Tildrakizumab for Psoriatic Arthritis
Recruiting in Palo Alto (17 mi)
+131 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Sun Pharma Global FZE
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?This is a multicenter Phase III, Randomized, Double-Blind, Single-Dose, Placebo-Controlled Study to Demonstrate the Efficacy and Safety of tildrakizumab in Subjects with Active Psoriatic Arthritis I (INSPIRE 1)
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, it does require prior exposure to anti-TNF agents for PsO or PsA treatment. Please consult with the study team for more details.
What data supports the idea that Tildrakizumab for Psoriatic Arthritis is an effective drug?
The available research shows that Tildrakizumab is primarily studied and approved for treating chronic plaque psoriasis, not specifically for Psoriatic Arthritis. The studies highlight its effectiveness in improving skin symptoms and quality of life for psoriasis patients. However, there is no specific data provided here about its effectiveness for Psoriatic Arthritis. Therefore, we cannot conclude its effectiveness for Psoriatic Arthritis based on the available information.
12345What safety data is available for Tildrakizumab?
Tildrakizumab, also known as Ilumya, is an anti-interleukin-23p19 monoclonal antibody approved for moderate to severe plaque psoriasis. Safety data from various studies indicate that it is generally well-tolerated. In phase 1 studies, most adverse events were mild, with the most common being upper respiratory tract infections and headaches. Phase 3 trials for psoriasis showed a low occurrence of adverse events, supporting its safety and tolerability. Additionally, a phase 2a study evaluated its safety in ankylosing spondylitis, further contributing to the safety profile of Tildrakizumab.
14567Is the drug Tildrakizumab a promising treatment for Psoriatic Arthritis?
Tildrakizumab is a promising drug because it has been shown to effectively treat moderate-to-severe plaque psoriasis, improving skin symptoms, sleep, and quality of life. It is a targeted therapy that works by blocking a specific part of the immune system, which can help reduce inflammation and symptoms.
24589Eligibility Criteria
This trial is for adults over 18 with active psoriatic arthritis who've tried anti-TNF agents before. They must not have any current cancer, major blood loss recently, or a history of substance abuse in the last two years. Participants need to use effective birth control and can't be enrolled in another study or have certain infections.Inclusion Criteria
I have been treated with anti-TNF medications for Psoriasis or Psoriatic Arthritis.
You tested negative for rheumatoid factor and anti-cyclic citrullinated peptide antibodies.
Subject has provided written informed consent.
+1 more
Exclusion Criteria
I have another active cancer, including skin cancers.
Subject previously has been enrolled (randomized) in this study.
I am currently institutionalized by legal or official order.
+11 more
Participant Groups
The trial tests Tildrakizumab (TILD), an investigational medication against a placebo injection to see if it's effective and safe for treating psoriatic arthritis. It's a Phase III study where participants are randomly assigned to receive either TILD or placebo without knowing which one they're getting.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm AExperimental Treatment1 Intervention
Group II: Arm BPlacebo Group1 Intervention
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:
Paramount Medical ResearchMiddleburg Heights, OH
GNP ResearchHollywood, FL
Sunpharma Site no 49Grapevine, TX
West Broward Rheumatology AssociatesTamarac, FL
More Trial Locations
Loading ...
Who Is Running the Clinical Trial?
Sun Pharma Global FZELead Sponsor
Sun Pharmaceutical Industries LimitedLead 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.
A Randomized, Double-Blind, Placebo-Controlled Phase 2a Study of Tildrakizumab Efficacy and Safety in Patients With Active Ankylosing Spondylitis. [2023]Tildrakizumab is an anti-interleukin-23p19 monoclonal antibody approved to treat moderate to severe plaque psoriasis. This study evaluated the efficacy and safety of tildrakizumab in patients with ankylosing spondylitis (AS).
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 for the treatment of psoriasis. [2020]Introduction: Psoriasis is an immune-mediated skin disease amenable to targeted immunotherapy. Tildrakizumab is a humanized IgG1 monoclonal antibody targeting interleukin-23 p19 and is approved for use in moderate to severe psoriasis. Areas covered: This article reviews the mechanism of action, pharmacokinetics, safety, tolerability, and clinical efficacy of tildrakizumab, administered subcutaneously every 12 weeks, in treatment of moderate to severe psoriasis. Expert commentary: In two phase 3 clinical trials, tildrakizumab showed a consistent low occurrence of adverse events, underlining safety and tolerance. The long half-life permits subcutaneous injections every 12 weeks. Seventy eight percent of patients achieved PASI 75 (a > 75% improvement from baseline PASI) at 28 weeks, 58% achieved PASI 90, 29% achieved PASI 100 and 70% achieved a Physician's Global Assessment score of clear or almost clear. A high proportion of patients maintained PASI response after 2 years of treatment. Tildrakizumab improved Dermatology Life Quality Index, psoriasis-related personal relationship problems and sexual difficulties. Baseline PASI score, PGA, and BMI were not predictive of PASI 90 response at week 12, however achievement of PASI 50 by week 8 was predictive of a PASI 90 response at week 12.
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 (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.
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.