Secukinumab in Tumor Necrosis Factor (TNF) - Inadequate Response (IR) Psoriasis Participants.
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Secukinumab (AIN457)
Intervention description: Secukinumab was supplied in 150mg pre-filled syringes.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 235.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic plaque psoriasis

Summary:

      This study was designed to prove and quantify the hypothesis that secukinumab is effective,
      safe and well tolerated in the treatment of moderate to severe chronic plaque-type psoriasis
      in patients who are inadequate responders to anti-TNFα therapy in a United Kingdom (UK) and
      Republic of Ireland) specific population.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Written informed consent must be obtained before any assessment is performed

          2. Aged at least 18 years at screening

          3. Chronic plaque-type psoriasis diagnosed for at least 6 months prior to screening

          4. Moderate to severe disease severity:

               -  PASI ≥10 and

               -  DLQI >10

          5. Failed to respond to systemic therapies including cyclosporine and/or methotrexate
             and/or PUVA (or is intolerant and/or has a contraindication to these)

          6. Previously treated with at least one anti-TNFα for moderate or severe psoriasis but is
             a primary or secondary non-responder

          7. Able to communicate well with the investigator, to understand and comply with the
             requirements of the study.

        Key Exclusion Criteria:

          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 must 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
             treatments must be on a stable dose for at least four weeks before initiation of study
             drug.

          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 unless they use 2 (two) effective forms of contraception during the
             study and for 16 weeks after stopping treatment.

          8. Men with a female partner of child bearing potential defined as all women
             physiologically capable of becoming pregnant unless they use 1 (one) effective form of
             contraception during the study and for 16 weeks after stopping treatment.

          9. Active systemic infections during the last two weeks (exception: common cold) prior to
             initiation of study drug and any infections that reoccur on a regular basis;
             investigator discretion should be used regarding patients who have travelled or
             recently resided in areas of endemic mycoses, such as histoplasmosis,
             coccidioidomycosis or blastomycosis and for patients with underlying conditions that
             may predispose them to infection, such as advanced or poorly controlled diabetes

         10. 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. Patients with a positive QFT test may participate in the study if further
             work up establishes conclusively that the patient has no evidence of active
             tuberculosis. If presence of latent tuberculosis is established, then treatment must
             have been initiated and maintained according to UK guidelines.

         11. Known infection with HIV, hepatitis B or hepatitis C at screening or at initiation of
             study drug.