A 24-week, Multicenter, proSpective stUdy to Evaluate the PASI 90 Clinical Response Rate and the Safety PRofile of sEcukinuMab 300 mg in Cw6-negativE and Cw6-positive Patients With Moderate to Severe Chronic Plaque-type Psoriasis (SUPREME)

NCT02394561 | Completed Phase 3 Results DMC

• 1 other identifier: CAIN457AIT01
• Study Type: interventional
• Target: 434
• Locations: 1 country
• Sites: 45

Brief Summary

A study to evaluate the differences in the efficacy and safety of secukinumab between Cw6-negative and Cw6-positive patients with moderate to severe plaque-type psoriasis

Conditions

Plaque Type Psorisis

Outcome Measures

Primary Outcomes (1)

• Percentage (%) of Patients Who Reach Psoriasis Area Severity Index (PASI) 90 at 16 Weeks - LOCF Approach (ITT Set)

  PASI (Langley et al 2015) combines the assessment of the severity of lesions and the area affected into a single score with a range of 0 (no disease) to 72 (maximal disease). The PASI was assessed at all visits in CORE and extension phases. PASI 90 response: patients achieving ≥ 90% improvement (reduction) in PASI score compared to baseline are defined as PASI 90 responders.

  Baseline up to 16 weeks

Secondary Outcomes (9)

• Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set)

  Baseline up to approximately 72 weeks

• Percent Mean Changes From Baseline in IGA Mod 2011 Between Cohorts at Each Time Point (LOCF) (ITT)

  Baseline up to approximately 72 weeks

• Median Time to Reach PASI 90 and 75 (ITT)

  Baseline up to approximately 72 weeks

• Change From Baseline in the Dermatology Life Quality Index (DLQI) (LOCF) (FAS)

  Baseline up to approximatly 72 weeks

• Change From Baseline in Mean Scores of HAD-A and HAD-D (Anxiety and Depression) (LOCF) (FAS)

  Baseline up approximately 72 weeks

Study Arms (2)

Cw6-positive AIN457 300 mg

EXPERIMENTAL

Stratified to Cw6 positive cohort. Investigators and patients were blinded to Cw6 results. All patients were treated according to an induction regimen of two injections of secukinumab 150 mg a week for five weeks starting at baseline (week 0), followed by a maintenance period of two injections per month. At week 16, patients achieving PASI 50 response were eligible to continue on secukinumab for an additional 8 weeks in CORE. Eligible patients with at least a PASI 75 response were included in the extension phase, up to 72 weeks

Biological: Secukinumab

Cw6-negative AIN457 300 mg

EXPERIMENTAL

Stratified to Cw6 negative cohort. Investigators and patients were blinded to Cw6 results. All patients were treated according to an induction regimen of two injections of secukinumab 150 mg a week for five weeks starting at baseline (week 0), followed by a maintenance period of two injections per month. At week 16, patients achieving PASI 50 response were eligible to continue on secukinumab for an additional 8 weeks in CORE. Eligible patients with at least a PASI 75 response were included in the extension phase, up to 72 weeks

Biological: Secukinumab

Interventions

Secukinumab BIOLOGICAL

Secukinumab was supplied as 150 mg solution in pre-filled syringe for subcutaneous injection

Also known as: AIN457

Cw6-negative AIN457 300 mg; Cw6-positive AIN457 300 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must have been able to understand and communicate with the investigator and to comply with the requirements of the study and must have given a written, signed and dated informed consent before any study related activity was performed.
• Men or women at least 18 years of age at time of screening.
• Diagnosis of moderate to severe chronic plaque-type psoriasis for at least 6 months (including concomitant psoriatic arthritis as per the Classification Criteria for Psoriatic Arthritis criteria \[CASPAR\]).
• Moderate to severe psoriasis as defined at enrollment by:
• PASI score ≥ 10 or
• PASI score \> 5 but \< 10 and DLQI ≥10
• Patients that are candidates for systemic therapy, whether treatment naïve or after failed response to other systemic therapy (i.e. cyclosporine, methotrexate and PUVA) or to an anti-TNFα (or is intolerant and/or has a contraindication to these).

You may not qualify if:

• Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis).
• Cyclosporine or methotrexate therapy within 4 weeks prior to Day 1.
• Anti-TNFα therapy within timelines depending on drug half-life.
• Previous exposure to secukinumab or any other biologic drug directly targeting IL-17 or the IL-17 receptor.
• Previous exposure to ustekinumab or any other biologic drug for the treatment of psoriasis that was not anti-TNFα therapy.
• Intravenous or intramuscular steroids within 2 weeks prior to screening and during screening.
• Ongoing use of corticosteroid topical treatments or UV therapy.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (45)

Novartis Investigative Site

Milan, (MI), 20161, Italy

Location

Novartis Investigative Site

Ancona, AN, 60126, Italy

Location

Novartis Investigative Site

L’Aquila, AQ, 67100, Italy

Location

Novartis Investigative Site

Bari, BA, 70124, Italy

Location

Novartis Investigative Site

Bergamo, BG, 24127, Italy

Location

Novartis Investigative Site

Benevento, BN, 82100, Italy

Location

Novartis Investigative Site

Bologna, BO, 40138, Italy

Location

Novartis Investigative Site

Brindisi, BR, 72100, Italy

Location

Novartis Investigative Site

Brescia, BS, 25123, Italy

Location

Novartis Investigative Site

Cagliari, CA, 09124, Italy

Location

Novartis Investigative Site

Chieti, CH, 66100, Italy

Location

Novartis Investigative Site

Catania, CT, 95123, Italy

Location

Novartis Investigative Site

Catanzaro, CZ, 88100, Italy

Location

Novartis Investigative Site

Florence, FI, 50122, Italy

Location

Novartis Investigative Site

Genova, GE, 16132, Italy

Location

Novartis Investigative Site

Grosseto, GR, 58100, Italy

Location

Novartis Investigative Site

Lecce, LE, 73100, Italy

Location

Novartis Investigative Site

Terracina, LT, 04019, Italy

Location

Novartis Investigative Site

Lucca, LU, 55100, Italy

Location

Novartis Investigative Site

Macerata, MC, 62100, Italy

Location

Novartis Investigative Site

Messina, ME, 98158, Italy

Location

Novartis Investigative Site

Milan, MI, 20122, Italy

Location

Novartis Investigative Site

Milan, MI, 20132, Italy

Location

Novartis Investigative Site

San Donato Milanese, MI, 20097, Italy

Location

Novartis Investigative Site

Mantova, MN, 46100, Italy

Location

Novartis Investigative Site

Modena, MO, 41124, Italy

Location

Novartis Investigative Site

Padua, PD, 35128, Italy

Location

Novartis Investigative Site

Perugia, PG, 06100, Italy

Location

Novartis Investigative Site

Pisa, PI, 56124, Italy

Location

Novartis Investigative Site

Parma, PR, 43100, Italy

Location

Novartis Investigative Site

Pavia, PV, 27100, Italy

Location

Novartis Investigative Site

Reggio Emilia, RE, 42123, Italy

Location

Novartis Investigative Site

Roma, RM, 00133, Italy

Location

Novartis Investigative Site

Roma, RM, 00144, Italy

Location

Novartis Investigative Site

Roma, RM, 00161, Italy

Location

Novartis Investigative Site

Roma, RM, 00167, Italy

Location

Novartis Investigative Site

Roma, RM, 00168, Italy

Location

Novartis Investigative Site

Siena, SI, 53100, Italy

Location

Novartis Investigative Site

Torino, TO, 10126, Italy

Location

Novartis Investigative Site

Erice, TP, 91016, Italy

Location

Novartis Investigative Site

Terni, TR, 05100, Italy

Location

Novartis Investigative Site

Trieste, TS, 34129, Italy

Location

Novartis Investigative Site

Udine, UD, 33100, Italy

Location

Novartis Investigative Site

Verona, VR, 37126, Italy

Location

Novartis Investigative Site

Napoli, 80131, Italy

Location

MeSH Terms

Interventions

secukinumab

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@novartis.com

862-778-8300

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Arms represent stratification of Cw6 positive and Cw6 negative patients

Study Record Dates

• First Submitted: February 25, 2015
• First Posted: March 20, 2015
• Study Start: April 10, 2015
• Primary Completion: June 8, 2017
• Study Completion: June 8, 2017
• Last Updated: April 23, 2019
• Results First Posted: April 23, 2019

Record last verified: 2019-04

Locations

IT (45)