A Phase II Trial of the Safety and Efficacy of RSS0309 Ointment in Adults With Atopic Dermatitis

Reistone Biopharma

Status and phase: Active, not recruiting; Phase 2

Conditions: Atopic Dermatitis of Adults

Treatments: Drug: RSS0393 ointment

Study type: Interventional

Funder types: Industry

Identifiers

NCT07158151

RSS0393Oint-202

Details and patient eligibility

About

This study is ongoing to explore the efficacy and safety of different strengths of RSS0393 ointment in adults with atopic dermatitis

Enrollment: 168 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥18 years old and ≤75 years old at screening.
2. History of atopic dermatitis ≥ 6 months.
3. BSA is between 3% and 20% (inclusive) and EASI score is ≥ 5 and vIGA-AD is 2 or 3.
4. The subjects signed informed consent before any study-related procedures began.

Exclusion criteria

1. Diagnosis of other dermatologic diseases 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: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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168 participants in 4 patient groups

Treatment group 1: RSS0393 ointment 0.05%

Experimental group

Treatment:

Drug: RSS0393 ointment

Drug: RSS0393 ointment

Drug: RSS0393 ointment

Drug: RSS0393 ointment

Treatment group 2: RSS0393 ointment 0.01%

Experimental group

Treatment:

Drug: RSS0393 ointment

Drug: RSS0393 ointment

Drug: RSS0393 ointment

Drug: RSS0393 ointment

Treatment group 3: RSS0393 ointment 0.03%

Experimental group

Treatment:

Drug: RSS0393 ointment

Drug: RSS0393 ointment

Drug: RSS0393 ointment

Drug: RSS0393 ointment

Treatment group 4: RSS0393 ointment placebo

Sham Comparator group

Treatment:

Drug: RSS0393 ointment

Drug: RSS0393 ointment

Drug: RSS0393 ointment

Drug: RSS0393 ointment