Study of Secukinumab With 2 mL Pre-filled Syringes (ALLURE)

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

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.

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: Placebo; Drug: Secukinumab 2 mL form; Drug: Secukinumab 1 mL form

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 214
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Bruxelles, Belgium, 1200
    • Novartis Investigative Site
  • Liege, Belgium, 4000
    • Novartis Investigative Site
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T5K 1X3
      • Novartis Investigative Site
  • British Columbia
    • Surrey, British Columbia, Canada, V3R 6A7
      • Novartis Investigative Site
• Germany
  • Berlin, Germany, 10629
    • Novartis Investigative Site
  • Bielefeld, Germany, 33647
    • Novartis Investigative Site
  • Essen, Germany, 45147
    • Novartis Investigative Site
  • Heidelberg, Germany, 69120
    • Novartis Investigative Site
  • Muenchen, Germany, 80337
    • Novartis Investigative Site
• Iceland
  • Kopavogur, Iceland, 201
    • Novartis Investigative Site
• Latvia
  • Riga, Latvia, 1012
    • Novartis Investigative Site
  • Riga, Latvia, LV-1001
    • Novartis Investigative Site
  • LVA
    • Daugavpils, LVA, Latvia, LV-5404
      • Novartis Investigative Site
    • Jelgava, LVA, Latvia, LV-3001
      • Novartis Investigative Site
    • Riga, LVA, Latvia, LV-1003
      • Novartis Investigative Site
    • Ventspils, LVA, Latvia, LV-3601
      • Novartis Investigative Site
• Poland
  • Olsztyn, Poland, 10-045
    • Novartis Investigative Site
  • Warszawa, Poland, 02-507
    • Novartis Investigative Site
• Russian Federation
  • Chelyabinsk, Russian Federation, 454092
    • Novartis Investigative Site
  • Kazan, Russian Federation, 420012
    • Novartis Investigative Site
  • Moscow, Russian Federation, 107076
    • Novartis Investigative Site
  • Saint Petersburg, Russian Federation, 191123
    • Novartis Investigative Site
  • Saint-Petersburg, Russian Federation, 194021
    • Novartis Investigative Site
• Spain
  • Madrid, Spain, 28046
    • Novartis Investigative Site
  • Madrid, Spain, 28009
    • Novartis Investigative Site
  • Pontevedra, Spain, 36003
    • Novartis Investigative Site
  • Andalucia
    • Malaga, Andalucia, Spain, 29010
      • Novartis Investigative Site
  • Barcelona
    • Sant Joan Despi, Barcelona, Spain, 08970
      • Novartis Investigative Site
  • Bizkaia
    • Bilbao, Bizkaia, Spain, 48013
      • Novartis Investigative Site
  • Castilla Y Leon
    • Salamanca, Castilla Y Leon, Spain, 37007
      • Novartis Investigative Site
  • Comunidad Valenciana
    • Valencia, Comunidad Valenciana, Spain, 46026
      • Novartis Investigative Site
• Turkey
  • Bursa, Turkey, 16059
    • Novartis Investigative Site
  • Izmir, Turkey, 35040
    • Novartis Investigative Site
• United Kingdom
  • Cambridge, United Kingdom, CB7 5JD
    • Novartis Investigative Site
  • Dundee, United Kingdom, DD1 9SY
    • Novartis Investigative Site
  • Surrey, United Kingdom, RH1 5RH
    • Novartis Investigative Site
  • West Midlands
    • Dudley, West Midlands, United Kingdom, DY1 2HQ
      • Novartis Investigative Site
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85032
      • Novartis Investigative Site
  • California
    • Fountain Valley, California, United States, 92708
      • Novartis Investigative Site
    • Fremont, California, United States, 95438
      • Novartis Investigative Site
  • Florida
    • Miami, Florida, United States, 33155
      • Novartis Investigative Site
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Novartis Investigative Site
    • Savannah, Georgia, United States, 31406
      • Novartis Investigative Site
  • Missouri
    • Saint Joseph, Missouri, United States, 64506
      • Novartis Investigative Site
  • New Jersey
    • Verona, New Jersey, United States, 07044
      • Novartis Investigative Site
  • Oregon
    • Portland, Oregon, United States, 97210
      • Novartis Investigative Site
    • Portland, Oregon, United States, 97223
      • Novartis Investigative Site
  • Texas
    • Houston, Texas, United States, 77030
      • Novartis Investigative Site
    • San Antonio, Texas, United States, 78218
      • Novartis Investigative Site
    • Sugar Land, Texas, United States, 77479
      • Novartis Investigative Site
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Novartis Investigative Site
  • Washington
    • Tacoma, Washington, United States, 98405
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo, provided in a 2 mL pre-filled syringe Placebo, provided in a 1 mL pre-filled syringe	Drug: Placebo; 2 mL + 2 x 1 mL Placebo s.c. at randomization, weeks 1, 3, and 4, thereafter 4-weekly until week 48
Experimental: Secukinumab 2 mL form; Secukinumab 300 mg, provided in a 2 mL pre-filled syringe	Drug: 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
Active Comparator: Secukinumab 1 mL form; Secukinumab 300 mg provided in 2 pre-filled syringes of 1 mL/150 mg (current approved form)	Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Number of Participants With PASI 100 Response After 12 Weeks of Treatment	Participants who achieved 100% reduction in PASI compared to baseline	12 weeks
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

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Publications and helpful links

General Publications

• Sigurgeirsson B, Schakel K, Hong CH, Effendy I, Placek W, Rich P, Keefe D, Bruin G, Charef P, Fu R, Hampele I, Patekar M. Efficacy, tolerability, patient usability, and satisfaction with a 2 mL pre-filled syringe containing secukinumab 300 mg in patients with moderate to severe plaque psoriasis: results from the phase 3 randomized, double-blind, placebo-controlled ALLURE study. J Dermatolog Treat. 2022 May;33(3):1718-1726. doi: 10.1080/09546634.2021.1902925. Epub 2021 Apr 26.

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2016
• Primary Completion (Actual): August 8, 2017
• Study Completion (Actual): June 8, 2018

Study Registration Dates

• First Submitted: March 8, 2016
• First Submitted That Met QC Criteria: April 19, 2016
• First Posted (Estimate): April 22, 2016

Study Record Updates

• Last Update Posted (Actual): July 15, 2019
• Last Update Submitted That Met QC Criteria: July 11, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: psoriasis; secukinumab; pre-filled syringes
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Immunologic Factors; Antibodies, Monoclonal
• Other Study ID Numbers: CAIN457A2323

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes