Long-Term Safety of Tildrakizumab for Psoriatic Arthritis

No longer recruiting at 107 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Sun Pharma Global FZE

Must not be taking: Leflunomide, Methotrexate, Biologics, others

Disqualifiers: Pregnancy, Tuberculosis, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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: 208 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the long-term safety of tildrakizumab, a treatment for psoriatic arthritis, which causes joint pain and swelling. The study examines different dosing schedules of tildrakizumab to assess its safety over an extended period. Individuals who completed a previous trial with tildrakizumab and have psoriatic arthritis without any new joint conditions may qualify for this study. As a Phase 2, Phase 3 trial, this research assesses the treatment's effectiveness in an initial group and represents the final step before FDA approval, offering participants an opportunity to contribute to advancing treatment options.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does prohibit the use of certain medications like leflunomide and methotrexate together, as well as other biologic therapies for psoriatic arthritis. It's best to discuss your current medications with the study team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that tildrakizumab is generally safe. Studies found no major safety issues over three years for people using tildrakizumab for psoriasis, indicating it is well-tolerated long-term. For psoriatic arthritis, trials demonstrated that both 200 mg and 100 mg doses of tildrakizumab were more effective than a placebo and consistently safe.

Another study confirmed tildrakizumab's safety over five years, with no major concerns reported. Side effects that appeared after starting treatment remained stable over time. This research suggests that tildrakizumab is generally safe for people with psoriasis and psoriatic arthritis. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Tildrakizumab is unique because it specifically targets the p19 subunit of interleukin-23 (IL-23), a key player in the inflammation process of psoriatic arthritis. Unlike standard treatments such as TNF inhibitors, which broadly suppress the immune system, tildrakizumab offers a more targeted approach, potentially leading to fewer side effects. Researchers are excited about this treatment because it can be administered less frequently, with options to switch from a higher dose every four weeks to a lower dose every twelve weeks, providing flexibility and convenience for patients.

What evidence suggests that Tildrakizumab might be an effective treatment for psoriatic arthritis?

Research has shown that tildrakizumab effectively treats psoriatic arthritis. Studies found that more patients treated with tildrakizumab experienced a 20% improvement in their symptoms, known as an ACR20 response. This trial will evaluate different dosing regimens of tildrakizumab, including high and low doses administered at varying intervals. Over several years, this treatment consistently reduced psoriasis symptoms. Patients reported feeling significantly better at various times during the study. These findings suggest that tildrakizumab could be a promising option for managing psoriatic arthritis symptoms. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals with Psoriatic Arthritis who completed a previous Tildrakizumab study. They must not have active tuberculosis, use certain arthritis medications together, or be on prohibited drugs. Participants need to consent and follow strict contraception guidelines if of childbearing potential.

Inclusion Criteria

Subject has provided written informed consent for this long-term extension study.

No history of active tuberculosis (TB) or symptoms of TB.

You cannot take both leflunomide and methotrexate at the same time.

Exclusion Criteria

Concomitant use of prohibited medications or use of commercially available or investigational biologic therapies (other than tildrakizumab) for PsO and/or PsA

Subjects who have been placed in an institution on official or judicial orders

Subjects who are related to or dependent on the Investigator, Sponsor, or study site such that a conflict of interest may arise

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Tildrakizumab in various dosing regimens as part of the long-term extension study

208 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Tildrakizumab

Trial Overview The safety of long-term use of Tildrakizumab in treating Psoriatic Arthritis is being tested. This extension study requires participants from an earlier phase who are continuing treatment to assess ongoing effects and monitor any long-term side effects.

How Is the Trial Designed?

Group I: SUNPG18_07 q4 weeks, high dose Experimental Treatment 1 Intervention

Tildrakizumab 200 mg q4 Weeks

Group II: SUNPG18_07 q4 Weeks, High Dose to SUNPG18_07 q12 Weeks, Low Dose Experimental Treatment 2 Interventions

Tildrakizumab 200 mg q4 weeks switched to tildrakizumab 100 mg q12 weeks

Group III: SUNPG18_07 q12 weeks, low dose Experimental Treatment 1 Intervention

Tildrakizumab 100 mg q12 Weeks

Group IV: SUNPG18_07 q12 weeks, high dose Experimental Treatment 1 Intervention

Tildrakizumab 200 mg q12 Weeks

Group V: SUNPG18_07 q12 Weeks, High Dose to SUNPG18_07 q12 Weeks, Low Dose Experimental Treatment 2 Interventions

Tildrakizumab 200 mg q12 weeks switched to tildrakizumab 100 mg q12 weeks

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

Published Research Related to This Trial

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 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 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 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]

Citations

1. rheumatologyadvisor.com rheumatologyadvisor.com/news/tildrakizumab-meets-acr20-endpoint-in-two-psoriatic-arthritis-trials/

Tildrakizumab Meets ACR20 Endpoint in Two Psoriatic ... Findings showed that both studies met the primary endpoint, with a higher proportion of tildrakizumab-treated patients achieving ACR20 responses ...

2. ilumyapro.com ilumyapro.com/ilumya-results

Pivotal Trial Data | ILUMYA® (tildrakizumab-asmn) View ILUMYA® (tildrakizumab-asmn) pivotal trial data and how it provided consistent reduction of detectable psoriasis activity through 5 years.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12219165/

52-week Interim Data of the Phase IV Positive Study A total of 89.8%, 93.6% and 97.2% of patients achieved a PBI total score ≥1 at weeks 16, 28 and 52, respectively, considered a minimum ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04314531

NCT04314531 | Efficacy and Safety of Tildrakizumab ... This is a randomized, double-blinded, placebo-controlled, Phase 3 study to evaluate the efficacy and safety of tildrakizumab compared to placebo in anti-TNF ...

5. sunpharma.com sunpharma.com/wp-content/uploads/2025/07/Press-Release-Phase-3-Clinical-Studies-PsA-ILUMYA-Topline.pdf

Press-Release-Phase-3-Clinical-Studies-PsA-ILUMYA- ... Use of tildrakizumab 100 mg (ILUMYA) in psoriatic arthritis is not approved, and its safety and efficacy have not been evaluated by regulatory ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7064936/

Long‐term efficacy and safety of tildrakizumab ... High levels of efficacy are maintained for up to 3 years of psoriasis treatment with tildrakizumab. There is a favourable long‐term safety profile with both ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04991116

Study Details | NCT04991116 | Long Term Evaluation of ... An open-label extension study to evaluate long term safety and efficacy of Tildrakizumab in patients with psoriatic arthritis.

8. ard.bmj.com ard.bmj.com/content/80/9/1147

Efficacy and safety of tildrakizumab in patients with active ... These findings demonstrate that treatment with tildrakizumab 200 or 100 mg was more effective than placebo for rates of ACR20/50, DAS28-CRP, MDA and PASI 75/90/ ...

9. ilumyapro.com ilumyapro.com/safety-profile

Safety Profile - ILUMYA® (tildrakizumab-asmn) In Clinical Trial 1 and reSURFACE 1 and 2, ILUMYA® (tildrakizumab-asmn) demonstrated 5 years of consistent safety data1*. Treatment-emergent Adverse Events of ...