A Study of Tildrakizumab in Pediatric Subjects With Chronic Plaque Psoriasis

Moderate-to-severe Chronic Plaque Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03997786
• Other study ID #: TILD-19-12
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: January 15, 2020
• Est. completion date: July 23, 2031

Study information

• Verified date: June 2024
• Source: Sun Pharmaceutical Industries Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 130
• Est. completion date: July 23, 2031
• Est. primary completion date: May 23, 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 215 Months

Eligibility

Inclusion Criteria:

• 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, meaning psoriasis inadequately controlled by topical treatments (corticosteroids), and/or phototherapy, and/or previous systemic therapy

• 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.

Exclusion Criteria:

• 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 surface (HBS) antigen, or hepatitis C virus (HCV) test result

Related Conditions & MeSH terms

• Moderate-to-severe Chronic Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• Tildrakizumab
Week 0 (Day 1), Week 4 (Day 28) and week 16 (Day 112)
• Placebo
(Weeks 0 to 16)
• Tildrakizumab
(Weeks 16 to 52)
• Tildrakizumab
at every 12 weeks in open label fashion till 5 years (240 weeks).
• Tildrakizumab
(Weeks 0 to 16)
• Etanercept
(Weeks 0 to 16)
• Placebo
(Weeks 16 to 52)

Locations

Country	Name	City	State
Hungary	Site 62	Budapest
Hungary	Site 63	Budapest
Hungary	Site 61	Debrecen
Hungary	Site 64	Kaposvar
India	Site 70	Ahmedabad
India	Site 79	Ahmedabad
India	Site 78	Chennai
India	Site 71	Lucknow
India	Site 74	Surat
India	Site 77	Surat
India	Site 80	Warangal
Poland	Site 57	Bialystok
Poland	Site 55	Gdansk
Poland	Site 51	Katowice
Poland	Site 54	Lodz
Poland	Site 56	Lodz
Poland	Site 58	Lublin
Poland	Site 50	Ostrowiec Swietokrzyski
Poland	Site 59	Sosnowiec
Poland	Site 52	Szczecin
Poland	Site 53	Warszawa
Poland	Site 38	Wroclaw
Poland	Site 39	Wroclaw
Slovakia	Site 92	Bardejov
Slovakia	Site 91	Svidnik
Slovakia	Site 90	Trnava
Spain	Site 41	Barcelona
Spain	Site 47	Las Palmas De Gran Canaria
United States	Site 1	Fountain Valley	California
United States	Site 20	Miami	Florida
United States	Site 7	Miami	Florida
United States	Site 14	Spokane	Washington
United States	Site 2	Thousand Oaks	California

Sponsors (1)

Lead Sponsor	Collaborator
Sun Pharmaceutical Industries Limited

Countries where clinical trial is conducted

United States,  Hungary,  India,  Poland,  Slovakia,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Relapse rates after withdrawal of treatment with tildrakizumab		Week 52
Other	Rebound rates after withdrawal of treatment with tildrakizumab		Week 52
Other	response to retreatment after relapse after withdrawal of treatment with tildrakizumab - Proportion of subjects with at least 75% improvement in the PASI response from baseline		Week 52
Other	response to retreatment after relapse after withdrawal of treatment with tildrakizumab - Proportion of subjects with PGA of "clear" or "almost clear" with at least a 2 grade reduction from baseline		Week 52
Other	Maintenance of response - Proportion of subjects with at least 75% improvement in the PASI response from baseline		Week 52
Other	Maintenance of response - Proportion of subjects with PGA of "clear" or "almost clear" with at least a 2 grade reduction from baseline		Week 52
Primary	Part A - Maximum Plasma Concentration		Day 3, 7 and 28 following first dose
Primary	Part A - Area under the plasma concentration-time curve		Day 3, 7 and 28 following first dose
Primary	Part A - Maximum Plasma Concentration		Weeks 4,8, and 12 following second dose
Primary	Part A - Area under the plasma concentration-time curve		Weeks 4,8, and 12 following second dose
Primary	Proportion of subjects with at least 75% improvement in the PASI response from baseline		Week 12
Primary	Proportion of subjects with PGA of "clear" or "almost clear" with at least a 2 grade reduction from baseline		Week 12
Primary	Number of subjects with adverse events		Week 52
Secondary	Proportion of subjects achieving Psoriasis Area & Severity Index (PASI) 50 from baseline		Week 12, 16, 28, 40, 52, 64, 76 and 88
Secondary	Proportion of subjects achieving Psoriasis Area & Severity Index (PASI) 90 from baseline		Week 12, 16, 28, 40, 52, 64, 76 and 88
Secondary	Proportion of subjects achieving Psoriasis Area & Severity Index (PASI) 100 from baseline		Week 12, 16, 28, 40, 52, 64, 76 and 88
Secondary	Proportion of subjects achieving PASI 75 and PGA score of "clear" or "almost clear" with at least a 2 grade reduction from baseline		Week 16, 28, 40, 52, 64, 76 and 88
Secondary	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.	Week 108
Secondary	Number of subjects with Adverse events		Week 108
Secondary	Immunogenicity - Anti-drug antibody status		Week 108
Secondary	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	Week 108
Secondary	Percent of subjects with malignancies	including non-melanoma and melanoma skin cancer, but excluding carcinoma in situ of the cervix	Week 108
Secondary	Percent of subjects with confirmed major adverse cardiovascular events	major adverse cardiovascular events	Week 108
Secondary	Percent of subjects with drug- related hypersensitivity reactions	e.g. anaphylaxis, urticarial, angioedema, etc	Week 108