To Study Generic Calcipotriene and Betamethasone Dipropionate Topical Foam, 0.005%/0.064%, in the Treatment of Psoriasis Vulgaris (Plaque Psoriasis).

NCT ID: NCT03731091

Last Updated: 2020-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 494 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-31
• Study Completion Date: 2020-03-17

Brief Summary

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)

Conditions

Psoriasis Vulgaris

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Calcipotriene/ betamethasone dipropionate topical foam

Topical foam once daily for 4 weeks (28 days)

Group Type: EXPERIMENTAL

Calcipotriene/ betamethasone dipropionate topical foam, 0.005%/0.064%

Intervention Type: DRUG

Once daily for 4 weeks (28 days)

Enstilar®

Topical foam once daily for 4 weeks (28 days)

Group Type: ACTIVE_COMPARATOR

Enstilar® foam (LEO Pharma Inc.)

Intervention Type: DRUG

Once daily for 4 weeks (28 days)

Placebo

Topical foam once daily for 4 weeks (28 days)

Group Type: PLACEBO_COMPARATOR

Placebo of Calcipotriene/ betamethasone dipropionate topical foam

Intervention Type: OTHER

Once daily for 4 weeks (28 days)

Interventions

Calcipotriene/ betamethasone dipropionate topical foam, 0.005%/0.064%

Once daily for 4 weeks (28 days)

Intervention Type: DRUG

Enstilar® foam (LEO Pharma Inc.)

Once daily for 4 weeks (28 days)

Intervention Type: DRUG

Placebo of Calcipotriene/ betamethasone dipropionate topical foam

Once daily for 4 weeks (28 days)

Intervention Type: OTHER

Eligibility Criteria

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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• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Glenmark Pharmaceuticals Ltd. India

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William Todd Kays

Role: STUDY_DIRECTOR

Glenmark Pharmaceuticals

Locations

Investigational Site 20

Encinitas, California, United States

Investigational Site 18

Fountain Valley, California, United States

Investigational Site 19

San Diego, California, United States

Investigational Site 15

San Diego, California, United States

Investigational Site 23

San Diego, California, United States

Investigational Site 17

Santa Ana, California, United States

Investigational Site 22

Santa Monica, California, United States

Investigational Site 29

Clearwater, Florida, United States

Investigational Site 27

Coral Gables, Florida, United States

Investigational Site 1

Miami, Florida, United States

Investigational Site 26

Pinellas Park, Florida, United States

Investigational Site 10

New Albany, Indiana, United States

Investigational Site 3

Overland Park, Kansas, United States

Investigational Site 16

Louisville, Kentucky, United States

Investigational Site 21

Saint Joseph, Missouri, United States

Investigational Site 12

Henderson, Nevada, United States

Investigational Site 28

New York, New York, United States

Investigational Site 4

High Point, North Carolina, United States

Investigational Site 24

Wilmington, North Carolina, United States

Investigational Site 8

Beachwood, Ohio, United States

Investigational Site 2

Cincinnati, Ohio, United States

Investigational Site 13

Greenville, South Carolina, United States

Investigational Site 7

Knoxville, Tennessee, United States

Investigational site 31

Murfreesboro, Tennessee, United States

Investigational Site 25

Nashville, Tennessee, United States

Investigational Site 5

Austin, Texas, United States

Investigational Site 11

San Antonio, Texas, United States

Investigational Site 14

San Antonio, Texas, United States

Investigational Site 30

Webster, Texas, United States

Investigational Site 6

Norfolk, Virginia, United States

Countries

United States

Other Identifiers

GLK-1801

Identifier Type: -

Identifier Source: org_study_id