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

Phase 3

Completed

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

• Registration Number: NCT03731091
• Lead Sponsor: Glenmark Pharmaceuticals Ltd. India

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-31
• Study First Submitted: 2018-10-31
• Study First Submitted QC: 2018-11-02
• Study First Posted: 2018-11-06
• Primary Completion: 2020-03-17
• Study Completion: 2020-03-17
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-17
• Last Update Posted: 2020-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 494

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Calcipotriene/ betamethasone dipropionate topical foam	Calcipotriene/ betamethasone dipropionate topical foam, 0.005%/0.064%	Topical foam once daily for 4 weeks (28 days)
Placebo	Placebo of Calcipotriene/ betamethasone dipropionate topical foam	Topical foam once daily for 4 weeks (28 days)
Enstilar®	Enstilar® foam (LEO Pharma Inc.)	Topical foam once daily for 4 weeks (28 days)

Primary Outcome Measures

Name	Time	Method
The proportion of subjects in each treatment group with treatment success	Day 29	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
The proportion of subjects in each treatment group with clinical success	Day 29	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

Trial Locations

Locations (30)

Investigational Site 20; 🇺🇸 Encinitas, California, United States

Investigational Site 18; 🇺🇸 Fountain Valley, California, United States

Investigational Site 28; 🇺🇸 New York, New York, United States

Investigational Site 22; 🇺🇸 Santa Monica, California, United States

Investigational Site 16; 🇺🇸 Louisville, Kentucky, United States

Investigational Site 27; 🇺🇸 Coral Gables, Florida, United States

Investigational Site 29; 🇺🇸 Clearwater, Florida, United States

Investigational Site 3; 🇺🇸 Overland Park, Kansas, United States

Investigational Site 19; 🇺🇸 San Diego, California, United States

Investigational Site 15; 🇺🇸 San Diego, California, United States

Investigational Site 1; 🇺🇸 Miami, Florida, United States

Investigational Site 23; 🇺🇸 San Diego, California, United States

Investigational Site 2; 🇺🇸 Cincinnati, Ohio, United States

Investigational Site 11; 🇺🇸 San Antonio, Texas, United States

Investigational Site 17; 🇺🇸 Santa Ana, California, United States

Investigational Site 10; 🇺🇸 New Albany, Indiana, United States

Investigational Site 26; 🇺🇸 Pinellas Park, Florida, United States

Investigational Site 21; 🇺🇸 Saint Joseph, Missouri, United States

Investigational Site 12; 🇺🇸 Henderson, Nevada, United States

Investigational Site 24; 🇺🇸 Wilmington, North Carolina, United States

Investigational Site 4; 🇺🇸 High Point, North Carolina, United States

Investigational Site 8; 🇺🇸 Beachwood, 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 14; 🇺🇸 San Antonio, Texas, United States

Investigational Site 5; 🇺🇸 Austin, Texas, United States

Investigational Site 6; 🇺🇸 Norfolk, Virginia, United States

Investigational Site 30; 🇺🇸 Webster, Texas, United States