A Clinical Study to Evaluate the Safety and Pharmacokinetics of Topical RSS0393 Ointment in Children and Adolescents With Plaque Psoriasis
A Phase II Clinical Study to Evaluate the Safety and Pharmacokinetics of Topical RSS0393 Ointment in Children and Adolescents With Plaque Psoriasis
1 other identifier
interventional
20
1 country
1
Brief Summary
This study is to evaluate the safety, tolerability, pharmacokinetics and efficacy of RSS0393 topical ointment in the treatment of plaque psoriasis in children and adolescents.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Aug 2025
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 29, 2025
CompletedStudy Start
First participant enrolled
August 1, 2025
CompletedFirst Posted
Study publicly available on registry
August 5, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2026
CompletedAugust 5, 2025
July 1, 2025
6 months
July 29, 2025
July 29, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Adverse events (AEs).
About 4 weeks.
Secondary Outcomes (1)
The trough concentration of RSS0393.
About 4 weeks.
Study Arms (1)
RSS0393 Ointment Group
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Age ≥ 6 years old and \< 18 years old at screening.
- History of plaque psoriasis ≥ 3 months.
- The subjects and their parents or legal guardians voluntarily signed informed consent before any study-related procedures began.
You may not qualify if:
- Diagnosis of psoriasis other than plaque at screening.
- Subjects have other skin diseases or conditions that may affect the evaluation of the relevant endpoints of this study.
- Subjects with any other persistent active autoimmune disease.
- Subjects who have received topical medication for psoriasis within 14 days before baseline, or systemic medication or phototherapy for psoriasis within 28 days before baseline, or biological agents for psoriasis within a specified time before baseline.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beijing Children's Hospital, Capital Medical University
Beijing, Beijing Municipality, 100045, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 29, 2025
First Posted
August 5, 2025
Study Start
August 1, 2025
Primary Completion
February 1, 2026
Study Completion
February 1, 2026
Last Updated
August 5, 2025
Record last verified: 2025-07