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

Novartis

Status and phase: Completed; Phase 3

Conditions: Psoriasis

Treatments: Drug: Secukinumab 2 mL form; Drug: Secukinumab 1 mL form; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02748863

CAIN457A2323

Details and patient eligibility

About

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.

Full 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.

Enrollment: 214 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

214 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Secukinumab 2 mL form

Experimental group

Description:

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

Treatment:

Drug: Secukinumab 2 mL form

Secukinumab 1 mL form

Active Comparator group

Description:

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

Treatment:

Drug: Secukinumab 1 mL form