moderate to severe chronic plaque-type psoriasis

The purpose of this study is to demonstrate superiority of secukinumab at Week 12, based on both PASI 75 and IGA 0 or 1 response rates versus placebo, along with the maintenance of efficacy of secukinumab at Week 52 in subjects with chronic plaque-type psoriasis

Secukinumab (AIN457)

Secukinumab (AIN457)

針劑

150

To demonstrate the superiority of secukinumab in subjects with moderate to severe chronic plaquetype
psoriasis with respect to both PASI 75 and IGA 0 or 1 response (co-primary endpoints) at Week
12, compared to placebo.

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 at least 18 years of age at time of screening.
3. Chronic plaque-type psoriasis diagnosed for at least 6 months 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, defined as having chronic plaque-type psoriasis considered inadequately controlled by:
• topical treatment and/or
• phototherapy and/or
• previous systemic therapy.

1. Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate
psoriasis)
2. Drug-induced psoriasis (i.e., new onset or current exacerbation from beta-blockers, calcium
channel inhibitors or lithium)
3. Ongoing use of prohibited psoriasis treatments (e.g., topical or systemic corticosteroids (CS),
UV therapy). Washout periods detailed in the protocol have to be adhered to.
4. Ongoing use of other non-psoriasis prohibited treatments. Washout periods detailed in the
protocol have to be adhered to. All other prior non-psoriasis concomitant medications must
be on a stable dose for at least four weeks before randomization
5. Previous exposure to secukinumab or any other biologic drug directly targeting IL-17 or the
IL-17 receptor
6. 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 (> 5 mIU/mL)
7. Women of child-bearing potential, defined as all women physiologically capable of becoming
pregnant, unwilling to use effective contraception during the study and for 16 weeks after
stopping treatment. Effective contraception is defined as either:
• Barrier method: Condom or Occlusive cap (diaphragm or cervical/vault caps) with
spermicide (where available). Spermicides alone are not a barrier method of
contraception and should not be used alone
The following methods are considered more effective than the barrier method and are also
acceptable:
• Total abstinence: When this is in line with the preferred and usual lifestyle of the subject
[Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods)
and withdrawal are not acceptable methods of contraception]
• Female sterilization: have had a surgical bilateral oophorectomy (with or without
hysterectomy) or tubal ligation at least six weeks before taking study treatment. In case
of oophorectomy alone, only when the reproductive status of the woman has been
confirmed by follow up hormone level assessment
• Male partner sterilization (with the appropriate post-vasectomy documentation of
absence of sperm in the ejaculate). [For female subjects on the study, the vasectomised
male partner should be the sole partner for that subject]
• Use of established oral, injected or implanted hormonal methods of contraception,
intrauterine device (IUD) or intrauterine system (IUS)
NOTE: Women are considered post-menopausal and not of child bearing potential if they have
had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g.
age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea
with serum FSH levels > 40 mIU/mL
[for US only: and estradiol < 20 pg/mL].
8. Active ongoing inflammatory diseases other than psoriasis that might confound the evaluation
of the benefit of secukinumab therapy.
9. Underlying condition (including, but not limited to metabolic, hematologic, renal, hepatic,
pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal) which in the opinion
of the investigator significantly immunocompromises the subject and/or places the subject at
unacceptable risk for receiving an immunomodulatory therapy.
10. Significant medical problems, including but not limited to the following: uncontrolled
hypertension (≥160 systolic /95 diastolic mmHg), congestive heart failure [New York Heart
Association status of class III or IV]
11. Subjects with a serum creatinine level exceeding 176.8 μmol/L (2.0 mg/dL)
12. Screening total WBC count <2,500/μL, or platelets <100,000/μL or neutrophils <1,500/μL or
hemoglobin <8.5 g/dL
13. Chest X-ray or MRI with evidence of ongoing infectious or malignant process, obtained within
3 months prior to screening, and evaluated by a qualified physician
14. Active systemic infections during the last two weeks (exception: common cold) prior to
randomization
15. History of an ongoing, chronic or recurrent infectious disease, or evidence of tuberculosis
infection as defined by a positive QuantiFERON TB-Gold test (QFT) at screening. Subjects
with a positive QFT test may participate in the study if further work up (according to local
practice/guidelines) establishes conclusively that the subject has no evidence of active
tuberculosis. If presence of latent tuberculosis is established, then treatment must have been
initiated and maintained according to local country guidelines.
16. Known infection with HIV, hepatitis B or hepatitis C at screening or randomization
17. History of lymphoproliferative disease or any known malignancy or history of malignancy of
any organ system within the past 5 years (except for basal cell carcinoma or actinic keratoses
that have been treated with no evidence of recurrence in the past 3 months; carcinoma in situ
of the cervix or non-invasive malignant colon polyps that have been removed)
18. Current severe progressive or uncontrolled disease which in the judgment of the clinical
investigator renders the subject unsuitable for the trial
19. Inability or unwillingness to undergo repeated venipuncture (e.g., because of poor tolerability
or lack of access to veins)
20. Any medical or psychiatric condition which, in the Investigator’s opinion, would preclude the
participant from adhering to the protocol or completing the study per protocol
21. History or evidence of ongoing alcohol or drug abuse, within the last six months before
randomization
22. Plans for administration of live vaccines during the study period or 6 weeks prior to
randomization
23. Use of investigational treatments within 4 weeks before randomization, or within a period of 5 half-lives of the investigational treatment, whichever is longer.