| CTRI Number |
CTRI/2023/05/052628 [Registered on: 15/05/2023] Trial Registered Prospectively |
| Last Modified On: |
07/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
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Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
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Public Title of Study
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A study of Tildrakizumab in children with moderate to severe psoriasis. |
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Scientific Title of Study
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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 less than 18 Years of Age with Moderate to Severe Chronic Plaque Psoriasis |
| Trial Acronym |
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Secondary IDs if Any
Modification(s)
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| Secondary ID |
Identifier |
| NCT03997786 |
ClinicalTrials.gov |
| TILD-19-12, Amendment Amendment 3, dated 18 Oct 2024 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
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| Designation |
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| Affiliation |
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| Address |
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| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
Modification(s)
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| Name |
Dr Tushar Nishandar |
| Designation |
Senior Manager |
| Affiliation |
Sun Pharmaceutical Industries Limited |
| Address |
17/B, Mahal Industries Limited, Mahakali Caves Road, Andheri(East)
Mumbai
MAHARASHTRA
400093
India |
| Phone |
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| Fax |
|
| Email |
Tushar.Nishandar@sunpharma.com |
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Details of Contact Person
Public Query
Modification(s)
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| Name |
Shruti Pal |
| Designation |
Senior Executive, Regulatory |
| Affiliation |
Sun Pharmaceutical Industries Limited |
| Address |
17/B, Mahal Industries Limited, Mahakali Caves Road, Andheri
(East) Mumbai
Mumbai
Mumbai
MAHARASHTRA
400 093
India |
| Phone |
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| Fax |
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| Email |
Clinical.Trial@sunpharma.com |
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Source of Monetary or Material Support
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| Sun Pharmaceutical Industries Limited |
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Primary Sponsor
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| Name |
Sun Pharmaceutical Industries Limited |
| Address |
Sun house, CTS No. 201 B/1, Western Express Highway, Goregaon (E), Mumbai 400063
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| Type of Sponsor |
Pharmaceutical industry-Indian |
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Details of Secondary Sponsor
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Countries of Recruitment
Modification(s)
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Hungary
India
Poland
Slovakia
Spain
United States of America |
Sites of Study
Modification(s)
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| No of Sites = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Amit Madan |
Ajanta Hospital & IVF Centre |
Hall C, Dermatology Department, Ground floor 765, ABC Complex, Kanpur road, Alambagh, Lucknow-226005 Uttar Pradesh India
Lucknow
UTTAR PRADESH |
9838001239
amitmadan_2000@yahoo.com |
| Dr AM Jayaraaman |
Chennai Meenakshi Multispecialty Hospital Limited |
Basement, Clinical Research Department, New no 72, Luz Church Rd, Kattukoil Garden, Mylapore, Chennai, Tamil Nadu 600004
Chennai
TAMIL NADU |
91-44-24993282
jayaraamana@gmail.com |
| Dr Smita Nagpal |
Khyati Multispeciality Hospital |
Research Room, Basement 1
S.No.: 235/2, B/s Tata Motors Showroom, Opposite Rajpath Club, S G Highway, Bodakdev
Ahmedabad- 380015
Gujarat
India
Ahmadabad
GUJARAT |
9825721525
nagpalsmita@gmail.com |
| Chekuri Madhu Babu |
Mahatma Gandhi Memorial Hospital |
Room No. 116, Ground Floor, Department of Dermatology, General Medicine Block,
Sherpura, Warangal- 506002, Telangana, India
Warangal
TELANGANA |
9866242211
drmadhubabuch.krcwgl@gmail.com |
| Mitulkumar Ranchhodlal Patel |
Navneet Memorial Hospital "SUSHRUSHA" |
Basement, Clinical Research Room, Clinical Research Department,
Opp. Sardar Patel Seva Samaj Hall, In the Lane, Opp. Tele. Exchange, Navrangpura, Ahmedabad- 380006, Gujarat, India
Ahmadabad
GUJARAT |
9558025435
drmitulpatelcr@gmail.com |
| Dr Dipak Patel |
Nirmal Hospital |
Room#108, 1st Floor, Adult OPD, Ring Road, Surat, Gujarat, India 395002
Surat
GUJARAT |
9374711540
drdipakapatel@gmail.com |
| Dr Sunil Trivedi |
Unity Hospital |
Room#2, OPD 1st Floor, Aai Mata Rd, Parvat Patiya, Surat, Gujarat 395010
Surat
GUJARAT |
9426031787
trivedidrsunil@gmail.com |
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Details of Ethics Committee
Modification(s)
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| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| Asian Education and Research Foundation |
Approved |
| Chennai Meenakshi Multispeciality Hospital Ethics Committee |
Approved |
| IEC-ARC Institutional Ethics Committee for Ajanta Hospital & IVF Centre |
Approved |
| Kakatiya Institutional Ethics Committee |
Approved |
| NIRMAL HOSPITAL ETHICS COMMITTEE |
Approved |
| Sangini Hospital Ethics Committee |
Approved |
| UNITY HOSPITAL ETHICS COMMITTEE |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L408||Other psoriasis, |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Comparator Agent |
Placebo |
Route: Subcutaneous; Dosage: 1
ml injection; Duration of
treatment: 52 Week, post week
52 to week 72- no IMP, only
safety follow up. |
| Intervention |
Tildrakizumab |
Route: Subcutaneous dosage: 1
ml injection Duration of
treatment: 52 Week, post week
52 to week 72- no IMP, only
safety follow up. LTE - Subjects
continuing with the LTE study
shall receive tildrakizumab till
240 weeks. |
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Inclusion Criteria
Modification(s)
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| Age From |
6.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
1.Subject must be 6 to less than or equal to 17 years of age, of either sex, of any race/ ethnicity, must weigh greater than 15 kg at screening. 2.Diagnosis of predominantly plaque psoriasis for greater than or equal to 6 months (as determined by subject interview and confirmation of diagnosis through physical examination by investigator). 3.Moderate to severe psoriasis at baseline defined as :- At least 10% body surface area (BSA) involvement , PGA score greater than or equal to 3, PASI score greater than or equal to 12. 4.Subject must be considered a candidate for systemic therapy and/or phototherapy. 5.Subject has a negative evaluation for tuberculosis (TB).A maximum of 2 QuantiFERON tests are allowed. A re-test is only permitted if the first is indeterminate; the result of the second test will then be used. 6.Subject should have documentation of adequate, up-to-date, age-appropriate vaccination status at screening. 7.Subject is unlikely to conceive, as indicated by at least one yes answer to the following questions: Subject is a male, Subject is a female of child-bearing potential and agrees to abstain from heterosexual activity OR use a medically accepted method of contraception OR use appropriate effective contraception as per local regulations or guidelines for continued use during the study and for 6 months following administration of the last dose of the investigational medicinal product. Subject is a surgically sterilized female or is documented to be pre- menarchal.8.For a female with childbearing potential, a negative serum pregnancy test at Screening and a negative urine pregnancy test within 24 hours prior to the first dose of study medication and at all subsequent visits as per the schedule of assessments.9.Subject must have results of a physical examination within normal limits or clinically acceptable limits to the investigator prior to the first dose of study medication. 10.To participate in whole-body photography at designated sites, the subject must be willing to give assent or written informed consent and be able to adhere to dose and visit schedules. Photography will be an optional procedure for subjects to participate in the trial. |
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| ExclusionCriteria |
| Details |
1.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.
2. Subject has laboratory abnormalities at screening, including any of the following:a) Alanine transaminase (ALT) or aspartate transaminase (AST) greater than or equal to 2X the upper limit of normal
b) Creatinine greater than or equal to 1.5X the upper limit of normal.
c) Serum direct bilirubin greater than or equal to 1.5 mg/dL
d) White blood cell count less than 3.0 x 103/μL
e) 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.
3. Subject who is expected to require topical therapy, phototherapy, or additional systemic therapy for psoriasis during the trial.
4. Female subjects of childbearing potential who are pregnant or intend to become pregnant (within 6 months following administration of the last dose of the investigational medicinal product) or are lactating (Sexually active adolescent girls will be required to use contraception)
5. 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
6. Positive human immunodeficiency virus (HIV) test result, hepatitis B Virus(HBV) test result, or hepatitis C virus (HCV) test result.
7. Prior malignancy or concurrent malignancy.
8. Subject who intends to receive live viral or bacterial vaccination during the trial.
9. Subject who is currently participating in another interventional clinical trial.
10. Subject has sustained, uncontrolled hypertension or has uncontrolled diabetes.
11. Subject has been hospitalized due to an acute cardiovascular event, illness or surgery within 6 months prior to screening
12. Within 6 months prior to screening, any significant organ dysfunction or clinically significant laboratory abnormalities that place the subject at unacceptable risk for participation in a trial of immunomodulatory therapy are in the judgment of the investigator.
13. The subject or a family member is among the personnel of the investigational site or sponsor/designee staff directly involved with this trial.
14. Any concomitant medical condition that in the opinion of the Investigator could affect the trial outcome or present an unacceptable risk
15. Subject who, in the opinion of the Investigator, will not be a reliable participant in the trial.
16. Subject who has a history of alcohol or drug abuse in the previous year.
17. Subjects with a history of psychiatric inpatient hospitalization within the past year
18. Subjects with any other clinically significant 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
19. History of hypersensitivity to the applicable IMP or any ingredients of the study drug or placebo.
20. Subjects who have a high risk of suicidality at the Screening assessment based on the Investigators judgment or if appropriate as indicated by a response of yes within the last 12 months to Questions 4 or 5 in the suicidal ideation section or any positive response in the behavioral section of the CSSRS.
21.Subject who has received any of the prohibited medications, supplements or substances during the study.
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Method of Generating Random Sequence
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Not Applicable |
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Method of Concealment
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Not Applicable |
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Blinding/Masking
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Outcome Assessor Blinded |
Primary Outcome
Modification(s)
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| Outcome |
TimePoints |
Part A - Dose determination for paediatrics population 12 to 18-year-old age group [Time Frame: Up to week 16]
Part A - Dose determination for paediatrics 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]
|
Week 16 |
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Secondary Outcome
Modification(s)
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| Outcome |
TimePoints |
| The proportion of subjects with PASI 75 score (PASI 75 response) |
week 4, 8, 12, 28, 40 and 52 |
| Proportion of subjects with PGA score of "clear" or "minimal" with at least a 2-grade reduction from baseline |
Week 4, 8, 12, 28, 40 & 52. |
| The proportion of subjects with PASI 50, PASI 90 and PASI 100 response |
Weeks 4, 8, 12, 16, 28, 40 and 52. |
| Change in quality of life as measured by Childrens Dermatology Life Quality Index (CDLQI) |
Weeks 4, 8, 12, 16, 28, 40 & 52. |
| Mean change from baseline in Itch, pain and scaling NRS |
Weeks 4, 8, 12, 16, 28, 40 and 52 |
| The proportion of PGA responders at Week 16 who maintained response on continued treatment with Tildrakizumab through Week 52 |
Week 52 |
| The proportion of subjects achieving remission with tildrakizumab treatment |
Week 16 |
| Median time to loss of remission in subjects achieving remission |
Week 16 |
| The proportion of tildrakizumab responders at week 16 who relapse over 52 weeks upon treatment withdrawal |
Week 52 |
| The proportion of tildrakizumab responders at Week 16 who rebound over 52 weeks upon treatment withdrawal |
Week 52 |
| Incidence and severity of adverse events. |
Part A- Upto Week 16
Part B - Upto Week 72
Part C- Upto Week 260 |
| The proportion of subjects responding to re-treatment on relapse and rebound of the disease on withdrawal from tildrakizumab treatment |
until week 16 from the relapse or rebound |
| The proportion of subjects with malignancies (including non-melanoma and melanoma skin cancer, but excluding carcinoma in situ of the cervix) over 52 weeks |
Week 52 |
| Percentage of subjects with severe infection over 52 weeks |
Week 52 |
| The proportion of subjects with MACE (Major Adverse Cardiovascular Events) over 52 weeks |
Week 52 |
| The proportion of subjects with drug-related hypersensitivity reactions (e.g., anaphylaxis, urticarial, angioedema, etc.) over 52 weeks |
Week 52 |
| The proportion of subjects with injection site reaction over 52 weeks |
Week 52 |
| Incidence of immunogenicity over 52 weeks after treatment with tildrakizumab |
Week 52 |
| Median time to relapse(defined as a PGA score of greater than or equal to 3)upon withdrawal of tildrakizumab in subjects responding at Week 16 |
Week 16 |
| Median time to relapse (defined as reduction by greater than 50 percent in maximum improvement achieved at week 16) upon withdrawal of tildrakizumab in subjects responding at Week 16 |
Week 16 |
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Target Sample Size
Modification(s)
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Total Sample Size="130"
Sample Size from India="35"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
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Phase of Trial
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Phase 2/ Phase 3 |
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Date of First Enrollment (India)
|
01/06/2023 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
03/02/2022 |
| Date of Study Completion (Global) |
Date Missing |
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Estimated Duration of Trial
|
Years="10"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
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Dose finding Component - To characterize pharmacokinetics
(PK) and safety of tildrakizumab in pediatric subjects during a 16-week
treatment period in support of final pediatric dose selection
Randomized Trial Component- To evaluate the efficacy of
tildrakizumab in pediatric subjects from 6 to <18 years of age with moderate
to severe chronic plaque psoriasis as measured by the proportion of subjects
with at least 75% improvement in the Psoriasis Area & Severity Index (PASI
75 response) from baseline, and the proportion of subjects with Physician’s
Global Assessment (PGA) score of “clear†or “almost clear†with at least a 2
grade reduction from baseline at Week 16 compared to placebo
To evaluate the efficacy of tildrakizumab in pediatric
subjects from 6 to <18 years of age with moderate to severe chronic plaque
psoriasis as measured by the proportion of subjects with at least 75%
improvement in the Psoriasis Area & Severity Index (PASI 75 response) from
baseline, and the proportion of subjects with Physician’s Global Assessment
(PGA) score of “clear†or “almost clear†with at least a 2 grade reduction from
baseline at Week 12 compared to placebo.
|