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

NCT03331523 | Completed Phase 3 FDA Drug

• 1 other identifier: GLK-1701
• Study Type: interventional
• Target: 643
• Locations: 1 country
• Sites: 31

Brief Summary

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.

Conditions

Scalp Psoriasis

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

Calcipotriene/betamethasone dipropionate

EXPERIMENTAL

Drug: Calcipotriene/Betamethasone Dipropionate

Taclonex®

ACTIVE COMPARATOR

Drug: Taclonex®

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Calcipotriene/Betamethasone Dipropionate DRUG

Topical suspension 0.005%/0.064% (Glenmark Pharmaceuticals Ltd)

Calcipotriene/betamethasone dipropionate

Taclonex® DRUG

Calcipotriene/ betamethasone dipropionate topical suspension, 0.005%/0.064% (LEO Pharma Inc.)

Taclonex®

Placebo DRUG

Placebo of Calcipotriene/ betamethasone dipropionate topical suspension, 0.005%/0.064% (Glenmark Pharmaceuticals Ltd.)

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or non-pregnant, non-lactating female subjects aged at least 18 years at Visit 1.
• 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.
• A PGA of disease severity of the scalp psoriasis consistent with at least moderate disease severity (Grade ≥ 3).
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Glenmark Pharmaceuticals Ltd. India: lead

Study Sites (31)

Investigational Site 24

Encinitas, California, 92024, United States

Location

Investigational Site 3

Fremont, California, 94538, United States

Location

Investigational Site 13

San Diego, California, 92108, United States

Location

Investigational Site 20

San Diego, California, 92123, United States

Location

Investigational Site 32

Santa Monica, California, 90404, United States

Location

Investigational Site 14

Denver, Colorado, 80220, United States

Location

Investigational Site 1

Miami, Florida, 33144, United States

Location

Investigational Site 30

Miami, Florida, 33175, United States

Location

Investigational Site 7

Miramar, Florida, 33027, United States

Location

Investigational Site 22

Tampa, Florida, 33609, United States

Location

Investigational Site 15

New Albany, Indiana, 47150, United States

Location

Investigational Site 10

South Bend, Indiana, 46617, United States

Location

Investigational Site 21

Louisville, Kentucky, 40241, United States

Location

Investigational Site 6

Ann Arbor, Michigan, 48103, United States

Location

Investigational Site 12

Fridley, Minnesota, 55432, United States

Location

Investigational Site 26

Saint Joseph, Missouri, 64506, United States

Location

Investigational Site 17

Henderson, Nevada, 89052, United States

Location

Investigational Site 25

Las Vegas, Nevada, 89128, United States

Location

Investigational Site 29

Forest Hills, New York, 11375, United States

Location

Investigational Site 28

Rochester, New York, 14623, United States

Location

Investigational Site 4

High Point, North Carolina, 27262, United States

Location

Investigational Site 18

Fountain Inn, South Carolina, 29644, United States

Location

Investigational Site 27

Mt. Pleasant, South Carolina, 29464, United States

Location

Investigational Site 9

Knoxville, Tennessee, 37922, United States

Location

Investigational Site 8

Nashville, Tennessee, 37215, United States

Location

Investigational Site 5

Austin, Texas, 78759, United States

Location

Investigational Site 11

College Station, Texas, 77845, United States

Location

Investigational Site 16

San Antonio, Texas, 78213, United States

Location

Investigational Site 19

San Antonio, Texas, 78249, United States

Location

Investigational Site 31

Norfolk, Virginia, 23507, United States

Location

Investigational Site 23

Richmond, Virginia, 23294, United States

Location

MeSH Terms

Interventions

betamethasone dipropionate, calcipotriol drug combination

Study Officials

• William Todd Kays

  Glenmark Pharmaceuticals Inc., USA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2017
• First Posted: November 6, 2017
• Study Start: October 20, 2017
• Primary Completion: October 25, 2018
• Study Completion: October 25, 2018
• Last Updated: December 21, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (31)