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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-005685-35 | EudraCT Number |
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This multicenter, randomised, double-dummy, Fumaderm® and placebo-controlled, parallel-group study will compare the efficacy and safety of 500 mg of FP187 (250 mg twice daily) compared to 720 mg Fumaderm® (240 mg three times daily) over 20 weeks of treatment. After an initial wash-out non-drug treatment phase of 1 to 6 weeks, all patients will receive allocated Study treatment up-titrated to the relevant dose level (i.e., 500 mg daily FP187, 720 mg daily Fumaderm®, or placebo). The up-titration to full dose will last 4 weeks for FP187 and 9 weeks for Fumaderm®. After 20 weeks of treatment, all patients will be asked to enter a separate open label treatment protocol expected to continue for up to 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FP187 | Experimental | 500 mg FP187 daily (250 mg twice daily) |
|
| Dimethyl fumarate | Active Comparator | 720 mg Fumaderm® daily (240 mg three times daily) |
|
| Placebo | Placebo Comparator | Matching FP187 and Fumaderm® placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FP187 | Drug | 500 mg FP187 daily, two tablets of 125 mg twice daily, from 125 mg daily up-titrated to full dose over a 4-week phase, total treatment phase of 20 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients achieving a 75% reduction in their Psoriasis Area and Severity Index (PASI75) score from baseline | after 20 weeks of treatment | |
| Responder rate of Static Physician's Global Assessment (sPGA) | Achieving a score of clear or almost clear or a 2 step improvement on a 6-point scale as compared to baseline. | after 20 weeks of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kim A. Papp, MD | Probity Medical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Probity Medical Research | Waterloo | Ontario | N2J 1C4 | Canada |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000069462 | Dimethyl Fumarate |
| ID | Term |
|---|---|
| D005650 | Fumarates |
| D003998 | Dicarboxylic Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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| Dimethyl fumarate | Drug | 720 mg Fumaderm® daily, two tablets of 120 mg three times daily, from 30 mg daily up-titrated to full dose over a 9-week phase, total treatment phase of 20 weeks |
|
|
| FP187 placebo | Drug | FP187 matching placebo tablets in the same regimen as for FP187 arm |
|
| Fumaderm® placebo | Drug | Fumaderm® matching placebo tablets in the same regimen as for Fumaderm® arm |
|
| D009930 |
| Organic Chemicals |