Safety and Efficacy of Secukinumab in Mild Psoriasis

• Status: Completed
• Trial end date: 2021-06-21
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: James G. Krueger, MD, PhD
• Collaborator: Novartis
• Treatments: Antibodies, Monoclonal

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.