Hidradenitis suppurativa
Conditions
Interventions
Drug: Spesolimab (Spevigo) / Solution for injection
Sponsors
Arita Takafumi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed and dated written informed consent in accordance with ICH Harmonized Guideline for Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial 2. Participants must be within the defined Residual Effect Period corresponding to 16 weeks since last spesolimab administration. 3. Participants who have completed treatment in the parent HS spesolimab trial without premature discontinuation and are willing and able to continue treatment in this trial. etc.
Exclusion criteria
Exclusion criteria: 1. Women who are pregnant, nursing, or who plan to become pregnant while in the trial. 2. Use of any drug considered by the investigator likely to interfere with the safe conduct of the trial since the last visit of the parent trials. 3. Participants who require/ intend to use certain restricted medications such as immunomodulatory biologics or other investigational drugs/devices during the course of the trial. etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the occurrence of treatment emergent adverse events (TEAE) up to the end of maintenance treatment period including REP (i.e., 16 weeks after the last study treatment). | — |
Secondary
| Measure | Time frame |
|---|---|
| Not applicable. | — |
Countries
Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Chile, China, Czech Republic, Denmark, Finland, France, Germany, Greece, Israel, Italy, Japan, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Singapore, Slovakia, South Africa, South Korea, Spain
Contacts
Public ContactNobuko Yamada
Boehringer Ingelheim
Outcome results
None listed