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Monoclonal Antibodies

TILDRAKIZUMAB for Psoriasis

Phase 4
Waitlist Available
Led By Carlos G Wambier, MD, PhD
Research Sponsored by Carlos Wambier
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Control Subjects with other skin diseases without psoriasis
Age: 35 years of age or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and treatment weeks 28 and 52.
Awards & highlights

Study Summary

This trial will study if the drug tildrakizumab can help to improve psoriasis by looking at if it can reverse the epigenetic aging in people with chronic psoriasis.

Who is the study for?
This trial is for adults over 35 with moderate-to-severe psoriasis, indicated by a PASI score of at least 12 and BSA involvement of 10%. It excludes those allergic to ILUMYA, have chronic infections or latent tuberculosis, history of skin or other cancers, are under 35 years old, women who could get pregnant but aren't using contraception or are breastfeeding.Check my eligibility
What is being tested?
The study tests if Tildrakizumab can reverse signs of aging in blood cells' DNA due to chronic psoriasis. It involves an intervention group with psoriasis receiving the drug and a control group with other skin conditions. Blood samples will be collected periodically over one year from participants at Rhode Island Hospital.See study design
What are the potential side effects?
Potential side effects may include reactions similar to those seen in patients taking ILUMYA since Tildrakizumab is related. These can range from injection site reactions to more serious issues like severe allergies or infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a skin condition, but it is not psoriasis.
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I am 35 years old or older.
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My psoriasis is severe, covering at least 10% of my body.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and treatment weeks 28 and 52.
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and treatment weeks 28 and 52. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dynamics of tildrakizumab on epigenetic aging of psoriatic patients.
Epigenetic aging in psoriatic patients.
Secondary outcome measures
Effects of individual characteristics on tildrakizumab response
Evaluate the transcriptomic impact of tildrakizumab therapy in patients with psoriasis

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: PSORIASIS TREATMENTExperimental Treatment1 Intervention
1 syringe containing 1 mL of 100 mg/mL tildrakizumab-asmn. 100mg delivered by subcutaneous injection at weeks 0, 4, 16 and 28. Total of 20 subjects (10 male, 10 female).
Group II: NON-PSORIASISActive Control1 Intervention
No intervention. Total of 10 subjects (5 male, 5 female).

Find a Location

Who is running the clinical trial?

Ocean State Research Institute, Inc.OTHER
2 Previous Clinical Trials
274 Total Patients Enrolled
Carlos WambierLead Sponsor
Brown UniversityOTHER
456 Previous Clinical Trials
558,226 Total Patients Enrolled
1 Trials studying Psoriasis
173,229 Patients Enrolled for Psoriasis
~10 spots leftby Jun 2025
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