← Back to Search

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

Select...

I have a skin condition, but it is not psoriasis.

Select...

I am 35 years old or older.

Select...

My psoriasis is severe, covering at least 10% of my body.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and treatment weeks 28 and 52.

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).

0 / 3Eligibility criteria met

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

558,286 Total Patients Enrolled

1 Trials studying Psoriasis

173,229 Patients Enrolled for Psoriasis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities for subjects to join this research endeavor?

"As per the information provided by clinicaltrials.gov, this research endeavour is actively recruiting participants. This trial was first made available on April 8th 2022 and underwent its last update a day later on April 9th 2022."

Answered by AI

Could you please explain if any previous experiments have been done with TILDRAKIZUMAB?

"Presently, 2 out of the 10 live TILDRAKIZUMAB trials are in Phase 3. These investigations mainly occur at sites within Milwaukee, Wisconsin yet there are 106 other locales running studies for this drug."

Answered by AI

How many subjects are being evaluated in this clinical research?

"Confirmed. The clinical trial listing, posted on April 8th 2022 and recently updated on the 9th, found at clinicaltrials.gov indicates that this study is actively finding participants. A total of 30 patients are to be enrolled from a single site."

Answered by AI

Has TILDRAKIZUMAB been authorized by the U.S. Food and Drug Administration?

"Our team at Power rated the safety of TILDRAKIZUMAB a 3 out of 3 due to its status as an approved Phase 4 trial."

Answered by AI

Has this type of experimentation ever been attempted before?

"Since its initial clinical trial in 2020, sponsored by Sun Pharma Global FZE and consisting of 120 participants, TILDRAKIZUMAB has been approved for Phase 2 &3 trials. Currently there are 10 active studies taking place across 9 nations and 52 cities globally."

Answered by AI

Recent research and studies

Molecular CellJournal

Genome-wide Methylation Profiles Reveal Quantitative Views of Human Aging Rates

Hannum, Gregory, Justin Guinney, Ling Zhao, Li Zhang, Guy Hughes, SriniVas Sadda, Brandy Klotzle, et al.. 2013. “Genome-wide Methylation Profiles Reveal Quantitative Views of Human Aging Rates”. Molecular Cell. Elsevier BV. doi:10.1016/j.molcel.2012.10.016.

Journal of Investigative DermatologyJournal

A Role for Epigenetics in Psoriasis: Methylated Cytosine–guanine Sites Differentiate Lesional from Nonlesional Skin and from Normal Skin

Gudjonsson, Johann E., and Gerald Krueger. 2012. “A Role for Epigenetics in Psoriasis: Methylated Cytosine–guanine Sites Differentiate Lesional from Nonlesional Skin and from Normal Skin”. Journal of Investigative Dermatology. Elsevier BV. doi:10.1038/jid.2011.364.

Journal of Infectious DiseasesJournal

HIV-1 Infection Accelerates Age According to the Epigenetic Clock

Horvath, Steve, and Andrew J. Levine. 2015. “HIV-1 Infection Accelerates Age According to the Epigenetic Clock”. Journal of Infectious Diseases. Oxford University Press (OUP). doi:10.1093/infdis/jiv277.

AgingJournal