Hidradenitis Suppurativa MedDRA version: 20.0 Level: LLT Classification code 10020041 Term: Hidradenitis suppurativa System Organ Class: 100000004858
Conditions
Sponsors
Boehringer Ingelheim RCV GmbH & Co KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients who have completed treatment in the parent HS spesolimab trial (1368-0052) without premature discontinuation. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: - Women who are pregnant, nursing, or who plan to become pregnant while in the trial. - Patients who experienced study treatment-limiting adverse events during the 1368-0052 parent trial. - Severe, progressive, or uncontrolled condition such as renal, hepatic, haematological, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease, or signs and symptoms thereof. - Any condition which in the opinion of the investigator affects the safety of the patient, the patient’s ability to participate in this trial or could compromise the quality of data. - Any suicidal behaviour in the past 2 years (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behaviour). - Any suicidal ideation of type 4 or 5 on the C-SSRS in the past 3 months (i.e. active suicidal thoughts with method and intent but without specific plan, or active suicidal thoughts with method, intent and plan).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this trial is to assess the long-term safety of spesolimab in patients with HS who have completed the 1368-0052 PoCC trial and are qualified for entry into this trial.;Secondary Objective: The secondary objectives are to evaluate efficacy at a lower dose than tested in PoCC trial.;Primary end point(s): 1) 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).;Timepoint(s) of evaluation of this end point: 1) 120 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Percentage change in total abscess and inflammatory nodule (AN) count from baseline up to Week 12. 2) Percentage change in total draining fistula (DF) count from baseline up to Week 12. 3) Hidradenitis Suppurativa Clinical Response (HiSCR) up to Week 12. 4) Change from baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) value up to Week 12. 5) Hidradenitis Suppurativa Physician Global Assessment (HS-PGA) score of 0 or 1 up to Week 12. 6) Absolute change from baseline in Hidradenitis Suppurativa Area and Severity Index (HASI) score up to Week 12. 7) Occurence of at least one flare (defined as at least 25 % increase in AN count with a minimum increase of 2 relative to baseline) up to Week 12. 8) Achievement of at least 30% reduction from baseline in Numerical Rating Scale (NRS30) in Patient’s Global Assessment of HS Pain up to Week 12.;Timepoint(s) of evaluation of this end point: 1) week 12 2) week 12 3) week 12 4) week 12 5) week 12 6) week 12 7) week 12 8) week 12 | — |
Countries
Australia, Belgium, Canada, Czechia, Czech Republic, Denmark, France, Germany, Greece, Hungary, Italy, Netherlands, Norway, Poland, Spain, United Kingdom, United States
Contacts
Public ContactCT Disclosure & Data Transparency
Boehringer Ingelheim Pharma GmbH&Co KG
Outcome results
None listed