A Clinical Study to Evaluate the Safety and Pharmacokinetics of Topical RSS0393 Ointment in Children and Adolescents With Plaque Psoriasis

Hengrui Medicine

Status and phase: Not yet enrolling; Phase 2

Conditions: Plaque Psoriasis in Children; Plaque Psoriasis in Adolescents

Treatments: Drug: RSS0393 Ointment

Study type: Interventional

Funder types: Industry

Identifiers

NCT07102888

RSS0393Oint-203

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥ 6 years old and < 18 years old at screening.
2. History of plaque psoriasis ≥ 3 months.
3. The subjects and their parents or legal guardians voluntarily signed informed consent before any study-related procedures began.

Exclusion criteria

1. Diagnosis of psoriasis other than plaque at screening.
2. Subjects have other skin diseases or conditions that may affect the evaluation of the relevant endpoints of this study.
3. Subjects with any other persistent active autoimmune disease.
4. 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

RSS0393 Ointment Group

Experimental group

Treatment:

Drug: RSS0393 Ointment