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Compares treatment options for Psoriasis
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
ClinicalTrials.gov ID: NCT06399432
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 94
You may be able to join 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
- BSA ≥5% OR
- sPGA ≥3 (moderate to severe) OR
- PASI ≥5
You likely can't join if
- Other than psoriasis, history of any clinically significant (as determined by the Investigator) cardiac (clinically advanced cardiovascular disease...
- Any condition, including the presence of laboratory abnormalities, which would place the subject at unacceptable risk if he/she were to participate...
- 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...
- Pregnant or breast-feeding.
- Have failed more than 3 systemic agents for treatment of psoriasis.
See the full eligibility 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
- BSA ≥5% OR
- sPGA ≥3 (moderate to severe) OR
- 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...
- 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.
- 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...
- 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...
- 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...
- 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...
- Malignancy or history of malignancy, except for:
- treated [i.e., cured] basal cell or squamous cell in situ skin carcinomas;
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Cleveland, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 94 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cleveland, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.