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An open label, safety study to assess the potential for adrenal suppression following maximal use treatment with DSXS administered twice daily for 28 days in patients with moderate to severe plaque psoriasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DSXS1503 | Experimental | administered twice daily for 28 days in patients with moderate to severe plaque psoriasis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DSXS | Drug | twice daily for 28 days |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With HPA Axis Suppression | Hypothalamic Pituitary Adrenal (HPA) Axis Response to Cosyntropin demonstrating the absence or presence of adrenal suppression at the end of treatment. HPA Axis suppression is defined as a 30 minute post CortrosynTM injection level cortisol level of ≤ 18 mcg/100ml. | 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novum Pharmaceutical Research Services | http://www.novumprs.com/contact | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taro Pharmaceuticals USA Inc. | Hawthorne | New York | 10532 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | DSXS1503 Cohort 1 | Administered twice daily for 28 days in patients with moderate to severe plaque psoriasis, age 19 years and older. DSXS: twice daily for 28 days |
| FG001 | DSXS1503 Cohort 2 | Administered twice daily for 28 days in patients with moderate to severe plaque psoriasis, age 16-18 years of age. DSXS: twice daily for 28 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | DSXS1503 Cohort 1 | Administered twice daily for 28 days in patients with moderate to severe plaque psoriasis, age 19 years and older. DSXS: twice daily for 28 days |
| BG001 | DSXS1503 Cohort 2 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Participants With HPA Axis Suppression | Hypothalamic Pituitary Adrenal (HPA) Axis Response to Cosyntropin demonstrating the absence or presence of adrenal suppression at the end of treatment. HPA Axis suppression is defined as a 30 minute post CortrosynTM injection level cortisol level of ≤ 18 mcg/100ml. | Posted | Count of Participants | Participants | 28 days |
|
1 year, 4 months
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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 | DSXS1503 Cohort 1 | Administered twice daily for 28 days in patients with moderate to severe plaque psoriasis, age 19 years and older. DSXS: twice daily for 28 days |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Natalie Yantovskiy | Taro Pharmaceuticals U.S.A. Inc | +1 914-345-9001 | 6849 | Natalie.Yantovskiy@Taro.com |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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Administered twice daily for 28 days in patients with moderate to severe plaque psoriasis, age 16-18 years of age.
DSXS: twice daily for 28 days
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Baseline Total BSA | Mean | Standard Deviation | meters squared |
|
| Baseline IGA | Count of Participants | Participants |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 7 |
| 25 |
| EG001 | DSXS1503 Cohort 2 | Administered twice daily for 28 days in patients with moderate to severe plaque psoriasis, age 16-18 years of age. DSXS: twice daily for 28 days | 0 | 1 | 0 | 1 | 0 | 1 |
| Diarrhoea | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
|
| Application site irritation | General disorders | MedDRA (18.0) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
|
| ACTH stimulation test abnormal | Investigations | MedDRA (18.0) | Systematic Assessment |
|
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
|
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