Safety and Efficacy of Secukinumab in Mild Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Secukinumab; Placebo followed by Secukinumab
Intervention description: Arms: Group 1 - Group 1 will receive Secukinumab at a dose of 300 mg with injections administered once weekly at baseline and at weeks 1, 2, 3, and 4 and then every 4 weeks for 6 months of period. In order to maintain the blind for the Group 2, Group 1 will receive placebo injections at weeks 13, 14, and 15. Group 1 will discontinue Secukinumab after 6 months of period being observed from week 25 to week 72 (48 weeks).; Arms: Group 2 - Group 2 will receive placebo injections corresponding to the Group 1 regimen until week 8 in order to maintain a double-dummy design until week 12. From week 12, Group 2 will receive Secukinumab with injections administered once weekly at week 12 and at weeks 13, 14, 15, and 16 and then every 4 weeks for 3 months of period. Group 2 will discontinue Secukinumab after 6 months of period being observed from week 25 to week 72 (48 weeks).
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: To compare the secukinumab-receiving mild psoriasis subjects (Group 1) and the placebo-receiving mild psoriasis subjects (Group 2).
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Psoriasis; Chronic Plaque Psoriasis; Secukinumab

Summary:

      Mild psoriasis not only progresses to moderate-to-severe psoriasis but also precedes systemic
      inflammation that leads to psoriatic arthritis and cardiovascular comorbidities. By curing
      mild psoriasis with a short-term anti- interleukin (IL)-17A treatment, investigators may
      reduce the costs of treating psoriasis and associated medical conditions, including psoriatic
      arthritis, cardiovascular disease, and diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Written informed consent must be obtained before any assessment is performed

          2. 18 years of age or older

          3. Chronic plaque-type psoriasis for at least 6 months

          4. Negative PPD (negative chest w-ray if positive) or negative QuantiFERON-TB Gold

          5. Have a PASI between 6 and 12 and Body Surface Area (BSA) affected by plaque-type
             psoriasis less than 10% at screening and baseline

          6. Willing to wash off steroid creams and ultraviolet B light (UVB) therapy for 2 weeks
             prior to the baseline visit

        Exclusion Criteria:

          1. Has a nonplaque form of psoriasis (eg, erythrodermic, guttate, or pustular)

          2. Has previously received Secukinumab or other biologics

          3. History of Inflammatory Bowel Disease (IBD)

          4. History of Rheumatoid Arthritis

          5. Use of topical treatments for psoriasis, including steroids, vitamin D derivatives,
             vitamin A derivatives, salicylic acid, tar (except moisturizers) and/or ultraviolet A
             light (UVA)/UVB phototherapy within the last 2 weeks (if these have used them, the
             participant needs to wash off of them for at least 2 weeks after signing consent prior
             to baseline)

          6. Is pregnant, nursing, or planning a pregnancy (both men and women) within 5 months
             following the last administration of study drug

          7. Has recently received or is planning to receive a vaccination while on the study

          8. HIV positive

          9. Chronic untreated hepatitis C, positive hepatitis B surface antigen and acute
             hepatitis A infection

         10. Known tuberculosis (TB) or evidence of TB infection. Subjects with a positive
             QuantiFERON; TB test or a positive purified protein derivate (PPD) skin test result
             may participate in the study if further work up (according to local
             practice/guidelines) establishes conclusively that the subject has no evidence of
             active TB.

         11. Any severe, progressive or uncontrolled medical condition at screening that in the
             judgment of the investigator prevents the subject from participating in the study.