Trials Today

Study of Efficacy and Safety of Investigational Treatments in Patients With Moderate to Severe Hidradenitis Suppurativa

Purpose

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.

Condition

Hidradenitis Suppurativa

Eligibility

Eligible Ages: Between 18 Years and 65 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

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

Exclusion Criteria

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

Study Design

Phase: Phase 2
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Cohort A - CFZ533 600 mg	CFZ533 600 mg administered subcutaneous (s.c) weekly for 4 weeks, followed by bi-weekly until Week 15.	Drug: CFZ533 CFZ533 600 mg administered subcutaneous (s.c) weekly for 4 weeks, followed by bi-weekly until Week 15. Other names: iscalimab
Experimental Cohort B - LYS006 20 mg	LYS006 20 mg administered orally twice per day until Week 16.	Drug: LYS006 LYS006 20 mg administered orally twice per day until Week 16.
Placebo Comparator Cohort A - Placebo to CFZ533	Placebo administered subcutaneous (s.c) weekly for 4 weeks, followed by bi-weekly until Week 15.	Drug: Placebo to CFZ533 Placebo administered subcutaneous (s.c) weekly for 4 weeks, followed by bi-weekly until Week 15.
Placebo Comparator Cohort B - Placebo to LYS006	Placebo administered orally twice per day until Week 16.	Drug: Placebo to LYS006 Placebo administered orally twice per day until Week 16.
Experimental Cohort C - MAS825 300 mg	MAS825 300 mg administered s.c. bi-weekly for 4 weeks, followed by monthly until Week 13.	Drug: MAS825 MAS825 300 mg administered s.c. bi-weekly for 4 weeks, followed by monthly until Week 13.
Placebo Comparator Cohort C - Placebo to MAS825	Placebo administered s.c. bi-weekly for 4 weeks, followed by monthly until Week 13.	Drug: Placebo to MAS825 Placebo administered s.c. bi-weekly for 4 weeks, followed by monthly until Week 13.
Experimental Cohort D - LOU064 25mg	LOU064 25 mg administered orally twice per day until Week 16.	Drug: LOU064 25mg LOU064 25 mg administered orally twice per day until Week 16. Other names: remibrutinib
Experimental Cohort D - LOU064 100mg	LOU064 100 mg administered orally twice per day until Week 16.	Drug: LOU064 100mg LOU064 100 mg administered orally twice per day until Week 16. Other names: remibrutinib
Placebo Comparator Cohort D - Placebo to LOU064	Placebo administered orally twice per day until Week 16.	Drug: Placebo to LOU064 Placebo administered orally twice per day until Week 16.
Experimental Cohort E - VAY736 300 mg	VAY736 300 mg administered s.c every 4 weeks until Week 13.	Drug: VAY736 VAY736 300 mg administered s.c every 4 weeks until Week 13. Other names: ianalumab
Placebo Comparator Cohort E - Placebo to VAY736	Placebo administered s.c every 4 weeks until Week 13.	Drug: Placebo to VAY736 Placebo administered s.c every 4 weeks until Week 13.

Recruiting Locations

More Details

NCT ID: NCT03827798
Status: Active, not recruiting
Sponsor: Novartis Pharmaceuticals

Detailed Description

This is a randomized, subject and investigator-blinded, placebo-controlled, multi-center and parallel-group non-confirmatory study to assess the efficacy, safety and tolerability of five investigational drugs, CFZ533 (iscalimab), LYS006, MAS825, LOU064 (remibrutinib) and VAY736 (ianalumab) in subjects with moderate to severe hidradenitis suppurativa. All participants from Cohorts A, B and C had planned a 16-week treatment period and 12-week safety follow up period. All participants for Cohort D had planned a 16-week treatment period and 4-week safety follow up period. All participants for Cohort E had planned a 16-week treatment period and a mandatory 16-week safety follow-up period, plus a conditional follow-up period for up to 84 weeks for a total maximum follow up period of 2 years. Cohorts A-D are completed and Cohort E is ongoing.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.