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History of Changes for Study: NCT03837743
Safety and Efficacy Study of DUR-928 Topical Solution in Subjects With Plaque Psoriasis
Latest version (submitted September 27, 2019) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 February 8, 2019 Nothing (earliest Version on record)
2 March 12, 2019
Recruitment Status
, Study Status and Contacts/Locations
3 August 8, 2019 Study Status and Contacts/Locations
4 September 27, 2019
Recruitment Status
, Study Status, Contacts/Locations and Study Design
Comparison Format:

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Changes (Merged) for Study: NCT03837743
March 12, 2019 (v2) -- August 8, 2019 (v3)

Changes in: Study Status and Contacts/Locations

Study Identification
Unique Protocol ID: C928-015
Brief Title: Safety and Efficacy Study of DUR-928 Topical Solution in Subjects With Plaque Psoriasis
Official Title: A Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Proof of Concept Comparison Study of the Safety and Efficacy of DUR-928 Topical Solution With Occlusion in Subjects With Mild to Moderate Plaque Psoriasis
Secondary IDs:
Study Status
Record Verification: March 2019 August 2019
Overall Status: Recruiting
Study Start: February 21, 2019
Primary Completion: July October 2019 [Anticipated]
Study Completion: July October 2019 [Anticipated]
First Submitted: February 5, 2019
First Submitted that
Met QC Criteria:
February 8, 2019
First Posted: February 12, 2019 [Actual]
Last Update Submitted that
Met QC Criteria:
March 12, 2019 August 8, 2019
Last Update Posted: March 13 August 9, 2019 [Actual]
Sponsor/Collaborators
Sponsor: Therapeutics, Inc.
Responsible Party: Sponsor
Collaborators: Durect
Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: No
Study Description
Brief Summary: This Phase 2 study has been designed to determine and compare the safety, tolerability, and efficacy of DUR-928 topical solution with that of the vehicle topical solution when applied once daily for approximately four weeks in subjects with plaque psoriasis. Subjects will be instructed (randomly assigned) to apply DUR-928 solution to a target lesion on one arm and vehicle solution to a target lesion on the opposite arm once daily for up to four weeks. Subjects will occlude the treated areas for approximately two hours after each application.
Detailed Description:
Conditions
Conditions: Plaque Psoriasis
Keywords:
Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: QuadrupleParticipant, Care Provider, Investigator, Outcomes Assessor
Allocation: Randomized
Enrollment: 20 [Anticipated]
Arms and Interventions
Arms Assigned Interventions
Experimental: DUR-928 Topical Solution
DUR-928 Topical Solution applied topically once daily to one target lesion on an arm for approximately four weeks.
Drug: DUR-928 Topical Solution
Topical solution containing active drug
Placebo Comparator: Vehicle Topical Solution
Vehicle Topical Solution applied topically once daily to one target lesion on an arm for approximately four weeks.
Drug: Vehicle Topical Solution
Topical solution containing no active drug
Outcome Measures
Primary Outcome Measures:
1. The change from Baseline as assessed on the Investigator's Global Assessment (IGA) Score.
The IGA of the Target Plaques will be determined on a 5-point scale ranging from "Clear - 0" to "Severe - 4."

[Time Frame: Up to Day 57]
Secondary Outcome Measures:
2. The change from Baseline as assessed on the Clinical Signs of Psoriasis (plaque elevation, scaling, and erythema)
Each clinical sign (plaque elevation, scaling, erythema) will be graded on a 5-point scale ranging from "Clear - 0" to "Severe - 4."

[Time Frame: Up to Day 57]
3. The change from Baseline as assessed on the Local Psoriasis Severity Index (LPSI)
The LPSI is a sum of all three parameters including plaque elevation, scaling, and erythema.

[Time Frame: Up to Day 57]
4. The change from Baseline as assessed by the Target Plaque Area.
The surface areas of Target Plaque A (plaque on left arm) and Target Plaque B (plaque on right arm) will be measured.

[Time Frame: Up to Day 57]
5. The change from Baseline as assessed on the Numeric Rating Scale (NRS) for Pruritus.
The NRS score is based on an 11-point scale where 0 represents "no itching" and 10 represents "worst itch imaginable."

[Time Frame: Up to Day 57]
Other Pre-specified Outcome Measures:
6. The change from Baseline as assessed on the Target Plaque Comparison
The Target Plaque Comparison is scored on a 3-point scale: 1A = Target Plaque A is better than Target Plaque B, 0 = Target Plaque A is the same as Target Plaque B, and 1B = Target Plaque A is worse than Target Plaque B.

[Time Frame: Up to Day 57]
Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  1. Subject is a male or non-pregnant female 18 years of age or older.
  2. Subject has provided written informed consent.
  3. Subject has a clinical diagnosis of stable mild to moderate plaque psoriasis for at least two months.
  4. Females must be post-menopausal , surgically sterile , or use an effective method of birth control. Women of childbearing potential (WOCBP) must have a negative urine pregnancy test (UPT) at Visit 2/Baseline.
  5. Males (or their female partner) must agree to use an effective method of birth control throughout the study.
  6. Subject has two similar contralateral Target Plaques.
  7. Subject is willing and able to apply the test article(s) as directed, comply with study instructions, and commit to all follow-up visits for the duration of the study.
  8. Subject, in the investigator's opinion, is in good general health and free of any disease state or physical condition that might impair evaluation of the plaque psoriasis or exposes the subject to an unacceptable risk by study participation.

Exclusion Criteria:

  1. Subject is pregnant, lactating, or is planning to become pregnant during the study.
  2. Subject has spontaneously improving or rapidly deteriorating plaque psoriasis.
  3. Subject has guttate, pustular, erythrodermic, inverse, or other non-plaque forms of psoriasis.
  4. Subject has psoriasis beyond the two Target Plaques that, in the investigator's opinion, could not be reasonably managed with only a bland emollient during the study.
  5. Subject is currently enrolled in an investigational drug or device study.
  6. Subject has been previously enrolled in this study and treated with test article.

Other protocol-defined inclusion and exclusion criteria assessed by the study staff may apply.

Contacts/Locations
Central Contact: TI Clinical Operations
Telephone: 1-858-571-1800 Ext. 147
Email: clinicalresearch@therapeuticsinc.com
Study Officials: Tony Andrasfay
Study Director
Therapeutics, Inc.
Locations: United States, California
Site 01
[Recruiting]
San Diego, California, United States, 92123
Contact: 858-571-6800
United States, Florida
Site 05
[Recruiting]
Brandon, Florida, United States, 33511
Contact: 858-571-1800 Ext. 147
Site 04
[Recruiting]
Miami, Florida, United States, 33162
Contact: 858-571-1800 Ext. 147
United States, Indiana
Site 02
[Recruiting]
Plainfield, Indiana, United States, 46168
Contact: 317-837-6082
United States, Washington
Site 03
[Recruiting]
Spokane, Washington, United States, 99202
Contact: 509-343-3710
IPDSharing
Plan to Share IPD: No
References
Citations:
Links:
Available IPD/Information:

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