Study of Efficacy and Safety of Investigational Treatments in Patients With Moderate to Severe Hidradenitis Suppurativa
Key facts
- Who runs it
- Novartis Pharmaceuticals
- Where
- Charleston, Clearwater, Evanston, Hershey, Indianapolis, Orange Park, Sandy Springs, and Tampa, United StatesSee the 8 sitesAlso in 10 other countries, 21 sites
- Status
- Completed
- Phase
- Phase 2
- People taking part
- 248 people enrolled
- Started
- 27 Feb 2019
- Ended
- 11 Sept 2026
- Type of study
- Interventional, 11 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- CFZ533
- Placebo to CFZ533
- LYS006
- Placebo to LYS006
- MAS825
- Placebo to MAS825
- LOU064 25mg
- LOU064 100mg
- Placebo to LOU064
- VAY736
- Placebo to VAY736
- Record updated
- 16 October 2026
Who can take part
- Age
- 18 years to 65 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 6 criteriaShow less
Who can take part
- Patients with moderate to severe HS based on the number of lesions, fistulae and anatomical areas involved
- Minimal body weight of 50 kg
- Able to communicate well with the investigator and understand and comply with the requirements of the study, and the ability and willingness to conduct study visits as per the study schedule
Who cannot take part
- Use of other investigational drugs at the time of screening or before
- Women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception
- Pregnant or lactating women; Other protocol-defined inclusion/exclusion criteria may apply
Where in United States
Also in 10 other countries, 21 sites
- Medical University of South Carolina (MUSC)Charleston, United States
- Olympian Clinical ResearchClearwater, United States
- Northshore University Health SystemEvanston, United States
- Penn State Milton S. Hershey Medical CenterHershey, United States
- Dawes Fretzin Clinical Rea GroupIndianapolis, United States
- Park Avenue Dermatology PAOrange Park, United States
- Advanced Medical ResearchSandy Springs, United States
- University of South FloridaTampa, United States
About the trial
What the trial wants to find out
The main purpose of this study is to assess preliminary efficacy and safety of CFZ533/iscalimab (Cohort A), LYS006 (Cohort B), MAS825 (Cohort C), LOU064/remibrutinib (Cohort D) and VAY736/ianalumab (Cohort E) in patients with moderate to severe hidradenitis suppurativa and to determine if CFZ533, LYS006, MAS825, LOU064 and VAY736 have an adequate clinical profile for further clinical development.
The 11 groups in the trial
- Cohort A - CFZ533 600 mgTreatment being tested
CFZ533 600 mg administered subcutaneous (s.c) weekly for 4 weeks, followed by bi-weekly until Week 15.
Treatment: CFZ533
- Cohort B - LYS006 20 mgTreatment being tested
LYS006 20 mg administered orally twice per day until Week 16.
Treatment: LYS006
- Cohort A - Placebo to CFZ533Placebo, for comparison
Placebo administered subcutaneous (s.c) weekly for 4 weeks, followed by bi-weekly until Week 15.
Treatment: Placebo to CFZ533
- Cohort B - Placebo to LYS006Placebo, for comparison
Placebo administered orally twice per day until Week 16.
Treatment: Placebo to LYS006
- Cohort C - MAS825 300 mgTreatment being tested
MAS825 300 mg administered s.c. bi-weekly for 4 weeks, followed by monthly until Week 13.
Treatment: MAS825
- Cohort C - Placebo to MAS825Placebo, for comparison
Placebo administered s.c. bi-weekly for 4 weeks, followed by monthly until Week 13.
Treatment: Placebo to MAS825
- Cohort D - LOU064 25mgTreatment being tested
LOU064 25 mg administered orally twice per day until Week 16.
Treatment: LOU064 25mg
- Cohort D - LOU064 100mgTreatment being tested
LOU064 100 mg administered orally twice per day until Week 16.
Treatment: LOU064 100mg
- Cohort D - Placebo to LOU064Placebo, for comparison
Placebo administered orally twice per day until Week 16.
Treatment: Placebo to LOU064
- Cohort E - VAY736 300 mgTreatment being tested
VAY736 300 mg administered s.c every 4 weeks until Week 13.
Treatment: VAY736
- Cohort E - Placebo to VAY736Placebo, for comparison
Placebo administered s.c every 4 weeks until Week 13.
Treatment: Placebo to VAY736
Data and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- 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
- Record updated
- 16 October 2026