Efficacy and Safety of 2 Secukinumab Regimens in 90kg or More Weight Group With Moderate/Severe Chronic Plaque Psoriasis

Moderate to Severe Chronic Plaque-type Psoriasis Clinical Trial

Official title:

A Randomized, Double-blind, Multicenter Study Assessing Short and Long-term Efficacy, Safety, and Tolerability of Sub-cutaneous Secukinumab in Subjects of Body Weight 90 kg or Higher With Moderate to Severe Chronic Plaque-type Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03504852
• Other study ID #: CAIN457A2324
• Secondary ID: 2015-004620-60
• Status: Completed
• Phase: Phase 3
• Start date: June 25, 2018
• Est. completion date: July 15, 2020

Study information

• Verified date: October 2021
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess secukinumab high dose (every 2 weeks) vs standard dose (every 4 weeks) in heavy body weight subjects with moderate to severe plaque psoriasis.

Description:

A 52-week multicenter, randomized, double-blind, parallel-group trial in 331 subjects with moderate to severe chronic plaque-type psoriasis of body weight 90 kg or higher at time of randomization.

This study consisted of 4 periods: screening (up to 4 weeks), treatment Period 1 (16 weeks), treatment Period 2 (36 weeks), and post-treatment follow-up (8 weeks).

Subjects were randomized using a 1:1 ratio to the following groups: Secukinumab 300 mg every 2 weeks; Secukinumab 300 mg every 4 weeks.

In addition, subjects from the 300 mg every 4 weeks group who did not achieve Psoriasis Area Severity Index (PASI) 90 response at Week 16 were reassigned using a 1:1 ratio to either remain on secukinumab 300 mg every 4 weeks or receive secukinumab 300 mg every 2 weeks starting at Week 16, until the end of treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 331
• Est. completion date: July 15, 2020
• Est. primary completion date: September 13, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• Written informed consent must have been obtained before any assessment was performed. Where relevant, a legal representative will also have signed the informed study consent according to local laws and regulations.

• Subjects must have been able to understand and communicate with the investigator and comply with the requirements of the study.

• Men or women at least 18 years of age at time of screening.

• Body weight of = 90 kg at the time of randomization.

• Chronic plaque-type psoriasis present for at least 6 months and diagnosed before randomization.

• Moderate to severe psoriasis as defined at randomization by:

• Psoriasis Area and Severity Index (PASI) score of 12 or greater, and

• Investigator's Global Assessment (IGA) mod 2011 score of 3 or greater (based on a static scale of 0 - 4), and

• Body Surface Area (BSA) affected by plaque-type psoriasis of 10% or greater.

• Candidate for systemic therapy. This is defined as a subject having moderate to severe chronic plaque-type psoriasis that is inadequately controlled by:

• topical treatment and/or,

• phototherapy and/or,

• previous systemic therapy.

Key Exclusion Criteria:

• Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis) at screening or Randomization.

• Ongoing use of prohibited treatments. Washout periods detailed in the protocol have to be adhered to. Subjects not willing to limit ultraviolet (UV) light exposure (e.g., sunbathing and / or the use of tanning devices) during the course of the study will be considered not eligible for this study since UV light exposure is prohibited. Note: administration of live vaccines 6 weeks prior to Randomization or during the study period is also prohibited.

• Previous exposure to secukinumab (AIN457) or any other biologic drug directly targeting Interleukin-17 (IL-17) or the IL-17 receptor.

• Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 4 weeks until the expected pharmacodynamic effect has returned to baseline, whichever is longer; or longer if required by local regulations.

• Pregnant or nursing (lactating) women

• History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system treated or untreated within the past 5 years, regardless of whether there is evidence of local recurrence or metastases (except for skin Bowen's disease, or basal cell carcinoma or actinic keratoses that have been treated with no evidence of recurrence in the past 12 weeks; carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed).

• History of hypersensitivity to any of the study drug constituents.

Related Conditions & MeSH terms

• Moderate to Severe Chronic Plaque-type Psoriasis
• Psoriasis

Intervention

Drug:
• secukinumab 150 mg
sub-cutaneous secukinumab prefilled syringe 150 mg

Locations

Country	Name	City	State
Canada	Novartis Investigative Site	Calgary	Alberta
Canada	Novartis Investigative Site	Etobicoke	Ontario
Canada	Novartis Investigative Site	Guelph	Ontario
Canada	Novartis Investigative Site	Hamilton	Ontario
Canada	Novartis Investigative Site	Quebec
Canada	Novartis Investigative Site	Red Deer	Alberta
Czechia	Novartis Investigative Site	Novy Jicin
Czechia	Novartis Investigative Site	Prague	Prague 1
Germany	Novartis Investigative Site	Bochum
Germany	Novartis Investigative Site	Frankfurt
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Kiel
Germany	Novartis Investigative Site	Leipzig
Hungary	Novartis Investigative Site	Debrecen
Hungary	Novartis Investigative Site	Pecs
Hungary	Novartis Investigative Site	Szeged
Italy	Novartis Investigative Site	Modena	MO
Italy	Novartis Investigative Site	Napoli
Italy	Novartis Investigative Site	Perugia	PG
Italy	Novartis Investigative Site	Rozzano	MI
Italy	Novartis Investigative Site	Siena	SI
Russian Federation	Novartis Investigative Site	Chelyabinsk
Russian Federation	Novartis Investigative Site	Ekaterinburg
Russian Federation	Novartis Investigative Site	Kazan
Russian Federation	Novartis Investigative Site	Krasnodar
Russian Federation	Novartis Investigative Site	Lipetsk
Russian Federation	Novartis Investigative Site	Saint Petersburg
Russian Federation	Novartis Investigative Site	Saratov
United States	Novartis Investigative Site	Alpharetta	Georgia
United States	Novartis Investigative Site	Birmingham	Alabama
United States	Novartis Investigative Site	Boston	Massachusetts
United States	Novartis Investigative Site	Centennial	Colorado
United States	Novartis Investigative Site	Charleston	South Carolina
United States	Novartis Investigative Site	Charlotte	North Carolina
United States	Novartis Investigative Site	East Windsor	New Jersey
United States	Novartis Investigative Site	Fairborn	Ohio
United States	Novartis Investigative Site	Forest Hills	New York
United States	Novartis Investigative Site	Houston	Texas
United States	Novartis Investigative Site	Indianapolis	Indiana
United States	Novartis Investigative Site	Irvine	California
United States	Novartis Investigative Site	Louisville	Kentucky
United States	Novartis Investigative Site	Madison	Wisconsin
United States	Novartis Investigative Site	Mesquite	Texas
United States	Novartis Investigative Site	New Albany	Indiana
United States	Novartis Investigative Site	New Brighton	Minnesota
United States	Novartis Investigative Site	New York	New York
United States	Novartis Investigative Site	Norfolk	Virginia
United States	Novartis Investigative Site	Oregon City	Oregon
United States	Novartis Investigative Site	Owensboro	Kentucky
United States	Novartis Investigative Site	Pflugerville	Texas
United States	Novartis Investigative Site	Phoenix	Arizona
United States	Novartis Investigative Site	Portland	Oregon
United States	Novartis Investigative Site	Rogers	Arkansas
United States	Novartis Investigative Site	Sacramento	California
United States	Novartis Investigative Site	Sacramento	California
United States	Novartis Investigative Site	Saint Joseph	Missouri
United States	Novartis Investigative Site	San Antonio	Texas
United States	Novartis Investigative Site	San Diego	California
United States	Novartis Investigative Site	Santa Monica	California
United States	Novartis Investigative Site	Skokie	Illinois
United States	Novartis Investigative Site	Snellville	Georgia
United States	Novartis Investigative Site	Tampa	Florida
United States	Novartis Investigative Site	Verona	New Jersey
United States	Novartis Investigative Site	Wenatchee	Washington
United States	Novartis Investigative Site	West Palm Beach	Florida
United States	Novartis Investigative Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada,  Czechia,  Germany,  Hungary,  Italy,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Subjects Who Achieve 90% or Greater Reduction in Psoriasis Area and Severity Index (PASI) Score - Week 16 (Full Analysis Set)	A subject was considered as a PASI 90 responder if s/he achieved a reduction of 90% or more of the PASI score, compared to baseline, at a given time point.The head, trunk, upper limbs and lower limbs were assessed separately for erythema, thickening, and scaling. PASI scores can range from a lower value of 0, corresponding to no signs of psoriasis, up to a theoretic maximum of 72.0, i.e., higher scores represent more severity.	16 weeks
Secondary	Percentage of Subjects Who Achieve Investigator Global Assessment (IGA Modified 2011) Score of 0 or 1 - Week 16 (Full Analysis Set)	IGA mod 2011 was conducted for overall psoriatic disease. The IGA modified 2011 used in this study was static, i.e., it referred exclusively to the subject's disease state at the time of the assessments, and did not attempt a comparison with any of the subject's previous disease states, whether at baseline or at a previous visit. The scale has 0 (clear) as min and 4 (severe) as max, i.e., a higher score indicates more severity.	16 weeks
Secondary	Absolute and Relative Frequencies for Deaths, Other Serious or Clinically Significant Adverse Events or Related Discontinuations - Entire Study Period (Safety Set)	An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.	Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment, up to a maximum timeframe of 470 days.

External Links

•   A Plain Language Trial Summary is available on novartisclinicaltrials.com