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This Phase 3 study (Study 306) 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 |
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| Vehicle Foam | Placebo Comparator | Vehicle Foam, topically applied twice daily |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 122-0551 Foam | Drug | Topical Foam |
| |
| Vehicle Foam |
| 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 of a subject's disease, taking into account all of the subject's psoriatic lesions. "Treatment success" is defined as a score of 0 or 1 representing "cleared" or "almost cleared" at Day 15 with at least a two grade decrease in severity score relative to Baseline. IGA is measured on a 5-point scale, ranging from 0 (clear) to 4 (severe/very 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) | A static assessment of the overall or "average" degree of severity of each of three key characteristics present within all of the subject's psoriatic lesions. "Treatment success" is defined as a score of 0 or 1 representing "cleared" or "almost cleared" at Day 15 with at least a two grade decrease in severity score relative to Baseline. Each clinical sign of psoriasis is measured on a 5-point scale, ranging from 0 (clear) to 4 (severe/very severe). |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With IGA "Treatment Success" | "Treatment success" and IGA as defined in the primary outcome measure. "Treatment success" is defined as a score of 0 or 1 representing "cleared" or "almost cleared" at Day 15 with at least a two grade decrease in severity score relative to Baseline. IGA is measured on a 5-point scale, ranging from 0 (clear) to 4 (severe/very severe). | Day 8 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anthony Andrasfay | Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Dermatology Clinical Research | Fremont | California | 94538 | United States | ||
| International Dermatology Research, Inc. |
| 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: January 2015 to June 2015
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 122-0551 Foam: Topical Foam |
| FG001 | Vehicle Foam | Vehicle Foam, topically applied twice daily Vehicle Foam: Topical Foam |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Drug |
Topical Foam |
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| Day 15 |
| Percentage of Subjects Rated a "Treatment Success" for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation) | "Treatment success" and clinical signs as defined in the secondary outcome measure. "Treatment success" is defined as a score of 0 or 1 representing "cleared" or "almost cleared" at Day 15 with at least a two grade decrease in severity score relative to Baseline. Each clinical sign of psoriasis is measured on a 5-point scale, ranging from 0 (clear) to 4 (severe/very severe). | Day 8 |
| Change From Baseline in Pruritus Score | Pruritus scale will be used to assess the subjective and multidimensional experience of the subject's pruritus (itching) during the previous two weeks at Baseline and Day 15. Possible scores range from 5 (no pruritus) to 25 (most severe pruritus). | Baseline and Day 15 |
| Change in Percent Body Surface Area (BSA) With Active Psoriasis | The investigator will use the assumption that 1% BSA is approximately equal to the surface area of the subject's palm and fingers, with the fingers extended yet grouped together, creating a flat oval-like surface area. | Baseline and Day 15 |
| Miami |
| Florida |
| 33144 |
| United States |
| Altman Dermatology Associates | Arlington Heights | Illinois | 60005 | United States |
| Minnesota Clinical Study Center | Fridley | Minnesota | 55432 | United States |
| Academic Dermatology Associates | Albuquerque | New Mexico | 87106 | United States |
| Dermatology Associates of Knoxville | Knoxville | Tennessee | 37917 | United States |
| The Center for Skin Research | Houston | Texas | 77056 | United States |
| Virginia Clinical Research, Inc. | Norfolk | Virginia | 23507 | United States |
| COMPLETED |
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| NOT COMPLETED |
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Demographics data is based on the Intent-To-Treat (ITT) population, defined as all enrolled subjects in the study who were randomized and dispensed the test article.
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| ID | Title | Description |
|---|---|---|
| BG000 | 122-0551 Foam | 122-0511 Foam, topically applied twice daily 122-0551 Foam: Topical Foam |
| BG001 | Vehicle Foam | Vehicle Foam, topically applied twice daily Vehicle Foam: Topical Foam |
| 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 | Count of Participants | 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 of a subject's disease, taking into account all of the subject's psoriatic lesions. "Treatment success" is defined as a score of 0 or 1 representing "cleared" or "almost cleared" at Day 15 with at least a two grade decrease in severity score relative to Baseline. IGA is measured on a 5-point scale, ranging from 0 (clear) to 4 (severe/very severe). | Analysis shown is based on the ITT 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) | A static assessment of the overall or "average" degree of severity of each of three key characteristics present within all of the subject's psoriatic lesions. "Treatment success" is defined as a score of 0 or 1 representing "cleared" or "almost cleared" at Day 15 with at least a two grade decrease in severity score relative to Baseline. Each clinical sign of psoriasis is measured on a 5-point scale, ranging from 0 (clear) to 4 (severe/very severe). | Analysis shown is based on the ITT 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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| Other Pre-specified | Percentage of Subjects With IGA "Treatment Success" | "Treatment success" and IGA as defined in the primary outcome measure. "Treatment success" is defined as a score of 0 or 1 representing "cleared" or "almost cleared" at Day 15 with at least a two grade decrease in severity score relative to Baseline. IGA is measured on a 5-point scale, ranging from 0 (clear) to 4 (severe/very severe). | Analysis shown is based on the Intent-to-Treat (ITT) population and observed results. | 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) | "Treatment success" and clinical signs as defined in the secondary outcome measure. "Treatment success" is defined as a score of 0 or 1 representing "cleared" or "almost cleared" at Day 15 with at least a two grade decrease in severity score relative to Baseline. Each clinical sign of psoriasis is measured on a 5-point scale, ranging from 0 (clear) to 4 (severe/very severe). | Analysis shown is based on the Intent-to-Treat (ITT) population and observed results. | Posted | Number | percentage of participants | Day 8 |
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| Other Pre-specified | Change From Baseline in Pruritus Score | Pruritus scale will be used to assess the subjective and multidimensional experience of the subject's pruritus (itching) during the previous two weeks at Baseline and Day 15. Possible scores range from 5 (no pruritus) to 25 (most severe pruritus). | Analysis shown is based on the Intent-to-Treat (ITT) population and observed results. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Day 15 |
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| Other Pre-specified | Change in Percent Body Surface Area (BSA) With Active Psoriasis | The investigator will use the assumption that 1% BSA is approximately equal to the surface area of the subject's palm and fingers, with the fingers extended yet grouped together, creating a flat oval-like surface area. | Analysis shown is based on the Intent-to-Treat (ITT) population and observed results. | Posted | Mean | Standard Deviation | Change in percent BSA | Baseline and 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 participants 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 participants (N=151) 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 122-0551 Foam: Topical Foam | 0 | 75 | 0 | 75 | 5 | 75 |
| EG001 | Vehicle Foam | Vehicle Foam, topically applied twice daily Vehicle Foam: Topical Foam | 0 | 76 | 0 | 76 | 3 | 76 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
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| Application site pain | General disorders | MedDRA (17.1) | Systematic Assessment |
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| Application site pruritus | General disorders | MedDRA (17.1) | Non-systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
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| Hordeolum | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
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| Influenza | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
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| Laceration | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
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| Muscle strain | Injury, poisoning and procedural complications | MedDRA (17.1) | Non-systematic Assessment |
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| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA (17.1) | 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 thirty days prior to public disclosure. The PI may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Director | Therapeutics, Inc. | 858-571-1800 | projectmanager@therapeuticsinc.com |
| 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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