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This Phase 3 study (Study 310) has been designed to determine and compare the efficacy and safety of 122-0551 Foam and Vehicle Foam applied twice daily for two weeks in subjects with plaque psoriasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 122-0551 Foam | Experimental | 122-0511 Foam, topically applied twice daily Intervention: Drug: 122-0551 Foam |
|
| Vehicle Foam | Placebo Comparator | Vehicle Foam, topically applied twice daily Intervention: Drug: Vehicle Foam |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 122-0551 Foam | Drug | Topical Foam containing active drug |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Rated a "Treatment Success" Based on the Investigator's Global Assessment (IGA) | The IGA score is a static evaluation of the overall or "average" degree of severity taking into account all of the subject's psoriatic lesions in the Treatment Area by the investigator or designee. This evaluation takes into consideration the three individual characteristics of psoriasis (scaling, erythema and plaque elevation) with the IGA score at each visit representing the average of scaling, erythema or plaque elevation that is present amongst all of the lesions eligible for treatment. IGA will be assessed on a 5-point scale where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. | Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Rated a "Treatment Success" for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation) | Scaling, erythema and plaque elevation will each be scored on a 5-point scale where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. These evaluations are an assessment of the overall or "average" degree of each of three key characteristics present within all of the subject's psoriatic lesions in the Treatment Area by the investigator or designee. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Rated a "Treatment Success" Based on the Investigator's Global Assessment (IGA) | Day 8 | |
| Percentage of Subjects Rated a "Treatment Success" for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation) | Day 8 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 14 | Fort Smith | Arkansas | 72916 | United States | ||
| Site 01 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31424709 | Derived | Bhatia N, Stein Gold L, Kircik LH, Schreiber R. Two Multicenter, Randomized, Double-Blind, Parallel Group Comparison Studies of a Novel Foam Formulation of Halobetasol Propionate, 0.05% vs Its Vehicle in Adult Subjects With Plaque Psoriasis. J Drugs Dermatol. 2019 Aug 1;18(8):790-796. |
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All subjects who met the entry criteria were randomized and enrolled into the study.
Recruitment period: June 2016 to February 2017
The location of clinical sites included dermatology clinics and clinical research centers.
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| ID | Title | Description |
|---|---|---|
| FG000 | 122-0551 Foam | 122-0511 Foam, topically applied twice daily Intervention: Drug: 122-0551 Foam 122-0551 Foam: Topical Foam containing active drug |
| FG001 | Vehicle Foam | Vehicle Foam, topically applied twice daily Intervention: Drug: Vehicle Foam Vehicle Foam: Topical Foam containing no active drug |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 17, 2016 |
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| Vehicle Foam |
| Drug |
Topical Foam containing no active drug |
|
| Day 15 |
| Change From Baseline in Pruritus Score | At the Baseline Visit, prior to the first application of the test article, the subject's overall experience of pruritus within the previous two (2) weeks will be assessed and scored (range 1-5) using a questionnaire that assesses the degree, duration, direction, disability, and distribution of the subject's pruritus. Possible total scores range from 5 (no pruritus) to 25 (most severe pruritus). At Day 15, the overall experience of pruritus, in the previous two weeks, will be scored using the same questionnaire. | Day 15 |
| Changes in Percent BSA With Active Psoriasis in the Treatment Area | The percent (%) Body Surface Area (BSA) with active psoriasis in the Treatment Area will be determined at the Baseline Visit and Week 2 (Day 15) and documented. At Baseline, the percent BSA with active psoriasis in the Treatment Area must be 2% to 12%, inclusive. | Day 15 |
| Hot Springs |
| Arkansas |
| 71913 |
| United States |
| Site 17 | Encino | California | 91436 | United States |
| Site 19 | Denver | Colorado | 80220 | United States |
| Site 16 | Brandon | Florida | 33511 | United States |
| Site 15 | Clearwater | Florida | 33756 | United States |
| Site 20 | Miami Lakes | Florida | 33014 | United States |
| Site 11 | North Miami Beach | Florida | 33162 | United States |
| Site 12 | Pinellas Park | Florida | 33781 | United States |
| Site 10 | Carmel | Indiana | 46032 | United States |
| Site 06 | New Albany | Indiana | 47150 | United States |
| Site 13 | Quincy | Massachusetts | 02169 | United States |
| Site 07 | Ann Arbor | Michigan | 48103 | United States |
| Site 02 | Saint Joseph | Missouri | 64506 | United States |
| Site 08 | Wilmington | North Carolina | 28405 | United States |
| Site 04 | Gahanna | Ohio | 43230 | United States |
| Site 05 | Nashville | Tennessee | 37215 | United States |
| Site 09 | Austin | Texas | 78746 | United States |
| Site 18 | San Antonio | Texas | 78229 | United States |
| Site 21 | Norfolk | Virginia | 23507 | United States |
| Site 03 | Spokane | Washington | 99202 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 122-0551 Foam | 122-0511 Foam, topically applied twice daily Intervention: Drug: 122-0551 Foam 122-0551 Foam: Topical Foam containing active drug |
| BG001 | Vehicle Foam | Vehicle Foam, topically applied twice daily Intervention: Drug: Vehicle Foam Vehicle Foam: Topical Foam containing no active drug |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Subjects Rated a "Treatment Success" Based on the Investigator's Global Assessment (IGA) | The IGA score is a static evaluation of the overall or "average" degree of severity taking into account all of the subject's psoriatic lesions in the Treatment Area by the investigator or designee. This evaluation takes into consideration the three individual characteristics of psoriasis (scaling, erythema and plaque elevation) with the IGA score at each visit representing the average of scaling, erythema or plaque elevation that is present amongst all of the lesions eligible for treatment. IGA will be assessed on a 5-point scale where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. | Analysis shown is based on the intent-to-treat population, defined as all enrolled participants who were randomized and applied at least one dose of the test article. | Posted | Number | percentage of participants | Day 15 |
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| Secondary | Percentage of Subjects Rated a "Treatment Success" for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation) | Scaling, erythema and plaque elevation will each be scored on a 5-point scale where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. These evaluations are an assessment of the overall or "average" degree of each of three key characteristics present within all of the subject's psoriatic lesions in the Treatment Area by the investigator or designee. | Analysis shown is based on the Intent-to-Treat (ITT) population. | Posted | Number | percentage of participants | Day 15 |
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| Other Pre-specified | Percentage of Subjects Rated a "Treatment Success" Based on the Investigator's Global Assessment (IGA) | Analysis shown is based on the ITT population. Only participants with observed values are reported. | Posted | Number | percentage of participants | Day 8 |
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| Other Pre-specified | Percentage of Subjects Rated a "Treatment Success" for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation) | Analysis shown is based on the ITT population. Only participants with observed values are reported. | Posted | Number | percentage of participants | Day 8 |
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| Other Pre-specified | Change From Baseline in Pruritus Score | At the Baseline Visit, prior to the first application of the test article, the subject's overall experience of pruritus within the previous two (2) weeks will be assessed and scored (range 1-5) using a questionnaire that assesses the degree, duration, direction, disability, and distribution of the subject's pruritus. Possible total scores range from 5 (no pruritus) to 25 (most severe pruritus). At Day 15, the overall experience of pruritus, in the previous two weeks, will be scored using the same questionnaire. | Analysis shown is based on the ITT population. Only participants with observed values are reported. Pruritus scores were based on the patient's assessment of pruritus ranging from a score of 5 (no pruritus) to 25 (most severe pruritus). | Posted | Mean | Standard Deviation | scores on a scale | Day 15 |
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| Other Pre-specified | Changes in Percent BSA With Active Psoriasis in the Treatment Area | The percent (%) Body Surface Area (BSA) with active psoriasis in the Treatment Area will be determined at the Baseline Visit and Week 2 (Day 15) and documented. At Baseline, the percent BSA with active psoriasis in the Treatment Area must be 2% to 12%, inclusive. | Analysis shown is based on the ITT population. Only participants with observed values are reported. The mean percent BSA with active psoriasis at Baseline was 5.4% and 5.1% for the active and vehicle groups, respectively. | Posted | Mean | Standard Deviation | Change in percent BSA | Day 15 |
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Adverse Events (AEs) were collected from Study Day 1 (enrollment/first dose) to study completion (Day 15) or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.
The safety population included all subjects enrolled in the study who were dispensed and applied the test article at least once; because the first dose of the test article was applied at the study site (Day 1), all enrolled subjects (N=409) were included in the safety population. Subjects reporting a particular AE more than once are counted only once for that AE.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 122-0551 Foam | 122-0511 Foam, topically applied twice daily Intervention: Drug: 122-0551 Foam 122-0551 Foam: Topical Foam containing active drug | 0 | 205 | 0 | 205 | 12 | 205 |
| EG001 | Vehicle Foam | Vehicle Foam, topically applied twice daily Intervention: Drug: Vehicle Foam Vehicle Foam: Topical Foam containing no active drug | 0 | 204 | 1 | 204 | 14 | 204 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment | The SAE was deemed unrelated to test article. |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site pain | General disorders | MedDRA (19.0) | Systematic Assessment |
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| Application site pruritis | General disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Blepharitis | Eye disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Gastritis haemorrhagic | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
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| Skin infection | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
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| Hand fracture | Injury, poisoning and procedural complications | MedDRA (19.0) | Non-systematic Assessment |
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| Radius fracture | Injury, poisoning and procedural complications | MedDRA (19.0) | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Fracture pain | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Medial tibial stress syndrome | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Migraine | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Hypovolaemic shock | Vascular disorders | MedDRA (19.0) | Non-systematic Assessment |
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The Sponsor has first right to publish pooled study data. In the event that such manuscript has not been submitted for publication within 12 months from study completion/termination at all participating sites, the PI shall have the right to single center publications provided they submit any data for presentation, oral or written, to the Sponsor for review 30 days prior to public disclosure. The PI may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research, Therapeutics, Inc. | Therapeutics, Inc. | 858-571-1800 | clinicalresearch@therapeuticsinc.com |
| Sep 17, 2018 |
| Prot_SAP_000.pdf |
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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