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This is a Study of Efficacy and Safety of Two Secukinumab Dose Regimens in Subjects With Moderate to Severe Hidradenitis Suppurativa (HS). (SUNSHINE)

Primary Purpose

Hidradenitis Suppurativa

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

secukinumab

Placebo

About this trial

This is an interventional treatment trial for Hidradenitis Suppurativa focused on measuring acne inversa, Hidradenitis suppurativa, maladie de Verneuil, inflammatory disease, AIN457, AIN457M, secukinumab

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.
Male and female patients ≥ 18 years of age.
Diagnosis of HS ≥ 1 year prior to baseline.
Patients with moderate to severe HS defined as:
A total of at least 5 inflammatory lesions, i.e. abscesses and/or inflammatory nodules AND
Inflammatory lesions should affect at least 2 distinct anatomic areas
Patients agree to daily use of topical over-the-counter antiseptics on the areas affected by HS lesions while on study treatment.

Exclusion Criteria:

Total fistulae count ≥ 20 at baseline.
Any other active skin disease or condition that may interfere with assessment of HS.
Active ongoing inflammatory diseases other than HS that require treatment with prohibited medications.
Use or planned use of prohibited treatment. Washout periods detailed in the protocol have to be adhered to.
History of hypersensitivity to any of the study drug constituents.
History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system treated or untreated within the past 5 years, regardless of whether there is evidence of local recurrence or metastases (except for skin Bowen's disease, or basal cell carcinoma or actinic keratoses that have been treated with no evidence of recurrence in the past 12 weeks; carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed).
Pregnant or lactating women.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Arm Label

secukinumab 1

secukinumab 2

placebo 1

placebo 2

Arm Description

Secukinumab 300mg every 2 weeks

Secukinumab 300mg every 4 weeks

Placebo group to secukinumab 300mg every 2 weeks

Placebo group to secukinumab 300mg every 4 weeks

Outcomes

Primary Outcome Measures

Proportion of participants with Hidradenitis Suppurativa clinical response (HiSCR)

HiSCR is defined as at least a 50% decrease in Abscess and Inflammatory Nodule (AN) count with no increase in the number of abscesses and/or in the number of draining fistulae.

Secondary Outcome Measures

Proportion of patients with Hidradenitis Suppurativa (HS) flares

Patients who experience at least one flare over 16 weeks, flare defined as at least a 25% increase in abscesses and inflammatory nodules (AN) count with a minimum increase of 2 AN relative to baseline

Participants achieving NRS30

HS-related skin pain Patients achieving Numerical Rating Scale score of 30 (NRS30) at week 16, defined as at least a 30% reduction and at least one unit reduction from baseline in the Patient's Global assessment of Skin Pain (where range 0 [no skin pain] to 10 [worst skin pain])

Percentage change in AN count

Percent change in abscesses and inflammatory nodules (AN) count

Full Information

NCT ID

NCT03713619

First Posted

October 18, 2018

Last Updated

January 17, 2023

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT03713619

Brief Title

This is a Study of Efficacy and Safety of Two Secukinumab Dose Regimens in Subjects With Moderate to Severe Hidradenitis Suppurativa (HS).

Acronym

SUNSHINE

Official Title

A Randomized, Double-blind, Multi-center Study Assessing Short (16 Weeks) and Long-term Efficacy (up to 1 Year), Safety, and Tolerability of 2 Subcutaneous Secukinumab Dose Regimens in Adult Patients With Moderate to Severe Hidradenitis Suppurativa (SUNSHINE).

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Completed

Study Start Date

January 31, 2019 (Actual)

Primary Completion Date

October 1, 2021 (Actual)

Study Completion Date

July 26, 2022 (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

The purpose of this study is to demonstrate superiority of secukinumab at Week 16, based on Hidradenitis Suppurativa Clinical Response (HiSCR) rates versus placebo, along with the maintenance of efficacy of secukinumab at Week 52 in subjects with moderate to severe HS. Moreover, this study will also assess the safety and tolerability of secukinumab.

Detailed Description

This is a multicenter, randomized, double-blind, placebo-controlled, parallel group study with two secukinumab dose regimens in approximately 541 patients with moderate to severe HS. The study consists of: screening (up to 4 weeks) treatment period 1 (16 weeks, active drug or placebo) and treatment period 2 (up to 1 year all patients on active drug); there will be an optional extension study. Adult males and females with moderate to severe HS will be included, with a diagnosis of HS greater than 1 year prior to baseline. Dosing will be once every 2 weeks, or once every 4 weeks via pre-filled syringe; periodic home-dosing is included. The primary objective is to demonstrate the efficacy of secukinumab compared to placebo with respect to HISCR after 16 weeks of treatment; primary secondary objectives are to assess difference in proportion of patients with HS flares, and proportion of patients with clinical response in HS related skin pain after 16 weeks of treatment. Key safety data will be collected, along with Patient Reported Outcomes.

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 Verneuil, inflammatory disease, AIN457, AIN457M, secukinumab

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

Multicenter, randomized, double-blind, placebo-controlled, parallel group study, with two secukinumab dose regimens in approximately 541 patients with moderate to severe HS

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

545 (Actual)

8. Arms, Groups, and Interventions

Arm Title

secukinumab 1

Arm Type

Active Comparator

Arm Description

Secukinumab 300mg every 2 weeks

Arm Title

secukinumab 2

Arm Type

Active Comparator

Arm Description

Secukinumab 300mg every 4 weeks

Arm Title

placebo 1

Arm Type

Placebo Comparator

Arm Description

Placebo group to secukinumab 300mg every 2 weeks

Arm Title

placebo 2

Arm Type

Placebo Comparator

Arm Description

Placebo group to secukinumab 300mg every 4 weeks

Intervention Type

Drug

Intervention Name(s)

secukinumab

Other Intervention Name(s)

AIN457

Intervention Description

Secukinumab 300mg every 2 or every 4 weeks

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo 300mg every 2 or every 4 weeks

Primary Outcome Measure Information:

Title

Proportion of participants with Hidradenitis Suppurativa clinical response (HiSCR)

Description

HiSCR is defined as at least a 50% decrease in Abscess and Inflammatory Nodule (AN) count with no increase in the number of abscesses and/or in the number of draining fistulae.

Time Frame

16 weeks

Secondary Outcome Measure Information:

Title

Proportion of patients with Hidradenitis Suppurativa (HS) flares

Description

Time Frame

16 weeks

Title

Participants achieving NRS30

Description

Time Frame

16 weeks

Title

Percentage change in AN count

Description

Percent change in abscesses and inflammatory nodules (AN) count

Time Frame

16 weeks

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. Male and female patients ≥ 18 years of age. Diagnosis of HS ≥ 1 year prior to baseline. Patients with moderate to severe HS defined as: A total of at least 5 inflammatory lesions, i.e. abscesses and/or inflammatory nodules AND Inflammatory lesions should affect at least 2 distinct anatomic areas Patients agree to daily use of topical over-the-counter antiseptics on the areas affected by HS lesions while on study treatment. Exclusion Criteria: Total fistulae count ≥ 20 at baseline. Any other active skin disease or condition that may interfere with assessment of HS. Active ongoing inflammatory diseases other than HS that require treatment with prohibited medications. Use or planned use of prohibited treatment. Washout periods detailed in the protocol have to be adhered to. History of hypersensitivity to any of the study drug constituents. History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system treated or untreated within the past 5 years, regardless of whether there is evidence of local recurrence or metastases (except for skin Bowen's disease, or basal cell carcinoma or actinic keratoses that have been treated with no evidence of recurrence in the past 12 weeks; carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed). Pregnant or lactating women.

Facility Information:

Facility Name

Novartis Investigative Site

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35205

Country

United States

Facility Name

Novartis Investigative Site

City

Rogers

State/Province

Arkansas

ZIP/Postal Code

72758

Country

United States

Facility Name

Novartis Investigative Site

City

Anaheim

State/Province

California

ZIP/Postal Code

92807

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

Miami

State/Province

Florida

ZIP/Postal Code

33125

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

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

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

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

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

75246-1613

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

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

Buenos Aires

ZIP/Postal Code

C1425DKG

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

State/Province

Brussels

ZIP/Postal Code

1070

Country

Belgium

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

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

Prague

State/Province

Prague 1

ZIP/Postal Code

11000

Country

Czechia

Facility Name

Novartis Investigative Site

City

Plzen

ZIP/Postal Code

30460

Country

Czechia

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

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

Paris Cedex 10

ZIP/Postal Code

75475

Country

France

Facility Name

Novartis Investigative Site

City

Toulouse

ZIP/Postal Code

31400

Country

France

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

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

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

Potsdam

ZIP/Postal Code

14467

Country

Germany

Facility Name

Novartis Investigative Site

City

Athens

ZIP/Postal Code

12462

Country

Greece

Facility Name

Novartis Investigative Site

City

Thessaloniki

ZIP/Postal Code

546 43

Country

Greece

Facility Name

Novartis Investigative Site

City

Budapest

ZIP/Postal Code

1085

Country

Hungary

Facility Name

Novartis Investigative Site

City

Pecs

ZIP/Postal Code

7623

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

Mangalore

State/Province

Karnataka

ZIP/Postal Code

575002

Country

India

Facility Name

Novartis Investigative Site

City

Mysore

State/Province

Karnataka

ZIP/Postal Code

570001

Country

India

Facility Name

Novartis Investigative Site

City

Nashik

State/Province

Maharashtra

ZIP/Postal Code

422 101

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

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

Modena

State/Province

ZIP/Postal Code

41124

Country

Italy

Facility Name

Novartis Investigative Site

City

Pisa

State/Province

ZIP/Postal Code

56124

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-city

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

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

Davao City

State/Province

Davao

ZIP/Postal Code

8000

Country

Philippines

Facility Name

Novartis Investigative Site

City

Quezon City

State/Province

Metro Manila

ZIP/Postal Code

1104

Country

Philippines

Facility Name

Novartis Investigative Site

City

Las Pinas

ZIP/Postal Code

1740

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

Ossy

ZIP/Postal Code

42 624

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

Matosinhos

ZIP/Postal Code

4454 513

Country

Portugal

Facility Name

Novartis Investigative Site

City

Porto

ZIP/Postal Code

4099-001

Country

Portugal

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

197022

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Yaroslavl

ZIP/Postal Code

150003

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Kosice

State/Province

Slovak Republic

ZIP/Postal Code

4190

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Martin

ZIP/Postal Code

03659

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Cadiz

State/Province

Andalucia

ZIP/Postal Code

11009

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

Barcelona

ZIP/Postal Code

08041

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

Novartis Investigative Site

City

Pontevedra

ZIP/Postal Code

36003

Country

Spain

Facility Name

Novartis Investigative Site

City

Uppsala

ZIP/Postal Code

751 85

Country

Sweden

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

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

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

Salford

State/Province

Manchester

ZIP/Postal Code

M6 8HD

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

BS2 8HN

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Exeter

ZIP/Postal Code

EX2 5DW

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Norwich

ZIP/Postal Code

NR4 7UY

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

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

This is a Study of Efficacy and Safety of Two Secukinumab Dose Regimens in Subjects With Moderate to Severe Hidradenitis Suppurativa (HS).

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This is a Study of Efficacy and Safety of Two Secukinumab Dose Regimens in Subjects With Moderate to Severe Hidradenitis Suppurativa (HS). (SUNSHINE)

Hidradenitis Suppurativa

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

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