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INCB 18424-320: A study to evaluate the efficacy and safety of ruxolitinib cream in participants with prurigo nodularis

If you suffer from prurigo nodularis, you develop a skin disease in which an extremely itchy, symmetrically distributed rash appears. In this study, we are therefore investigating whether the test substance ruxolitinib 1.5 % cream is effective and safe in prurigo nodularis. The test substance is not yet approved in Switzerland. Only when the efficacy of the test substance ruxolitinib cream has been scientifically investigated and proven can it be approved in Switzerland and used for the treatment of prurigo nodularis.

Aim of the study

In this study, we want to find out what effect the investigational product ruxolitnib cream 1.5 % has on prurigo nodularis.

Who can take part?

People with prurigo nodularis who are at least 18 years old.

Procedure

Participation in this study lasts up to 60 weeks (14 months). We will invite you to 18 study visits. The last part of the study is referred to as the "safety follow-up period". Your investigator will continue to monitor your health and the effect of the study cream after you have finished using the study cream. This period lasts up to 30 days after your last visit to the study center or the last application of the study cream (unless you complete the entire study). At the end of the follow-up period, you must return to the test center at least once.

Compensation

Original study name

A double-blind, randomized, vehicle-controlled phase III study of the efficacy and safety of ruxolitinib cream in participants with prurigo nodularis

BASEC number

2023-01895

Sponsors

Responsible Department