Moderate-to-severe Chronic Plaque PsoriasisPhase 2/3NCT03997786
A Study of Tildrakizumab in Pediatric Subjects With Chronic Plaque Psoriasis
A Phase 2/3 study testing Tildrakizumab and Etanercept in people with Moderate-to-severe Chronic Plaque Psoriasis, run by Sun Pharmaceutical Industries Limited at 27 sites in 6 countries.
Trial summary
The study has been designed with three components. Part A is an open label PK study followed by a randomized trial component (Part B) followed by open label Long Term Extension (LTE). Read more about this study
- Who is it for?
- Ages 6 years to 215 months
- Conditions the study is for
- Moderate-to-severe Chronic Plaque Psoriasis
- What is being tested?
- Tildrakizumab and Etanercept
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 135 participants
- Where
- 27 sitesin 6 countries
- Study dates
- 15 Jan 2020to 5 Aug 2031
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years to 215 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subject must be 6 to < 18 years of age, of either sex, of any race/ ethnicity, must weight greater than or equal to 15Kg.
- Diagnosis of predominantly plaque psoriasis for ≥6 months (as determined by subject interview and confirmation of diagnosis through physical examination by investigator).
- 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 considered a candidate for systemic therapy and/or phototherapy.
- Subject is considered to be eligible according to tuberculosis (TB) screening criteria
- A maximum of 2 QuantiFERON tests will be allowed. A re-test is only permitted if the first is indeterminate; the result of the second test will then be used.
Who cannot join
- Subject has predominantly non-plaque forms of psoriasis specifically erythrodermic psoriasis, predominantly pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new-onset guttate psoriasis
- Subject has laboratory abnormalities at screening including any of the following: Alanine transaminase (ALT) or aspartate transaminase, (AST) ≥2X the upper limit of normal, Creatinine ≥1.5X the upper limit of normal serum direct bilirubin ≥ 1.5 mg/dL, white blood cell count < 3.0 x 103/μL, and any other laboratory abnormality, which, in the opinion of the Investigator, will prevent the subject from completing the study or will interfere with the interpretation of the study results
- Subject who is expected to require topical therapy, phototherapy, or additional systemic therapy for psoriasis during the trial
- Female subjects of childbearing potential who are pregnant, intend to become pregnant (within 6 months of completing the trial), or are lactating. (Sexually active adolescent girls will be required to use contraception)
- Subject with presence of any infection or history of recurrent infection requiring treatment with systemic antibiotics within 2 weeks prior to Screening, or severe infection (e.g. pneumonia, cellulitis, bone or joint infections) requiring hospitalization or treatment with IV antibiotics within 8 weeks prior to Screening
- Positive human immunodeficiency virus (HIV) test result, hepatitis B Virus (HBV) test results, or hepatitis C virus (HCV) test result
- Subjects who have a high risk of suicidality at the Screening assessment as indicated by the C-SSRS (Columbia Suicide Severity Rating Scale), or based on the Investigator's judgment.
- Subject who has received any of the prohibited medications, supplements or substances during the study.
Trial locations and contacts
27 sites in 6 countries.
27 sites in 6 countries
Poland10 sites
Site 57
Bialystok, 15-453
Site 51
Katowice, 40-611
Site 54
Lodz, 90-265
Site 56
Lodz, 90-436
Site 58
Lublin, 20-573
Site 50
Ostrowiec Świętokrzyski, 27-400
Site 59
Sosnowiec, 41-200
Site 52
Szczecin, 70-332
Site 53
Warsaw, 02-507
Site 39
Wroclaw, 51-503
United States5 sites
Site 1
Fountain Valley, California, 92708
Site 20
Miami, Florida, 33126
Site 7
Miami, Florida, 33173
Site 14
Spokane, Washington, 99202
Site 2
Thousand Oaks, California, 91320
Hungary4 sites
Site 63
Budapest, H-1033
Site 62
Budapest, H-1036
Site 61
Debrecen, H-4032
Site 64
Kaposvár, H-7400
India3 sites
Site 79
Ahmedabad, 380009
Site 71
Lucknow, 226005
Site 74
Surat, 395002
Slovakia3 sites
Site 92
Bardejov, 8501
Site 91
Svidník, 8901
Site 90
Trnava, 91775
About this study
Official title: A Multicenter, Randomized, Placebo and Active Comparator-controlled Clinical Trial to Study the Efficacy, Safety and Pharmacokinetics (PK) of Tildrakizumab in Pediatric Subjects From 6 to <18 Years of Age With Moderate to Severe Chronic Plaque Psoriasis
The study has been designed with three components. Part A is an open label PK study followed by a randomized trial component (Part B) followed by open label Long Term Extension (LTE).
The initial PK analysis is first done in adolescent subjects (12 to <18 years) before initiating the PK study in younger cohort (6 to <12 years)
- Being tested
- Tildrakizumab, Placebo, Etanercept
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TildrakizumabDrug
Week 0 (Day 1), Week 4 (Day 28) and week 16 (Day 112)
PlaceboDrug
(Weeks 0 to 16)
TildrakizumabDrug
(Weeks 16 to 52)
TildrakizumabDrug
at every 12 weeks in open label fashion till 5 years (240 weeks).
TildrakizumabDrug
(Weeks 0 to 16)
EtanerceptDrug
(Weeks 0 to 16)
PlaceboDrug
(Weeks 16 to 52)
| Study group | Role | What they receive |
|---|---|---|
| Part A: Open-label PK and Safety: Part A | Active comparator | Part A is a DOSE FINDING COMPONENT: OPEN LABEL PK lead-in and safety component Receives: Drug: Tildrakizumab |
| Part B- 1: Placebo and active comparator controlled study | Experimental | Not described Receives: Drug: Placebo; Drug: Tildrakizumab; Drug: Etanercept |
| Part B-2: Randomized withdrawal and retreatment after relapse | Experimental | Not described Receives: Drug: Tildrakizumab; Drug: Placebo |
| Part B 3: Efficacy and Safety Follow-up | No intervention | Not described |
| Part C: LTE | Experimental | Not described Receives: Drug: Tildrakizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A - Dose determination for pediatrics population 12 to <18-year-old age group
Measured: Up to week 16
Part A - Dose determination for pediatrics population 6 to <12 year-old age group
Measured: Up to week 16
Proportion of subjects with at least 75% improvement in the PASI response from baseline
Measured: Week 16
Proportion of subjects with PGA score of "clear" or "minimal" with at least a 2-grade reduction from baseline
Measured: Week 16
Number of subjects with adverse events
Measured: Week 16
Secondary outcomes (12)
Proportion of subjects achieving Psoriasis Area & Severity Index (PASI) 50 from baseline
Measured: Week 12, 16, 28, 40, 52, 64, 76 and 88
Proportion of subjects achieving Psoriasis Area & Severity Index (PASI) 90 from baseline
Measured: Week 12, 16, 28, 40, 52, 64, 76 and 88
Proportion of subjects achieving Psoriasis Area & Severity Index (PASI) 100 from baseline
Measured: Week 12, 16, 28, 40, 52, 64, 76 and 88
Proportion of subjects achieving PASI 75 and PGA score of "clear" or "almost clear" with at least a 2 grade reduction from baseline
Measured: Week 16, 28, 40, 52, 64, 76 and 88
Change in quality of life as measured by Children's Dermatology Life Quality Index (CDLQI)
The CDLQI is a 10-item questionnaire that measures the impact of skin disease on children's (aged 2-15 years) quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The CDLQI total score was the sum of individual scores of question 1-10 and ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the children's life; 2-6 = small effect on the children's life; 7-12 = moderate effect on the children's life; 13-18 = very large effect on the children's life; 19-30 = extremely large effect on the children's life. Higher scores indicate more impact on quality of life of children.
Measured: Week 108
Number of subjects with Adverse events
Measured: Week 108
Immunogenicity - Anti-drug antibody status
Measured: Week 108
Percent of subjects with severe infections
defined as any infection meeting the regulatory definition of a serious adverse event, or any infection requiring IV antibiotics whether or not reported as a serious event as per the regulatory definition
Measured: Week 108
Percent of subjects with malignancies
including non-melanoma and melanoma skin cancer, but excluding carcinoma in situ of the cervix
Measured: Week 108
Percent of subjects with confirmed major adverse cardiovascular events
major adverse cardiovascular events
Measured: Week 108
Percent of subjects with drug- related hypersensitivity reactions
e.g. anaphylaxis, urticarial, angioedema, etc
Measured: Week 108
Number of subjects with adverse events
Measured: Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2019
- Study start15 Jan 2020
- Primary completion7 Apr 2025
- Study completion5 Aug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate-to-severe Chronic Plaque PsoriasisStudies of the same condition, open and under way.
- More trials run by Sun Pharmaceutical Industries LimitedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Pharmaceutical Industries Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03997786
- Sponsor's protocol ID
- TILD-19-12
- Status last verified
- Apr 2026
- First submitted
- 19 Jun 2019
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Placebo and Active Comparator-controlled Clinical Trial to Study the Efficacy, Safety and Pharmacokinetics (PK) of Tildrakizumab in Pediatric Subjects From 6 to <18 Years of Age With Moderate to Severe Chronic Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT03997786
- Acronym / sponsor ID
- TILD-19-12
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Sun Pharmaceutical Industries LimitedIndustry (pharma, biotech, devices)
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 7 Apr 2025 (actual)
- Study completion
- 5 Aug 2031 (estimated)
- First posted
- 25 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study has been designed with three components. Part A is an open label PK study followed by a randomized trial component (Part B) followed by open label Long Term Extension (LTE).
The initial PK analysis is first done in adolescent subjects (12 to <18 years) before initiating the PK study in younger cohort (6 to <12 years)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part A: Open-label PK and Safety: Part A | Active comparator | Drug: TildrakizumabPart A is a DOSE FINDING COMPONENT: OPEN LABEL PK lead-in and safety component |
| Part B- 1: Placebo and active comparator controlled study | Experimental | Drug: Placebo, Drug: Tildrakizumab, Drug: Etanercept |
| Part B-2: Randomized withdrawal and retreatment after relapse | Experimental | Drug: Tildrakizumab, Drug: Placebo |
| Part B 3: Efficacy and Safety Follow-up | No intervention | – |
| Part C: LTE | Experimental | Drug: Tildrakizumab |
Who may qualify
- Ages
- 6 years to 215 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Subject must be 6 to < 18 years of age, of either sex, of any race/ ethnicity, must weight greater than or equal to 15Kg.
- Diagnosis of predominantly plaque psoriasis for ≥6 months (as determined by subject interview and confirmation of diagnosis through physical examination by investigator).
- 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 considered a candidate for systemic therapy and/or phototherapy.
- Subject is considered to be eligible according to tuberculosis (TB) screening criteria
Key exclusion criteria (8 listed)
- Subject has predominantly non-plaque forms of psoriasis specifically erythrodermic psoriasis, predominantly pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new-onset guttate psoriasis
- Subject has laboratory abnormalities at screening including any of the following: Alanine transaminase (ALT) or aspartate transaminase, (AST) ≥2X the upper limit of normal, Creatinine ≥1.5X the upper limit of normal serum direct bilirubin ≥ 1.5 mg/dL, white blood cell count < 3.0 x 103/μL, and any other laboratory abnormality, which, in the opinion of the Investigator, will prevent the subject from completing the study or will interfere with the interpretation of the study results
- Subject who is expected to require topical therapy, phototherapy, or additional systemic therapy for psoriasis during the trial
- Female subjects of childbearing potential who are pregnant, intend to become pregnant (within 6 months of completing the trial), or are lactating. (Sexually active adolescent girls will be required to use contraception)
- Subject with presence of any infection or history of recurrent infection requiring treatment with systemic antibiotics within 2 weeks prior to Screening, or severe infection (e.g. pneumonia, cellulitis, bone or joint infections) requiring hospitalization or treatment with IV antibiotics within 8 weeks prior to Screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TildrakizumabWeek 0 (Day 1), Week 4 (Day 28) and week 16 (Day 112) | Drug | Part A: Open-label PK and Safety: Part A |
| Placebo(Weeks 0 to 16) | Drug | Part B- 1: Placebo and active comparator controlled study |
| Tildrakizumab(Weeks 16 to 52) | Drug | Part B-2: Randomized withdrawal and retreatment after relapse |
| Tildrakizumabat every 12 weeks in open label fashion till 5 years (240 weeks). | Drug | Part C: LTE |
| Tildrakizumab(Weeks 0 to 16) | Drug | Part B- 1: Placebo and active comparator controlled study |
| Etanercept(Weeks 0 to 16) | Drug | Part B- 1: Placebo and active comparator controlled study |
| Placebo(Weeks 16 to 52) | Drug | Part B-2: Randomized withdrawal and retreatment after relapse |
Primary outcome
Part A - Dose determination for pediatrics population 12 to <18-year-old age group
Time frame: Up to week 16
Part A - Dose determination for pediatrics population 6 to <12 year-old age group
Time frame: Up to week 16
Proportion of subjects with at least 75% improvement in the PASI response from baseline
Time frame: Week 16
Proportion of subjects with PGA score of "clear" or "minimal" with at least a 2-grade reduction from baseline
Time frame: Week 16
Number of subjects with adverse events
Time frame: Week 16
12 secondary outcomes
Proportion of subjects achieving Psoriasis Area & Severity Index (PASI) 50 from baseline
Time frame: Week 12, 16, 28, 40, 52, 64, 76 and 88
Proportion of subjects achieving Psoriasis Area & Severity Index (PASI) 90 from baseline
Time frame: Week 12, 16, 28, 40, 52, 64, 76 and 88
Proportion of subjects achieving Psoriasis Area & Severity Index (PASI) 100 from baseline
Time frame: Week 12, 16, 28, 40, 52, 64, 76 and 88
Proportion of subjects achieving PASI 75 and PGA score of "clear" or "almost clear" with at least a 2 grade reduction from baseline
Time frame: Week 16, 28, 40, 52, 64, 76 and 88
Change in quality of life as measured by Children's Dermatology Life Quality Index (CDLQI)
Time frame: Week 108
Number of subjects with Adverse events
Time frame: Week 108
Immunogenicity - Anti-drug antibody status
Time frame: Week 108
Percent of subjects with severe infections
Time frame: Week 108
Percent of subjects with malignancies
Time frame: Week 108
Percent of subjects with confirmed major adverse cardiovascular events
Time frame: Week 108
Percent of subjects with drug- related hypersensitivity reactions
Time frame: Week 108
Number of subjects with adverse events
Time frame: Week 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
27 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Tildrakizumab and Etanercept in people with Moderate-to-severe Chronic Plaque Psoriasis, run by Sun Pharmaceutical Industries Limited at 27 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in Poland, United States, Hungary, India, Slovakia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part A - Dose determination for pediatrics population 12 to <18-year-old age group (time frame: Up to week 16). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026; AzTrials last refreshed its copy on 26 Oct 2026.