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 sites90 target enrollmentJanuary 28, 2019

Overview

No summary available.

Registry

who.int

Start Date

January 28, 2019

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•\- Male or female, age 18\-65 years, at least 50 kg body weight with moderate to severe HS
•\- Clinically diagnosed HS for at least 12 months prior to screening
•\- For Cohort A (iscalimab): at least 5 inflammatory lesions, no more than 10 fistulae and at least two anatomical area involved with HS lesions
•\- For Cohort B (LYS006\): at least 3 inflammatory lesions; no more than 10 fistulae and at least two anatomical areas 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 89
•F.1\.3 Elderly (\>\=65 years) yes

•\- 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
•\- Women of childbearing potential, unless they are using highly effective methods of contraception during dosing and for a minimum of 12 weeks after stopping medication for cohort A (iscalimab) and a minimum of 2 weeks after the last study drug administration for cohort B (LYS006\).
•\- Pregnant or nursing (lactating) women
•Other protocol\-defined exclusion criteria may apply