What is the mechanism of action of this treatment?

Common treatments for Psoriatic Arthritis (PsA) include IL-23 inhibitors like tildrakizumab, which block the IL-23 cytokine to reduce the proliferation of Th17 cells and subsequent inflammation. TNF inhibitors, such as adalimumab, target and neutralize TNF-α, a key inflammatory mediator. IL-17 inhibitors, like secukinumab, directly inhibit IL-17, another cytokine involved in PsA. These treatments are crucial for PsA patients as they specifically target immune pathways, reducing inflammation, preventing joint damage, and improving overall quality of life.

What side effects are associated with this type of intervention?

Common treatments for Psoriatic Arthritis, particularly IL-23 inhibitors like Tildrakizumab, generally have side effects including nasopharyngitis, headache, and injection site reactions. Other biologic therapies, such as TNF inhibitors (e.g., Adalimumab) and IL-17 inhibitors (e.g., Secukinumab), may cause similar side effects along with potential risks of serious infections and gastrointestinal issues. Traditional treatments like Methotrexate can lead to gastrointestinal distress, hepatotoxicity, hematologic toxicity, and pulmonary toxicity, necessitating regular monitoring.

What prior FDA approvals exist?

The FDA has approved several biologic treatments for Psoriatic Arthritis, including IL-23 inhibitors like Guselkumab and Risankizumab. Guselkumab, an anti-IL-23 monoclonal antibody, has shown efficacy in treating PsA. Similarly, Risankizumab, another IL-23 inhibitor, has been approved for moderate-to-severe plaque psoriasis and is being explored for PsA. Other biologics targeting different pathways, such as IL-17 inhibitors (Secukinumab, Ixekizumab) and TNF inhibitors (Adalimumab, Etanercept), have also been approved for PsA treatment.

What other types of research exist?

Promising alternatives to Tildrakizumab for Psoriatic Arthritis patients include: <ol> <li>Secukinumab (IL-17A inhibitor) - Demonstrated significant improvement in joint and skin symptoms, physical function, and quality of life.</li> <li></li> </ol> Ixekizumab (IL-17A inhibitor) - Effective for both plaque psoriasis and PsA, showing sustained responses. 3. Guselkumab (IL-23 inhibitor) - Shown efficacy in PsA and psoriasis, with a good safety profile. 4. Ustekinumab (IL-12/23 inhibitor) - Effective in patients with inadequate response to other treatments. 5. Abatacept (T-cell modulator) - An option for patients resistant to multiple biologics.

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Monoclonal Antibodies

Tildrakizumab for Psoriatic Arthritis

Phase 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

Subjects must have no prior exposure to anti-tumor necrosis factor (anti-TNF) agent(s) use for the treatment of PsO or PsA.

Subject is ≥ 18 years of age at time of Screening.

Must not have

Subject has any active malignancy, including evidence of cutaneous basal or squamous cell carcinoma or melanoma.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up exclusive of weeks 24 and 52

Awards & highlights

Pivotal Trial

Summary

This trial is testing tildrakizumab, a medication that reduces inflammation, in patients with active Psoriatic Arthritis who haven't tried certain other treatments. It works by blocking a protein to help manage symptoms. Tildrakizumab is approved for treating moderate to severe plaque psoriasis.

Who is the study for?

This trial is for adults diagnosed with active Psoriatic Arthritis (PsA) for at least 6 months, who have never used anti-TNF treatments. Participants must test negative for certain antibodies and agree to use effective contraception if of childbearing potential. Exclusions include a history of serious infections, heart issues within the past 6 months, drug abuse in the last two years, or any condition that might compromise study participation.

What is being tested?

The INSPIRE 2 study is testing the effectiveness and safety of Tildrakizumab (TILD), an investigational medication, against a placebo in individuals who haven't previously been treated with anti-TNF drugs. This Phase 3 trial randomly assigns participants to receive either TILD or placebo injections without knowing which one they're getting.

What are the potential side effects?

While specific side effects are not listed here, common ones associated with medications like Tildrakizumab may include injection site reactions, increased risk of infection due to immune system suppression, headaches, fatigue and possibly allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have never used anti-TNF drugs for psoriasis or psoriatic arthritis.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an active cancer, including skin cancers like basal or squamous cell carcinoma or melanoma.

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I am not currently institutionalized by court or government order.

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I have not donated or lost 400 mL or more of blood in the last 8 weeks.

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I have a history of hepatitis B, C, or HIV.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ exclusive of weeks 24 and 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~exclusive of weeks 24 and 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and exclusive of weeks 24 and 52 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

The proportion of subjects who achieve American College of Rheumatology [ACR20]

Secondary study objectives

The Change from Baseline in American College of Rheumatology Response Criteria Components Score

The change from Baseline in American College of Rheumatology Response Criteria Components Score

The change from Baseline in anti-tumor necrosis factor naïve subjects with active Psoriasis and body surface area ≥ 3% (those with involvement of nails)

+2 more

Other study objectives

The proportion of subjects achieving American College of Rheumatology [ACR20]

The proportion of subjects achieving American College of Rheumatology [ACR50]

The proportion of subjects achieving American College of Rheumatology [ACR70]

+1 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm AExperimental Treatment1 Intervention

Group II: Arm BPlacebo Group1 Intervention

0 / 6Eligibility criteria met

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

Common treatments for Psoriatic Arthritis (PsA) include IL-23 inhibitors like tildrakizumab, which block the IL-23 cytokine to reduce the proliferation of Th17 cells and subsequent inflammation. TNF inhibitors, such as adalimumab, target and neutralize TNF-α, a key inflammatory mediator. IL-17 inhibitors, like secukinumab, directly inhibit IL-17, another cytokine involved in PsA. These treatments are crucial for PsA patients as they specifically target immune pathways, reducing inflammation, preventing joint damage, and improving overall quality of life.