Clinical Trial Results:
A Phase III, randomised, double blind, placebo controlled, parallel group study, to evaluate the safety and efficacy of subcutaneous implants of afamelanotide (16 mg) in patients suffering from polymorphic light eruption (PLE).
Summary
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EudraCT number |
2009-017359-92 |
Trial protocol |
DE BE NL |
Global completion date |
09 Dec 2010
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Paediatric regulatory details
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Is the trial part of an agreed EMA paediatric investigation plan? |
No
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Is the trial in scope of article 45 of Regulation (EC) No 1901/2006? |
No
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Is the trial in scope of article 46 of Regulation (EC) No 1901/2006? |
No
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Results information
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Results version number |
v1(current) |
This version publication date |
27 Dec 2020
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First version publication date |
27 Dec 2020
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Other versions |
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Summary report(s) |
CUV032 Summary results |
Note: The legislation allows summary attachments to be posted instead of the full dataset for this trial. Refer to Commission Guideline 2012/C 302/03
for further information.