002, Bulgaria

Location

Novartis Investigative Site

Sofia, 1407, Bulgaria

Location

Novartis Investigative Site

Sofia, 1431, Bulgaria

Location

Novartis Investigative Site

Sofia, 1632, Bulgaria

Location

Novartis Investigative Site

Greater Sudbury, Ontario, P3C 1X8, Canada

Location

Novartis Investigative Site

Markham, Ontario, L3P 1X2, Canada

Location

Novartis Investigative Site

Aarhus N, 8200, Denmark

Location

Novartis Investigative Site

Tallinn, 10138, Estonia

Location

Novartis Investigative Site

Tallinn, 13419, Estonia

Location

Novartis Investigative Site

Tartu, 50406, Estonia

Location

Novartis Investigative Site

Tampere, 33100, Finland

Location

Novartis Investigative Site

Turku, FIN-20100, Finland

Location

Novartis Investigative Site

Berlin, 10789, Germany

Location

Novartis Investigative Site

Berlin, 13353, Germany

Location

Novartis Investigative Site

Erlangen, 91054, Germany

Location

Novartis Investigative Site

Frankfurt, 60590, Germany

Location

Novartis Investigative Site

Nyíregyháza, 4400, Hungary

Location

Novartis Investigative Site

Szolnok, 5000, Hungary

Location

Novartis Investigative Site

Bialystok, 15-879, Poland

Location

Novartis Investigative Site

Bydgoszcz, 85-094, Poland

Location

Novartis Investigative Site

Gdansk, 80-803, Poland

Location

Novartis Investigative Site

Krakow, 31-070, Poland

Location

Novartis Investigative Site

Lodz, 90-436, Poland

Location

Novartis Investigative Site

Lodz, 90-647, Poland

Location

Novartis Investigative Site

Badalona, Catalonia, 08916, Spain

Location

Novartis Investigative Site

Barcelona, Catalonia, 08003, Spain

Location

Novartis Investigative Site

Barcelona, Catalonia, 08036, Spain

Location

Novartis Investigative Site

Alcorcón, Madrid, 28922, Spain

Location

Novartis Investigative Site

Alicante, Valencia, 03010, Spain

Location

Novartis Investigative Site

Valencia, Valencia, 46014, Spain

Location

Novartis Investigative Site

Las Palmas de Gran Canaria, 35010, Spain

Location

Novartis Investigative Site

Madrid, 28006, Spain

Location

Novartis Investigative Site

Madrid, 28031, Spain

Location

Novartis Investigative Site

Madrid, 28041, Spain

Location

Novartis Investigative Site

Gothenburg, 413 46, Sweden

Location

Novartis Investigative Site

Malmo, 214 28, Sweden

Location

Novartis Investigative Site

Lausanne, CH-1011, Switzerland

Location

Novartis Investigative Site

Bradford, West Yorkshire, BD5 0NA, United Kingdom

Location

Novartis Investigative Site

Leeds, West Yorkshire, LS7 4SA, United Kingdom

Location

Novartis Investigative Site

London, SE1 9RT, United Kingdom

Location

Novartis Investigative Site

Salford, M6 8HD, United Kingdom

Location

MeSH Terms

Conditions

Psoriasis

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@Novartis.com

+ 1 862 778 8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2016
• First Posted: January 13, 2017
• Study Start: March 27, 2017
• Primary Completion: November 30, 2021
• Study Completion: June 16, 2023
• Last Updated: January 28, 2025
• Results First Posted: October 1, 2024

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

AR (2); DK (1); DE (4); CA (2); BU (5); FI (2); HU (2); ES (10); SE (2); CH (1); GB (4); PL (6)