Your session is about to expire
← Back to Search
Monoclonal Antibodies
Tildrakizumab for Nail Psoriasis
Phase 3
Recruiting
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 with a chronic moderate to severe plaque-type psoriasis for at least 6 months (as determined by subject interview and confirmation of diagnosis through physical examination by Investigator).
Body Surface Area (BSA) involvement of ≥10%.
Must not have
Subjects who have predominantly non-plaque forms of psoriasis, specifically erythrodermic psoriasis, predominantly pustular psoriasis, medication-induced, or medication-exacerbated psoriasis, or new-onset guttate psoriasis.
Subjects with ongoing inflammatory skin diseases other than psoriasis or any other disease affecting the fingernails, which may potentially confound the evaluation of study treatment.
Timeline
Screening 1 day
Treatment Varies
Follow Up week 52
Awards & highlights
Pivotal Trial
Summary
This trial is testing Tildrakizumab, a medication that helps reduce inflammation, in patients with moderate to severe nail psoriasis. These patients often do not respond well to standard treatments. Tildrakizumab works by blocking a protein that causes inflammation, helping to calm the immune system and reduce symptoms. Tildrakizumab has been shown to be effective in improving skin manifestations as well as enhancing quality of life outcomes in patients with psoriasis.
Who is the study for?
This trial is for people with moderate to severe nail psoriasis who haven't had enough relief from topical treatments, light therapy, or other systemic therapies. They should have a history of plaque-type psoriasis for at least 6 months and meet specific severity scores (mNAPSI ≥20, s-PGA ≥3, PASI ≥12). Those with allergies to Tildrakizumab ingredients, non-plaque psoriasis types, fungal nail infections or previous use of IL-23/Th-17 inhibitors can't participate.
What is being tested?
The study tests the effectiveness and safety of Tildrakizumab compared to a placebo in treating nail psoriasis. It's a Phase 3b trial where participants are randomly assigned either the drug or placebo to see if there's an improvement in their condition.
What are the potential side effects?
While not specified here, drugs like Tildrakizumab may cause side effects such as injection site reactions, upper respiratory infections, headache and fatigue. The exact side effects will be monitored throughout the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had severe plaque psoriasis for at least 6 months.
Select...
Over 10% of my body is affected by my condition.
Select...
I have had severe plaque psoriasis for at least 6 months.
Select...
My nail psoriasis is moderate to severe, with a high mNAPSI score.
Select...
I have severe psoriasis with a significant area of my body affected.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My psoriasis is mostly non-plaque, including erythrodermic, pustular, medication-related, or new guttate types.
Select...
I do not have skin or nail diseases that could affect the study, except for psoriasis.
Select...
I have never used tildrakizumab or similar drugs for psoriasis.
Timeline
Screening ~ 1 day1 visit
Treatment ~ Varies
Follow Up ~ week 52
Screening ~ 1 day
Treatment ~ Varies
Follow Up ~week 52
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 at least a 75% improvement from baseline in totalmNAPSI at Week 28.
Secondary study objectives
The proportion of subjects with a score of "0 - normal" or "1 - minimal nail psoriasis" and at least a 2-point decrease from baseline at Week 28 as measured by the ViSENPsO.
The proportion of subjects with at least 3 point decrease from baseline, in Nail Pain NRS score in subjects with baseline nail pain NRS score of >3
Other study objectives
The percentage of subjects with Major Adverse Cardiovascular Events.
The percentage of subjects with incidence, seriousness, and severity of all adverse events.
The percentage of subjects with injection site reactions (eg. pain, erythema, edema etc)
+5 moreAwards & 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 Group2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tildrakizumab
2020
Completed Phase 4
~580
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
Plaque Psoriasis treatments often target specific cytokines to modulate the immune system and reduce inflammation. Tildrakizumab, for example, inhibits IL-23, a cytokine involved in the inflammatory process, thereby reducing the immune response and inflammation.
Other treatments, such as secukinumab and ixekizumab, target IL-17, while TNF-alpha inhibitors like adalimumab and etanercept block TNF-alpha. These treatments are crucial for Plaque Psoriasis patients as they help control the chronic inflammation and immune dysregulation that characterize the disease, leading to improved skin symptoms and overall quality of life.
Efficacy of tildrakizumab by patient demographic and disease characteristics across a phase 2b and 2 phase 3 trials in patients with moderate-to-severe chronic plaque psoriasis.
Efficacy of tildrakizumab by patient demographic and disease characteristics across a phase 2b and 2 phase 3 trials in patients with moderate-to-severe chronic plaque psoriasis.
Find a Location
Who is running the clinical trial?
Sun Pharma Global FZELead Sponsor
33 Previous Clinical Trials
10,055 Total Patients Enrolled
Sun Pharmaceutical Industries LimitedLead Sponsor
69 Previous Clinical Trials
13,699 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Over 10% of my body is affected by my condition.You are allergic to any of the ingredients in Tildrakizumab or the placebo.My psoriasis is mostly non-plaque, including erythrodermic, pustular, medication-related, or new guttate types.I have severe psoriasis with a significant area of my body affected.I do not have a fungal nail infection.My psoriasis is not well-managed with creams, light therapy, or previous medications.You have a mNAPSI score of ≥20.I have never used tildrakizumab or similar drugs for psoriasis.I have had severe plaque psoriasis for at least 6 months.I do not have skin or nail diseases that could affect the study, except for psoriasis.I have had severe plaque psoriasis for at least 6 months.My nail psoriasis is moderate to severe, with a high mNAPSI score.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B
- Group 2: Arm A
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 1 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.
Share this study with friends
Copy Link
Messenger