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)

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)

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).

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: Tacrolimus Ointment 0.1%; Drug: Protopic® ointment, 0.1%; Drug: Placebo of Tacrolimus Ointment

• Study Type: Interventional
• Enrollment (Actual): 1110
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tempe, Arizona, United States
      • Glenmark Investigational Site 49
  • California
    • Anaheim, California, United States
      • Glenmark Investigational Site 31
    • Bell Gardens, California, United States
      • Glenmark Investigational Site 23
    • Cerritos, California, United States
      • Glenmark Investigational Site 30
    • Chula Vista, California, United States
      • Glenmark Investigational Site 15
    • La Mesa, California, United States
      • Glenmark Investigational Site 14
    • Long Beach, California, United States
      • Glenmark Investigational Site 1
    • Oceanside, California, United States
      • Glenmark Investigational Site 17
    • Pasadena, California, United States
      • Glenmark Investigational Site 25
    • San Ramon, California, United States
      • Glenmark Investigational Site 20
    • Santa Ana, California, United States
      • Glenmark Investigational Site 44
  • Florida
    • Brooksville, Florida, United States
      • Glenmark Investigational Site 45
    • Coral Gables, Florida, United States
      • Glenmark Investigational Site 43
    • Doral, Florida, United States
      • Glenmark Investigational Site 34
    • Fort Lauderdale, Florida, United States
      • Glenmark Investigational Site 22
    • Hialeah, Florida, United States
      • Glenmark Investigational Site 35
    • Hialeah Gardens, Florida, United States
      • Glenmark Investigational Site 59
    • Miami, Florida, United States
      • Glenmark Investigational Site 11
    • Miami, Florida, United States
      • Glenmark Investigational Site 19
    • Miami, Florida, United States
      • Glenmark Investigational Site 33
    • Miami, Florida, United States
      • Glenmark Investigational Site 40
    • Miami, Florida, United States
      • Glenmark Investigational Site 42
    • Miami, Florida, United States
      • Glenmark Investigational Site 50
    • Miami, Florida, United States
      • Glenmark Investigational Site 51
    • Miami, Florida, United States
      • Glenmark Investigational Site 54
    • Miami, Florida, United States
      • Glenmark Investigational Site 56
    • Miami, Florida, United States
      • Glenmark Investigational Site 58
    • Miami, Florida, United States
      • Glenmark Investigational Site7
    • Miami Gardens, Florida, United States
      • Glenmark Investigational Site 28
    • Miami Lakes, Florida, United States
      • Glenmark Investigational Site 29
    • Miramar, Florida, United States
      • Glenmark Investigational Site 18
    • North Miami Beach, Florida, United States
      • Glenmark Investigational Site 32
    • Orlando, Florida, United States
      • Glenmark Investigational Site 48
    • Ormond Beach, Florida, United States
      • Glenmark Investigational Site 4
    • Pembroke Pines, Florida, United States
      • Glenmark Investigational Site 47
    • Winter Park, Florida, United States
      • Glenmark Investigational Site 5
  • Georgia
    • Macon, Georgia, United States
      • Glenmark Investigational Site 52
  • Kentucky
    • Madisonville, Kentucky, United States
      • Glenmark Investigational Site12
  • Missouri
    • Saint Joseph, Missouri, United States
      • Glenmark Investigational Site 2
  • Nevada
    • Henderson, Nevada, United States
      • Glenmark Investigational Site 41
    • Las Vegas, Nevada, United States
      • Glenmark Investigational Site 16
  • North Carolina
    • High Point, North Carolina, United States
      • Glenmark Investigational Site 9
    • Wilmington, North Carolina, United States
      • Glenmark Investigational Site 46
  • Ohio
    • Cincinnati, Ohio, United States
      • Glenmark Investigational Site 53
    • Cleveland, Ohio, United States
      • Glenmark Investigational Site 21
    • Toledo, Ohio, United States
      • Glenmark Investigational Site 36
  • Pennsylvania
    • Hazleton, Pennsylvania, United States
      • Glenmark Investigational Site 3
  • South Carolina
    • West Columbia, South Carolina, United States
      • Glenmark Investigational Site 57
  • Tennessee
    • Nashville, Tennessee, United States
      • Glenmark Investigational Site 6
  • Texas
    • Baytown, Texas, United States
      • Glenmark Investigational Site 60
    • Houston, Texas, United States
      • Glenmark Investigational Site 27
    • Houston, Texas, United States
      • Glenmark Investigational Site 39
    • Houston, Texas, United States
      • Glenmark Investigational Site 8
    • Lampasas, Texas, United States
      • Glenmark Investigational Site 24
    • Missouri City, Texas, United States
      • Glenmark Investigational Site 37
    • Pflugerville, Texas, United States
      • Glenmark Investigational Site 10
    • San Antonio, Texas, United States
      • Glenmark Investigational Site 13
    • San Antonio, Texas, United States
      • Glenmark Investigational Site 26
    • San Antonio, Texas, United States
      • Glenmark Investigational Site 55
    • Sugar Land, Texas, United States
      • Glenmark Investigational Site 38

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tacrolimus Ointment 0.1%	Drug: Tacrolimus Ointment 0.1%; apply thin layer of ointment to affected area
Active Comparator: Protopic® ointment, 0.1%	Drug: Protopic® ointment, 0.1%; apply thin layer of ointment to affected area
Placebo Comparator: Placebo of Tacrolimus Ointment	Drug: Placebo of Tacrolimus Ointment; apply thin layer of ointment to affected area

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Investigator's Global Assessment (IGA) score of 0 or 1 within all treatment areas at the end of treatment	Day 15

Secondary Outcome Measures

Outcome Measure	Time Frame
The change in severity score from baseline to study Day 15 of the four individual signs and symptoms of AD (i.e., erythema, induration/papulation, lichenification and pruritus).	Day 15

Collaborators and Investigators

• Sponsor: Glenmark Pharmaceuticals Ltd. India
• Investigators: Study Director: Dr. Nikhil Sawant, Glenmark Pharmaceuticals Ltd

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: November 9, 2015
• First Submitted That Met QC Criteria: November 9, 2015
• First Posted (Estimate): November 10, 2015

Study Record Updates

• Last Update Posted (Actual): July 31, 2019
• Last Update Submitted That Met QC Criteria: July 30, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Immunosuppressive Agents; Immunologic Factors; Calcineurin Inhibitors; Tacrolimus
• Other Study ID Numbers: GLK-1501