Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years - 89 Years|
- - Diagnosed with plaque-type psoriasis defined by either: - A board-certified dermatologist, OR.
- - Dermatology Nurse Practitioner, OR.
- - Skin punch biopsy.
- - Insurance that includes an anti-p40 biologic (ustekinumab/.
- - Must be naive to ustekinumab, guselkumab, and risankizumab.
- - Involvement of body surface area (BSA) of at least 10% at screening and baseline visit.
- - Able to give informed consent under IRB approval procedures.
- - Pregnant, breastfeeding, or planning to get pregnant 8 weeks before, during, and 8 weeks after the study.
- - Inability to provide informed consent.
- - Inability to secure ustekinumab and either gusekumab or risankizumab for use while on trial.
- - Use of tanning booths for at least 4 weeks prior to baseline visit.
- - Current or recent use of topical steroid, tar, phototherapy, Vitamin D, or retinoid therapy to target lesions for at least 2 weeks prior to baseline visit and for duration of trial.
- - Current or recent use of systemic or biologic therapy for at least 8 weeks prior to baseline visit.
- - Patients with psoriatic arthritis or other rheumatologic diseases (e.g., Crohn's disease).
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|University Hospitals Cleveland Medical Center|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Kevin Cooper, MD|
|Principal Investigator Affiliation||University Hospitals Cleveland Medical Center|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Overall Status||Not yet recruiting|
The disease, disorder, syndrome, illness, or injury that is being studied.
Psoriasis is a chronic systemic skin disease in which pro-inflammatory molecules contribute to the development of scaled inflamed skin and other disease-associated comorbidities such as increased risk of depression, heart attack, stroke, and metabolic syndrome. Some lesion-derived cytokines/chemokines are released into systemic circulation and increase lesional severity. Given their importance in the pathogenesis of psoriasis, the interleukins 12 (IL-12) and 23 (IL-23) are significant targets of biologic therapies. Importantly, psoriasis patients exhibit variable responses to treatments targeting interleukins; one size does not fit all for these therapeutics. Our preliminary data demonstrates individual skin improvement (Responders) as well as lack of skin improvement (Non-Responders) in patients treated with monoclonal antibody therapy specifically targeting the shared (p40) subunit common to IL-12 and IL-23 (ustekinumab/Stelara). Interestingly, some Non-Responders to ustekinumab respond well to inhibition of the IL-23 pathway via the unique p19 subunit. We hypothesize that the pattern of differentially expressed genes (DEGs) among Responders and Non-Responders following anti-IL-12 and anti-IL-23 therapy may enable us to predict the likelihood of patient response to p40 antagonism as well as antagonism of the p19 subunit of IL-23. Single cell transcriptome analysis will be used to generate gene expression patterns that identify variable patient response patterns (endotypes).
Patients will be treated with ustekinumab (90mg at week 0 and week 4 by subcutaneous injection) for 8 weeks followed by treatment with guselkumab (100mg at week 0 and week 4 by subcutaneous injection) or risankizumab (150mg at week 0 and week 4 by subcutaneous injection)
Drug: - Ustekinumab
Subjects will receive ustekinumab for 8 weeks followed by guselkumab or risankizumab for 8 weeks.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.