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| Sponsor: | Forward-Pharma GmbH |
|---|---|
| Information provided by (Responsible Party): | Forward-Pharma GmbH |
| ClinicalTrials.gov Identifier: | NCT01230138 |
Purpose
The purpose of this trial is to investigate the efficacy and safety of different doses and dose administrations of FP187 compared to a placebo treatment in patients with moderate to severe plaque psoriasis.
| Condition | Intervention | Phase |
|---|---|---|
|
Plaque Psoriasis |
Drug: Placebo Drug: FP187 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomised, Double Blind, Placebo Controlled Efficacy and Safety Trial of Different Doses/Dose Regimens of FP187 Compared to Placebo in Moderate to Severe Plaque Psoriasis (Phase 2 Study) |
| Enrollment: | 252 |
| Study Start Date: | September 2010 |
| Estimated Study Completion Date: | May 2012 |
| Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: FP187 - TID
FP187 250mg TID (total daily dose of 750mg)
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Drug: FP187
High daily dose of 750mg administered as 250mg TID
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Experimental: FP187- BID
FP187 375mg BID (total daily dose of 750mg)of 750mg administered as 375mg BID
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Drug: FP187
High daily dose of 750mg administered as 375mg BID
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Experimental: FP187-LD-BID
FP187 250mg BID (total daily dose of 500mg)
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Drug: FP187
Low daily dose of 500mg FP187 administered as 250mg BID
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Placebo Comparator: Placebo
Placebo treatment
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Drug: Placebo
Placebo tablets
Other Name: Placebo of FP187
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Experimental: Open, flexible dosing treatment arm
Open treatment using a flexible dosing schedule for 8 weeks with maximum dose of 750mg FP187 and with a total dosing of 20 weeks. All investigations following same schedule.
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Drug: FP187
Oral tablets, up to 3 times daily for 20 weeks.
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The trial tests two different dose levels and two different daily dosing schedules (twice daily (BID) and three times daily (TID))over 20 weeks of treatment. Key is effect as measured by achievement of a 75% reduction in PASI after 20 weeks and safety monitored by adverse events and safety lab.
There are 3 active arms:
and 1 placebo arm.
An additional open (flexible dosing) treatment arm has been amended to the trial
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Sexually active females of childbearing potential must be either surgically sterile (hysterectomy or tubal ligation) or use a highly effective (failure rate < 1%) medically accepted contraceptive method during the trial as well as one month after trial is finished such as:
Exclusion Criteria:
Contacts and Locations| Germany | |
| Dermatological Dept., Uniklinikum, TU-Dresden | |
| Dresden, Germany, 01307 | |
| SCIderm | |
| Hamburg, Germany, 20354 | |
| Study Director: | Peder M Andersen, MD | Forward-Pharma GmbH |
More Information
| Responsible Party: | Forward-Pharma GmbH |
| ClinicalTrials.gov Identifier: | NCT01230138 History of Changes |
| Other Study ID Numbers: | FP187-201 |
| Study First Received: | September 24, 2010 |
| Last Updated: | February 7, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
|
Psoriasis Skin Diseases, Papulosquamous Skin Diseases |