What side effects are associated with this type of intervention?

Common treatments for Psoriatic Arthritis include IL-23 inhibitors such as Tildrakizumab, Guselkumab, and Risankizumab. Known side effects of these treatments generally include upper respiratory infections, headache, fatigue, and injection site reactions. Long-term data have not shown an increased risk of internal malignancies with IL-23 inhibitors. Other treatments like TNF inhibitors (e.g., Adalimumab) and IL-17 inhibitors (e.g., Secukinumab) share similar side effects but may also include gastrointestinal issues and a potential risk of serious infections.

What prior FDA approvals exist?

The FDA has approved several biologic treatments for Psoriatic Arthritis, particularly those targeting interleukin pathways. Ustekinumab, an IL-12/23 inhibitor, has shown efficacy in treating PsA and is similar to Tildrakizumab, which specifically targets IL-23. Other notable IL-23 inhibitors include Guselkumab, which has also been approved for PsA. Additionally, TNF inhibitors like Adalimumab and IL-17 inhibitors such as Secukinumab and Ixekizumab have been approved for PsA treatment, offering a range of options for patients.

What other types of research exist?

Promising alternatives to Tildrakizumab for Psoriatic Arthritis patients include: 1) Secukinumab (IL-17A inhibition), which has shown significant improvement in joint and skin symptoms. 2) Ixekizumab (IL-17A inhibition), effective for both plaque psoriasis and PsA. 3) Guselkumab (IL-23 inhibition), which has demonstrated efficacy in PsA. 4) Upadacitinib (JAK inhibition), a novel oral treatment showing promise in clinical trials. 5) Bimekizumab (dual IL-17A and IL-17F inhibition), which has shown efficacy in plaque psoriasis and is being investigated for PsA.

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Monoclonal Antibodies

Long-Term Safety of Tildrakizumab for Psoriatic Arthritis

Phase 2 & 3

Waitlist Available

Research Sponsored by Sun Pharma Global FZE

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up upto week 208

Awards & highlights

No Placebo-Only Group

Summary

This trial studies the safety of Tildrakizumab in patients with psoriatic arthritis who have previously used this medication over an extended period. Tildrakizumab helps manage symptoms by reducing immune system activity that causes joint pain and skin issues. Tildrakizumab is a type of medication that targets specific parts of the immune system and has been shown to be effective in treating psoriasis and is now being tested for psoriatic arthritis.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While the specific side effects aren't listed here, generally such trials look out for allergic reactions, infection risks due to immune system changes, liver or kidney function alterations, and other drug-specific concerns over the extended period.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ upto week 208

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~upto week 208

This trial's timeline: 3 weeks for screening, Varies for treatment, and upto week 208 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants With Adverse Events

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups

Experimental Treatment

Group I: SUNPG18_07 q4 weeks, high doseExperimental Treatment1 Intervention

Tildrakizumab 200 mg q4 Weeks

Group II: SUNPG18_07 q4 Weeks, High Dose to SUNPG18_07 q12 Weeks, Low DoseExperimental Treatment2 Interventions

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

Group III: SUNPG18_07 q12 weeks, low doseExperimental Treatment1 Intervention

Tildrakizumab 100 mg q12 Weeks

Group IV: SUNPG18_07 q12 weeks, high doseExperimental Treatment1 Intervention

Tildrakizumab 200 mg q12 Weeks

Group V: SUNPG18_07 q12 Weeks, High Dose to SUNPG18_07 q12 Weeks, Low DoseExperimental Treatment2 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

SUNPG18_07 II (Tildrakizumab 100 mg)

2018

Completed Phase 3

~290

SUNPG18_07 I (Tildrakizumab 200 mg)

2018

Completed Phase 3

~290

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Psoriatic Arthritis (PsA) treatments often target specific pathways involved in the inflammatory process. Tildrakizumab, an IL-23 inhibitor, works by blocking the IL-23 cytokine, which is crucial in the differentiation and survival of Th17 cells that produce inflammatory cytokines like IL-17. This reduces inflammation and helps control PsA symptoms. Other common treatments include TNF inhibitors (e.g., adalimumab, infliximab) that block tumor necrosis factor, a key inflammatory mediator, and IL-17 inhibitors (e.g., secukinumab) that directly inhibit IL-17. These treatments are essential for PsA patients as they help manage chronic inflammation, reduce joint damage, and improve quality of life by targeting specific components of the immune response.

Lichenoid drug eruption after treatment with ixekizumab for plaque psoriasis.