Other Clinical Trial - A Study of Tildrakizumab in Pediatric Subjects With

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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)

See also
	Status	Clinical Trial	Phase
	Completed	`NCT01076192` - Study of Adalimumab (HUMIRA®) in Patients With Moderate to Severe Psoriasis (PS) in Spain (PROMISE)	N/A
	Completed	`NCT03463187` - Multi-Dose Study of SHR-1314 in Subjects With Moderate-to-severe Plaque Psoriasis	Phase 1/Phase 2

NCT number	NCT03997786
Study type	Interventional
Source	Sun Pharmaceutical Industries Limited
Contact
Status	Active, not recruiting
Phase	Phase 2/Phase 3
Start date	January 15, 2020
Completion date	July 23, 2031

A Study of Tildrakizumab in Pediatric Subjects With Chronic Plaque Psoriasis

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms