Study of Secukinumab With 2 mL Pre-filled Syringes

Psoriasis Clinical Trial

— ALLURE  

Official title:

A Multicenter, Randomized, Double-blind, Placebo-controlled, 52-weeks Study to Demonstrate the Efficacy, Safety and Tolerability of Subcutaneous Secukinumab Injections With 2 mL Pre-filled Syringes (300 mg) in Adult Subjects With Moderate to Severe Plaque Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02748863
• Other study ID #: CAIN457A2323
• Status: Completed
• Phase: Phase 3
• Start date: December 12, 2016
• Est. completion date: June 8, 2018

Study information

• Verified date: July 2019
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the study was to demonstrate efficacy, safety and tolerability of 2 mL pre-filled syringe of 300 mg secukinumab in treatment of moderate to severe plaque psoriasis.

Description:

This is a 52-weeks multicenter, randomized, double-blind, placebo-controlled, parallel-group trial in 24 subjects with moderate to severe plaque-type psoriasis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 214
• Est. completion date: June 8, 2018
• Est. primary completion date: August 8, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Subjects eligible for inclusion in this study must fulfill all of the following criteria:

1. Subjects must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study related activity is performed. Where relevant, a legal representative will also sign the informed study consent according to local laws and regulations.

2. Men or women of at least 18 years of age at the time of Screening.

3. Chronic plaque-type psoriasis present for at least 6 months and diagnosed before Randomization.

4. Moderate to severe psoriasis as defined at Randomization by:

• PASI score of 12 or greater, and

• IGA mod 2011 score of 3 or greater (based on a scale of 0 - 4), and

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

5. 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

Exclusion Criteria:

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

2. Ongoing use of prohibited treatments. Washout periods detailed in the protocol have to be adhered to. Subjects not willing to limit 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.

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

4. Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 30 days until the expected pharmacodynamic effect has returned to baseline, whichever is longer; or longer if required by local regulations.

5. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.

6. 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 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).

7. History of hypersensitivity to any of study drug constituent

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• Placebo
2 mL + 2 x 1 mL Placebo s.c. at randomization, weeks 1, 3, and 4, thereafter 4-weekly until week 48
• Secukinumab 2 mL form
Secukinumab 300 mg/2mL + 2 x 1 mL placebo s.c. at randomization, week 1 , 3, 4, thereafter 4-weekly until Week 48
• Secukinumab 1 mL form
Secukinumab 150 mg/1mL x 2 + 2 mL placebo s.c. at randomization, week 1 , 3, 4, thereafter 4-weekly until Week 48

Locations

Country	Name	City	State
Belgium	Novartis Investigative Site	Bruxelles
Belgium	Novartis Investigative Site	Liege
Canada	Novartis Investigative Site	Edmonton	Alberta
Canada	Novartis Investigative Site	Surrey	British Columbia
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Bielefeld
Germany	Novartis Investigative Site	Essen
Germany	Novartis Investigative Site	Heidelberg
Germany	Novartis Investigative Site	Muenchen
Iceland	Novartis Investigative Site	Kopavogur
Latvia	Novartis Investigative Site	Daugavpils	LVA
Latvia	Novartis Investigative Site	Jelgava	LVA
Latvia	Novartis Investigative Site	Riga	LVA
Latvia	Novartis Investigative Site	Riga
Latvia	Novartis Investigative Site	Riga
Latvia	Novartis Investigative Site	Ventspils	LVA
Poland	Novartis Investigative Site	Olsztyn
Poland	Novartis Investigative Site	Warszawa
Russian Federation	Novartis Investigative Site	Chelyabinsk
Russian Federation	Novartis Investigative Site	Kazan
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Saint Petersburg
Russian Federation	Novartis Investigative Site	Saint-Petersburg
Spain	Novartis Investigative Site	Bilbao	Bizkaia
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Malaga	Andalucia
Spain	Novartis Investigative Site	Pontevedra
Spain	Novartis Investigative Site	Salamanca	Castilla Y Leon
Spain	Novartis Investigative Site	Sant Joan Despi	Barcelona
Spain	Novartis Investigative Site	Valencia	Comunidad Valenciana
Turkey	Novartis Investigative Site	Bursa
Turkey	Novartis Investigative Site	Izmir
United Kingdom	Novartis Investigative Site	Cambridge
United Kingdom	Novartis Investigative Site	Dudley	West Midlands
United Kingdom	Novartis Investigative Site	Dundee
United Kingdom	Novartis Investigative Site	Surrey
United States	Novartis Investigative Site	Fountain Valley	California
United States	Novartis Investigative Site	Fremont	California
United States	Novartis Investigative Site	Houston	Texas
United States	Novartis Investigative Site	Marietta	Georgia
United States	Novartis Investigative Site	Miami	Florida
United States	Novartis Investigative Site	Norfolk	Virginia
United States	Novartis Investigative Site	Phoenix	Arizona
United States	Novartis Investigative Site	Portland	Oregon
United States	Novartis Investigative Site	Portland	Oregon
United States	Novartis Investigative Site	Saint Joseph	Missouri
United States	Novartis Investigative Site	San Antonio	Texas
United States	Novartis Investigative Site	Savannah	Georgia
United States	Novartis Investigative Site	Sugar Land	Texas
United States	Novartis Investigative Site	Tacoma	Washington
United States	Novartis Investigative Site	Verona	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Germany,  Iceland,  Latvia,  Poland,  Russian Federation,  Spain,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participants With Psoriasis Area and Severity Index (PASI) 75 Response After 12 Weeks of Treatment	Number of participants who achieved = 75% reduction in PASI compared to baseline; PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).	12 weeks
Primary	Participants With IGA Mod 2011 0 or 1 After 12 Weeks of Treatment	The Investigator's Global Assessment (IGA) mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. Treatment success was defined as achievement of IGA mod 2001 score of 0 or 1.; Number of participants who achieved IGA mod 2011 0 or 1 and improved by at least 2 points on the IGA scale compared to baseline	12 weeks
Secondary	Participants With PASI 90 After 12 Weeks of Treatment	Number of participants who achieved = 90% and 100% reduction in PASI compared to baseline	12 weeks
Secondary	Number of Participants With PASI 100 Response After 12 Weeks of Treatment	Participants who achieved 100% reduction in PASI compared to baseline	12 weeks
Secondary	Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response	PASI response over time up to week 52: Number of participants who achieved = 50%, 75%, 90% and 100% reduction in PASI and achieve IGA mod 2011 0 or 1 and improved by at least 2 points on the IGA scale compared to baseline	up to week 52