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

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

ClinicalTrials.gov Identifier: NCT03827798

Novartis Reference Number: CCFZ533H12201BC

Last Update: Feb 26, 2021

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

The main purpose of this study is to assess preliminary efficacy and safety of CFZ533 and LYS006 in patients with moderate to severe hidradenitis suppurativa and to determine if CFZ533 and LYS006 have an adequate clinical profile for further clinical development.

Condition

Hidradenitis Suppurativa

Phase

Phase 2

Overall status

Recruiting

Enrollment count

130 participants

Start date

Feb 27, 2019

Completion date

Dec 28, 2022

Gender

All

Age(s)

18 Years - 65 Years (Adult, Older Adult)

Interventions

Drug

CFZ533

s.c.

Drug

Placebo to CFZ533

s.c.

Drug

LYS006

p.o.

Drug

Placebo to LYS006

p.o.

Eligibility Criteria

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