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Study of Safety, Efficacy and Tolerability of Secukinumab Versus Placebo, in Combination With SoC Therapy, in Patients With Active Lupus Nephritis (SELUNE)

Primary Purpose

Lupus Nephritis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

secukinumab

About this trial

This is an interventional treatment trial for Lupus Nephritis focused on measuring SLE, LN, secukinumab, renal biopsy, eGFR, UPCR, SoC background therapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Adult male and female subjects aged 18 - 75 years old at the time of Baseline.
Confirmed diagnosis of:
- SLE as defined by the American College of Rheumatology (ACR), OR
- LN as the sole clinical criterion in the presence of ANA or anti-dsDNA antibodies.
Active lupus nephritis:
- International Society of Neurology/Renal Pathology Society (ISN/RPS) Class III or IV LN [excluding III (C), IV-S (C) and IV-G (C)]; subjects are permitted to have co-existing Class V.
- UPCR ≥1 at Screening.
- Estimated Glomerular Filtration Rate (eGFR) >30 mL/min/1.73 m2.
- Active urinary sediment.

Exclusion Criteria:

Severe renal impairment and subjects requiring dialysis dialysis within the previous 12 months before Screening.
Significant medical Problems like myocarditis, pericarditis, severe manifestations of neuropsychiatric SLE (NPSLE).
Cyclophosphamide (CYC) use (i.v. or oral) or more than 3000 mg i.v. pulse methylprednisolone (cumulative dose) within the month prior to Baseline.
Active ongoing inflammatory diseases.
Previous exposure to secukinumab (AIN457) or any other biologic drug targeting IL-17 or the IL-17 receptor.
Ongoing infections or malignant process.
Pregnant or lactating women.

Other inclusion and exclusion criteria may apply.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

secukinumab

placebo

Arm Description

secukinumab 300 mg s.c.

secukinumab placebo s.c.

Outcomes

Primary Outcome Measures

Proportion of subjects achieving Complete Renal Response (CRR)

Proportion of subjects achieving protocol-defined CRR

Secondary Outcome Measures

Change in 24-hour Urine Protein-to Creatinine Ratio (UPCR)

Change from Baseline in 24-hour UPCR

Proportion of subjects achieving Partial Renal Response (PRR)

Proportion of subjects achieving protocol-defined PRR

Average daily dose of oral corticosteroids

Average daily dose of oral corticosteroids compared to placebo

Proportion of subjects achieving PRR

Time to achieve CRR

Time to achieve PRR

Time to achieve UPCR ≤ 0.5 mg/mg

Time to achieve first morning void UPCR ≤ 0.5 mg/mg

Improvement in FACIT-Fatigue©

Improvement in FACIT-Fatigue© mean change of score compared to placebo The FACIT Fatigue Scale measures an individual's level of fatigue during their usual daily activities. The level of fatigue is measured on a four point Likert scale (4 = not at all fatigued to 0 = very much fatigued)

Improvement in SF-36 PCS mean

Improvement in SF-36 PCS mean change compared to placebo

Improvement in LupusQoL Physical Health mean

Improvement in LupusQoL Physical Health mean change of score compared to placebo

Incidence of Treatment-emergent AEs (TEAEs) / SAEs

Incidence of Treatment-emergent AEs (TEAEs) / SAEs from Baseline to Week 52; vital signs and body measurements, standard chemistry and hematology

Proportion of subjects with CRR at Week 104 within subjects who had achieved CRR at Week 52

Estimate the proportion of subjects with CRR at Week 104 within subjects who had achieved CRR at Week 52 in the secukinumab group

Proportion of subjects with improved or maintained renal response at Week 104

Estimate the proportion of subjects with improved or maintained response (PRR or CRR) in subjects who had achieved at least PRR at Week 52 in the secukinumab group

Full Information

NCT ID

NCT04181762

First Posted

November 27, 2019

Last Updated

October 17, 2023

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT04181762

Brief Title

Study of Safety, Efficacy and Tolerability of Secukinumab Versus Placebo, in Combination With SoC Therapy, in Patients With Active Lupus Nephritis

Acronym

SELUNE

Official Title

A Two-year, Phase III Randomized, Double-blind, Parallel-group, Placebo-controlled Trial to Evaluate the Safety, Efficacy, and Tolerability of 300 mg s.c. Secukinumab Versus Placebo, in Combination With SoC Therapy, in Patients With Active Lupus Nephritis

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Completed

Study Start Date

July 7, 2020 (Actual)

Primary Completion Date

September 13, 2023 (Actual)

Study Completion Date

September 13, 2023 (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 trial is to evaluate the efficacy and safety of subcutaneous secukinumab 300 mg compared to placebo, in combination with standard of care therapy (SoC), in subjects with active lupus nephritis (ISN/RPS Class III or IV, with or without co-existing class V features).

Detailed Description

A two-year, phase III randomized, double-blind, parallel-group, placebo-controlled trial to evaluate the safety, efficacy, and tolerability of 300 mg s.c. secukinumab versus placebo, in combination with SoC therapy, in patients with active lupus nephritis

6. Conditions and Keywords

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

Lupus Nephritis

Keywords

SLE, LN, secukinumab, renal biopsy, eGFR, UPCR, SoC background therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

double-blind

Allocation

Randomized

Enrollment

275 (Actual)

8. Arms, Groups, and Interventions

Arm Title

secukinumab

Arm Type

Experimental

Arm Description

secukinumab 300 mg s.c.

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

secukinumab placebo s.c.

Intervention Type

Drug

Intervention Name(s)

secukinumab

Other Intervention Name(s)

AIN457

Intervention Description

STUDY DRUG

Primary Outcome Measure Information:

Title

Proportion of subjects achieving Complete Renal Response (CRR)

Description

Proportion of subjects achieving protocol-defined CRR

Time Frame

Week 52

Secondary Outcome Measure Information:

Title

Change in 24-hour Urine Protein-to Creatinine Ratio (UPCR)

Description

Change from Baseline in 24-hour UPCR

Time Frame

Week 52

Title

Proportion of subjects achieving Partial Renal Response (PRR)

Description

Proportion of subjects achieving protocol-defined PRR

Time Frame

Week 52

Title

Average daily dose of oral corticosteroids

Description

Average daily dose of oral corticosteroids compared to placebo

Time Frame

Week 16 to Week 52

Title

Proportion of subjects achieving PRR

Description

Proportion of subjects achieving PRR

Time Frame

Week 24

Title

Time to achieve CRR

Description

Time to achieve CRR

Time Frame

Baseline to Week 52

Title

Time to achieve PRR

Description

Time to achieve PRR

Time Frame

Baseline to Week 52

Title

Time to achieve UPCR ≤ 0.5 mg/mg

Description

Time to achieve first morning void UPCR ≤ 0.5 mg/mg

Time Frame

Baseline to Week 52

Title

Improvement in FACIT-Fatigue©

Description

Time Frame

Baseline to Week 52

Title

Improvement in SF-36 PCS mean

Description

Improvement in SF-36 PCS mean change compared to placebo

Time Frame

Baseline to Week 52

Title

Improvement in LupusQoL Physical Health mean

Description

Improvement in LupusQoL Physical Health mean change of score compared to placebo

Time Frame

Baseline to Week 52

Title

Incidence of Treatment-emergent AEs (TEAEs) / SAEs

Description

Incidence of Treatment-emergent AEs (TEAEs) / SAEs from Baseline to Week 52; vital signs and body measurements, standard chemistry and hematology

Time Frame

Baseline to Week 52

Title

Proportion of subjects with CRR at Week 104 within subjects who had achieved CRR at Week 52

Description

Estimate the proportion of subjects with CRR at Week 104 within subjects who had achieved CRR at Week 52 in the secukinumab group

Time Frame

Week 52 to Week 104

Title

Proportion of subjects with improved or maintained renal response at Week 104

Description

Estimate the proportion of subjects with improved or maintained response (PRR or CRR) in subjects who had achieved at least PRR at Week 52 in the secukinumab group

Time Frame

Week 52 to Week 104

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adult male and female subjects aged 18 - 75 years old at the time of Baseline. Confirmed diagnosis of: SLE as defined by the American College of Rheumatology (ACR), OR LN as the sole clinical criterion in the presence of ANA or anti-dsDNA antibodies. Active lupus nephritis: International Society of Neurology/Renal Pathology Society (ISN/RPS) Class III or IV LN [excluding III (C), IV-S (C) and IV-G (C)]; subjects are permitted to have co-existing Class V. UPCR ≥1 at Screening. Estimated Glomerular Filtration Rate (eGFR) >30 mL/min/1.73 m2. Active urinary sediment. Exclusion Criteria: Severe renal impairment and subjects requiring dialysis dialysis within the previous 12 months before Screening. Significant medical Problems like myocarditis, pericarditis, severe manifestations of neuropsychiatric SLE (NPSLE). Cyclophosphamide (CYC) use (i.v. or oral) or more than 3000 mg i.v. pulse methylprednisolone (cumulative dose) within the month prior to Baseline. Active ongoing inflammatory diseases. Previous exposure to secukinumab (AIN457) or any other biologic drug targeting IL-17 or the IL-17 receptor. Ongoing infections or malignant process. Pregnant or lactating women. Other inclusion and exclusion criteria may apply.

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

Birmingham

State/Province

Alabama

ZIP/Postal Code

35294

Country

United States

Facility Name

Novartis Investigative Site

City

Fontana

State/Province

California

ZIP/Postal Code

92335

Country

United States

Facility Name

Novartis Investigative Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

Facility Name

Novartis Investigative Site

City

Aventura

State/Province

Florida

ZIP/Postal Code

33180

Country

United States

Facility Name

Novartis Investigative Site

City

Plantation

State/Province

Florida

ZIP/Postal Code

33324

Country

United States

Facility Name

Novartis Investigative Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30309

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

Grand Blanc

State/Province

Michigan

ZIP/Postal Code

48439

Country

United States

Facility Name

Novartis Investigative Site

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

C1280AEB

Country

Argentina

Facility Name

Novartis Investigative Site

City

Ciudad Autonoma de Bs As

State/Province

Buenos Aires

ZIP/Postal Code

C1015ABO

Country

Argentina

Facility Name

Novartis Investigative Site

City

Cordoba

ZIP/Postal Code

X5016JDA

Country

Argentina

Facility Name

Novartis Investigative Site

City

Westmead

State/Province

New South Wales

ZIP/Postal Code

2145

Country

Australia

Facility Name

Novartis Investigative Site

City

Fortaleza

State/Province

ZIP/Postal Code

60430 370

Country

Brazil

Facility Name

Novartis Investigative Site

City

Porto Alegre

State/Province

ZIP/Postal Code

90020-090

Country

Brazil

Facility Name

Novartis Investigative Site

City

Joinville

State/Province

Santa Catarina

ZIP/Postal Code

893227-680

Country

Brazil

Facility Name

Novartis Investigative Site

City

Santo Andre

State/Province

ZIP/Postal Code

09090-790

Country

Brazil

Facility Name

Novartis Investigative Site

City

Sao Paulo

State/Province

ZIP/Postal Code

05403 000

Country

Brazil

Facility Name

Novartis Investigative Site

City

São Paulo

State/Province

ZIP/Postal Code

04038-002

Country

Brazil

Facility Name

Novartis Investigative Site

City

Sao Jose do Rio Preto

ZIP/Postal Code

15090 000

Country

Brazil

Facility Name

Novartis Investigative Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5T 2S8

Country

Canada

Facility Name

Novartis Investigative Site

City

Valdivia

State/Province

Los Rios

ZIP/Postal Code

5100238

Country

Chile

Facility Name

Novartis Investigative Site

City

Santiago

State/Province

ZIP/Postal Code

7500588

Country

Chile

Facility Name

Novartis Investigative Site

City

Concepcion

ZIP/Postal Code

6740

Country

Chile

Facility Name

Novartis Investigative Site

City

Santiago

ZIP/Postal Code

7500710

Country

Chile

Facility Name

Novartis Investigative Site

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510280

Country

China

Facility Name

Novartis Investigative Site

City

Nanning

State/Province

Guangxi

ZIP/Postal Code

530021

Country

China

Facility Name

Novartis Investigative Site

City

Shijiazhuang

State/Province

Hebei

ZIP/Postal Code

050000

Country

China

Facility Name

Novartis Investigative Site

City

Changsha

State/Province

Hunan

ZIP/Postal Code

410011

Country

China

Facility Name

Novartis Investigative Site

City

Nanchang

State/Province

Jiangxi

ZIP/Postal Code

330006

Country

China

Facility Name

Novartis Investigative Site

City

Binzhou

State/Province

Shandong

ZIP/Postal Code

256603

Country

China

Facility Name

Novartis Investigative Site

City

Chengdu

State/Province

Sichuan

ZIP/Postal Code

610072

Country

China

Facility Name

Novartis Investigative Site

City

Beijing

ZIP/Postal Code

100034

Country

China

Facility Name

Novartis Investigative Site

City

Beijing

ZIP/Postal Code

100730

Country

China

Facility Name

Novartis Investigative Site

City

Chongqing

ZIP/Postal Code

400037

Country

China

Facility Name

Novartis Investigative Site

City

Shanghai

ZIP/Postal Code

200025

Country

China

Facility Name

Novartis Investigative Site

City

Shanghai

ZIP/Postal Code

200040

Country

China

Facility Name

Novartis Investigative Site

City

Wuhan

ZIP/Postal Code

430022

Country

China

Facility Name

Novartis Investigative Site

City

Medellin

State/Province

Antioquia

ZIP/Postal Code

050001

Country

Colombia

Facility Name

Novartis Investigative Site

City

Barranquilla

ZIP/Postal Code

080020

Country

Colombia

Facility Name

Novartis Investigative Site

City

Cali

ZIP/Postal Code

760012

Country

Colombia

Facility Name

Novartis Investigative Site

City

Cundinamarca

ZIP/Postal Code

111121

Country

Colombia

Facility Name

Novartis Investigative Site

City

Zagreb

ZIP/Postal Code

10000

Country

Croatia

Facility Name

Novartis Investigative Site

City

Prague 2

ZIP/Postal Code

128 50

Country

Czechia

Facility Name

Novartis Investigative Site

City

Praha 5

ZIP/Postal Code

150 06

Country

Czechia

Facility Name

Novartis Investigative Site

City

Praha

ZIP/Postal Code

12808

Country

Czechia

Facility Name

Novartis Investigative Site

City

Odense

ZIP/Postal Code

5000

Country

Denmark

Facility Name

Novartis Investigative Site

City

Marseille

ZIP/Postal Code

13385

Country

France

Facility Name

Novartis Investigative Site

City

Mainz

ZIP/Postal Code

55131

Country

Germany

Facility Name

Novartis Investigative Site

City

Thessaloniki

State/Province

Macedoni

ZIP/Postal Code

56403

Country

Greece

Facility Name

Novartis Investigative Site

City

Athens

ZIP/Postal Code

115 27

Country

Greece

Facility Name

Novartis Investigative Site

City

Guatemala City

ZIP/Postal Code

01011

Country

Guatemala

Facility Name

Novartis Investigative Site

City

Guatemala

ZIP/Postal Code

01010

Country

Guatemala

Facility Name

Novartis Investigative Site

City

Quetzaltenango

ZIP/Postal Code

9001

Country

Guatemala

Facility Name

Novartis Investigative Site

City

New Delhi

State/Province

Delhi

ZIP/Postal Code

110 017

Country

India

Facility Name

Novartis Investigative Site

City

New Delhi

State/Province

Delhi

ZIP/Postal Code

110 060

Country

India

Facility Name

Novartis Investigative Site

City

Padova

State/Province

ZIP/Postal Code

35128

Country

Italy

Facility Name

Novartis Investigative Site

City

Toyoake city

State/Province

Aichi

ZIP/Postal Code

470 1192

Country

Japan

Facility Name

Novartis Investigative Site

City

Kitakyushu-city

State/Province

Fukuoka

ZIP/Postal Code

807-8556

Country

Japan

Facility Name

Novartis Investigative Site

City

Sendai city

State/Province

Miyagi

ZIP/Postal Code

980 8574

Country

Japan

Facility Name

Novartis Investigative Site

City

Kurashiki

State/Province

Okayama

ZIP/Postal Code

701-0192

Country

Japan

Facility Name

Novartis Investigative Site

City

Chuo-city

State/Province

Yamanashi

ZIP/Postal Code

409-3898

Country

Japan

Facility Name

Novartis Investigative Site

City

Seoul

State/Province

Seocho Gu

ZIP/Postal Code

06591

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

ZIP/Postal Code

04763

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Mexicali

State/Province

Baja California Norte

ZIP/Postal Code

21200

Country

Mexico

Facility Name

Novartis Investigative Site

City

Ciudad de Mexico

State/Province

Mexico CP

ZIP/Postal Code

14080

Country

Mexico

Facility Name

Novartis Investigative Site

City

Merida

State/Province

Yucatan

ZIP/Postal Code

97070

Country

Mexico

Facility Name

Novartis Investigative Site

City

Mexico

ZIP/Postal Code

06726

Country

Mexico

Facility Name

Novartis Investigative Site

City

Oslo

ZIP/Postal Code

0372

Country

Norway

Facility Name

Novartis Investigative Site

City

Santiago de Surco

State/Province

Lima

ZIP/Postal Code

Country

Peru

Facility Name

Novartis Investigative Site

City

Lipa City

State/Province

Batangas

ZIP/Postal Code

4217

Country

Philippines

Facility Name

Novartis Investigative Site

City

Iloilo

ZIP/Postal Code

5000

Country

Philippines

Facility Name

Novartis Investigative Site

City

Manila

ZIP/Postal Code

1008

Country

Philippines

Facility Name

Novartis Investigative Site

City

Quezon

ZIP/Postal Code

1102

Country

Philippines

Facility Name

Novartis Investigative Site

City

Coimbra

ZIP/Postal Code

3000-075

Country

Portugal

Facility Name

Novartis Investigative Site

City

Guimaraes

ZIP/Postal Code

4835 044

Country

Portugal

Facility Name

Novartis Investigative Site

City

Lisbon

ZIP/Postal Code

1069-166

Country

Portugal

Facility Name

Novartis Investigative Site

City

Porto

ZIP/Postal Code

4099 001

Country

Portugal

Facility Name

Novartis Investigative Site

City

Oradea

State/Province

Jud. Bihor

ZIP/Postal Code

410619

Country

Romania

Facility Name

Novartis Investigative Site

City

Ramnicu Valcea

State/Province

Valcea

ZIP/Postal Code

240672

Country

Romania

Facility Name

Novartis Investigative Site

City

Bucharest

ZIP/Postal Code

022328

Country

Romania

Facility Name

Novartis Investigative Site

City

Bucuresti

ZIP/Postal Code

010 731

Country

Romania

Facility Name

Novartis Investigative Site

City

Bucuresti

ZIP/Postal Code

011172

Country

Romania

Facility Name

Novartis Investigative Site

City

Kazan

ZIP/Postal Code

420012

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Kemerovo

ZIP/Postal Code

650070

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Rostov On Don

ZIP/Postal Code

344022

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

150062

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Piestany

ZIP/Postal Code

92101

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Barcelona

State/Province

Catalunya

ZIP/Postal Code

08036

Country

Spain

Facility Name

Novartis Investigative Site

City

Santiago de Compostela

State/Province

Galicia

ZIP/Postal Code

15706

Country

Spain

Facility Name

Novartis Investigative Site

City

Vigo

State/Province

Pontevedra

ZIP/Postal Code

36200

Country

Spain

Facility Name

Novartis Investigative Site

City

Stockholm

ZIP/Postal Code

171 76

Country

Sweden

Facility Name

Novartis Investigative Site

City

St Gallen

ZIP/Postal Code

CH 9007

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Kaohsiung

ZIP/Postal Code

81346

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Taichung

ZIP/Postal Code

40447

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Taichung

ZIP/Postal Code

40705

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Tao Yuan

ZIP/Postal Code

333

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Bangkok

ZIP/Postal Code

10400

Country

Thailand

Facility Name

Novartis Investigative Site

City

Bangkok

ZIP/Postal Code

10700

Country

Thailand

Facility Name

Novartis Investigative Site

City

Istanbul

ZIP/Postal Code

34093

Country

Turkey

Facility Name

Novartis Investigative Site

City

Istanbul

ZIP/Postal Code

34300

Country

Turkey

Facility Name

Novartis Investigative Site

City

Zuhuratbaba / Istanbul

ZIP/Postal Code

34147

Country

Turkey

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

Ho Chi Minh

ZIP/Postal Code

700000

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

Study of Safety, Efficacy and Tolerability of Secukinumab Versus Placebo, in Combination With SoC Therapy, in Patients With Active Lupus Nephritis

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Study of Safety, Efficacy and Tolerability of Secukinumab Versus Placebo, in Combination With SoC Therapy, in Patients With Active Lupus Nephritis (SELUNE)

Lupus Nephritis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

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