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

Novartis

Status and phase: Active, not recruiting; Phase 2

Conditions: Hidradenitis Suppurativa

Treatments: Drug: Placebo to LYS006; Drug: LOU064 25mg; Drug: Placebo to MAS825; Drug: VAY736; Drug: LYS006; Drug: CFZ533; Drug: Placebo to VAY736; Drug: Placebo to CFZ533; Drug: Placebo to LOU064; Drug: MAS825; Drug: LOU064 100mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT03827798

CCFZ533H12201BC

Details and patient eligibility

About

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.

Enrollment: 248 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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248 participants in 11 patient groups, including a placebo group

CFZ533

Experimental group

Description:

s.c.

Treatment:

Drug: CFZ533

LYS006

Experimental group

Description:

p.o.

Treatment:

Drug: LYS006

Placebo to CFZ533

Placebo Comparator group

Description:

Matching placebo (s.c.)

Treatment:

Drug: Placebo to CFZ533

Placebo to LYS006

Placebo Comparator group

Description:

Matching placebo (p.o.)

Treatment:

Drug: Placebo to LYS006

MAS825

Experimental group

Description:

s.c.

Treatment:

Drug: MAS825

Placebo to MAS825

Placebo Comparator group

Description:

Matching placebo (s.c.)

Treatment:

Drug: Placebo to MAS825

LOU064 25mg

Active Comparator group

Description:

p.o.

Treatment:

Drug: LOU064 25mg

LOU064 100mg

Active Comparator group

Description:

p.o.

Treatment:

Drug: LOU064 100mg

Placebo to LOU064

Placebo Comparator group

Description:

Matching placebo p.o.

Treatment:

Drug: Placebo to LOU064

VAY736

Experimental group

Description:

s.c.

Treatment:

Drug: VAY736

Placebo to VAY736

Placebo Comparator group

Description:

Matching placebo (s.c.)

Treatment:

Drug: Placebo to VAY736