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
Eligible age
18–94 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: University Hospitals Cleveland Medical Center
You may qualify if…
- ✓ Diagnosis of chronic plaque psoriasis for at least 12 months prior to Screening.
- ✓ Have moderate to severe plaque psoriasis at Baseline as defined by
- ✓ 1. BSA ≥5% OR
- ✓ 2. sPGA ≥3 (moderate to severe) OR
- ✓ 3. PASI ≥5
- ✓ Must have been prescribed, per standard-of-care, an Anti-IL-17 or Anti-IL-23 therapy for psoriasis, which the patient has not yet started, but is willing to start during the study.
- ✓ Eligible therapies are Secukinumab, Ixekizumab, Brodalumab, Guselkumab, Risankizumab, and Tildrakizumab.
- ✓ Must be in good health (except for psoriasis) as judged by the Investigator, based on medical history and physical examination.
You may not qualify if…
- ✕ Other than psoriasis, history of any clinically significant (as determined by the Investigator) cardiac (clinically advanced cardiovascular disease including stent, past history of MI, thrombotic event or arterial calcification), active or history of inflammatory bowel disease, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major uncontrolled disease.
- ✕ Any condition, including the presence of laboratory abnormalities, which would place the subject at unacceptable risk if he/she were to participate in the study.
- ✕ Any condition, including other inflammatory diseases or dermatologic conditions that confound the ability to interpret data from the study.
- ✕ Prior history of suicide attempt at any time in the subject's lifetime prior to screening or randomization, or major psychiatric illness requiring hospitalization within the last 3 years.
- ✕ Pregnant or breast-feeding.
- ✕ Have failed more than 3 systemic agents for treatment of psoriasis.
- ✕ History of allergy to any component of Anti-IL-17 or Anti-IL-23 therapies.
- ✕ Had a serious infection (including, but not limited to, hepatitis, pneumonia, sepsis, cellulitis, meningitis or pyelonephritis) or have been hospitalized for an infection. Subject must be cured of infection \> 4 weeks before Screening.
Where it's recruiting
Cleveland
Source: ClinicalTrials.gov · NCT06399432 · last updated 2026-06-03