Netherton syndrome (NS)
Conditions
Brief summary
IASI response, defined as a decrease of at least 50 % absolute change in IASI score from baseline (Yes/No).
Detailed description
Key secondary endpoint: IGA response, defined as a decrease of at least 1-grade absolute change in IGA score from baseline, IGA score of 0 or 1, IASI response, IASI-E subscore response, IASI-S subscore response, Percent change from baseline in IASI score, Absolute change from baseline in NRS pain, Absolute change from baseline in NRS itch, Absolute change from baseline in DLQI score, Absolute change from baseline in CDLQI score, The occurrence of treatment emergent adverse events including serious and/or opportunistic infections
Interventions
Sponsors
Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A., Boehringer Ingelheim RCV GmbH & Co. KG
Eligibility
Sex/Gender
All
Age
0 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IASI response, defined as a decrease of at least 50 % absolute change in IASI score from baseline (Yes/No). | — |
Secondary
| Measure | Time frame |
|---|---|
| Key secondary endpoint: IGA response, defined as a decrease of at least 1-grade absolute change in IGA score from baseline, IGA score of 0 or 1, IASI response, IASI-E subscore response, IASI-S subscore response, Percent change from baseline in IASI score, Absolute change from baseline in NRS pain, Absolute change from baseline in NRS itch, Absolute change from baseline in DLQI score, Absolute change from baseline in CDLQI score, The occurrence of treatment emergent adverse events including serious and/or opportunistic infections | — |
Countries
Austria, Belgium, Bulgaria, Czechia, Finland, France, Germany, Italy, Netherlands, Portugal, Spain
Outcome results
None listed