Hidradenitis suppurativa MedDRA version: 20.0 Level: LLT Classification code 10020041 Term: Hidradenitis suppurativa System Organ Class: 100000004858
Conditions
Interventions
Product Name: iscalimab
Product Code: CFZ533
Pharmaceutical Form: Solution for injection
INN or Proposed INN: iscalimab
Current Sponsor code: CFZ533
Other descriptive name: CFZ533
Concentration unit:
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male and female patients, 18 to 65 years of age (inclusive), with clinically diagnosed HS for at least 12 months prior to Screening. - For Cohort A (iscalimab) and C (MAS825): A total of at least 5 inflammatory lesions, i.e., abscesses and/or inflammatory nodules. - For Cohort B (LYS006): A total of at least 3 inflammatory lesions, i.e., abscesses and/or inflammatory nodules. - For all Cohorts: No more than 15 fistulae and at least two anatomical areas need to be involved with HS lesions. Other protocol-defined inclusion criteria may apply 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 128 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
Exclusion criteria: 1. Use of other investigational drugs at the time of screening, or within 30 days or 5 half-lives of randomization, whichever is longer; or longer if required by local regulations. 2. Use/receipt of some specific treatments during specified time frames 3. WOCBP, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for the subsequent 14 weeks after the last study drug administration for Cohort A (iscalimab) and the subsequent 2 weeks after the last study drug administration for Cohort B (LYS006). In Cohort C (MAS825), WoCBP will be asked to adhere to highly effective contraception from at least 3 months prior to first drug administration and until 5 months after the final dose (Day 225 to Day 253), when a pregnancy test will be conducted. Other protocol-defined exclusion criteria may apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of the investigational treatments when compared to placebo, in moderate to severe inflammatory HS Patients;Secondary Objective: To assess the safety and tolerability of the investigational treatments in Patients with moderate to severe hidradenitis suppurativa (HS);Primary end point(s): Proportion of patients achieving hidradenitis suppurativa clinical response after 16 weeks of treatment;Timepoint(s) of evaluation of this end point: 16 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Number and severity of adverse events - Physical exam, vital signs, safety laboratory measurements, ECGs;Timepoint(s) of evaluation of this end point: At baseline and repeatedly until study completion | — |
Countries
Belgium, Czech Republic, Denmark, France, Germany, Hungary, Iceland, Netherlands, Spain, United States
Contacts
Public ContactClinical Trial Information Desk
Novartis Pharma Services AG
Outcome results
None listed