← Back to Search

Monoclonal Antibodies

Tildrakizumab for Pediatric Psoriasis

Phase 2 & 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
Moderate to severe psoriasis at baseline defined as: at least 10% Body Surface Area (BSA) involvement, PGA score ≥ 3, and PASI score ≥ 12
Subject must be 6 to < 18 years of age, of either sex, of any race/ethnicity, must weigh greater than or equal to 15Kg
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12, 16, 28, 40, 52, 64, 76 and 88
Awards & highlights

Study Summary

This trial has 3 parts. In the first part, researchers study how the drug affects adolescents. In the second part, they study how the drug affects younger children, and in the third part, they study how the drug affects children over the long term.

Who is the study for?
This trial is for children and teens aged 6 to <18 with moderate to severe plaque psoriasis, who haven't responded well to topical treatments or phototherapy. They must weigh at least 15 kg and have a confirmed diagnosis of plaque psoriasis for over six months. Participants should not have recent serious infections, HIV, hepatitis B/C, significant lab abnormalities, or be pregnant.Check my eligibility
What is being tested?
The study tests Tildrakizumab's effects on pediatric chronic plaque psoriasis. It starts with an open-label phase to understand how the body processes the drug (pharmacokinetics), followed by a randomized comparison with Etanercept and placebo, then a long-term extension phase for further evaluation.See study design
What are the potential side effects?
Potential side effects may include reactions at the injection site like pain or swelling, increased risk of infections due to immune system suppression, possible liver issues indicated by blood test changes, and allergic reactions that could manifest as rashes or difficulty breathing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My psoriasis is severe, affecting over 10% of my body.
Select...
I am between 6 and 18 years old, weigh at least 15Kg.
Select...
I have passed the screening for tuberculosis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12, 16, 28, 40, 52, 64, 76 and 88
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12, 16, 28, 40, 52, 64, 76 and 88 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of subjects with adverse events
Part A - Area under the plasma concentration-time curve
Part A - Maximum Plasma Concentration
+2 more
Secondary outcome measures
Change in quality of life as measured by Children's Dermatology Life Quality Index (CDLQI)
Immunogenicity - Anti-drug antibody status
Number of subjects with Adverse events
+8 more
Other outcome measures
Maintenance of response - Proportion of subjects with PGA of "clear" or "almost clear" with at least a 2 grade reduction from baseline
Maintenance of response - Proportion of subjects with at least 75% improvement in the PASI response from baseline
Rebound rates after withdrawal of treatment with tildrakizumab
+3 more

Trial Design

5Treatment groups
Experimental Treatment
Active Control
Group I: Part C: LTEExperimental Treatment1 Intervention
Group II: Part B-1 and B-2: Randomized withdrawal and retreatment after relapseExperimental Treatment2 Interventions
Group III: Part B Part 1: Placebo and active comparator controlled studyExperimental Treatment3 Interventions
Group IV: Part B 3: Efficacy and Safety Follow-upActive Control1 Intervention
Group V: Part AActive Control1 Intervention
Part A is a DOSE FINDING COMPONENT: OPEN LABEL PK lead-in and safety component
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Etanercept
2005
Completed Phase 4
~4740
Tildrakizumab
2019
Completed Phase 4
~190
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Sun Pharma Global FZELead Sponsor
33 Previous Clinical Trials
10,021 Total Patients Enrolled
Sun Pharmaceutical Industries LimitedLead Sponsor
64 Previous Clinical Trials
13,381 Total Patients Enrolled

Media Library

Tildrakizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03997786 — Phase 2 & 3
Plaque Psoriasis Research Study Groups: Part B Part 1: Placebo and active comparator controlled study, Part B-1 and B-2: Randomized withdrawal and retreatment after relapse, Part B 3: Efficacy and Safety Follow-up, Part A, Part C: LTE
Plaque Psoriasis Clinical Trial 2023: Tildrakizumab Highlights & Side Effects. Trial Name: NCT03997786 — Phase 2 & 3
Tildrakizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03997786 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are elderly patients being included in this experiment?

"Eligibility requirements for participants state that they must be between 6 and 215 months old."

Answered by AI

How many individuals are participating in this clinical research?

"The latest information from clinicaltrials.gov shows that this study is actively looking for patients to enroll. This specific trial was posted on 1/15/2020, and the most recent update was on 8/26/2022. In total, the research group hopes to find 120 people willing to participate at 34 different locations."

Answered by AI

Can you explain what Tildrakizumab is most often utilized for?

"Tildrakizumab is a medication that is used to quell moderate to severe symptoms. In addition, it can also help patients with other conditions like plaque psoriasis, rheumatoid arthritis, and ankylosing spondylitis."

Answered by AI

In how many different geographic areas is this trial being run today?

"Currently, this study is being conducted at 34 seperate sites. Some of these locations include Spokane, Thousand Oaks and Boca Raton. If you enroll in the study, choose a clinic that is nearest to your location to avoid having to travel long distances."

Answered by AI

Are investigators still enrolling individuals into this research project?

"Yes, this information is accurate. The clinical trial in question is still recruiting patients, and originally posted on January 15th 2020. It was most recently edited on August 26th 2022. This study is looking for 120 patients at 34 different locations."

Answered by AI

To whom is this research opportunity available?

"This clinical trial is looking for 120 participants that have psoriasis and meet the following criteria: they must be 6 to 18 years old, of any sex or race/ethnicity, weigh more than 15 kg, have had moderate to severe plaque psoriasis for at least 6 months (as determined by subject interview and confirmation of diagnosis through physical examination by investigator), be considered a candidate for systemic therapy according to tuberculosis (TB) screening criteria, and have had no more than 2 QuantiFERON tests (with a re-test only permitted if the first is indeterminate)."

Answered by AI

Are there precedents for Tildrakizumab's efficacy?

"The first clinical trial for tildrakizumab was completed in 2007 at University of Nebraska Medical Center. Out of the 18479 total trials, 44 are currently active with a significant portion taking place in Spokane, Washington."

Answered by AI

Who else is applying?

What state do they live in?
Tennessee
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
What site did they apply to?
Site 11
Recent research and studies
clinicaltrials.govStudy
A Study of Tildrakizumab in Pediatric Subjects With Chronic Plaque Psoriasis
2020. "A Study of Tildrakizumab in Pediatric Subjects With Chronic Plaque Psoriasis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03997786.
All > Psoriasis > Plaque Psoriasis
~81 spots leftby May 2031
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top