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.

NCT ID: NCT06673654

Last Updated: 2024-11-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 476 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-11
• Study Completion Date: 2024-09-23

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.

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Ruxolitinib Topical Cream 1.5%

Intervention Type: DRUG

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.

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.

Group Type: ACTIVE_COMPARATOR

OPZELURA (Ruxolitinib) Cream

Intervention Type: DRUG

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

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

Test Product; Reference Product; Vehicle

Eligibility Criteria

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.

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).

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sun Pharmaceutical Industries, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andy Silverman

Role: STUDY_CHAIR

Catawba Research, LLC

Locations

Taro Pharmaceuticals USA Inc.

Hawthorne, New York, United States

Countries

United States

Other Identifiers

RXLC-2118

Identifier Type: -

Identifier Source: org_study_id