Clinical trial NCT03589885: Study of Efficacy and Safety of Secukinumab 2 mL Auto-injector (300 mg) in Subjects With Moderate to Severe Plaque Psoriasis
Official title: Multicenter, rAndomized, Double-blind, Placebo-conTrolled, 52-week stUdy to demonstRatE the Efficacy, Safety and Tolerability of Secukinumab Injections With 2 mL Auto-injectors (300 mg) in Adult Subjects With Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Plaque Psoriasis
Keywords: Plaque psoriasis, auto-injector, 2 mL injection, secukinumab
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2018-07-18
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Phase IIIb 52-week multicenter, randomized, double-blind, placebo-controlled, parallel-group trial in approximately 120 subjects with moderate to severe plaque-type psoriasis
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to assess efficacy, safety and tolerability of a 2 mL pre-filled auto-injector (AI) of 300 mg secukinumab in patients with moderate to severe plaque psoriasis

Detailed description: This is a 52-weeks multicenter, randomized, double-blind, placebo-controlled, parallel-group trial in approximately 120 subjects with moderate to severe plaque-type psoriasis

Eligibility criteria: Inclusion Criteria:

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

1. Men or Women of at least 18 years of age at time of Screening
2. Subjects able to understand and communicate with the investigator and comply with the requirements of the study and must have given a written, signed and dated informed consent before any study related activity was performed. Where relevant, a legal representative signed the informed study consent according to local laws and regulations.
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 had 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 were considered not eligible for this study since UV light exposure was prohibited.

   Note: administration of live vaccines 6 weeks prior to Randomization or during the study period was 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 had returned to baseline, whichever is longer; or longer if required by local regulations.
5. Pregnant or nursing (lactating) women, where pregnancy was 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 was evidence of local recurrence or metastases (except for Bowen's disease, or basal cell carcinoma or actinic keratoses that had 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

Primary outcomes:
measure: PASI 75 Response After 12 Weeks of Treatment
timeFrame: 12 weeks
measure: IGA Mod 2011 0 or 1 Response After 12 Weeks of Treatment
timeFrame: 12 weeks
Secondary outcomes:
measure: PASI 90 Response
timeFrame: 12 weeks
measure: PASI 50, 75, 90 and 100 and IGA Mod 2011 0 or 1 Response
timeFrame: 52 weeks
measure: Successful Self-injection
timeFrame: From randomization until Week 28
measure: Dermatology Life Quality Index, (DLQI) 0 or 1 Score (Total Score)
timeFrame: Change from Baseline up to 52 weeks
Other outcomes:
Locations:
city: Miami
country: United States
facility: Novartis Investigative Site
state: Florida
city: Marietta
country: United States
facility: Novartis Investigative Site
state: Georgia
city: Saint Joseph
country: United States
facility: Novartis Investigative Site
state: Missouri
city: Verona
country: United States
facility: Novartis Investigative Site
state: New Jersey
city: Portland
country: United States
facility: Novartis Investigative Site
state: Oregon
city: Houston
country: United States
facility: Novartis Investigative Site
state: Texas
city: San Antonio
country: United States
facility: Novartis Investigative Site
state: Texas
city: Sugar Land
country: United States
facility: Novartis Investigative Site
state: Texas
city: Edmonton
country: Canada
facility: Novartis Investigative Site
state: Alberta
city: Surrey
country: Canada
facility: Novartis Investigative Site
state: British Columbia
city: Bielefeld
country: Germany
facility: Novartis Investigative Site
city: Essen
country: Germany
facility: Novartis Investigative Site
city: Vechta
country: Germany
facility: Novartis Investigative Site
city: Witten
country: Germany
facility: Novartis Investigative Site
city: Kopavogur
country: Iceland
facility: Novartis Investigative Site
city: Warszawa
country: Poland
facility: Novartis Investigative Site
state: Mazowian
city: Wroclaw
country: Poland
facility: Novartis Investigative Site
city: Alicante
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Valencia
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Barcelona
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
Study officials:
References: