A Study, Comparing Ruxolitinib Topical Cream 1.5% (Taro Pharmaceuticals U.S.A, Inc.) to OPZELURA (Ruxolitinib) Cream for the Treatment of Mild-to-Moderate Atopic Dermatitis.

Phase 1

Completed

• Conditions: Atopic Dermatitis
• Interventions: Drug: OPZELURA (Ruxolitinib) Cream; Drug: Ruxolitinib Topical Cream 1.5%; Drug: Placebo

• Registration Number: NCT06673654
• Lead Sponsor: Taro Pharmaceuticals USA

Brief Summary

To demonstrate the therapeutic equivalence and safety of Ruxolitinib Topical Cream 1.5% (Taro Pharmaceuticals U.S.A, Inc.) and OPZELURA (Ruxolitinib) Cream in the treatment of mild-to-moderate atopic dermatitis

Detailed Description

A multi-center, double-blind, randomized, placebo-controlled, parallel-group study, comparing Ruxolitinib Topical Cream 1.5% (Taro Pharmaceuticals U.S.A, Inc.) to OPZELURA (Ruxolitinib) Cream and both active treatments to a placebo control in the treatment of mild-to-moderate atopic dermatitis.

Study Timeline

• Study Start: 2023-08-11
• Status Verified: 2023-10
• Primary Completion: 2024-09-23
• Study Completion: 2024-09-23
• Study First Submitted: 2024-11-02
• Study First Submitted QC: 2024-11-02
• Last Update Submitted: 2024-11-02
• Study First Posted: 2024-11-05
• Last Update Posted: 2024-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 476

Inclusion Criteria

• Healthy male or non-pregnant female aged ≥ 12 years
• Subjects who are 18 years of age or older must have provided IRB approved written informed consent. Subjects 12 to 17 years of age, inclusive, must have provided IRB approved written assent; this written assent must be accompanied by an IRB approved written informed consent from the Subject's legally acceptable representative (i.e., parent or guardian).
• Subjects who have a clinical diagnosis of AD as defined by the criteria of Hanifin and Rajka.
• Subjects who have a clinical diagnosis of AD for at least 2 years.
• Subjects who have IGA Score of 2 (Mild) or 3 (Moderate) for AD severity.
• Subjects who have AD involvement of 3-20% of the body surface area (BSA) and does not include the scalp.

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Exclusion Criteria

• Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.
• Subjects with a history of hypersensitivity or allergy to Ruxolitinib and/or any of the study medication ingredients
• Subjects with unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator in the 4 weeks prior to baseline.
• Subjects with the presence of any skin condition that would interfere with the diagnosis or assessment of AD (e.g., other types of eczema, pigmentation, or extensive scarring).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OPZELURA (Ruxolitinib) Cream	OPZELURA (Ruxolitinib) Cream	The investigational product is to be self-administered by applying a thin layer twice daily to cover the affected areas up to 20% body surface area for approximately 8 weeks. The maximum weekly dose of the study drug should not exceed 60 g.
Ruxolitinib Topical Cream 1.5%	Ruxolitinib Topical Cream 1.5%	The investigational product is to be self-administered by applying a thin layer twice daily to cover the affected areas up to 20% body surface area for approximately 8 weeks. The maximum weekly dose of the study drug should not exceed 60 g.
Placebo Control	Placebo	The investigational product is to be self-administered by applying a thin layer twice daily to cover the affected areas up to 20% body surface area for approximately 8 weeks. The maximum weekly dose of the study drug should not exceed 60 g.

Primary Outcome Measures

Name	Time	Method
Demonstration of therapeutic equivalence, superiority, and safety of the Investigational Products.	Baseline to Week 8	The percentage of subjects in each treatment group with "Treatment Success" (defined as an IGA score of 0 (clear) or 1 (almost clear) with at least a two-point improvement from baseline, at the Week 8 (Day 56 ± 4 days) visit.

Trial Locations

Locations (1)

Taro Pharmaceuticals USA Inc.; 🇺🇸 Hawthorne, New York, United States