A Study of the Efficacy and Safety of DFD-06 Cream in the Treatment of Moderate to Severe Plaque Psoriasis

NCT02445807 | Completed Phase 3 Results

• 1 other identifier: DFD06-CD-005
• Study Type: interventional
• Target: 265
• Locations: 1 country
• Sites: 30

Brief Summary

This study will compare the efficacy and safety of DFD-06 Cream to Vehicle Cream for topical treatment of moderate to severe plaque psoriasis after 3, 7, and 14 days of treatment.

Conditions

Chronic Stable Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• Efficacy (Percentage of Subjects With Treatment Success)

  The primary efficacy endpoint is the percentage of subjects with treatment success (defined as IGA = 0 or 1 and at least a 2 grade reduction from Baseline) at the Day 15 visit. The primary analysis was done with multiple imputations. Results are combined analyses from 5 imputed data sets.

  Day 15 Visit

Secondary Outcomes (2)

• The Percent Change in Body Surface Area of Psoriasis

  From Baseline to Day 15

• The Percentage of Subjects With Treatment Success at the Day 8 Visit.

  At Day 8 Visit

Study Arms (2)

DFD-06 cream

EXPERIMENTAL

DFD-06 Cream will be applied to subjects with moderate plaque psoriasis twice daily for 14 days.

Drug: DFD06-Cream

Vehicle Cream

PLACEBO COMPARATOR

Vehicle Cream will be applied to subjects with moderate plaque psoriasis twice daily for 14 days.

Drug: Vehicle Cream

Interventions

DFD06-Cream DRUG

Twice daily topical application for 14 days.

Also known as: Clobetasol propionate Cream, 0.025%

DFD-06 cream

Vehicle Cream DRUG

Twice daily topical application for 14 days.

Vehicle Cream

Eligibility Criteria

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

You may qualify if:

• Subject understands the study procedures and agrees to participate by giving written informed consent. Subjects must be willing to authorize use and disclosure of protected health information collected for the study.
• Subject must be at least 18 years of age.
• Subject must present with a clinical diagnosis of stable (at least 3 months) plaque-type psoriasis.
• Subject with psoriasis involving 3% or greater BSA, not including the face, scalp, groin, axillae and other intertriginous areas.
• Subject must have an IGA grade of 3 or 4 (moderate to severe) at the Baseline Visit.
• Female subjects of childbearing potential must agree to use contraception during the study which can include abstinence with an adequate secondary option should the subject become sexually active. All women of childbearing potential must complete a urine pregnancy test (test must have a sensitivity of at least 25mIU/ml for human chorionic gonadotropin) at the Baseline Visit (Visit 2) and the test result must be negative to be eligible for enrollment.
• Subject must be in good general health as determined by the investigator and supported by the medical history and normal or not clinically significant abnormal vital signs (blood pressure and pulse).

You may not qualify if:

• Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative or pustular psoriasis.
• Other inflammatory skin disease that may confound the evaluation of the plaque psoriasis (e.g., atopic dermatitis, contact dermatitis, tinea corporis).
• Presence of pigmentation, extensive scarring, or pigmented lesions or sunburn which could interfere with the rating of efficacy parameters.
• History of psoriasis unresponsive to biological or topical treatments.
• History of organ transplant requiring immunosuppression, HIV, or other immunocompromised state.
• Use within 180 days prior to Baseline Visit of biologic treatment for psoriasis (e.g., infliximab, adalimumab, etanercept, ustekinumab, secukinumab, or alefacept).
• Have received treatment for any type of cancer within 5 years of the Baseline Visit except skin cancer and cervical cancer (in situ) are allowed if at least 1 year before the Baseline Visit.
• Use within 60 days prior to the Baseline Visit of: 1) systemic or topical immunosuppressive drugs (e.g., tacrolimus, pimecrolimus), 2) systemic antipsoriatic treatment (e.g., methotrexate, cyclosporine, hydroxyurea) or 3) oral retinoids (e.g., acitretin, isotretinoin).
• Use within 30 days prior to the Baseline Visit of: 1) systemic steroids, 2) PUVA therapy, 3) systemic anti-inflammatory agents (e.g., mycophenolate mofetil, sulfasalazine, 6-thioguanine), or 4) UVB therapy. Inhaled, intraocular, and intranasal steroids are allowed.
• Use within 14 days prior to the Baseline Visit of: 1) topical antipsoriatic drugs (e.g., salicylic acid, anthralin, coal tar, calcipotriene), 2) topical retinoids (e.g., tazarotene, tretinoin) or 3) topical corticosteroids.
• Subjects who have participated in a study of an investigational drug 60 days prior to the Baseline Visit.

Sponsors & Collaborators

• Promius Pharma, LLC: lead

Study Sites (30)

Site 101

Birmingham, Alabama, 35205, United States

Location

Site 103

Mobile, Alabama, 36608, United States

Location

Site 130

Mesa, Arizona, 85202, United States

Location

Site 116

Phoenix, Arizona, 85251, United States

Location

Site 125

Tucson, Arizona, 85712, United States

Location

Site 120

North Hollywood, California, 91606, United States

Location

Site 114

San Diego, California, 92117, United States

Location

Site 127

Santa Monica, California, 90404, United States

Location

Site 128

Clearwater, Florida, 33756, United States

Location

Site 115

Miami, Florida, 33144, United States

Location

Site 118

Indianapolis, Indiana, 46256, United States

Location

Site 110

Louisville, Kentucky, 40202, United States

Location

Site 105

Glenn Dale, Maryland, 20769, United States

Location

Site 111

Warren, Michigan, 48088, United States

Location

Site 113

Fridley, Minnesota, 55432, United States

Location

Site 123

Saint Joseph, Missouri, 64506, United States

Location

Site 106

Newington, New Hampshire, 03801, United States

Location

Site 104

Albuquerque, New Mexico, 87106, United States

Location

Site 117

Stony Brook, New York, 11790, United States

Location

Site 124

High Point, North Carolina, 27262, United States

Location

Site 109

Winston-Salem, North Carolina, 27157, United States

Location

Site 129

Johnston, Rhode Island, 02919, United States

Location

Site 119

Anderson, South Carolina, 29621, United States

Location

Site 102

Greenville, South Carolina, 29607, United States

Location

Site 108

Austin, Texas, 78759, United States

Location

Site 122

Houston, Texas, 77030, United States

Location

Site 107

Plano, Texas, 75024, United States

Location

Site 112

Draper, Utah, 84020, United States

Location

Site 126

Spokane, Washington, 99202, United States

Location

Site 121

Walla Walla, Washington, 99362, United States

Location

Results Point of Contact

• Title: Srinivas Sidgiddi, MD
• Organization: Dr. Reddy's Lab, Inc

srinivassidgiddi@drreddys.com

609-375-9900

Study Officials

• Srinivas Sidgiddi, MD

  Dr Reddy's Laboratories Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: May 13, 2015
• First Posted: May 15, 2015
• Study Start: December 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: May 15, 2018
• Results First Posted: April 13, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (30)