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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 up to 5 years
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 ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: SUNPG18_07 q4 weeks, high doseExperimental Treatment2 Interventions
Group II: SUNPG18_07 q12 weeks, low doseExperimental Treatment1 Intervention
Group III: SUNPG18_07 q12 weeks, high doseExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SUNPG18_07 I
2018
Completed Phase 3
~290
SUNPG18_07 II
2018
Completed Phase 3
~290
SUNPG18_07 III
2018
Completed Phase 3
~290
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.
Lichenoid drug eruption after treatment with ixekizumab for plaque psoriasis.
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Who is running the clinical trial?
Sun Pharma Global FZELead Sponsor
33 Previous Clinical Trials
9,865 Total Patients Enrolled
1 Trials studying Psoriatic Arthritis
650 Patients Enrolled for Psoriatic Arthritis
Sun Pharmaceutical Industries LimitedLead Sponsor
69 Previous Clinical Trials
13,509 Total Patients Enrolled
1 Trials studying Psoriatic Arthritis
650 Patients Enrolled for Psoriatic Arthritis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You cannot take both leflunomide and methotrexate at the same time.
Research Study Groups:
This trial has the following groups:- Group 1: SUNPG18_07 q12 weeks, high dose
- Group 2: SUNPG18_07 q12 weeks, low dose
- Group 3: SUNPG18_07 q4 weeks, high dose
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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