Actively Recruiting
Mediterranean Diet vs no Dietary Intervention for Improving Signs and Symptoms of Psoriasis in Patients Treated With Anti-IL-17 or Anti-IL-23 Inhibitors
Led by University Hospitals Cleveland Medical Center · Updated on 2025-05-25
36
Participants Needed
1
Research Sites
193 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
In this study, participants will have 3 or 4 total study visits over approximately 10 total weeks. There is a two week medication washout period in between the 1st and 2nd visits. This washout only applies if participants are using a prohibited psoriasis medication (such as topical steroids or oral psoriasis medications, like methotrexate). During the washout period, participants will have to stop the prohibited medication(s). If participants are not using any prohibited medications, then the 1st and 2nd visits can be combined and participants will only have 3 total in-person visits. Participants will be randomly assigned (by chance; like flipping a coin) to either the Mediterranean Diet or no dietary intervention. After 4 weeks on the diet, participants will start treatment with either Anti-IL-17 or Anti-IL-23 therapy. The biologic treatments will prescribed by the participants regular dermatologist and not as a part of the study.
CONDITIONS
Official Title
Mediterranean Diet vs no Dietary Intervention for Improving Signs and Symptoms of Psoriasis in Patients Treated With Anti-IL-17 or Anti-IL-23 Inhibitors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of chronic plaque psoriasis for at least 12 months prior to Screening
- Moderate to severe plaque psoriasis at Baseline defined by BSA 65%, or sPGA 63, or PASI 65
- Prescribed Anti-IL-17 or Anti-IL-23 therapy for psoriasis but not yet started, willing to start during the study
- Eligible for a weight loss program with BMI between 25 to 40
- In good health except for psoriasis, as judged by the Investigator
You will not qualify if you...
- History of significant cardiac, inflammatory bowel, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic, or other major uncontrolled diseases apart from psoriasis
- Any condition or lab abnormality placing subject at unacceptable risk for study participation
- Other inflammatory or dermatologic conditions that interfere with study data
- Prior suicide attempt or major psychiatric hospitalization within last 3 years
- Pregnant or breastfeeding
- Failure of more than 3 systemic agents for psoriasis treatment
- Allergy to components of Anti-IL-17 or Anti-IL-23 therapies
- Recent serious infection or ongoing chronic/recurrent infections
- Bacillus Calmette-Gu�E9rin (BCG) vaccination within 1 year prior to screening
- HIV positive or congenital/acquired immunodeficiency
- Active or recent substance abuse within 6 months
- Recent bacterial, viral, or fungal infections treated within 4 weeks
- Malignancy history except certain treated skin or cervical cancers
- Known nut allergy
- Currently in a supervised dietary program
- Use of psoriasis therapy within 2 weeks prior to Baseline, except limited low-potency corticosteroids for specific areas
- Use of investigational drugs within 2 weeks prior to Baseline
- Prolonged sun exposure or use of UV light sources
- Currently flaring or unstable psoriasis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
Research Team
K
Kym Warner
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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