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

Plaque Psoriasis Clinical Trial

— STEPin  

Official title:

A Randomized, Multicenter STudy to Evaluate the Effect of Secukinumab 300 mg s.c. Administered During 52 Weeks to Patients Suffering From New-onset Moderate to Severe Plaque Psoriasis as Early Intervention Compared to Standard Treatment With Narrow-band UVB (STEPIn Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03020199
• Other study ID #: CAIN457A2322
• Secondary ID: 2015-002423-26
• Status: Completed
• Phase: Phase 4
• Start date: March 27, 2017
• Est. completion date: June 16, 2023

Study information

• Verified date: January 2024
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 design consists of the Main Study and a Mechanistic Sub study:

1. The Main Study will be multicenter, randomized, 2-treatment-arm (secukinumab and nb-UVB), parallel-group and open-label. It will include 3 clinical periods (Screening period, Treatment period, and Follow-up period) involving all patients in Arms A1 (A1a and A1b) and B1 (B1a and B1b).

2. The Mechanistic Sub-study will be open-label and comprise 5 treatment arms (A1b, A2, B1b, C1, and C2). It will include 2 periods (Screening period and Treatment period) for patients in Arms C1, C2 and A2. Patients from Arms A1b and B1b will undergo the 3 clinical periods of the Main Study.

The overall study population (Main Study and Mechanistic Sub-study) will consist of a total of 196 male and female patients aged between 18 and 50 years inclusive.

1. 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 75 sites worldwide. Since a maximum screening failure rate of 20% is expected, approximately 245 patients will be screened.

2. 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 (12 patients each).

For Arm A1b or Arm B1b, the first 12 patients will be included on a first come first serve basis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 196
• Est. completion date: June 16, 2023
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Key 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).

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Biological:
• Secukinumab
Secukinumab (AIN457) 300 mg will be 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 will be provided as 2 pre-filled syringes of 150-mg secukinumab in a single box. Each syringe is labeled as AIN457 150 mg/1 mL.

Radiation:
• 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 will be 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 is recommended

Drug:
• Calcipotriol
Its a topical treatment for Psoriasis. the concentration it is used is 50mcg/g
• Betamethasone
this is topical cream which is used in 0.5mg/g concentration

Locations

Country	Name	City	State
Argentina	Novartis Investigative Site	Buenos Aires
Argentina	Novartis Investigative Site	Ciudad Autonoma de Bs As	Buenos Aires
Bulgaria	Novartis Investigative Site	Pleven
Bulgaria	Novartis Investigative Site	Plovdiv
Bulgaria	Novartis Investigative Site	Sofia
Bulgaria	Novartis Investigative Site	Sofia
Canada	Novartis Investigative Site	Markham	Ontario
Canada	Novartis Investigative Site	Sudbury	Ontario
Denmark	Novartis Investigative Site	Aarhus
Estonia	Novartis Investigative Site	Tallinn
Estonia	Novartis Investigative Site	Tallinn
Estonia	Novartis Investigative Site	Tartu
Finland	Novartis Investigative Site	Tampere
Finland	Novartis Investigative Site	Turku
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Erlangen
Germany	Novartis Investigative Site	Frankfurt
Hungary	Novartis Investigative Site	Nyiregyhaza
Hungary	Novartis Investigative Site	Szolnok
Poland	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
Spain	Novartis Investigative Site	Alcorcon	Madrid
Spain	Novartis Investigative Site	Alicante	Comunidad Valenciana
Spain	Novartis Investigative Site	Barcelona	Catalunya
Spain	Novartis Investigative Site	Barcelona	Catalunya
Spain	Novartis Investigative Site	Las Palmas de Gran Canaria
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Valencia	Comunidad Valenciana
Sweden	Novartis Investigative Site	Goethenburg
Sweden	Novartis Investigative Site	Malmo
Switzerland	Novartis Investigative Site	Lausanne
United Kingdom	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

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients who achieve Pain Assessment Severity Index (PASI) 90 at Week 52.	The primary objective of this study is to demonstrate that early treatment with secukinumab 300 mg s.c. (Arm A1) is superior to standard of care treatment with nb UVB (Arm B1) in patients with new onset moderate to severe plaque psoriasis with respect to patients achieving = 90% improvement (reduction) in psoriasis area and severity index (PASI 90) response at Week 52. PASI takes into account the extent of the disease, as well as the severity of erythema, scaling, and thickness in different body areas affected by psoriasis. A PASI 90 represents an improvement in the PASI score of at least 90% as compared with baseline.	Week 52
Secondary	Proportion of all randomized patients who achieve PASI 90 at Week 104	The key secondary objective of this study is to evaluate the superiority of early treatment with secukinumab (Arm A1) versus nb UVB (Arm B1) based on the proportion of all randomized patients who achieve at least PASI 90 at Week 104. PASI takes into account the extent of the disease, as well as the severity of erythema, scaling, and thickness in different body areas affected by psoriasis. A PASI 90 represents an improvement in the PASI score of at least 90% as compared with baseline.	Week 104