To Study Generic Calcipotriene and Betamethasone Dipropionate Topical Suspension, 0.005%/0.064%, in the Treatment of Scalp Psoriasis

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Site Study to Evaluate the Therapeutic Equivalence of a Generic Calcipotriene and Betamethasone Dipropionate Topical Suspension, 0.005%/0.064% (Glenmark Pharmaceuticals Ltd) to the Marketed Product Taclonex® Topical Suspension (LEO Pharma Inc.) in the Treatment of Scalp Psoriasis

This is a phase III, randomized, double-blind, placebo-controlled, parallel- group, multiple-site study to evaluate the therapeutic equivalence of generic calcipotriene and betamethasone dipropionate topical suspension, 0.005%/0.064% of Glenmark Pharmaceuticals Ltd to that of the marketed product Taclonex® topical suspension of Leo Pharma Inc. in the treatment of scalp psoriasis.

Study Overview

• Status: Completed
• Conditions: Scalp Psoriasis
• Intervention / Treatment: Drug: Calcipotriene/Betamethasone Dipropionate; Drug: Taclonex®; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 643
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Encinitas, California, United States, 92024
      • Investigational site 24
    • Fremont, California, United States, 94538
      • Investigational site 3
    • San Diego, California, United States, 92108
      • Investigational site 13
    • San Diego, California, United States, 92123
      • Investigational site 20
    • Santa Monica, California, United States, 90404
      • Investigational site 32
  • Colorado
    • Denver, Colorado, United States, 80220
      • Investigational site 14
  • Florida
    • Miami, Florida, United States, 33144
      • Investigational site 1
    • Miami, Florida, United States, 33175
      • Investigational site 30
    • Miramar, Florida, United States, 33027
      • Investigational site 7
    • Tampa, Florida, United States, 33609
      • Investigational site 22
  • Indiana
    • New Albany, Indiana, United States, 47150
      • Investigational site 15
    • South Bend, Indiana, United States, 46617
      • Investigational site 10
  • Kentucky
    • Louisville, Kentucky, United States, 40241
      • Investigational site 21
  • Michigan
    • Ann Arbor, Michigan, United States, 48103
      • Investigational site 6
  • Minnesota
    • Fridley, Minnesota, United States, 55432
      • Investigational site 12
  • Missouri
    • Saint Joseph, Missouri, United States, 64506
      • Investigational site 26
  • Nevada
    • Henderson, Nevada, United States, 89052
      • Investigational site 17
    • Las Vegas, Nevada, United States, 89128
      • Investigational site 25
  • New York
    • Forest Hills, New York, United States, 11375
      • Investigational site 29
    • Rochester, New York, United States, 14623
      • Investigational site 28
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • Investigational site 4
  • South Carolina
    • Fountain Inn, South Carolina, United States, 29644
      • Investigational site 18
    • Mount Pleasant, South Carolina, United States, 29464
      • Investigational site 27
  • Tennessee
    • Knoxville, Tennessee, United States, 37922
      • Investigational site 9
    • Nashville, Tennessee, United States, 37215
      • Investigational site 8
  • Texas
    • Austin, Texas, United States, 78759
      • Investigational site 5
    • College Station, Texas, United States, 77845
      • Investigational site 11
    • San Antonio, Texas, United States, 78213
      • Investigational Site 16
    • San Antonio, Texas, United States, 78249
      • Investigational site 19
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Investigational site 31
    • Richmond, Virginia, United States, 23294
      • Investigational site 23

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

Inclusion Criteria:

1. Male or non-pregnant, non-lactating female subjects aged at least 18 years at Visit 1.
2. A clinical diagnosis of stable (at least 6 months) scalp psoriasis involving at least 10% of the scalp and clinical signs of psoriasis vulgaris on trunk and/or limbs.
3. A PGA of disease severity of the scalp psoriasis consistent with at least moderate disease severity (Grade ≥ 3).
4. A plaque elevation of at least moderate severity (Grade ≥ 3) at the scalp target lesion site. The most severe scalp lesion at baseline should be identified as the target lesion.

Exclusion Criteria:

1. Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative, or pustular psoriasis.
2. Other inflammatory skin disease in the scalp that may confound the evaluation of the scalp psoriasis (e.g., atopic dermatitis, contact dermatitis, tinea capitis).
3. Presence of pigmentation, extensive scarring, pigmented lesions, or sunburn in the scalp that could interfere with the rating of efficacy parameters.
4. Presence of viral lesions, fungal, bacterial, or parasitic infections and/or atrophic (thinning) skin on the scalp.
5. History of psoriasis unresponsive to topical treatments.
6. Subjects with planned phototherapy and/or exposure to ultraviolet A (UVA) and/or UVB during the study.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo of Calcipotriene/ betamethasone dipropionate topical suspension, 0.005%/0.064% (Glenmark Pharmaceuticals Ltd.)
Experimental: Calcipotriene/betamethasone dipropionate	Drug: Calcipotriene/Betamethasone Dipropionate; Topical suspension 0.005%/0.064% (Glenmark Pharmaceuticals Ltd)
Active Comparator: Taclonex®	Drug: Taclonex®; Calcipotriene/ betamethasone dipropionate topical suspension, 0.005%/0.064% (LEO Pharma Inc.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of subjects in each treatment group with treatment success, defined as a score of 0 or 1, within the treatment area(s) on the PGA scale of disease severity, at the end of study visit.	Day 29
Proportion of subjects in each treatment group with clinical success, defined as a score of 0 or 1, at the target lesion site on the PASI scale at the end of study visit.	Day 29

Collaborators and Investigators

• Sponsor: Glenmark Pharmaceuticals Ltd. India
• Investigators: Study Director: William Todd Kays, Glenmark Pharmaceuticals Inc., USA

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2017
• Primary Completion (Actual): October 25, 2018
• Study Completion (Actual): October 25, 2018

Study Registration Dates

• First Submitted: November 1, 2017
• First Submitted That Met QC Criteria: November 2, 2017
• First Posted (Actual): November 6, 2017

Study Record Updates

• Last Update Posted (Actual): December 21, 2018
• Last Update Submitted That Met QC Criteria: December 20, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Dermatologic Agents; Anti-Asthmatic Agents; Respiratory System Agents; Betamethasone; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Betamethasone benzoate; Calcipotriene; Betamethasone sodium phosphate
• Other Study ID Numbers: GLK-1701

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No