Study of Secukinumab With 2 mL Pre-filled Syringes

NCT02748863 | Completed Phase 3 Results FDA Drug

• 1 other identifier: CAIN457A2323
• Study Type: interventional
• Target: 214
• Locations: 11 countries
• Sites: 52

Brief 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.

Conditions

Psoriasis

Keywords

psoriasis; secukinumab; pre-filled syringes

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Participants With PASI 90 After 12 Weeks of Treatment

  12 weeks

• Number of Participants With PASI 100 Response After 12 Weeks of Treatment

  12 weeks

• Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response

  up to week 52

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo, provided in a 2 mL pre-filled syringe Placebo, provided in a 1 mL pre-filled syringe

Drug: Placebo

Secukinumab 2 mL form

EXPERIMENTAL

Secukinumab 300 mg, provided in a 2 mL pre-filled syringe

Drug: Secukinumab 2 mL form

Secukinumab 1 mL form

ACTIVE COMPARATOR

Secukinumab 300 mg provided in 2 pre-filled syringes of 1 mL/150 mg (current approved form)

Drug: Secukinumab 1 mL form

Interventions

Placebo DRUG

2 mL + 2 x 1 mL Placebo s.c. at randomization, weeks 1, 3, and 4, thereafter 4-weekly until week 48

Placebo

Secukinumab 2 mL form DRUG

Secukinumab 300 mg/2mL + 2 x 1 mL placebo s.c. at randomization, week 1 , 3, 4, thereafter 4-weekly until Week 48

Secukinumab 2 mL form

Secukinumab 1 mL form DRUG

Secukinumab 150 mg/1mL x 2 + 2 mL placebo s.c. at randomization, week 1 , 3, 4, thereafter 4-weekly until Week 48

Secukinumab 1 mL form

Eligibility Criteria

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

You may qualify if:

• 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.
• Men or women of at least 18 years of age at the time of Screening.
• Chronic plaque-type psoriasis present for at least 6 months and diagnosed before Randomization.
• 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.
• 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

You may not qualify if:

• 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 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 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 30 days until the expected pharmacodynamic effect has returned to baseline, whichever is longer; or longer if required by local regulations.
• 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.
• 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).
• History of hypersensitivity to any of study drug constituent

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (52)

Novartis Investigative Site

Phoenix, Arizona, 85032, United States

Location

Novartis Investigative Site

Fountain Valley, California, 92708, United States

Location

Novartis Investigative Site

Fremont, California, 95438, United States

Location

Novartis Investigative Site

Miami, Florida, 33155, United States

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Novartis Investigative Site

Marietta, Georgia, 30060, United States

Location

Novartis Investigative Site

Savannah, Georgia, 31406, United States

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Novartis Investigative Site

Saint Joseph, Missouri, 64506, United States

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Novartis Investigative Site

Verona, New Jersey, 07044, United States

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Novartis Investigative Site

Portland, Oregon, 97210, United States

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Novartis Investigative Site

Portland, Oregon, 97223, United States

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Novartis Investigative Site

Houston, Texas, 77030, United States

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Novartis Investigative Site

San Antonio, Texas, 78218, United States

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Novartis Investigative Site

Sugar Land, Texas, 77479, United States

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Novartis Investigative Site

Norfolk, Virginia, 23507, United States

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Novartis Investigative Site

Tacoma, Washington, 98405, United States

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Novartis Investigative Site

Brussels, 1200, Belgium

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Novartis Investigative Site

Liège, 4000, Belgium

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Novartis Investigative Site

Edmonton, Alberta, T5K 1X3, Canada

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Novartis Investigative Site

Surrey, British Columbia, V3R 6A7, Canada

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Novartis Investigative Site

Berlin, 10629, Germany

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Novartis Investigative Site

Bielefeld, 33647, Germany

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Novartis Investigative Site

Essen, 45147, Germany

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Novartis Investigative Site

Heidelberg, 69120, Germany

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Novartis Investigative Site

München, 80337, Germany

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Novartis Investigative Site

Kopavogur, 201, Iceland

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Novartis Investigative Site

Daugavpils, LVA, LV-5404, Latvia

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Novartis Investigative Site

Jelgava, LVA, LV-3001, Latvia

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Novartis Investigative Site

Riga, LVA, LV-1003, Latvia

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Novartis Investigative Site

Ventspils, LVA, LV-3601, Latvia

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Novartis Investigative Site

Riga, 1012, Latvia

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Novartis Investigative Site

Riga, LV-1001, Latvia

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Novartis Investigative Site

Olsztyn, 10-045, Poland

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Novartis Investigative Site

Warsaw, 02-507, Poland

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Novartis Investigative Site

Chelyabinsk, 454092, Russia

Location

Novartis Investigative Site

Kazan', 420012, Russia

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Novartis Investigative Site

Moscow, 107076, Russia

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Novartis Investigative Site

Saint Petersburg, 191123, Russia

Location

Novartis Investigative Site

Saint Petersburg, 194021, Russia

Location

Novartis Investigative Site

Málaga, Andalusia, 29010, Spain

Location

Novartis Investigative Site

Sant Joan Despí, Barcelona, 08970, Spain

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Novartis Investigative Site

Bilbao, Bizkaia, 48013, Spain

Location

Novartis Investigative Site

Salamanca, Castille and León, 37007, Spain

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Novartis Investigative Site

Valencia, Valencia, 46026, Spain

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Novartis Investigative Site

Madrid, 28009, Spain

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Novartis Investigative Site

Madrid, 28046, Spain

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Novartis Investigative Site

Pontevedra, 36003, Spain

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Novartis Investigative Site

Bursa, 16059, Turkey (Türkiye)

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Novartis Investigative Site

Izmir, 35040, Turkey (Türkiye)

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Novartis Investigative Site

Dudley, West Midlands, DY1 2HQ, United Kingdom

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Novartis Investigative Site

Cambridge, CB7 5JD, United Kingdom

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Novartis Investigative Site

Dundee, DD1 9SY, United Kingdom

Location

Novartis Investigative Site

Surrey, RH1 5RH, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 33896356 DERIVED

MeSH Terms

Conditions

Psoriasis

Interventions

secukinumab; Metabolism

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

"Other pre-specified outcomes" such as assess the subject usability and assessment of Dermatology Life Quality Index (DLQI) scores are exploratory in nature and are not reported in these results

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

novartis.email@novartis.com

+1 (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: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2016
• First Posted: April 22, 2016
• Study Start: December 12, 2016
• Primary Completion: August 8, 2017
• Study Completion: June 8, 2018
• Last Updated: July 15, 2019
• Results First Posted: June 26, 2019

Record last verified: 2019-07

Locations

US (15); IC (1); PL (2); ES (8); CA (2); GB (4); TU (2); BE (2); LA (6); RU (5); DE (5)