Tildrakizumab for Psoriatic Arthritis

Recruiting at 131 trial locations

Overseen By Head, Clinical development

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Sun Pharma Global FZE

Must be taking: Anti-TNF agents

Disqualifiers: Active infection, Hepatitis B/C, HIV, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

510 Participants Needed

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.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

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. ^{1 2 3 4 5}

What data supports the effectiveness of the drug Tildrakizumab for Psoriatic Arthritis?

Tildrakizumab has shown effectiveness in treating moderate-to-severe chronic plaque psoriasis by targeting a specific protein involved in inflammation, which suggests it may also help with other inflammatory conditions like psoriatic arthritis. ^{1 2 3 4 5}

What 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. ^{1 4 5 6 7}

Is tildrakizumab generally safe for humans?

Tildrakizumab has been shown to be generally safe and well-tolerated in clinical trials for conditions like psoriasis and ankylosing spondylitis, with most side effects being mild, such as upper respiratory infections and headaches. ^{1 4 5 6 7}

Is 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. ^{2 4 5 8 9}

How is the drug Tildrakizumab different from other treatments for psoriatic arthritis?

Tildrakizumab is unique because it specifically targets the p19 subunit of interleukin-23, a protein involved in inflammation, which is different from many other treatments that may target broader immune responses. This specificity can potentially lead to fewer side effects and a more focused treatment approach. ^{2 4 5 8 9}

Eligibility 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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of tildrakizumab or placebo and are monitored for efficacy and safety

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

28 weeks

Treatment Details

Interventions

• Matching Placebo Injections
• Tildrakizumab

Trial Overview 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.

Participant Groups

Group I: Arm A Experimental Treatment 1 Intervention

Group II: Arm B Placebo Group 1 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

Who Is Running the Clinical Trial?

Sun Pharma Global FZE

Lead Sponsor

Trials

34

Recruited

10,200+

Sun Pharmaceutical Industries Limited

Lead Sponsor

Trials

71

Recruited

14,000+

Dilip Shanghvi

Sun Pharmaceutical Industries Limited

Chief Executive Officer since 1993

Majored in Cellular and Molecular Biology at the University of Michigan – Ann Arbor

Dr. Azadar H. Khan

Sun Pharmaceutical Industries Limited

Chief Medical Officer since 2023

MD from a recognized institution

Findings from Research

Tildrakizumab is a monoclonal antibody that specifically targets interleukin-23 p19, which plays a key role in the inflammatory process of chronic plaque psoriasis.

The drug received FDA approval based on positive outcomes from the phase III reSURFACE clinical trial program, demonstrating its efficacy for adults with moderate-to-severe chronic plaque psoriasis who require systemic therapy or phototherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tildrakizumab: First Global Approval. Markham, A.[2020]

In a study of 51 patients with moderate-to-severe plaque psoriasis who had previously failed biologic treatments, tildrakizumab showed significant effectiveness, with a marked reduction in the Psoriasis Area Severity Index (PASI) score from 19.2 at baseline to 0.6 at 48 weeks (P < 0.001).

The treatment also led to substantial improvements in Body Surface Area (BSA) and Dermatology Life Quality Index (DLQI) scores, indicating enhanced quality of life for patients, with significant results observed at both 12 and 48 weeks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and Safety After a Switch to Tildrakizumab: A Real World Multicenter Italian Study in Psoriasis. Di Brizzi, EV., Buononato, D., Benvenuto, P., et al.[2023]

In two phase 3 trials involving 1862 patients, tildrakizumab (200 mg and 100 mg) demonstrated significant efficacy in treating moderate-to-severe chronic plaque psoriasis, achieving PASI 75 responses in 62-66% of patients compared to only 6% in the placebo group.

Tildrakizumab was well tolerated, with serious adverse events being low and similar across all treatment groups, indicating a favorable safety profile for this new treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tildrakizumab versus placebo or etanercept for chronic plaque psoriasis (reSURFACE 1 and reSURFACE 2): results from two randomised controlled, phase 3 trials. Reich, K., Papp, KA., Blauvelt, A., et al.[2019]

In a study involving 101 patients with ankylosing spondylitis, tildrakizumab did not show a significant improvement in the ASAS20 response rate compared to placebo at week 24, with a response rate of 74.0% for tildrakizumab versus 80.4% for placebo.

The treatment was generally well tolerated, with no unexpected safety issues reported, but the study was terminated early due to the lack of efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized, Double-Blind, Placebo-Controlled Phase 2a Study of Tildrakizumab Efficacy and Safety in Patients With Active Ankylosing Spondylitis. Peters, E., Chou, RC., Rozzo, SJ., et al.[2023]

In the TRIBUTE study involving 177 adult patients with moderate-to-severe plaque psoriasis, treatment with Tildrakizumab (TIL) 100 mg for 24 weeks resulted in significant improvements in psoriasis severity, with 88.4% of patients achieving a PASI score of ≤3 and 92.5% achieving PASI 75.

The treatment also led to notable enhancements in health-related quality of life, including reduced pruritus, pain, and improved sleep, with a high patient satisfaction score (mean TSQM score of 80.5), and a favorable safety profile with only one serious adverse event reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Costanzo, A., Llamas-Velasco, M., Fabbrocini, G., et al.[2023]

Tildrakizumab, a monoclonal antibody targeting interleukin-23, demonstrated high efficacy in treating moderate to severe psoriasis, with 78% of patients achieving a significant improvement (PASI 75) at 28 weeks in two phase 3 clinical trials.

The treatment showed a favorable safety profile with a low occurrence of adverse events, and its long half-life allows for convenient subcutaneous administration every 12 weeks, making it a practical option for long-term management of psoriasis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tildrakizumab for the treatment of psoriasis. Sinclair, R., Thirthar Palanivelu, V.[2020]

Tildrakizumab, an antibody targeting IL-23, was found to be safe and well tolerated in healthy adults, with mild adverse events like upper respiratory infections and headaches reported.

The pharmacokinetics showed that both intravenous and subcutaneous doses resulted in slow clearance and a long half-life, with subcutaneous bioavailability around 80%, indicating effective delivery of the drug.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics of Tildrakizumab (MK-3222), an Anti-IL-23 Monoclonal Antibody, After Intravenous or Subcutaneous Administration in Healthy Subjects. Khalilieh, S., Hodsman, P., Xu, C., et al.[2019]

In a phase IIb trial involving 355 adults with moderate-to-severe chronic plaque psoriasis, tildrakizumab demonstrated significant efficacy, with PASI 75 responses of up to 74.4% at week 16 compared to only 4.4% in the placebo group, indicating its effectiveness in reducing psoriasis severity.

Tildrakizumab was generally safe and well tolerated, with serious adverse events reported but not common, suggesting that targeting IL-23p19 could be a promising approach for psoriasis treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tildrakizumab (MK-3222), an anti-interleukin-23p19 monoclonal antibody, improves psoriasis in a phase IIb randomized placebo-controlled trial. Papp, K., Thaçi, D., Reich, K., et al.[2018]

In a 52-week study involving 237 adults with moderate-to-severe plaque psoriasis, tildrakizumab demonstrated high efficacy, with 90.91% of patients achieving at least a 75% reduction in psoriasis severity (PASI 75) and 58.68% achieving complete skin clearance (PASI 100) by Week 52.

The safety profile of tildrakizumab was favorable, with no significant adverse events reported, and no patients had to discontinue treatment due to side effects, indicating it is a well-tolerated option for psoriasis management in real-life settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-life effectiveness of tildrakizumab in chronic plaque psoriasis: A 52-week multicentre retrospective study-IL PSO (Italian landscape psoriasis). Narcisi, A., Valenti, M., Gargiulo, L., et al.[2023]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Tildrakizumab: First Global Approval. [2020]

2. Austria pubmed.ncbi.nlm.nih.gov

Effectiveness and Safety After a Switch to Tildrakizumab: A Real World Multicenter Italian Study in Psoriasis. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Tildrakizumab versus placebo or etanercept for chronic plaque psoriasis (reSURFACE 1 and reSURFACE 2): results from two randomised controlled, phase 3 trials. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

A Randomized, Double-Blind, Placebo-Controlled Phase 2a Study of Tildrakizumab Efficacy and Safety in Patients With Active Ankylosing Spondylitis. [2023]

5. England pubmed.ncbi.nlm.nih.gov

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]

6. England pubmed.ncbi.nlm.nih.gov

Tildrakizumab for the treatment of psoriasis. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Pharmacokinetics of Tildrakizumab (MK-3222), an Anti-IL-23 Monoclonal Antibody, After Intravenous or Subcutaneous Administration in Healthy Subjects. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Tildrakizumab (MK-3222), an anti-interleukin-23p19 monoclonal antibody, improves psoriasis in a phase IIb randomized placebo-controlled trial. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Real-life effectiveness of tildrakizumab in chronic plaque psoriasis: A 52-week multicentre retrospective study-IL PSO (Italian landscape psoriasis). [2023]