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

Sponsor

Glenmark Pharmaceuticals Ltd. India (Industry)

Overall Status

Completed

CT.gov ID

NCT03731091

Collaborator

(none)

494

Enrollment

Locations

Arms

16.5

Actual Duration (Months)

16.5

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Psoriasis Vulgaris	Drug: Calcipotriene/ betamethasone dipropionate topical foam, 0.005%/0.064% Drug: Enstilar® foam (LEO Pharma Inc.) Other: Placebo of Calcipotriene/ betamethasone dipropionate topical foam	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

494 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Double Blind

Primary Purpose:

Treatment

Official Title:

Actual Study Start Date :

Oct 31, 2018

Actual Primary Completion Date :

Mar 17, 2020

Actual Study Completion Date :

Mar 17, 2020

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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) psoriasis vulgaris involving 5% to 30% body surface area (BSA), not including the face, axilla and groin.
A PGA of disease severity of at least moderate disease severity (Grade ≥ 3).
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.
Provide written informed consent. -

Exclusion Criteria:

Current diagnosis of unstable forms of psoriasis in the treatment area including guttate, erythrodermic, exfoliative, or pustular psoriasis.
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).
Presence of pigmentation, extensive scarring, pigmented lesions, or sunburn in the treatment areas that could interfere with the rating of efficacy parameters.
History of psoriasis unresponsive to topical treatments.
History of hypersensitivity to any component of the Test or Reference product.
Current or past history of hypercalcemia, calcium metabolism disorder, vitamin D toxicity, severe renal insufficiency, or severe hepatic disorders.
Current immunosuppression.
Use within 6 months prior to baseline of biologic treatment for psoriasis (e.g., infliximab, adalimumab, alefacept).
Use within 3 months prior to baseline of: 1) chemotherapy or 2) radiation therapy.
Use within 2 months prior to baseline of: 1) immunosuppressive drugs (e.g., tacrolimus, pimecrolimus) or 2) oral retinoids.
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.
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.
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).
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.
Subjects with planned phototherapy and/or exposure to ultraviolet A (UVA) and/or UVB during the study.

Contacts and Locations

Locations

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