A randomized, subject and investigator blinded, placebo controlled and multi-center platform study, to assess efficacy and safety of different investigational drugs in patients with moderate to severe hidradenitis suppurativa - Efficacy and safety of different investigational drugs for the treatment of hidradenitis suppurativa

ovartis Pharma AG0 sites200 target enrollmentMarch 5, 2020

Overview

No summary available.

Registry

who.int

Start Date

March 5, 2020

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•\- 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\) and D (LOU064\): 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 197
•F.1\.3 Elderly (\>\=65 years) yes

•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\) and cohort D (LOU064\). 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