Study of Secukinumab With 2 mL Pre-filled Syringes
Status: | Completed |
---|---|
Conditions: | Psoriasis |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 9/28/2018 |
Start Date: | December 12, 2016 |
End Date: | June 8, 2018 |
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 is to demonstrate efficacy, safety and tolerability of 2 mL pre-filled
syringe of 300 mg secukinumab in treatment of moderate to severe plaque psoriasis.
syringe of 300 mg secukinumab in treatment of moderate to severe plaque psoriasis.
This is a 52-weeks multicenter, randomized, double-blind, placebo-controlled, parallel-group
trial in approximately 210 subjects with moderate to severe plaque-type psoriasis.
trial in approximately 210 subjects with moderate to severe plaque-type psoriasis.
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
We found this trial at
15
sites
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Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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