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

Primary Purpose

Hidradenitis Suppurativa

Status

Recruiting

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

CFZ533

Placebo to CFZ533

LYS006

Placebo to LYS006

MAS825

Placebo to MAS825

LOU064 25mg

LOU064 100mg

Placebo to LOU064

VAY736

Placebo to VAY736

About this trial

This is an interventional treatment trial for Hidradenitis Suppurativa focused on measuring Hidradenitis suppurativa, acne inversa, platform study

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Active Comparator

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

CFZ533

LYS006

Placebo to CFZ533

Placebo to LYS006

MAS825

Placebo to MAS825

LOU064 25mg

LOU064 100mg

Placebo to LOU064

VAY736

Placebo to VAY736

Arm Description

s.c.

p.o.

Matching placebo (s.c.)

Matching placebo (p.o.)

s.c.

Matching placebo (s.c.)

p.o.

Matching placebo p.o.

s.c.

Matching placebo (s.c.)

Outcomes

Primary Outcome Measures

Hidradenitis Suppurativa Clinical Response (HiSCR)

Proportion of patients achieving clinical response after 16 weeks of treatment

Secondary Outcome Measures

Full Information

NCT ID

NCT03827798

First Posted

January 31, 2019

Last Updated

October 24, 2023

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT03827798

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 27, 2019 (Actual)

Primary Completion Date

October 23, 2026 (Anticipated)

Study Completion Date

October 23, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hidradenitis Suppurativa

Keywords

Hidradenitis suppurativa, acne inversa, platform study

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

245 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CFZ533

Arm Type

Experimental

Arm Description

s.c.

Arm Title

LYS006

Arm Type

Experimental

Arm Description

p.o.

Arm Title

Placebo to CFZ533

Arm Type

Placebo Comparator

Arm Description

Matching placebo (s.c.)

Arm Title

Placebo to LYS006

Arm Type

Placebo Comparator

Arm Description

Matching placebo (p.o.)

Arm Title

MAS825

Arm Type

Experimental

Arm Description

s.c.

Arm Title

Placebo to MAS825

Arm Type

Placebo Comparator

Arm Description

Matching placebo (s.c.)

Arm Title

LOU064 25mg

Arm Type

Active Comparator

Arm Description

p.o.

Arm Title

LOU064 100mg

Arm Type

Active Comparator

Arm Description

p.o.

Arm Title

Placebo to LOU064

Arm Type

Placebo Comparator

Arm Description

Matching placebo p.o.

Arm Title

VAY736

Arm Type

Experimental

Arm Description

s.c.

Arm Title

Placebo to VAY736

Arm Type

Placebo Comparator

Arm Description

Matching placebo (s.c.)

Intervention Type

Drug

Intervention Name(s)

CFZ533

Intervention Description

s.c.

Intervention Type

Drug

Intervention Name(s)

Placebo to CFZ533

Intervention Description

s.c.

Intervention Type

Drug

Intervention Name(s)

LYS006

Intervention Description

p.o.

Intervention Type

Drug

Intervention Name(s)

Placebo to LYS006

Intervention Description

p.o.

Intervention Type

Drug

Intervention Name(s)

MAS825

Intervention Description

s.c.

Intervention Type

Drug

Intervention Name(s)

Placebo to MAS825

Intervention Description

s.c.

Intervention Type

Drug

Intervention Name(s)

LOU064 25mg

Intervention Description

p.o.

Intervention Type

Drug

Intervention Name(s)

LOU064 100mg

Intervention Description

p.o.

Intervention Type

Drug

Intervention Name(s)

Placebo to LOU064

Intervention Description

p.o.

Intervention Type

Drug

Intervention Name(s)

VAY736

Intervention Description

s.c.

Intervention Type

Drug

Intervention Name(s)

Placebo to VAY736

Intervention Description

s.c.

Primary Outcome Measure Information:

Title

Hidradenitis Suppurativa Clinical Response (HiSCR)

Description

Proportion of patients achieving clinical response after 16 weeks of treatment

Time Frame

16 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Novartis Pharmaceuticals

Phone

1-888-669-6682

novartis.email@novartis.com

First Name & Middle Initial & Last Name or Official Title & Degree

Novartis Pharmaceuticals

Phone

+41613241111

Facility Information:

Facility Name

Novartis Investigative Site

City

Orange Park

State/Province

Florida

ZIP/Postal Code

32073

Country

United States

Individual Site Status

Completed

Facility Name

Novartis Investigative Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33609

Country

United States

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33609

Country

United States

Individual Site Status

Withdrawn

Facility Name

Novartis Investigative Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Sandy Springs

State/Province

Georgia

ZIP/Postal Code

30328

Country

United States

Individual Site Status

Completed

Facility Name

Novartis Investigative Site

City

Evanston

State/Province

Illinois

ZIP/Postal Code

60201

Country

United States

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46256

Country

United States

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Individual Site Status

Withdrawn

Facility Name

Novartis Investigative Site

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68144

Country

United States

Individual Site Status

Withdrawn

Facility Name

Novartis Investigative Site

City

Hershey

State/Province

Pennsylvania

ZIP/Postal Code

17033-0850

Country

United States

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Graz

ZIP/Postal Code

8036

Country

Austria

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Wien

ZIP/Postal Code

A 1090

Country

Austria

Individual Site Status

Withdrawn

Facility Name

Novartis Investigative Site

City

Bruxelles

ZIP/Postal Code

1070

Country

Belgium

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Prague

State/Province

Prague 1

ZIP/Postal Code

11000

Country

Czechia

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Copenhagen NV

ZIP/Postal Code

2400

Country

Denmark

Individual Site Status

Completed

Facility Name

Novartis Investigative Site

City

Roskilde

ZIP/Postal Code

4000

Country

Denmark

Individual Site Status

Completed

Facility Name

Novartis Investigative Site

City

Antony

ZIP/Postal Code

92160

Country

France

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Lyon

ZIP/Postal Code

69437

Country

France

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Marseille Cedex 05

ZIP/Postal Code

13885

Country

France

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Nice

ZIP/Postal Code

06202

Country

France

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Reims

ZIP/Postal Code

51100

Country

France

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Rouen Cedex

ZIP/Postal Code

76031

Country

France

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Bochum

ZIP/Postal Code

44791

Country

Germany

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Darmstadt

ZIP/Postal Code

64297

Country

Germany

Individual Site Status

Withdrawn

Facility Name

Novartis Investigative Site

City

Frankfurt

ZIP/Postal Code

60590

Country

Germany

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Halle (Saale)

ZIP/Postal Code

06108

Country

Germany

Individual Site Status

Withdrawn

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Koeln

ZIP/Postal Code

50937

Country

Germany

Individual Site Status

Withdrawn

Facility Name

Novartis Investigative Site

City

Schwerin

ZIP/Postal Code

19055

Country

Germany

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Budapest

ZIP/Postal Code

1085

Country

Hungary

Individual Site Status

Completed

Facility Name

Novartis Investigative Site

City

Debrecen

ZIP/Postal Code

4032

Country

Hungary

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Pecs

ZIP/Postal Code

7623

Country

Hungary

Individual Site Status

Completed

Facility Name

Novartis Investigative Site

City

Szeged

ZIP/Postal Code

H 6725

Country

Hungary

Individual Site Status

Completed

Facility Name

Novartis Investigative Site

City

Kopavogur

ZIP/Postal Code

201

Country

Iceland

Individual Site Status

Completed

Facility Name

Novartis Investigative Site

City

Groningen

ZIP/Postal Code

9713 GZ

Country

Netherlands

Individual Site Status

Completed

Facility Name

Novartis Investigative Site

City

Rotterdam

ZIP/Postal Code

3015 CE

Country

Netherlands

Individual Site Status

Completed

Facility Name

Novartis Investigative Site

City

Sabadell

State/Province

Barcelona

ZIP/Postal Code

08208

Country

Spain

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Valencia

State/Province

Comunidad Valenciana

ZIP/Postal Code

46026

Country

Spain

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Manises

State/Province

Valencia

ZIP/Postal Code

46940

Country

Spain

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Barcelona

ZIP/Postal Code

08041

Country

Spain

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Granada

ZIP/Postal Code

18012

Country

Spain

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Las Palmas de Gran Canaria

ZIP/Postal Code

35010

Country

Spain

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28031

Country

Spain

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Learn more about this trial

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

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

Hidradenitis Suppurativa

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial