To Study Generic Calcipotriene and Betamethasone Dipropionate Topical Foam, 0.005%/0.064%, in the Treatment of Psoriasis Vulgaris (Plaque 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 Foam, 0.005%/0.064% (Glenmark Pharmaceuticals Ltd) to the Marketed Product Enstilar® Foam (LEO Pharma Inc.) in the Treatment of Psoriasis Vulgaris (Plaque 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 Foam, 0.005%/0.064% (Glenmark Pharmaceuticals Ltd) to the Marketed Product Enstilar® Foam (LEO Pharma Inc.) in the Treatment of Psoriasis Vulgaris (Plaque Psoriasis)

Study Overview

• Status: Completed
• Conditions: Psoriasis Vulgaris
• Intervention / Treatment: Drug: Calcipotriene/ betamethasone dipropionate topical foam, 0.005%/0.064%; Drug: Enstilar® foam (LEO Pharma Inc.); Other: Placebo of Calcipotriene/ betamethasone dipropionate topical foam

• Study Type: Interventional
• Enrollment (Actual): 494
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Encinitas, California, United States, 92024
      • Investigational site 20
    • Fountain Valley, California, United States, 92708
      • Investigational site 18
    • San Diego, California, United States, 92108
      • Investigational site 19
    • San Diego, California, United States, 92123
      • Investigational site 15
    • San Diego, California, United States, 92123
      • Investigational site 23
    • Santa Ana, California, United States, 92705
      • Investigational site 17
    • Santa Monica, California, United States, 90404
      • Investigational site 22
  • Florida
    • Clearwater, Florida, United States, 33761
      • Investigational site 29
    • Coral Gables, Florida, United States, 33134
      • Investigational site 27
    • Miami, Florida, United States, 33144
      • Investigational Site 1
    • Pinellas Park, Florida, United States, 33781
      • Investigational site 26
  • Indiana
    • New Albany, Indiana, United States, 47150
      • Investigational site 10
  • Kansas
    • Overland Park, Kansas, United States, 66215
      • Investigational Site 3
  • Kentucky
    • Louisville, Kentucky, United States, 40241
      • Investigational site 16
  • Missouri
    • Saint Joseph, Missouri, United States, 64506
      • Investigational site 21
  • Nevada
    • Henderson, Nevada, United States, 89052
      • Investigational site 12
  • New York
    • New York, New York, United States, 10019
      • Investigational site 28
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • Investigational Site 4
    • Wilmington, North Carolina, United States, 28405
      • Investigational site 24
  • Ohio
    • Beachwood, Ohio, United States, 44122
      • Investigational Site 8
    • Cincinnati, Ohio, United States, 45246
      • Investigational Site 2
  • South Carolina
    • Greenville, South Carolina, United States, 29607
      • Investigational site 13
  • Tennessee
    • Knoxville, Tennessee, United States, 37922
      • Investigational Site 7
    • Murfreesboro, Tennessee, United States, 37130
      • Investigational site 31
    • Nashville, Tennessee, United States, 37215
      • Investigational site 25
  • Texas
    • Austin, Texas, United States, 78759
      • Investigational Site 5
    • San Antonio, Texas, United States, 78213
      • Investigational site 11
    • San Antonio, Texas, United States, 78249
      • Investigational site 14
    • Webster, Texas, United States, 77598
      • Investigational site 30
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Investigational Site 6

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) psoriasis vulgaris involving 5% to 30% body surface area (BSA), not including the face, axilla and groin.
3. A PGA of disease severity of at least moderate disease severity (Grade ≥ 3).
4. A plaque elevation of at least moderate severity (Grade ≥ 3) at the target lesion site. The most severe lesion at baseline should be identified as the target lesion.
5. Provide written informed consent. -

Exclusion Criteria:

1. Current diagnosis of unstable forms of psoriasis in the treatment area including guttate, erythrodermic, exfoliative, or pustular psoriasis.
2. Other inflammatory skin disease in the treatment area that may confound the evaluation of the psoriasis vulgaris (e.g., atopic dermatitis, contact dermatitis, tinea corporis).
3. Presence of pigmentation, extensive scarring, pigmented lesions, or sunburn in the treatment areas that could interfere with the rating of efficacy parameters.
4. History of psoriasis unresponsive to topical treatments.
5. History of hypersensitivity to any component of the Test or Reference product.
6. Current or past history of hypercalcemia, calcium metabolism disorder, vitamin D toxicity, severe renal insufficiency, or severe hepatic disorders.
7. Current immunosuppression.
8. Use within 6 months prior to baseline of biologic treatment for psoriasis (e.g., infliximab, adalimumab, alefacept).
9. Use within 3 months prior to baseline of: 1) chemotherapy or 2) radiation therapy.
10. Use within 2 months prior to baseline of: 1) immunosuppressive drugs (e.g., tacrolimus, pimecrolimus) or 2) oral retinoids.
11. Use within 1 month prior to baseline of: 1) systemic steroids, 2) systemic antibiotics, 3) other systemic antipsoriatic treatment, 4) psoralen and ultraviolet A (PUVA) therapy, 5) ultraviolet B (UVB) therapy, or 6) systemic anti-inflammatory agents. Note: a) Non-steroidal anti-inflammatory drugs (NSAIDs) and aspirin use on an as-needed basis and if not used consecutively for > 14 days prior to baseline and/or during the study is acceptable. Low-dose (81 mg) aspirin taken daily is acceptable. b) Intranasal or inhaled corticosteroids are acceptable if kept constant throughout the study. Intra-articular steroid injections are permissible.
12. Use within 2 weeks prior to baseline of: 1) topical antipsoriatic drugs (e.g., salicylic acid, anthralin, coal tar, calcipotriene, tazarotene), 2) topical corticosteroids, or 3) topical retinoids.
13. Use within 2 weeks prior to baseline of: 1) vitamin D supplements 2) vitamin D analogs at a dose >400 IU/day; or 3) calcium supplements (including multivitamins containing calcium).
14. Started beta-blocker therapy, antimalarial products, and/or lithium within 3 months of baseline. Subjects who have been on a steady dose for at least 3 months prior to baseline and will remain on the same dose throughout the study are eligible for study participation.

15. Subjects with planned phototherapy and/or exposure to ultraviolet A (UVA) and/or UVB during the study.

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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
Experimental: Calcipotriene/ betamethasone dipropionate topical foam; Topical foam once daily for 4 weeks (28 days)	Drug: Calcipotriene/ betamethasone dipropionate topical foam, 0.005%/0.064%; Once daily for 4 weeks (28 days)
Active Comparator: Enstilar®; Topical foam once daily for 4 weeks (28 days)	Drug: Enstilar® foam (LEO Pharma Inc.); Once daily for 4 weeks (28 days)
Placebo Comparator: Placebo; Topical foam once daily for 4 weeks (28 days)	Other: Placebo of Calcipotriene/ betamethasone dipropionate topical foam; Once daily for 4 weeks (28 days)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of subjects in each treatment group with treatment success	Treatment success defined as none or minimal disease , a score of 0 or 1, within the treatment area(s) on the PGA scale of disease severity	Day 29
The proportion of subjects in each treatment group with clinical success	Clinical success defined as clear or almost clear, a score of 0 or 1, at the target lesion site on the PASI scale. Each psoriatic sign of scaling, erythema, and plaque elevation should have a score of 0 or 1	Day 29

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2018
• Primary Completion (Actual): March 17, 2020
• Study Completion (Actual): March 17, 2020

Study Registration Dates

• First Submitted: October 31, 2018
• First Submitted That Met QC Criteria: November 2, 2018
• First Posted (Actual): November 6, 2018

Study Record Updates

• Last Update Posted (Actual): August 19, 2020
• Last Update Submitted That Met QC Criteria: August 17, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Dermatologic Agents; Micronutrients; Membrane Transport Modulators; Anti-Asthmatic Agents; Respiratory System Agents; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vasoconstrictor Agents; Calcium Channel Agonists; Betamethasone; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Betamethasone benzoate; Calcipotriene; Betamethasone sodium phosphate; Calcitriol
• Other Study ID Numbers: GLK-1801

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No