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

Phase 2

Active, not recruiting

• Conditions: Hidradenitis Suppurativa
• Interventions: Drug: LYS006; Drug: Placebo to LYS006; Drug: Placebo to MAS825; Drug: Placebo to CFZ533; Drug: LOU064 25mg; Drug: CFZ533; Drug: LOU064 100mg; Drug: Placebo to VAY736; Drug: VAY736; Drug: Placebo to LOU064; Drug: MAS825

• Registration Number: NCT03827798
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

The main purpose of this study is to assess preliminary efficacy and safety of CFZ533, LYS006, MAS825 , LOU064 and VAY736 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-31
• Study First Submitted QC: 2019-01-31
• Study First Posted: 2019-02-01
• Study Start: 2019-02-27
• Status Verified: 2024-12
• Primary Completion: 2024-12-04
• Last Update Submitted: 2025-01-01
• Last Update Posted: 2025-01-03
• Study Completion: 2026-12-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 248

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LYS006	LYS006	p.o.
Placebo to LYS006	Placebo to LYS006	Matching placebo (p.o.)
Placebo to MAS825	Placebo to MAS825	Matching placebo (s.c.)
Placebo to CFZ533	Placebo to CFZ533	Matching placebo (s.c.)
LOU064 25mg	LOU064 25mg	p.o.
CFZ533	CFZ533	s.c.
LOU064 100mg	LOU064 100mg	p.o.
Placebo to VAY736	Placebo to VAY736	Matching placebo (s.c.)
VAY736	VAY736	s.c.
Placebo to LOU064	Placebo to LOU064	Matching placebo p.o.
MAS825	MAS825	s.c.

Primary Outcome Measures

Name	Time	Method
simplified Hidradenitis Suppurativa Clinical Response (sHiSCR)	16 weeks	Proportion of patients achieving clinical response after 16 weeks of treatment

Trial Locations

Locations (9)

Penn State Milton S Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States

Olympian Clinical Research .; 🇺🇸 Clearwater, Florida, United States

Park Avenue Dermatology, PA; 🇺🇸 Orange Park, Florida, United States

University of South Florida; 🇺🇸 Tampa, Florida, United States

Advanced Medical Research; 🇺🇸 Sandy Springs, Georgia, United States

NorthShore University Health System North Shore; 🇺🇸 Skokie, Illinois, United States

Dawes Fretzin Clinical Rea Group; 🇺🇸 Indianapolis, Indiana, United States

Medical University of South Carolina MUSC .; 🇺🇸 Charleston, South Carolina, United States

Novartis Investigative Site; 🇪🇸 Valencia, Spain