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4 Year Extension Study of Efficacy and Safety of Secukinumab in Patients With Moderate to Severe Chronic Plaque-type Psoriasis

Primary Purpose

Moderate to Severe Chronic Plaque-Type Psoriasis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

AIN457 150 mg

AIN457 300 mg

Placebo

About this trial

This is an interventional treatment trial for Moderate to Severe Chronic Plaque-Type Psoriasis focused on measuring Psoriasis, Plaque, Inflammatory skin disease, Scaly patches, AIN457, Secukinumab, Moderate to Severe Plaque-type Psoriasis

Eligibility Criteria

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

Inclusion Criteria:

Subjects must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study related activity is performed. Where relevant, a legal representative will also sign the informed consent according to local laws and regulations.
Subjects who complete Week 52 of study CAIN457A2304 or complete Week 40 of study CAIN457A2307
Subjects expected to benefit from participation in the extension study, as assessed by the subject and investigator

Exclusion Criteria:

A protocol deviation in the core studies which according to the investigator will prevent the meaningful analysis of the extension study for the individual subject
Ongoing use of prohibited psoriasis or non-psoriasis treatments. Time period from last use of prohibited treatments in the core study to first dose of study drug in this extension study.
Subjects expected to be exposed to an undue safety risk if participating in the trial
Current severe progressive or uncontrolled disease which in the judgment of the investigator renders the subject unsuitable for the trial
Plans for administration of live vaccines during the study period
Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (>10 mIU/mL).

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Arm Label

AIN457 150 mg - Fixed Interval (FI)

AIN457 150 mg - Start of relapse (SoR)

AIN457 300 mg - Fixed Interval (FI)

AIN457 300 mg - Start of Relapse (SoR)

AIN457 300 mg - Open Label (OL)

Arm Description

1 s.c. Secukinumab 150 mg Pre-filled seringue (PFS) injection + 1 s.c. Placebo (PBO) Secukinumab PFS injection every 4 weeks

Start of relapse: 1 s.c. Secukinumab 150 mg PFS injection + 1 s.c. PBO Secukinumab PFS injection every 4 weeks Otherwise: 2 s.c. PBO Secukinumab PFS injections every 4 weeks

2 s.c. Secukinumab 150 mg PFS injections every 4 weeks

Start of relapse: 2 s.c. Secukinumab 150 mg PFS injection every 4 weeks Otherwise: 2 s.c. PBO Secukinumab PFS injections every 4 weeks

Open Label - Secukinumab 300mg every 4 weeks

Outcomes

Primary Outcome Measures

Long-term Safety and Tolerability of Secukinumab

Analysis of absolute and relative frequencies for treatment emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by primary System Organ Class (SOC)

Secondary Outcome Measures

Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) Score of 75 at Weeks 52, 104, 156, 208 and 260

PASI: Combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area * area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4)

Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) Scores of 50, 90 and 100 Over Time at Weeks 52, 104, 156, 208 and 260

Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Weeks 52, 104, 156, 208 and 260

Percentage of Participants Achieving Investigator's Global Assessment Modified 2011 (IGA) 2011 Score of 0 or 1 Over Time at Weeks 52, 104, 156, 208 and 260

The IGA mod 2011 is a static scale, i.e., it refers exclusively to the participant's disease state at the time of the assessments and does not attempt a comparison to any of the participant's previous disease states at prior visits. The score ranges from 0 (clear) to 4 (severe). The score 0 is clear, 1 is almost clear, 2 is mild, 3 is moderate, and 4 is severe.

Percentage Change From Baseline in Dermatology Life Quality Index (DLQI©) Response at Weeks 52, 104, 156, 208 and 260

The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions

Percentage of Participants With Dermatology Life Quality Index (DLQI©) Response (DLQI 0 or 1) Over Time at Weeks 52, 104, 156, 208 and 260

EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D©) Score and Percent Change From Baseline at Weeks 52, 104 and 156

ED-5Q: Participant rated questionnaire to assess health related quality of life in terms of a single utility score. Five domains are assessed mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each with three possible score: 1 indicates no problems, better state of health; 3 indicates worst state of health (example "confined to bed") A visual analog scale (VAS) assesses the health status from 0 (worst possible health state) to 100 (best possible health state)

Number of Participants With Treatment Emergent Anti-drug Antibodies (ADA)

The development of anti-secunimubab anti-bodies will decrease a participant's ability to respond to secukinumab treatment.

Percentage of Patients With Experiencing a Relapse

Relapse is defined as greater than 50% loss of the maximal PASI improvement from baseline. PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). A negative mean percentage change indicates improvement.

Percentage of Patients With Experiencing a Rebound

Rebound of disease is defined as a worsening of PASI of > 125% of the value at baseline (core study), or new pustular, erythrodermic or more inflammatory psoriasis occurring within 8 weeks of stopping therapy (i.e., if this definition was fulfilled at more than 8 weeks after last study treatment administration, this was defined as rebound like event). PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). A negative mean percentage change indicates improvement.

Full Information

NCT ID

NCT01640951

First Posted

July 12, 2012

Last Updated

April 24, 2018

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01640951

Brief Title

4 Year Extension Study of Efficacy and Safety of Secukinumab in Patients With Moderate to Severe Chronic Plaque-type Psoriasis

Official Title

A Multicenter, Double-blind and Open Label, 4 Year Extension Study of Subcutaneous Secukinumab in Prefilled Syringes, Assessing Long-term Safety, Tolerability and Efficacy in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Treated With Either a Fixed Dose Regimen or on a Retreatment at Start of Relapse Regimen

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

September 16, 2012 (Actual)

Primary Completion Date

May 4, 2017 (Actual)

Study Completion Date

May 4, 2017 (Actual)

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

CAIN457A2304E1 was an extension study to two phase III studies, CAIN457A2304 and CAIN457A2307 (core studies). This extension study planned to collect up to four years of long-term safety, tolerability and efficacy data of secukinumab in both the fixed interval regimen and the retreatment at start of relapse regimen. All subjects who completed the full study treatment period (52 weeks) in the cores studies CAIN457A2304 and CAIN457A2307 were eligible to participate in this extension study. In this extension study, the prefilled syringe (PFS) liquid formulation of secukinumab was used.

6. Conditions and Keywords

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

Moderate to Severe Chronic Plaque-Type Psoriasis

Keywords

Psoriasis, Plaque, Inflammatory skin disease, Scaly patches, AIN457, Secukinumab, Moderate to Severe Plaque-type Psoriasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Non-Randomized

Enrollment

675 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AIN457 150 mg - Fixed Interval (FI)

Arm Type

Experimental

Arm Description

1 s.c. Secukinumab 150 mg Pre-filled seringue (PFS) injection + 1 s.c. Placebo (PBO) Secukinumab PFS injection every 4 weeks

Arm Title

AIN457 150 mg - Start of relapse (SoR)

Arm Type

Experimental

Arm Description

Start of relapse: 1 s.c. Secukinumab 150 mg PFS injection + 1 s.c. PBO Secukinumab PFS injection every 4 weeks Otherwise: 2 s.c. PBO Secukinumab PFS injections every 4 weeks

Arm Title

AIN457 300 mg - Fixed Interval (FI)

Arm Type

Experimental

Arm Description

2 s.c. Secukinumab 150 mg PFS injections every 4 weeks

Arm Title

AIN457 300 mg - Start of Relapse (SoR)

Arm Type

Experimental

Arm Description

Start of relapse: 2 s.c. Secukinumab 150 mg PFS injection every 4 weeks Otherwise: 2 s.c. PBO Secukinumab PFS injections every 4 weeks

Arm Title

AIN457 300 mg - Open Label (OL)

Arm Type

Experimental

Arm Description

Open Label - Secukinumab 300mg every 4 weeks

Intervention Type

Drug

Intervention Name(s)

AIN457 150 mg

Other Intervention Name(s)

Secukinumab 150 mg

Intervention Description

(1 injection per dose) and placebo to Secukinumab 150 mg

Intervention Type

Drug

Intervention Name(s)

AIN457 300 mg

Other Intervention Name(s)

Secukinumab 300 mg

Intervention Description

Secukinumab 150 mg (2 injections per dose)

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Long-term Safety and Tolerability of Secukinumab

Description

Analysis of absolute and relative frequencies for treatment emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by primary System Organ Class (SOC)

Time Frame

Week 268

Secondary Outcome Measure Information:

Title

Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) Score of 75 at Weeks 52, 104, 156, 208 and 260

Description

Time Frame

Week 52, Week 104, Week 156, Week 208, Week 260

Title

Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) Scores of 50, 90 and 100 Over Time at Weeks 52, 104, 156, 208 and 260

Description

Time Frame

Week 52, Week 104, Week 156, Week 208, Week 260

Title

Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Weeks 52, 104, 156, 208 and 260

Description

Time Frame

Baseline, Week 52, Week 104, Week 156, Week 208, Week 260

Title

Percentage of Participants Achieving Investigator's Global Assessment Modified 2011 (IGA) 2011 Score of 0 or 1 Over Time at Weeks 52, 104, 156, 208 and 260

Description

Time Frame

Week 52, Week 104, Week 156, Week 208, Week 260

Title

Percentage Change From Baseline in Dermatology Life Quality Index (DLQI©) Response at Weeks 52, 104, 156, 208 and 260

Description

Time Frame

Baseline, Week 52, Week 104, Week 156, Week 208, Week 260

Title

Percentage of Participants With Dermatology Life Quality Index (DLQI©) Response (DLQI 0 or 1) Over Time at Weeks 52, 104, 156, 208 and 260

Description

Time Frame

Week 52, Week 104, Week 156, Week 208, Week 260

Title

EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D©) Score and Percent Change From Baseline at Weeks 52, 104 and 156

Description

Time Frame

Baseline, Week 52, Week 104, Week 156

Title

Number of Participants With Treatment Emergent Anti-drug Antibodies (ADA)

Description

The development of anti-secunimubab anti-bodies will decrease a participant's ability to respond to secukinumab treatment.

Time Frame

Week 268

Title

Percentage of Patients With Experiencing a Relapse

Description

Time Frame

Week 260

Title

Percentage of Patients With Experiencing a Rebound

Description

Time Frame

Up to Week 264 (8 weeks post last dose)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study related activity is performed. Where relevant, a legal representative will also sign the informed consent according to local laws and regulations. Subjects who complete Week 52 of study CAIN457A2304 or complete Week 40 of study CAIN457A2307 Subjects expected to benefit from participation in the extension study, as assessed by the subject and investigator Exclusion Criteria: A protocol deviation in the core studies which according to the investigator will prevent the meaningful analysis of the extension study for the individual subject Ongoing use of prohibited psoriasis or non-psoriasis treatments. Time period from last use of prohibited treatments in the core study to first dose of study drug in this extension study. Subjects expected to be exposed to an undue safety risk if participating in the trial Current severe progressive or uncontrolled disease which in the judgment of the investigator renders the subject unsuitable for the trial Plans for administration of live vaccines during the study period Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (>10 mIU/mL).

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

Fresno

State/Province

California

ZIP/Postal Code

93710

Country

United States

Facility Name

Novartis Investigative Site

City

Pasadena

State/Province

California

ZIP/Postal Code

91105

Country

United States

Facility Name

Novartis Investigative Site

City

San Francisco

State/Province

California

ZIP/Postal Code

94118

Country

United States

Facility Name

Novartis Investigative Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32204

Country

United States

Facility Name

Novartis Investigative Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32216

Country

United States

Facility Name

Novartis Investigative Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

Facility Name

Novartis Investigative Site

City

South Miami

State/Province

Florida

ZIP/Postal Code

33143

Country

United States

Facility Name

Novartis Investigative Site

City

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33409

Country

United States

Facility Name

Novartis Investigative Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30342

Country

United States

Facility Name

Novartis Investigative Site

City

Champaign

State/Province

Illinois

ZIP/Postal Code

61820

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

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46256

Country

United States

Facility Name

Novartis Investigative Site

City

Overland Park

State/Province

Kansas

ZIP/Postal Code

66215

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

Fridley

State/Province

Minnesota

ZIP/Postal Code

55432

Country

United States

Facility Name

Novartis Investigative Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63117

Country

United States

Facility Name

Novartis Investigative Site

City

Henderson

State/Province

Nevada

ZIP/Postal Code

89052

Country

United States

Facility Name

Novartis Investigative Site

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89119

Country

United States

Facility Name

Novartis Investigative Site

City

Verona

State/Province

New Jersey

ZIP/Postal Code

07044

Country

United States

Facility Name

Novartis Investigative Site

City

Greensboro

State/Province

North Carolina

ZIP/Postal Code

27401

Country

United States

Facility Name

Novartis Investigative Site

City

High Point

State/Province

North Carolina

ZIP/Postal Code

27262

Country

United States

Facility Name

Novartis Investigative Site

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27103

Country

United States

Facility Name

Novartis Investigative Site

City

Anderson

State/Province

South Carolina

ZIP/Postal Code

29621

Country

United States

Facility Name

Novartis Investigative Site

City

Greer

State/Province

South Carolina

ZIP/Postal Code

29651

Country

United States

Facility Name

Novartis Investigative Site

City

Goodlettsville

State/Province

Tennessee

ZIP/Postal Code

37072-2301

Country

United States

Facility Name

Novartis Investigative Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

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

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84124

Country

United States

Facility Name

Novartis Investigative Site

City

Wels

ZIP/Postal Code

4600

Country

Austria

Facility Name

Novartis Investigative Site

City

Pleven

ZIP/Postal Code

5800

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Sofia

ZIP/Postal Code

1231

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Sofia

ZIP/Postal Code

1404

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Sofia

ZIP/Postal Code

1431

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Varna

ZIP/Postal Code

9010

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Barrie

State/Province

Ontario

ZIP/Postal Code

L4M 6L2

Country

Canada

Facility Name

Novartis Investigative Site

City

Oakville

State/Province

Ontario

ZIP/Postal Code

L6J 7W5

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

Windsor

State/Province

Ontario

ZIP/Postal Code

N8W 1E6

Country

Canada

Facility Name

Novartis Investigative Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2K 4L5

Country

Canada

Facility Name

Novartis Investigative Site

City

Brno - Bohunice

State/Province

Czech Republic

ZIP/Postal Code

625 00

Country

Czechia

Facility Name

Novartis Investigative Site

City

Hradec Kralove

State/Province

CZE

ZIP/Postal Code

500 05

Country

Czechia

Facility Name

Novartis Investigative Site

City

Prague 8

State/Province

CZE

ZIP/Postal Code

180 81

Country

Czechia

Facility Name

Novartis Investigative Site

City

Ceske Budejovice

ZIP/Postal Code

370 01

Country

Czechia

Facility Name

Novartis Investigative Site

City

Novy Jicin

ZIP/Postal Code

741 01

Country

Czechia

Facility Name

Novartis Investigative Site

City

Prague 10

ZIP/Postal Code

100 34

Country

Czechia

Facility Name

Novartis Investigative Site

City

Antony

ZIP/Postal Code

92160

Country

France

Facility Name

Novartis Investigative Site

City

Nice Cedex 3

ZIP/Postal Code

06202

Country

France

Facility Name

Novartis Investigative Site

City

Pierre-Benite Cedex

ZIP/Postal Code

69495

Country

France

Facility Name

Novartis Investigative Site

City

Rouen

ZIP/Postal Code

76031

Country

France

Facility Name

Novartis Investigative Site

City

Toulouse Cedex

ZIP/Postal Code

31400

Country

France

Facility Name

Novartis Investigative Site

City

Koeln

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

50937

Country

Germany

Facility Name

Novartis Investigative Site

City

Bad Wildbad

ZIP/Postal Code

75323

Country

Germany

Facility Name

Novartis Investigative Site

City

Bochum

ZIP/Postal Code

44793

Country

Germany

Facility Name

Novartis Investigative Site

City

Buchholz I. D. Nordheide

ZIP/Postal Code

21244

Country

Germany

Facility Name

Novartis Investigative Site

City

Dippoldiswalde-Schmiedeberg

ZIP/Postal Code

01744

Country

Germany

Facility Name

Novartis Investigative Site

City

Duesseldorf

ZIP/Postal Code

D-40225

Country

Germany

Facility Name

Novartis Investigative Site

City

Duisburg

ZIP/Postal Code

47166

Country

Germany

Facility Name

Novartis Investigative Site

City

Essen

ZIP/Postal Code

45147

Country

Germany

Facility Name

Novartis Investigative Site

City

Frankfurt

ZIP/Postal Code

60590

Country

Germany

Facility Name

Novartis Investigative Site

City

Freiburg

ZIP/Postal Code

79104

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

22143

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

22391

Country

Germany

Facility Name

Novartis Investigative Site

City

Hannover

ZIP/Postal Code

30625

Country

Germany

Facility Name

Novartis Investigative Site

City

Kiel

ZIP/Postal Code

24105

Country

Germany

Facility Name

Novartis Investigative Site

City

Luebeck

ZIP/Postal Code

23538

Country

Germany

Facility Name

Novartis Investigative Site

City

Mahlow

ZIP/Postal Code

15831

Country

Germany

Facility Name

Novartis Investigative Site

City

Mainz

ZIP/Postal Code

55131

Country

Germany

Facility Name

Novartis Investigative Site

City

Muenster

ZIP/Postal Code

48149

Country

Germany

Facility Name

Novartis Investigative Site

City

Wuppertal

ZIP/Postal Code

42103

Country

Germany

Facility Name

Novartis Investigative Site

City

Roma

State/Province

ZIP/Postal Code

00133

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

State/Province

ZIP/Postal Code

00144

Country

Italy

Facility Name

Novartis Investigative Site

City

Siena

State/Province

ZIP/Postal Code

53100

Country

Italy

Facility Name

Novartis Investigative Site

City

Verona

State/Province

ZIP/Postal Code

37126

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

Fukuoka-city

State/Province

Fukuoka

ZIP/Postal Code

815-8588

Country

Japan

Facility Name

Novartis Investigative Site

City

Kitakyushu-city

State/Province

Fukuoka

ZIP/Postal Code

800-0296

Country

Japan

Facility Name

Novartis Investigative Site

City

Maebashi city

State/Province

Gunma

ZIP/Postal Code

371 8511

Country

Japan

Facility Name

Novartis Investigative Site

City

Asahikawa-city

State/Province

Hokkaido

ZIP/Postal Code

078-8510

Country

Japan

Facility Name

Novartis Investigative Site

City

Sapporo-city

State/Province

Hokkaido

ZIP/Postal Code

060-0033

Country

Japan

Facility Name

Novartis Investigative Site

City

Osaka-city

State/Province

Osaka

ZIP/Postal Code

550-0012

Country

Japan

Facility Name

Novartis Investigative Site

City

Shimotsuke-city

State/Province

Tochigi

ZIP/Postal Code

329-0498

Country

Japan

Facility Name

Novartis Investigative Site

City

Chiyoda-ku

State/Province

Tokyo

ZIP/Postal Code

102-8798

Country

Japan

Facility Name

Novartis Investigative Site

City

Hachioji-city

State/Province

Tokyo

ZIP/Postal Code

193-0944

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

Minato-ku

State/Province

Tokyo

ZIP/Postal Code

105-8471

Country

Japan

Facility Name

Novartis Investigative Site

City

Shinjuku-ku

State/Province

Tokyo

ZIP/Postal Code

160-0023

Country

Japan

Facility Name

Novartis Investigative Site

City

Shinjuku-ku

State/Province

Tokyo

ZIP/Postal Code

160-8582

Country

Japan

Facility Name

Novartis Investigative Site

City

Lodz

ZIP/Postal Code

90-265

Country

Poland

Facility Name

Novartis Investigative Site

City

Poznan

ZIP/Postal Code

60 529

Country

Poland

Facility Name

Novartis Investigative Site

City

Wroclaw

ZIP/Postal Code

50-368

Country

Poland

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

Kosice

State/Province

Slovak Republic

ZIP/Postal Code

040 15

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Kosice

ZIP/Postal Code

04011

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Poprad

ZIP/Postal Code

05845

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Svidnik

ZIP/Postal Code

089 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Zilina

ZIP/Postal Code

01207

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Bern

ZIP/Postal Code

3010

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Lausanne

ZIP/Postal Code

1011

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Zuerich

ZIP/Postal Code

8091

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Leytonstone

State/Province

London

ZIP/Postal Code

E11 1NR

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Birmingham

ZIP/Postal Code

B15 2WB

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Blackpool

ZIP/Postal Code

FY3 7EN

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Leicester

ZIP/Postal Code

LE7 5WW

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Poole

ZIP/Postal Code

BH15 2JB

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Ho Chi Minh

State/Province

VNM

ZIP/Postal Code

700000

Country

Vietnam

Facility Name

Novartis Investigative Site

City

Hanoi

ZIP/Postal Code

100000

Country

Vietnam

Facility Name

Novartis Investigative Site

City

Hanoi

ZIP/Postal Code

1000

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

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

Citations:

PubMed Identifier

28580579

Citation

Bissonnette R, Luger T, Thaci D, Toth D, Messina I, You R, Guana A, Fox T, Papavassilis C, Gilloteau I, Mrowietz U. Secukinumab sustains good efficacy and favourable safety in moderate-to-severe psoriasis after up to 3 years of treatment: results from a double-blind extension study. Br J Dermatol. 2017 Oct;177(4):1033-1042. doi: 10.1111/bjd.15706. Epub 2017 Sep 4.

Results Reference

derived

Learn more about this trial

4 Year Extension Study of Efficacy and Safety of Secukinumab in Patients With Moderate to Severe Chronic Plaque-type Psoriasis

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4 Year Extension Study of Efficacy and Safety of Secukinumab in Patients With Moderate to Severe Chronic Plaque-type Psoriasis

Moderate to Severe Chronic Plaque-Type Psoriasis

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