Tildrakizumab for Psoriasis
Recruiting in Palo Alto (17 mi)
Overseen byRaymond Cho, MD, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: University of California, San Francisco
Must not be taking: Systemic immunosuppressives
Disqualifiers: Pregnancy, Severe immunodeficiency, Tuberculosis, others
No Placebo Group
Prior Safety Data
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?This study aims to assess cutaneous and blood immune cell function of patients with psoriasis before and after initiation of treatment with the IL23 blocker, tildrakizumab.
Will I have to stop taking my current medications?
The trial requires that you have not taken systemic immunosuppressives (medications that suppress the immune system) in the last 4 weeks. If you are on such medications, you may need to stop them before participating.
What data supports the effectiveness of the drug Tildrakizumab for treating psoriasis?
Tildrakizumab has been shown to be effective in treating moderate-to-severe chronic plaque psoriasis, as demonstrated by positive results from phase III clinical trials (reSURFACE 1 and reSURFACE 2) where it was found to be superior to placebo and etanercept. It works by targeting a specific part of the immune system (interleukin-23 p19) that is involved in the development of psoriasis.
12345Is Tildrakizumab safe for humans?
Tildrakizumab has been shown to be generally safe and well-tolerated in clinical trials for psoriasis, with most side effects being mild, such as upper respiratory tract infections and headaches.
12567How is the drug Tildrakizumab different from other psoriasis treatments?
Tildrakizumab is unique because it specifically targets the p19 subunit of interleukin-23, a protein involved in inflammation, without affecting interleukin-12, which is different from some other treatments that target both. This specificity may lead to fewer side effects and improved effectiveness for moderate-to-severe chronic plaque psoriasis.
12489Eligibility Criteria
This trial is for adults over 18 with moderate to severe psoriasis, affecting more than 5% of their body. It's not suitable for those on systemic immunosuppressives in the last month, pregnant or breastfeeding individuals, people with severe immune deficiencies, active tuberculosis or other serious infections, and anyone with an active systemic cancer.Inclusion Criteria
I am 18 years old or older.
My psoriasis is severe or covers more than 5% of my body.
My psoriasis covers more than 5% of my body.
Exclusion Criteria
I have not taken any immunosuppressive drugs in the last 4 weeks.
I have an active cancer that is affecting my whole body.
Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive tildrakizumab and undergo biopsy and blood sample collection for molecular profiling
3 months
Multiple visits for sample collection
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study is testing Tildrakizumab injections to see how they affect skin and blood immune cells in psoriasis patients. The goal is to understand the changes in immune function after starting treatment with this IL23 blocker.
1Treatment groups
Experimental Treatment
Group I: Tildrakizumab treatmentExperimental Treatment1 Intervention
Biological/vaccine: tildrakizumab
Tildrakizumab is already approved in European Union, United States for the following indications:
🇪🇺 Approved in European Union as Ilumya for:
- Moderate to severe plaque psoriasis
🇺🇸 Approved in United States as Ilumya for:
- Moderate to severe plaque psoriasis
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of California, San FranciscoSan Francisco, CA
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Who Is Running the Clinical Trial?
University of California, San FranciscoLead Sponsor
Sun Pharmaceutical Industries LimitedIndustry Sponsor
References
Tildrakizumab: First Global Approval. [2020]Merck & Company Inc. have developed tildrakizumab (tildrakizumab-asmn; Ilumya™), a high-affinity, humanised IgG1 κ monoclonal antibody that specifically targets interleukin-23 p19, as a treatment for chronic plaque psoriasis. The drug was recently approved for marketing by the US FDA based on positive results from the phase III reSURFACE clinical trial programme in patients with chronic plaque psoriasis. This article summarizes the milestones in the development of tildrakizumab leading to this first approval for the treatment of adults with moderate-to-severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.
Effectiveness and Safety After a Switch to Tildrakizumab: A Real World Multicenter Italian Study in Psoriasis. [2023]Tildrakizumab is a humanized IgG1κ monoclonal antibody targeting the p19 subunit of interleukin (IL)-23, approved in 2018 for the treatment of patients with moderate-to-severe chronic plaque psoriasis.
Tildrakizumab versus placebo or etanercept for chronic plaque psoriasis (reSURFACE 1 and reSURFACE 2): results from two randomised controlled, phase 3 trials. [2019]Tildrakizumab is a high-affinity, humanised, IgG1 κ antibody targeting interleukin 23 p19 that represents an evolving treatment strategy in chronic plaque psoriasis. Previous research suggested clinical improvement with inhibition of interleukin 23 p19. We did two phase 3 trials to investigate whether tildrakizumab is superior to placebo and etanercept in the treatment of chronic plaque psoriasis.
Real-life effectiveness of tildrakizumab in chronic plaque psoriasis: A 52-week multicentre retrospective study-IL PSO (Italian landscape psoriasis). [2023]Tildrakizumab is a humanized monoclonal antibody that binds selectively the p19 subunit of interleukin-23. It is approved for treatment of moderate-severe chronic plaque psoriasis.
Exposure-response characterisation of tildrakizumab in chronic plaque psoriasis: Pooled analysis of 3 randomised controlled trials. [2021]In this exposure-response analysis, the dosing regimen for tildrakizumab, an antibody for treating moderate-to-severe chronic plaque psoriasis, was determined using data from 3 randomised controlled trials (P05495/NCT01225731: phase 2b, n = 355; reSURFACE 1/NCT01722331: phase 3, n = 772; reSURFACE 2/NCT01729754: phase 3, n = 1090).
Pharmacokinetics of Tildrakizumab (MK-3222), an Anti-IL-23 Monoclonal Antibody, After Intravenous or Subcutaneous Administration in Healthy Subjects. [2019]Tildrakizumab, a high-affinity humanized IgG1k antibody that selectively binds interleukin (IL)-23 p19 subunit of cytokine IL-23 and neutralizes its function, is under investigation for treatment of moderate-to-severe chronic plaque psoriasis. The objective of this analysis was to assess the pharmacokinetics, bioavailability and safety/tolerability of single ascending doses of tildrakizumab after intravenous (IV) and subcutaneous (SC) dosing in healthy subjects. P05661 was a phase 1, single-dose, randomized, placebo-controlled study of tildrakizumab IV doses of 0.1, 0.5, 3 and 10 mg/kg, or placebo. P05776 was a phase 1, single-dose, randomized, placebo-controlled study of tildrakizumab SC doses of 50 or 200 mg, or placebo. After either single IV or SC dosing, tildrakizumab exhibited slow systemic clearance (CL), limited volume of distribution and a long t1/2 . Both the Cmax and the area under the curve (AUC) increased proportionally with doses from 0.1 to 10 mg/kg, or 50-200 mg. The bioavailability of SC dosing was ~80% (90% CI: 62-103%) for 50 mg and ~73% (90% CI: 46-115%) for 200 mg, respectively, versus 0.5 and 3 mg/kg IV. Across both studies, six of 43 evaluable subjects were positive for post-dose antidrug antibodies; two of these were positive for neutralizing antibodies. Most adverse events (AEs) were mild; the most frequent AEs included upper respiratory tract infection and headache. Single doses of tildrakizumab 0.1, 0.5, 3 and 10 mg/kg administered IV or single doses of 50 and 200 mg administered SC were safe and well tolerated in healthy adult subjects.
Tildrakizumab improves high burden skin symptoms, impaired sleep and quality of life of moderate-to-severe plaque psoriasis patients in conditions close to clinical practice. [2023]Tildrakizumab (TIL) is an interleukin (IL)-23p19 inhibitor for the treatment of moderate-to-severe plaque psoriasis with long-term efficacy and safety demonstrated in Phase III trials. Studies conducted in conditions closer to clinical practice are needed.
Tildrakizumab (MK-3222), an anti-interleukin-23p19 monoclonal antibody, improves psoriasis in a phase IIb randomized placebo-controlled trial. [2018]Tildrakizumab is a high-affinity, humanized, IgG1/κ, anti-interleukin (IL)-23p19 monoclonal antibody that does not bind human IL-12 or p40 is being developed for the treatment of chronic plaque psoriasis.
Effectiveness and safety of tildrakizumab for the treatment of psoriasis in real-world settings at 24 weeks: A retrospective, observational, multicentre study by the Spanish Psoriasis Group. [2023]Tildrakizumab is a humanized, IgG1/κ antibody that interacts with the p19 subunit of interleukin 23. It is approved for the treatment of moderate-to-severe plaque psoriasis. Real-world evidence on the effectiveness and safety of tildrakizumab is limited.