Back to results

Extension Study to Assess Effects of Non-interrupted Versus Interrupted and Long Term Treatment of Two Dose Regimes of Secukinumab in Subjects With Hidradenitis Suppurativa

Primary Purpose

Hidradenitis Suppurativa

Status

Active

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

secukinumab

About this trial

This is an interventional treatment trial for Hidradenitis Suppurativa focused on measuring acne inversa, Hidradenitis suppurativa, maladie de Vemeuil, inflammatory disease, AIN457, AIN457M, secukinumab, Loss of response, HiSCR, IL-17A

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

written informed consent must be obtained before any assessment is performed
subject must have completed the study treatment period (52 weeks) in the core studies (AIN457M2301 or AIN457M2302)and have been receiving secukinumab treatment during Treatment Period 2

Exclusion Criteria:

protocol deviation in the core study which will prevent the meaningful analysis of the extension study
ongoing or planned use of prohibited HS or non-HS treatment
participation in the extension could expose the subject to an undue safety risk
current sever progressive or uncontrolled disease which renders the subject unsuitable for the study.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Arm Label

secukinumab 1 HiSCR Responder

secukinumab 2 HiSCR Responder

placebo 1 HiSCR Responder

placebo 2 HiSCR Responder

HiSCR non-responders

Arm Description

HiSCR responder in core trial, secukinumab 300mg every 2 weeks

HiSCR responder in core trial, secukinumab 300mg every 4 weeks

HiSCR responder in core trial, placebo to secukinumab 300mg every 2 weeks

HiSCR responder in core trial, placebo to secukinumab 300 mg every 4 weeks

non-responder to core trial treatment; secukinumab 300mg every 2 weeks

Outcomes

Primary Outcome Measures

time to loss of response (LOR) in HiSCR reponders

Loss of response is defined as: at least a 50% increase in abscess and/or nodules count (AN) compared to the average AN count from the 3 previous visits and the increase was at least of 3 AN from the average AN count of the 3 previous visits. at least a 30% increase in AN compared to the average AN count from the 3 previous visits with an increase of at least 2 AN from the average count of the 3 previous visits or a further increase in the AN count of at least 2 AN .

Secondary Outcome Measures

Cumulative rate of subjects who experience a flare in core HiScr responders

Subjects who experience at least one flare by Week 104. flare is defined as at least a 25% increase in AN count with a minimum increase of 2 AN relative to baseline.

subjects achieving NRS30

HS-related skin pain; subjects achieving NRS30 at week 104, defined as at least a 30% reduction and at least one unit reduction from baseline in the subject's Global Assessment of Skin Pain

Full Information

NCT ID

NCT04179175

First Posted

November 25, 2019

Last Updated

September 18, 2023

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT04179175

Brief Title

Extension Study to Assess Effects of Non-interrupted Versus Interrupted and Long Term Treatment of Two Dose Regimes of Secukinumab in Subjects With Hidradenitis Suppurativa

Official Title

A Multicenter, Double-blind, Randomized Withdrawal Extension Study of Subcutaneous Secukinumab to Demonstrate Long-term Efficacy, Safety and Tolerability in Subjects With Moderate to Severe Hidradenitis Suppurativa

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

March 18, 2020 (Actual)

Primary Completion Date

April 3, 2024 (Anticipated)

Study Completion Date

May 27, 2027 (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

Yes

5. Study Description

Brief Summary

The purpose of this extension study is to evaluate maintenance of HiSCR response at Week 104 in either continuous or interrupted therapy (using a randomized withdrawal period) of two dose regimens and to assess long-term efficacy, safety and tolerability of secukinumab in subjects with moderate to severe hidradenitis suppurativa completing either of the 2 Phase III studies. This is an expanded access trial for the core trials AIN457M2301 (NCT03713619) and AIN457M2302 (NCT03713619).

Detailed Description

This is a multicenter extension study to both core Phase III studies CAIN457M2301 and CAIN457M2302 (Core studies). This study contains a randomized withdrawal design, double blinded and placebo controlled up to Week 104 or loss of response. The subjects with HiSCR response after 52 weeks of treatment in the "Core studies" will be randomized at 2:1 ratio to either continue on one of the two secukinumab dosing regimens assigned in "Core studies" for another 52 weeks or will be placed on placebo. The primary endpoint is loss of response (LOR) assessed during the 52-week treatment duration (up to Week 104). Subjects who attained LOR will be transferred to open-label treatment to continue until the end of the study. Subjects on placebo who did not reach LOR up to Week 104 will be offered to continue in the open-label treatment or discontinue the study. Thus for subjects who were HiSCR responders at Week 52 of "Core studies", the open label treatment duration will vary and start either from the time of LOR or from Week 104 dose and last until Week 260 followed by 8 weeks of a post treatment follow-up period to week 268. Subjects who were HiSCR non-responders at the end of "Core studies" will be offered to continue in open-label treatment until Week 260. Subjects who prematurely discontinue the study, or who complete the study will enter a post-treatment follow up period (8 weeks) The primary objective is to evaluate maintenance of HiSCR reponse at Week 104 in either continuous or interrupted therapy compared to placebo. Secondary objectives are to assess the long-term safety and tolerability evaluated by adverse events, abnormal laboratory values and vital signs.

6. Conditions and Keywords

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

Hidradenitis Suppurativa

Keywords

acne inversa, Hidradenitis suppurativa, maladie de Vemeuil, inflammatory disease, AIN457, AIN457M, secukinumab, Loss of response, HiSCR, IL-17A

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

Multicenter, double-blind, randomized withdrawal extension, parallel group study followed by an open-label, active-treatment period with two secukinumab dose regimens in approximately 856 patients with moderate to severe HS

Masking

ParticipantCare ProviderInvestigator

Masking Description

Patients considered HiSCR responders will be randomized 2:1 to continue their current regimen or undergo withdrawal to placebo. HiScr non-responders will enter open label therapy with secukinumab if desired

Allocation

Randomized

Enrollment

704 (Actual)

8. Arms, Groups, and Interventions

Arm Title

secukinumab 1 HiSCR Responder

Arm Type

Active Comparator

Arm Description

HiSCR responder in core trial, secukinumab 300mg every 2 weeks

Arm Title

secukinumab 2 HiSCR Responder

Arm Type

Active Comparator

Arm Description

HiSCR responder in core trial, secukinumab 300mg every 4 weeks

Arm Title

placebo 1 HiSCR Responder

Arm Type

Placebo Comparator

Arm Description

HiSCR responder in core trial, placebo to secukinumab 300mg every 2 weeks

Arm Title

placebo 2 HiSCR Responder

Arm Type

Placebo Comparator

Arm Description

HiSCR responder in core trial, placebo to secukinumab 300 mg every 4 weeks

Arm Title

HiSCR non-responders

Arm Type

Active Comparator

Arm Description

non-responder to core trial treatment; secukinumab 300mg every 2 weeks

Intervention Type

Drug

Intervention Name(s)

secukinumab

Other Intervention Name(s)

AIN457

Intervention Description

secukinumab 300mg every 2 or every 4 weeks

Primary Outcome Measure Information:

Title

time to loss of response (LOR) in HiSCR reponders

Description

Time Frame

Weeks 52 - 104

Secondary Outcome Measure Information:

Title

Cumulative rate of subjects who experience a flare in core HiScr responders

Description

Subjects who experience at least one flare by Week 104. flare is defined as at least a 25% increase in AN count with a minimum increase of 2 AN relative to baseline.

Time Frame

Week 104

Title

subjects achieving NRS30

Description

HS-related skin pain; subjects achieving NRS30 at week 104, defined as at least a 30% reduction and at least one unit reduction from baseline in the subject's Global Assessment of Skin Pain

Time Frame

Week 104

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: written informed consent must be obtained before any assessment is performed subject must have completed the study treatment period (52 weeks) in the core studies (AIN457M2301 or AIN457M2302)and have been receiving secukinumab treatment during Treatment Period 2 Exclusion Criteria: protocol deviation in the core study which will prevent the meaningful analysis of the extension study ongoing or planned use of prohibited HS or non-HS treatment participation in the extension could expose the subject to an undue safety risk current sever progressive or uncontrolled disease which renders the subject unsuitable for the study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Rogers

State/Province

Arkansas

ZIP/Postal Code

72758

Country

United States

Facility Name

Novartis Investigative Site

City

San Diego

State/Province

California

ZIP/Postal Code

92103

Country

United States

Facility Name

Novartis Investigative Site

City

San Diego

State/Province

California

ZIP/Postal Code

92123

Country

United States

Facility Name

Novartis Investigative Site

City

Whittier

State/Province

California

ZIP/Postal Code

92677

Country

United States

Facility Name

Novartis Investigative Site

City

Coral Gables

State/Province

Florida

ZIP/Postal Code

33134

Country

United States

Facility Name

Novartis Investigative Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33125

Country

United States

Facility Name

Novartis Investigative Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33609

Country

United States

Facility Name

Novartis Investigative Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

Facility Name

Novartis Investigative Site

City

Sandy Springs

State/Province

Georgia

ZIP/Postal Code

30328

Country

United States

Facility Name

Novartis Investigative Site

City

Skokie

State/Province

Illinois

ZIP/Postal Code

60077

Country

United States

Facility Name

Novartis Investigative Site

City

West Dundee

State/Province

Illinois

ZIP/Postal Code

60118

Country

United States

Facility Name

Novartis Investigative Site

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46256

Country

United States

Facility Name

Novartis Investigative Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02111

Country

United States

Facility Name

Novartis Investigative Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

Novartis Investigative Site

City

New Brighton

State/Province

Minnesota

ZIP/Postal Code

55112

Country

United States

Facility Name

Novartis Investigative Site

City

Saint Joseph

State/Province

Missouri

ZIP/Postal Code

64506

Country

United States

Facility Name

Novartis Investigative Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63104

Country

United States

Facility Name

Novartis Investigative Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

Novartis Investigative Site

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68144

Country

United States

Facility Name

Novartis Investigative Site

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

Facility Name

Novartis Investigative Site

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27516

Country

United States

Facility Name

Novartis Investigative Site

City

Fairborn

State/Province

Ohio

ZIP/Postal Code

45324

Country

United States

Facility Name

Novartis Investigative Site

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213-3403

Country

United States

Facility Name

Novartis Investigative Site

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29407

Country

United States

Facility Name

Novartis Investigative Site

City

Bellaire

State/Province

Texas

ZIP/Postal Code

77401

Country

United States

Facility Name

Novartis Investigative Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75246-1613

Country

United States

Facility Name

Novartis Investigative Site

City

Pflugerville

State/Province

Texas

ZIP/Postal Code

78660

Country

United States

Facility Name

Novartis Investigative Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Novartis Investigative Site

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23507

Country

United States

Facility Name

Novartis Investigative Site

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

C1056ABJ

Country

Argentina

Facility Name

Novartis Investigative Site

City

Ciudad Autonoma de Bs As

State/Province

Buenos Aires

ZIP/Postal Code

C1425BEA

Country

Argentina

Facility Name

Novartis Investigative Site

City

La Plata

State/Province

Buenos Aires

ZIP/Postal Code

B1902COS

Country

Argentina

Facility Name

Novartis Investigative Site

City

Rosario

State/Province

Santa Fe

ZIP/Postal Code

S2000DBS

Country

Argentina

Facility Name

Novartis Investigative Site

City

Buenos Aires

ZIP/Postal Code

C1425DKG

Country

Argentina

Facility Name

Novartis Investigative Site

City

Capital Federal

ZIP/Postal Code

C1023AAB

Country

Argentina

Facility Name

Novartis Investigative Site

City

Phillip

State/Province

Australian Capital Territory

ZIP/Postal Code

2606

Country

Australia

Facility Name

Novartis Investigative Site

City

Benowa

State/Province

Queensland

ZIP/Postal Code

4217

Country

Australia

Facility Name

Novartis Investigative Site

City

East Melbourne

State/Province

Victoria

ZIP/Postal Code

3002

Country

Australia

Facility Name

Novartis Investigative Site

City

Linz

ZIP/Postal Code

4020

Country

Austria

Facility Name

Novartis Investigative Site

City

Wien

ZIP/Postal Code

A 1090

Country

Austria

Facility Name

Novartis Investigative Site

City

Bruxelles

ZIP/Postal Code

1070

Country

Belgium

Facility Name

Novartis Investigative Site

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Liege

ZIP/Postal Code

4000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Pleven

ZIP/Postal Code

5800

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Sofia

ZIP/Postal Code

1407

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Sofia

ZIP/Postal Code

1606

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Stara Zagora

ZIP/Postal Code

6000

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Barrie

State/Province

Ontario

ZIP/Postal Code

L4M 7G1

Country

Canada

Facility Name

Novartis Investigative Site

City

London

State/Province

Ontario

ZIP/Postal Code

N6H 5L5

Country

Canada

Facility Name

Novartis Investigative Site

City

Peterborough

State/Province

Ontario

ZIP/Postal Code

K9J 5K2

Country

Canada

Facility Name

Novartis Investigative Site

City

Waterloo

State/Province

Ontario

ZIP/Postal Code

N2J 1C4

Country

Canada

Facility Name

Novartis Investigative Site

City

Barranquilla

State/Province

Atlantico

ZIP/Postal Code

080002

Country

Colombia

Facility Name

Novartis Investigative Site

City

Zagreb

State/Province

HRV

ZIP/Postal Code

10000

Country

Croatia

Facility Name

Novartis Investigative Site

City

Usti nad Labem

State/Province

Czech Republic

ZIP/Postal Code

400 11

Country

Czechia

Facility Name

Novartis Investigative Site

City

Prague

State/Province

Prague 1

ZIP/Postal Code

11000

Country

Czechia

Facility Name

Novartis Investigative Site

City

JIhlava

ZIP/Postal Code

586 01

Country

Czechia

Facility Name

Novartis Investigative Site

City

Plzen

ZIP/Postal Code

30460

Country

Czechia

Facility Name

Novartis Investigative Site

City

Limoges

State/Province

Haute Vienne

ZIP/Postal Code

87000

Country

France

Facility Name

Novartis Investigative Site

City

Toulon Cedex 9

State/Province

Val De Marne

ZIP/Postal Code

83800

Country

France

Facility Name

Novartis Investigative Site

City

Antony

ZIP/Postal Code

92160

Country

France

Facility Name

Novartis Investigative Site

City

Bordeaux Cedex

ZIP/Postal Code

33075

Country

France

Facility Name

Novartis Investigative Site

City

Brest

ZIP/Postal Code

29609

Country

France

Facility Name

Novartis Investigative Site

City

Creteil

ZIP/Postal Code

94010

Country

France

Facility Name

Novartis Investigative Site

City

Lyon

ZIP/Postal Code

69437

Country

France

Facility Name

Novartis Investigative Site

City

Martigues

ZIP/Postal Code

13500

Country

France

Facility Name

Novartis Investigative Site

City

Montpellier cedex 5

ZIP/Postal Code

34295

Country

France

Facility Name

Novartis Investigative Site

City

Nantes Cedex 1

ZIP/Postal Code

44093

Country

France

Facility Name

Novartis Investigative Site

City

Nice

ZIP/Postal Code

06202

Country

France

Facility Name

Novartis Investigative Site

City

Paris 10

ZIP/Postal Code

75475

Country

France

Facility Name

Novartis Investigative Site

City

Reims

ZIP/Postal Code

51100

Country

France

Facility Name

Novartis Investigative Site

City

Rouen Cedex

ZIP/Postal Code

76031

Country

France

Facility Name

Novartis Investigative Site

City

Saint Mande

ZIP/Postal Code

94160

Country

France

Facility Name

Novartis Investigative Site

City

Saint-Etienne

ZIP/Postal Code

42055

Country

France

Facility Name

Novartis Investigative Site

City

Toulouse

ZIP/Postal Code

31400

Country

France

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

10789

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

13353

Country

Germany

Facility Name

Novartis Investigative Site

City

Bielefeld

ZIP/Postal Code

33647

Country

Germany

Facility Name

Novartis Investigative Site

City

Bochum

ZIP/Postal Code

44791

Country

Germany

Facility Name

Novartis Investigative Site

City

Erlangen

ZIP/Postal Code

91054

Country

Germany

Facility Name

Novartis Investigative Site

City

Frankfurt

ZIP/Postal Code

60590

Country

Germany

Facility Name

Novartis Investigative Site

City

Halle (Saale)

ZIP/Postal Code

06108

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

Facility Name

Novartis Investigative Site

City

Heidelberg

ZIP/Postal Code

69120

Country

Germany

Facility Name

Novartis Investigative Site

City

Langenau

ZIP/Postal Code

89129

Country

Germany

Facility Name

Novartis Investigative Site

City

Memmingen

ZIP/Postal Code

87700

Country

Germany

Facility Name

Novartis Investigative Site

City

Muenchen

ZIP/Postal Code

80377

Country

Germany

Facility Name

Novartis Investigative Site

City

Muenchen

ZIP/Postal Code

81377

Country

Germany

Facility Name

Novartis Investigative Site

City

Muenster

ZIP/Postal Code

48149

Country

Germany

Facility Name

Novartis Investigative Site

City

Potsdam

ZIP/Postal Code

14467

Country

Germany

Facility Name

Novartis Investigative Site

City

Schwerin

ZIP/Postal Code

19055

Country

Germany

Facility Name

Novartis Investigative Site

City

Wuerzburg

ZIP/Postal Code

97080

Country

Germany

Facility Name

Novartis Investigative Site

City

Thessaloniki

State/Province

ZIP/Postal Code

564 03

Country

Greece

Facility Name

Novartis Investigative Site

City

Athens

ZIP/Postal Code

12462

Country

Greece

Facility Name

Novartis Investigative Site

City

Athens

ZIP/Postal Code

161 21

Country

Greece

Facility Name

Novartis Investigative Site

City

Thessaloniki

ZIP/Postal Code

546 43

Country

Greece

Facility Name

Novartis Investigative Site

City

Guatemala City

ZIP/Postal Code

01010

Country

Guatemala

Facility Name

Novartis Investigative Site

City

Guatemala City

ZIP/Postal Code

1015

Country

Guatemala

Facility Name

Novartis Investigative Site

City

Debrecen

ZIP/Postal Code

4032

Country

Hungary

Facility Name

Novartis Investigative Site

City

Kaposvar

ZIP/Postal Code

7400

Country

Hungary

Facility Name

Novartis Investigative Site

City

Pecs

ZIP/Postal Code

7632

Country

Hungary

Facility Name

Novartis Investigative Site

City

New Delhi

State/Province

Delhi

ZIP/Postal Code

110 060

Country

India

Facility Name

Novartis Investigative Site

City

Mysore

State/Province

Karnataka

ZIP/Postal Code

570001

Country

India

Facility Name

Novartis Investigative Site

City

Nagpur

State/Province

Maharashtra

ZIP/Postal Code

440009

Country

India

Facility Name

Novartis Investigative Site

City

Nashik

State/Province

Maharashtra

ZIP/Postal Code

422101

Country

India

Facility Name

Novartis Investigative Site

City

Jerusalem

ZIP/Postal Code

9112001

Country

Israel

Facility Name

Novartis Investigative Site

City

Petach Tikva

ZIP/Postal Code

4941492

Country

Israel

Facility Name

Novartis Investigative Site

City

Ramat Gan

ZIP/Postal Code

52621

Country

Israel

Facility Name

Novartis Investigative Site

City

Tel Aviv

ZIP/Postal Code

6423906

Country

Israel

Facility Name

Novartis Investigative Site

City

Ancona

State/Province

ZIP/Postal Code

60126

Country

Italy

Facility Name

Novartis Investigative Site

City

Cona

State/Province

ZIP/Postal Code

44100

Country

Italy

Facility Name

Novartis Investigative Site

City

Firenze

State/Province

ZIP/Postal Code

50122

Country

Italy

Facility Name

Novartis Investigative Site

City

Milano

State/Province

ZIP/Postal Code

20122

Country

Italy

Facility Name

Novartis Investigative Site

City

Pisa

State/Province

ZIP/Postal Code

56124

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

State/Province

ZIP/Postal Code

00133

Country

Italy

Facility Name

Novartis Investigative Site

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

Novartis Investigative Site

City

Nagoya-city

State/Province

Aichi

ZIP/Postal Code

467-8602

Country

Japan

Facility Name

Novartis Investigative Site

City

Kisarazu

State/Province

Chiba

ZIP/Postal Code

292-8535

Country

Japan

Facility Name

Novartis Investigative Site

City

Nakagami

State/Province

Okinawa

ZIP/Postal Code

903 0215

Country

Japan

Facility Name

Novartis Investigative Site

City

Koshigaya

State/Province

Saitama

ZIP/Postal Code

343-8555

Country

Japan

Facility Name

Novartis Investigative Site

City

Itabashi-ku

State/Province

Tokyo

ZIP/Postal Code

173-8610

Country

Japan

Facility Name

Novartis Investigative Site

City

Osaka

ZIP/Postal Code

545-8586

Country

Japan

Facility Name

Novartis Investigative Site

City

Seoul

ZIP/Postal Code

02841

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

ZIP/Postal Code

03080

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

ZIP/Postal Code

07441

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Saida

ZIP/Postal Code

652

Country

Lebanon

Facility Name

Novartis Investigative Site

City

Kaunas

State/Province

LTU

ZIP/Postal Code

LT 50161

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Vilnius

State/Province

Vilniaus

ZIP/Postal Code

LT 08661

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Kuala Lumpur

State/Province

Wilayah Persekutuan

ZIP/Postal Code

50586

Country

Malaysia

Facility Name

Novartis Investigative Site

City

Johor Bahru

ZIP/Postal Code

80100

Country

Malaysia

Facility Name

Novartis Investigative Site

City

Penang

ZIP/Postal Code

10990

Country

Malaysia

Facility Name

Novartis Investigative Site

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44657

Country

Mexico

Facility Name

Novartis Investigative Site

City

Monterrey

State/Province

Nuevo Leon

ZIP/Postal Code

64460

Country

Mexico

Facility Name

Novartis Investigative Site

City

Bergen op Zoom

ZIP/Postal Code

4624 VT

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Las Pinas

ZIP/Postal Code

1740

Country

Philippines

Facility Name

Novartis Investigative Site

City

Makati City

ZIP/Postal Code

1220

Country

Philippines

Facility Name

Novartis Investigative Site

City

Warszawa

State/Province

Mazowian

ZIP/Postal Code

02 495

Country

Poland

Facility Name

Novartis Investigative Site

City

Lodz

ZIP/Postal Code

90-436

Country

Poland

Facility Name

Novartis Investigative Site

City

Ossy

ZIP/Postal Code

42 624

Country

Poland

Facility Name

Novartis Investigative Site

City

Rzeszow

ZIP/Postal Code

35 055

Country

Poland

Facility Name

Novartis Investigative Site

City

Warszawa

ZIP/Postal Code

04141

Country

Poland

Facility Name

Novartis Investigative Site

City

Wroclaw

ZIP/Postal Code

50 566

Country

Poland

Facility Name

Novartis Investigative Site

City

Lisboa

ZIP/Postal Code

1150 314

Country

Portugal

Facility Name

Novartis Investigative Site

City

Lisboa

ZIP/Postal Code

1998-018

Country

Portugal

Facility Name

Novartis Investigative Site

City

Porto

ZIP/Postal Code

4099-001

Country

Portugal

Facility Name

Novartis Investigative Site

City

Chelyabinsk

ZIP/Postal Code

454048

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Kazan

ZIP/Postal Code

420012

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Krasnodar

ZIP/Postal Code

350020

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Saint Petersburg

ZIP/Postal Code

191123

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Saint Petersburg

ZIP/Postal Code

197022

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Smolensk

ZIP/Postal Code

214031

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Yaroslavl

ZIP/Postal Code

150003

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Singapore

ZIP/Postal Code

119074

Country

Singapore

Facility Name

Novartis Investigative Site

City

Singapore

ZIP/Postal Code

308205

Country

Singapore

Facility Name

Novartis Investigative Site

City

Banska Bystrica

State/Province

Slovak Republic

ZIP/Postal Code

97401

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Kosice

ZIP/Postal Code

04001

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Presov

ZIP/Postal Code

081 81

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Pretoria

State/Province

Gauteng

ZIP/Postal Code

0001

Country

South Africa

Facility Name

Novartis Investigative Site

City

Soweto

State/Province

Gauteng

ZIP/Postal Code

2013

Country

South Africa

Facility Name

Novartis Investigative Site

City

Cadiz

State/Province

Andalucia

ZIP/Postal Code

11009

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

State/Province

Catalunya

ZIP/Postal Code

08003

Country

Spain

Facility Name

Novartis Investigative Site

City

Alicante

State/Province

Comunidad Valenciana

ZIP/Postal Code

03010

Country

Spain

Facility Name

Novartis Investigative Site

City

Fuenlabrada

State/Province

Madrid

ZIP/Postal Code

28942

Country

Spain

Facility Name

Novartis Investigative Site

City

Manises

State/Province

Valencia

ZIP/Postal Code

46940

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

ZIP/Postal Code

08041

Country

Spain

Facility Name

Novartis Investigative Site

City

Granada

ZIP/Postal Code

18012

Country

Spain

Facility Name

Novartis Investigative Site

City

Las Palmas de Gran Canaria

ZIP/Postal Code

35010

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28006

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28009

Country

Spain

Facility Name

Novartis Investigative Site

City

Pontevedra

ZIP/Postal Code

36003

Country

Spain

Facility Name

Novartis Investigative Site

City

Bern

ZIP/Postal Code

3010

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Geneve

ZIP/Postal Code

1205

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Lausanne

ZIP/Postal Code

1011

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Taipei

ZIP/Postal Code

10002

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Taoyuan

ZIP/Postal Code

33305

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Istanbul

State/Province

TUR

ZIP/Postal Code

34098

Country

Turkey

Facility Name

Novartis Investigative Site

City

Altunizade

ZIP/Postal Code

34662

Country

Turkey

Facility Name

Novartis Investigative Site

City

Antalya

ZIP/Postal Code

07070

Country

Turkey

Facility Name

Novartis Investigative Site

City

Aydin

ZIP/Postal Code

09100

Country

Turkey

Facility Name

Novartis Investigative Site

City

Gaziantep

ZIP/Postal Code

27310

Country

Turkey

Facility Name

Novartis Investigative Site

City

Talas / Kayseri

ZIP/Postal Code

38039

Country

Turkey

Facility Name

Novartis Investigative Site

City

Leytonstone

State/Province

London

ZIP/Postal Code

E11 1NR

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Salford

State/Province

Manchester

ZIP/Postal Code

M6 8HD

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Dudley

State/Province

West Midlands

ZIP/Postal Code

DY1 2HQ

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Bradford

State/Province

West Yorkshire

ZIP/Postal Code

BD5 0NA

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Leeds

State/Province

West Yorkshire

ZIP/Postal Code

LS7 4SA

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Barnsley

ZIP/Postal Code

S75 2EP

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Bristol

ZIP/Postal Code

BS1 3NU

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Exeter

ZIP/Postal Code

EX2 5DW

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

London

ZIP/Postal Code

SE1 9RT

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Hanoi

ZIP/Postal Code

100000

Country

Vietnam

Facility Name

Novartis Investigative Site

City

Ho Chi Minh

ZIP/Postal Code

7000

Country

Vietnam

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect 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

Extension Study to Assess Effects of Non-interrupted Versus Interrupted and Long Term Treatment of Two Dose Regimes of Secukinumab in Subjects With Hidradenitis Suppurativa

We'll reach out to this number within 24 hrs

Extension Study to Assess Effects of Non-interrupted Versus Interrupted and Long Term Treatment of Two Dose Regimes of Secukinumab in Subjects With 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

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