Comparing the Mediterranean Diet to no diet for psoriasis treatment

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

This study is testing if following the Mediterranean Diet can help people with chronic plaque psoriasis feel better while they start new treatments.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 18 Years to 94 Years
• Sex: All
• Sponsor: University Hospitals Cleveland Medical Center (other)
• Drugs / interventions: Secukinumab, Ixekizumab, Brodalumab, Guselkumab, Risankizumab, Tildrakizumab, methotrexate
• Locations: 1 site (Cleveland, Ohio)
• Trial ID: NCT06399432 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of the Mediterranean Diet on patients with chronic plaque psoriasis who are starting treatment with Anti-IL-17 or Anti-IL-23 therapies. Participants will be randomly assigned to either follow the Mediterranean Diet or receive no dietary intervention over a period of approximately 10 weeks, with a medication washout period if necessary. The primary goal is to assess improvements in psoriasis symptoms as a result of dietary changes in conjunction with biologic treatments. The study involves 3 or 4 in-person visits depending on the use of prohibited medications.

Who should consider this trial

Good fit: Ideal candidates are adults with moderate to severe chronic plaque psoriasis who are about to start Anti-IL-17 or Anti-IL-23 therapy and have a BMI between 25 to 40.

Not a fit: Patients with mild psoriasis or those not eligible for weight loss programs may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide evidence that dietary changes can enhance the effectiveness of psoriasis treatments.

How similar studies have performed: While dietary interventions in psoriasis have been explored, this specific comparison of the Mediterranean Diet with no dietary intervention in conjunction with biologic therapies is relatively novel.

Eligibility criteria

Inclusion Criteria:

* 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.
* Must be eligible for a weight loss program, defined as being in good general health and having a BMI between 25 to 40.

Exclusion Criteria:

* 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.
* Have a history of, or ongoing, chronic or recurrent infectious disease, including, but not limited to, chronic renal infection, chronic chest infection (e.g., bronchiectasis), sinusitis, recurrent urinary tract infection (e.g., recurrent pyelonephritis, chronic non-remitting cystitis), an open, draining, or infected skin wound or ulcer.
* Had a Bacillus Calmette-Guérin (BCG) vaccination within 1 year prior to screening.
* History of positive human immunodeficiency virus (HIV), or have congenital or acquired immunodeficiency (e.g., common variable immunodeficiency disease).
* Active substance abuse or a history of substance abuse within 6 months prior to Screening.
* Bacterial infections requiring treatment with oral or injectable antibiotics, or significant viral or fungal infections, within 4 weeks of Screening. Any treatment and cure for such infections must have been completed at least 4 weeks prior to Screening.
* Malignancy or history of malignancy, except for:

  1. treated \[i.e., cured\] basal cell or squamous cell in situ skin carcinomas;
  2. treated \[i.e., cured\] cervical intraepithelial neoplasia \[CIN\] or carcinoma in situ of the cervix with no evidence of recurrence within the previous 5 years.
* Have a known nut allergy.
* Currently participating in a supervised dietary program.
* Use of psoriasis therapy 2 weeks prior to Baseline (including, but not limited to, topical corticosteroids, retinoids or vitamin D analog preparations, tacrolimus, pimecrolimus, anthralin/dithranol, cyclosporine, corticosteroids, methotrexate, retinoids, mycophenolate, thioguanine, hydroxyurea, sirolimus, sulfasalazine, azathioprine, fumaric acid esters, TNF inhibitors IL-17 inhibitors, IL-12/23 inhibitors, or phototherapy).

Exceptions: Low-potency corticosteroids will be allowed as background therapy and restricted to treatment of the face, axillae, and groin in accordance with the manufacturers' suggested usage during the course of the study (this restricted usage should be documented). Subjects with scalp psoriasis will be permitted to use coal tar shampoo and/or salicylic acid scalp preparations on scalp lesions. An unmedicated skin moisturizer (e.g. Eucerin®) will be also permitted for body lesions only. Subjects should not use these topical treatments within 24 hours prior to the clinic visit.

* Use of any investigational drug within 2 weeks prior to Baseline.
* Prolonged sun exposure or use of tanning booths or other ultraviolet (UV) light sources.
* Currently flaring or unstable psoriasis.

Where this trial is running

Cleveland, Ohio

• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (RECRUITING)

Study contacts

• Principal investigator: Neil Korman, MD — University Hospitals Cleveland Medical Center
• Study coordinator: Kym Warner

Conditions: Psoriasis, risankizumab, tildrakizumab, brodalumab, izekizumab, secukinumab, guselkumab