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

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, HS, lumps, skin, lesions

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

Percentage of Participants With Hidradenitis Suppurativa Clinical Response (HiSCR50)

HiSCR50 at Week 16 is defined as at least a 50% decrease in Abscess and inflammatory Nodule (AN) count compared to baseline with no increase in the number of abscesses and/or in the number of draining fistulas from baseline to Week 16. The baseline is defined as the last assessment (including unscheduled visits) obtained before/on the day of the first administration of the study treatment, or on the randomization date if there had been no drug administration. This endpoint was analyzed by logistic regression.

Secondary Outcome Measures

Percentage Change From Baseline in AN Count

Percent change from baseline in abscesses and inflammatory nodules (AN) count. This endpoint was analyzed by analysis of covariance.

Percentage of Participants With Hidradenitis Suppurativa (HS) Flares

Percentage of participants who experience at least one flare over 16 weeks. A flare is defined as at least a 25% increase in abscesses and inflammatory nodules (AN) count with a minimum increase of 2 AN relative to baseline. This endpoint was analyzed by logistic regression.

Percentage of Participants Achieving NRS30

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]). This endpoint was analyzed by logistic regression. The protocol defines this outcome measure to be tested using combined data with CAIN457M2301 (NCT03713619). As this record is supposed to contain only results from CAIN457M2302, descriptive data based only on CAIN457M2302 are presented.

Full Information

NCT ID

NCT03713632

First Posted

October 18, 2018

Last Updated

July 12, 2023

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT03713632

Brief Title

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

Acronym

SUNRISE

Official Title

A Randomized, Double-blind, Multicenter 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 (SUNRISE)

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

February 25, 2019 (Actual)

Primary Completion Date

September 23, 2021 (Actual)

Study Completion Date

July 19, 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 was 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 assessed the safety and tolerability of secukinumab.

Detailed Description

This was a multicenter, randomized, double-blind, placebo-controlled, parallel group study with two secukinumab dose regimens in patients with moderate to severe HS. The study consisted 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 was an optional extension study (NCT04179175). Adult males and females with moderate to severe HS were included, with a diagnosis of HS greater than 1 year prior to baseline. Dosing was once every 2 weeks, or once every 4 weeks via pre-filled syringe; periodic home-dosing is included. In Treatment Period 1, participants were randomized to secukinumab Q2W, secukinumab Q4W, placebo Q2W or placebo Q4W in 1:1:0.5:0.5 ratio. In Treatment Period 2, at the Week 16 visit participants initially randomized to placebo were switched to one of the two active dose regimens (secukinumab Q2W or Q4W), while subjects randomized to secukinumab during Treatment Period 1 continued on the same dose.

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, HS, lumps, skin, lesions

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

544 (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

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

Percentage of Participants With Hidradenitis Suppurativa Clinical Response (HiSCR50)

Description

Time Frame

16 weeks

Secondary Outcome Measure Information:

Title

Percentage Change From Baseline in AN Count

Description

Percent change from baseline in abscesses and inflammatory nodules (AN) count. This endpoint was analyzed by analysis of covariance.

Time Frame

Baseline, 16 weeks

Title

Percentage of Participants With Hidradenitis Suppurativa (HS) Flares

Description

Time Frame

16 weeks

Title

Percentage of Participants Achieving NRS30

Description

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Study Lead Study Director

Organizational Affiliation

Novartis

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

San Diego

State/Province

California

ZIP/Postal Code

92103

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

Tampa

State/Province

Florida

ZIP/Postal Code

33609

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

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

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

Portland

State/Province

Oregon

ZIP/Postal Code

97239

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

Pflugerville

State/Province

Texas

ZIP/Postal Code

78660

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

Rosario

State/Province

Santa Fe

ZIP/Postal Code

S2000DBS

Country

Argentina

Facility Name

Novartis Investigative Site

City

Capital Federal

ZIP/Postal Code

C1023AAB

Country

Argentina

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

1431

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

Richmond Hill

State/Province

Ontario

ZIP/Postal Code

L4C 9M7

Country

Canada

Facility Name

Novartis Investigative Site

City

Drummondville

State/Province

Quebec

ZIP/Postal Code

J2B 5L4

Country

Canada

Facility Name

Novartis Investigative Site

City

Saint Jerome

State/Province

Quebec

ZIP/Postal Code

J7Z 3B8

Country

Canada

Facility Name

Novartis Investigative Site

City

Barranquilla

State/Province

Atlantico

ZIP/Postal Code

080002

Country

Colombia

Facility Name

Novartis Investigative Site

City

Bogota

ZIP/Postal Code

110221

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

Jihlava

ZIP/Postal Code

586 33

Country

Czechia

Facility Name

Novartis Investigative Site

City

Aarhus

ZIP/Postal Code

8000

Country

Denmark

Facility Name

Novartis Investigative Site

City

Copenhagen NV

ZIP/Postal Code

2400

Country

Denmark

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

Martigues

ZIP/Postal Code

13500

Country

France

Facility Name

Novartis Investigative Site

City

Nice Cedex

ZIP/Postal Code

06202

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

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

Dessau Rosslau

ZIP/Postal Code

06847

Country

Germany

Facility Name

Novartis Investigative Site

City

Erlangen

ZIP/Postal Code

91054

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

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

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

161 21

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

Szeged

ZIP/Postal Code

6725

Country

Hungary

Facility Name

Novartis Investigative Site

City

Nagpur

State/Province

Maharashtra

ZIP/Postal Code

440009

Country

India

Facility Name

Novartis Investigative Site

City

Navi Mumbai

State/Province

Maharashtra

ZIP/Postal Code

400 706

Country

India

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

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

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

Bergen op Zoom

ZIP/Postal Code

4624 VT

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Makati City

ZIP/Postal Code

1220

Country

Philippines

Facility Name

Novartis Investigative Site

City

Lodz

ZIP/Postal Code

90-436

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

Chelyabinsk

ZIP/Postal Code

454048

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Saint Petersburg

ZIP/Postal Code

191123

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Smolensk

ZIP/Postal Code

214031

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

169608

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

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

Barcelona

State/Province

Catalunya

ZIP/Postal Code

08003

Country

Spain

Facility Name

Novartis Investigative Site

City

Manises

State/Province

Valencia

ZIP/Postal Code

46940

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

Lausanne

ZIP/Postal Code

1011

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Zurich

ZIP/Postal Code

CH-8091

Country

Switzerland

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

Izmir

ZIP/Postal Code

35040

Country

Turkey

Facility Name

Novartis Investigative Site

City

Talas / Kayseri

ZIP/Postal Code

38039

Country

Turkey

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

Birmingham

ZIP/Postal Code

B15 2TH

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Harrogate

ZIP/Postal Code

HG2 7SX

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

London

ZIP/Postal Code

E1 1BB

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 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 Two Secukinumab Dose Regimens in Subjects With Moderate to Severe Hidradenitis Suppurativa (HS)

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

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