Aging Clinical Trial
Official title:
Effects of Tildrakizumab (ILUMYA) Use on Epigenetic Age Acceleration and Psoriasis
Verified date | December 2023 |
Source | Rhode Island Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Design: Single-center open-label clinical trial. Objective: Evaluate if tildrakizumab reverses peripheral blood leukocyte DNA methylation (epigenetic aging) observed in chronic psoriasis. Number of subjects: 30. Intervention group: 20 (10 men, 10 women) with moderate-to-severe psoriasis. Control group: 10 (5 men, 5 women) with other skin diagnosis. Population: >35-year-old subjects will be recruited from Brown Dermatology clinics. Biological samples: Blood samples will be collected for all subjects at screening, and weeks 16, 28 and 52. Urine pregnancy tests will be performed for females of childbearing potential at weeks 4, 16, and 28. Serum pregnancy test and QuantiFERON test for tuberculosis will be performed at screening visit. Safety parameters: Adverse events, and screening, week 16, week 28 blood samples laboratory results. Females of childbearing potential: serum pregnancy test at screening visit, urine pregnancy test at weeks 4, 16, and 28. Data Safety Monitoring Board will review data and laboratory flags quarterly. Study center: Rhode Island Hospital, Providence, RI, USA. Trial Duration: One year.
Status | Active, not recruiting |
Enrollment | 30 |
Est. completion date | August 1, 2024 |
Est. primary completion date | May 1, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 35 Years and older |
Eligibility | Inclusion Criteria: - Age: 35 years of age or older. - Psoriasis subjects: moderate-to-severe psoriasis: PASI (Psoriasis Area and Severity Index =12) and a minimum Body Surface Area (BSA) involvement of 10%. - Control Subjects: other skin diseases without psoriasis. Exclusion Criteria: 1. Patients aged less than 35 years. 2. Patients with previous skin cancer or other cancers. 3. Women of childbearing potential without effective contraceptive method, or lactating women. 4. Prisoners. 5. Psoriasis patients who have had a severe allergic reaction to ILUMYA or any of its ingredients. 6. Psoriasis patients who have chronic or recurring infections. Positive QuantiFERON upon screening will be exclusionary for this trial (latent tuberculosis). 7. Any condition that, in the opinion of the investigator, may interfere with patient's ability to participate in the study, such as severe cognitive impairment or other comorbidities that would, in the opinion of the investigator, predictably limit compliance with the study plan. |
Country | Name | City | State |
---|---|---|---|
United States | Clinical Trials Center for Skin Diseases: Rhode Island Hospital, 593 Eddy Street, Dermatology Research, Jane Brown Building, 1st floor, Room 115 | Providence | Rhode Island |
Lead Sponsor | Collaborator |
---|---|
Carlos Wambier | Brown University, Lifespan, Ocean State Research Institute, Inc., Sun Pharmaceutical Industries Limited |
United States,
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* Note: There are 19 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Epigenetic aging in psoriatic patients. | To examine the association between epigenetic age acceleration and psoriasis: by comparing the baseline samples of peripheral blood leukocyte genome-wide DNA methylation assay sample collected at the screening visit for psoriasis vs non-psoriasis patients.
The epigenetic aging test is based on the Methylation EPIC BeadChip (Illumina), covering over 850,000 methylation sites. Specific patterns and quantifications will be compared between groups. |
Baseline | |
Primary | Dynamics of tildrakizumab on epigenetic aging of psoriatic patients. | To evaluate dynamic effects and changes in epigenetic age of the on-label use of ILUMYA (week 28 vs screening visit). And upon discontinuation (week 28 vs week 52). Assess if epigenetic age could be a marker for the effect of ILUMYA on psoriasis through psoriasis severity scores.
Specific patterns and quantifications will be compared between timeframes. |
Baseline and treatment weeks 28 and 52. | |
Secondary | Evaluate the transcriptomic impact of tildrakizumab therapy in patients with psoriasis | To evaluate the blood transcriptome changes with anti-IL-23 therapy in patients with psoriasis, and possible correlation/association with psoriasis severity scores (BSA, PASI and CAPP), serum markers, and the presence of systemic co-morbidities on epigenetic aging. | Baseline and treatment week 28. | |
Secondary | Effects of individual characteristics on tildrakizumab response | To evaluate the possible correlation/association with changes in psoriasis severity scores (BSA, PASI and CAPP) and the presence of systemic co-morbidities on epigenetic aging. Multivariate analysis will be conducted with variables that include, but are not limited to baseline epigenetic aging assay results, age, body mass index, previous diagnoses, and medical interventions. | Baseline and treatment weeks 28 and 52. |
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