To Study Generic Tacrolimus Ointment, 0.1% in the Treatment of Moderate to Severe Atopic Dermatitis (Inflammation of Skin: Itchy, Red, Swollen, and Cracked Skin)

Glenmark Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Atopic Dermatitis

Treatments: Drug: Tacrolimus Ointment 0.1%; Drug: Placebo of Tacrolimus Ointment; Drug: Protopic® ointment, 0.1%

Study type: Interventional

Funder types: Industry

Identifiers

NCT02601703

GLK-1501

Details and patient eligibility

About

This is a Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Site Study to Evaluate the Therapeutic Equivalence of a Generic Tacrolimus Ointment, 0.1% (Glenmark Pharmaceuticals, Ltd) to the Marketed Product Protopic® (tacrolimus) ointment, 0.1% (Astellas Pharma US, Inc.) in the Treatment of Moderate to Severe Atopic Dermatitis (AD).

Enrollment: 1,110 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

1. Non-immunocompromised male or non-pregnant, non-lactating female, 18 years of age or older with a clinical diagnosis of moderate to severe AD.
2. Have confirmed diagnosis of atopic dermatitis for at least 3 months using the diagnostic features as described by Hanifin and Rajka
3. Have an IGA score of 3 (moderate) or 4 (severe).
4. Have an affected Body Surface Area (BSA) of at least 20% at baseline.
5. Treated with a bland emollient for at least 7 days.

Key Exclusion Criteria:

1. Active cutaneous bacterial or viral infection in any treatment area at baseline.
2. Sunburn, extensive scarring, or pigmented lesion(s) in any treatment area at baseline.
3. History of confounding skin conditions, e.g., psoriasis, rosacea, erythroderma, or ichthyosis.
4. History or presence of Netherton's Syndrome, immunological deficiencies or diseases, HIV, diabetes, malignancy, serious active or recurrent infection, clinically significant severe renal insufficiency or severe hepatic disorders.
5. Known allergy or hypersensitivity to tacrolimus or any other component of the Study products.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,110 participants in 3 patient groups, including a placebo group

Tacrolimus Ointment 0.1%

Experimental group

Treatment:

Drug: Tacrolimus Ointment 0.1%

Protopic® ointment, 0.1%

Active Comparator group

Treatment:

Drug: Protopic® ointment, 0.1%

Placebo of Tacrolimus Ointment

Placebo Comparator group

Treatment:

Drug: Placebo of Tacrolimus Ointment