NCT05110313CompletedPhase 4
Effects of Tildrakizumab on Epigenetic Age
Effects of Tildrakizumab (ILUMYA) Use on Epigenetic Age Acceleration and Psoriasis
Source: ClinicalTrials.gov · Last updated 18 Jul 2024
Brief summary (registry, in English)
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 (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 30 (actual)
- First submitted
- 26 Oct 2021
- Start date
- 8 Apr 2022
- Primary completion date
- 24 May 2024
- Lead sponsor
- Carlos Wambier
- Diseases
- Psoriasis
- NCT number
- NCT05110313
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 30
- From 8 Apr 2022 to the primary completion date, 24 May 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with previous skin cancer or other cancers.
Other illness
- Psoriasis patients who have had a severe allergic reaction to ILUMYA or any of its ingredients.
- Psoriasis patients who have chronic or recurring infections. Positive QuantiFERON upon screening will be exclusionary for this trial (latent tuberculosis).
- 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.
Age
- Patients aged less than 35 years.
Other
- Women of childbearing potential without effective contraceptive method, or lactating women.
- Prisoners.
Who the study is looking for
- 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.
Age in the registry: 35 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinical Trials Center for Skin Diseases: Rhode Island Hospital, 593 Eddy Street, Dermatology Research, Jane Brown Building, 1st floor, Room 115 Coordinator of this site? Confirm its status | Providence | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.