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Safety, Efficacy and Tolerability of Ianalumab Versus Placebo, Combination With SoC Therapy, in Participants With Active Lupus Nephritis

NCT ID: NCT05126277

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

462 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-14

Study Completion Date

2030-11-05

Brief Summary

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This trial will evaluate efficacy, safety, and tolerability of subcutaneous (s.c.) ianalumab given every 4 weeks (q4w) or every 12 weeks (q12w) compared to placebo, in combination with SoC, in adult participants with active LN

Detailed Description

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This trial will evaluate the efficacy, safety, and tolerability of subcutaneous (s.c.) ianalumab given every 4 weeks (q4w) or ianalumab given every 12 weeks (q12w) compared to placebo, in combination with SoC, in adult participants with active LN (ISN/RPS class III, IV active glomerulonephritis with or without co-existing class V features, or pure class V membranous). using the 2003 International Society for Nephrology (ISN)/Renal Pathology Society (RPS) criteria).

Conditions

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Lupus Nephritis

Keywords

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SLE Systemic Lupus Erythematosus (SLE) Kidney inflammation Anti-BAFF-receptor B cell depletion Ianalumab VAY736

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a pivotal double-blind, randomized, placebo-controlled, multi-center three-arm study, evaluating at Week 72 efficacy and safety of ianalumab administered s.c. every 4 weeks or ianalumab administered s.c. every 12 weeks versus placebo, administered s.c. every 4 weeks, in adult participants with active LN receiving SoC. In addition, long-term efficacy, safety and tolerability will be collected up to Week 144.
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Double-blind

Study Groups

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Arm 1 - ianalumab s.c. q4w

ianalumab s.c. q4w in addition to standard of care (SoC)

Group Type EXPERIMENTAL

ianalumab s.c. q4w

Intervention Type DRUG

ianalumab s.c. q4w in addition to SoC

Arm 2 - ianalumab s.c. q12w

ianalumab s.c. q12w in addition to SoC

Group Type EXPERIMENTAL

ianalumab s.c. q12w

Intervention Type DRUG

ianalumab s.c. q12w in addition to SoC

Arm 3 - placebo s.c. q4w

Placebo s.c. q4w in addition to SoC

Group Type PLACEBO_COMPARATOR

placebo s.c.

Intervention Type DRUG

placebo s.c. q4w in addition to SoC

Interventions

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ianalumab s.c. q4w

ianalumab s.c. q4w in addition to SoC

Intervention Type DRUG

ianalumab s.c. q12w

ianalumab s.c. q12w in addition to SoC

Intervention Type DRUG

placebo s.c.

placebo s.c. q4w in addition to SoC

Intervention Type DRUG

Other Intervention Names

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VAY736 VAY736 placebo

Eligibility Criteria

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Inclusion Criteria

Participants eligible for inclusion in this study must meet all of the following criteria:

* Adult male and female participants aged 18 years or older at the time of screening
* Weigh at least 35 kg at screening
* Have a confirmed clinical diagnosis of SLE according to European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) Systemic Lupus Erythematosus (SLE) classification criteria
* Have a positive anti-nuclear antibody (ANA) test result; ANA titer ≥ 1:80 at screening visit based on central or local laboratory result
* Active LN at screening, as defined by meeting the 3 following criteria:

Exclusion Criteria

* UPCR ≥ 1.0 g/g on 24h urine collection at Screening
* eGFR ≥ 25mL/min/1.73 m2. Participants with eGFR \< 30 mL/min/1.73 m2 require renal biopsy during the screening period showing sclerosis in ≤ 50% of glomeruli
* Newly diagnosed participants as well as pre-treated LN participants (including refractory cases) can be included, as long as they are currently on, or willing to initiate SoC induction therapy for LN using MPA

* Induction therapy, as defined by treatment including both high dose corticosteroids and MPA, should be initiated prior to or on day of randomization
* Anti-malarial treatment at stable dosing prior to randomization is strongly recommended, in the absence of contraindications
* Participants on azathioprine treatment at Screening must be switched to MPA prior to randomization
* Receipt of at least one dose of pulse methylprednisolone i.v. (250 - 1000 mg per day up to 3000 mg cumulative dose) or equivalent for treatment of current episode of active LN within 60 days prior randomization. Participant who cannot take the pulse i.v. corticosteroid therapy should directly start on 0.8-1.0 mg/day (max 80mg/day) oral predniso(lo)ne.
* Able to communicate well with the Investigator to understand and comply with the requirements of the study


Participants meeting any of the following criteria are not eligible for inclusion in this study:

* Severe renal impairment as defined by i.) presence of oliguria (defined as a documented urine volume \<400 mL/24 hrs) or ii.) End-Stage Renal Disease (ESRD) requiring dialysis or transplantation
* Sclerosis in \> 50% of glomeruli on renal biopsy
* Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days or until the expected pharmacodynamic effect has returned to baseline. Use of certain Traditional Chinese Medicines
* Prior use of ianalumab (ever); or prior use other B cell depleting therapy within 36 weeks prior to randomization or if therapy was administered \< 36 weeks prior to randomization, B cell count less than the lower limit of normal or patient's own baseline value prior to having received an earlier B cell-depleting therapy
* Prior treatment with any of the following within 12 weeks prior to randomization

* Belimumab, telitacicept, abatacept, TNF-α mAb, immunoglobulins (i.v./s.c.) plasmapheresis
* Any other immuno-suppressants (i.v. or oral cyclophosphamide, calcineurin inhibitors, JAK inhibitors or other kinase inhibitors)
* Thalidomide treatment and/or methotrexate
* Combination of DMARDs
* Imidazole derivative (e.g., azathioprine, mizoribine) must be discontinued prior to starting treatment with MPA
* Receipt of more than 3000 mg i.v. pulse methylprednisolone (cumulative dose) within 12 weeks prior to randomization
* History of major organ transplant or hematopoietic stem cell/bone marrow transplant or are due to receive transplantation
* Any one of the following laboratory values at screening:

* Hemoglobin levels \< 8.0 g/dL (\< 5 mmol/L), or \< 7.0 g/dL (\< 4.3 mmol/L) if related to participant's SLE such as in active hemolytic anaemia
* Platelet count \< 25 x 1000/µL
* Absolute neutrophil count (ANC) \< 0.8 x 1000/µL
* Active viral, bacterial or other infections requiring intravenous or intramuscular treatment for clinically significant infection or history of recurrent clinically significant infection which in the opinion of the investigator will place the participant at risk for participation.
* History of known intolerance/hypersensitivity to MPA, oral corticosteroids, or any component of the study drug(s) or its excipients
* Receipt of live/attenuated vaccine within a 4-week period prior to randomization
* History of primary or secondary immunodeficiency, including a positive HIV test result
* History of malignancy of any organ system (other than localized basal cell carcinoma or squamous cell carcinoma of the skin or or in-situ cervical cancer), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases
* Any surgical, medical (e.g., uncontrolled hypertension, heart failure or diabetes), psychiatric or additional physical condition that the Investigator feels may jeopardize the participants in case of participation in this study
* Chronic infection with hepatitis B (HBV) or hepatitis C (HCV). Positive serology for hepatitis B surface antigen (HBsAg) excludes the participant
* Evidence of active tuberculosis (TB) infection (after anti-TB treatment, participants with history of TB may become eligible according to national local guidelines)
* Pregnant or nursing (lactating) women
* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 6 months after stopping of investigational medication
* Sexually active male participants, who do not agree to use barrier protection during intercourse with women of child-bearing potential while taking study treatment

Other protocol -defined Inclusion/Exclusion may apply.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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University Of Alabama

Birmingham, Alabama, United States

Site Status RECRUITING

Advanced Medical Research

La Palma, California, United States

Site Status RECRUITING

Wallace Rheumatic Study Center

Los Angeles, California, United States

Site Status WITHDRAWN

University of California LA

Los Angeles, California, United States

Site Status RECRUITING

University of California Irvine

Orange, California, United States

Site Status RECRUITING

School Of Medicine

Sacramento, California, United States

Site Status RECRUITING

University of California San Diego

San Diego, California, United States

Site Status RECRUITING

Kaiser Permanente

San Diego, California, United States

Site Status RECRUITING

Mayo Clinic Jacksonville

Jacksonville, Florida, United States

Site Status RECRUITING

University Of Miami

Miami, Florida, United States

Site Status RECRUITING

Emory University School of Medicine

Atlanta, Georgia, United States

Site Status RECRUITING

Fides Clinical Research

Atlanta, Georgia, United States

Site Status RECRUITING

Parris and Associates Rheumatology

Lawrenceville, Georgia, United States

Site Status RECRUITING

University of Kansas Hospital

Kansas City, Kansas, United States

Site Status WITHDRAWN

Accurate Clinical Research

Lake Charles, Louisiana, United States

Site Status RECRUITING

UMC New Orleans

New Orleans, Louisiana, United States

Site Status RECRUITING

Wayne State University

Detroit, Michigan, United States

Site Status RECRUITING

Univ of Nevada School of Med

Las Vegas, Nevada, United States

Site Status RECRUITING

Sahni Rheumatology and Therapy

West Long Branch, New Jersey, United States

Site Status WITHDRAWN

VA NM Healthcare System

Albuquerque, New Mexico, United States

Site Status RECRUITING

NY Nephrology

Clifton Park, New York, United States

Site Status RECRUITING

Hospital for Special Surgery

New York, New York, United States

Site Status RECRUITING

Northwell Health

New York, New York, United States

Site Status RECRUITING

Circuit Clinical

Orchard Park, New York, United States

Site Status RECRUITING

James J Peters VA Medical Center

The Bronx, New York, United States

Site Status RECRUITING

Brookview Hills Research Assoc

Winston-Salem, North Carolina, United States

Site Status WITHDRAWN

University Of Cincinnati

Cincinnati, Ohio, United States

Site Status RECRUITING

Univ of Pennsylvania Medical Center

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Arthritis and Rheumatology Ins

Allen, Texas, United States

Site Status RECRUITING

Precision Comprehensive Research

Colleyville, Texas, United States

Site Status RECRUITING

Liberty Research Center

Dallas, Texas, United States

Site Status RECRUITING

Univof Texas Southwestern Med Cntr

Dallas, Texas, United States

Site Status RECRUITING

University of Texas Medical Branch

Galveston, Texas, United States

Site Status WITHDRAWN

Uni of Texas Health Science Center

San Antonio, Texas, United States

Site Status RECRUITING

Baylor Scott and White Research

Temple, Texas, United States

Site Status RECRUITING

Northern Assoc of Northern VA

Fairfax, Virginia, United States

Site Status RECRUITING

Uni Wisconsin School Med Pub Health

Madison, Wisconsin, United States

Site Status RECRUITING

Novartis Investigative Site

CABA, Buenos Aires, Argentina

Site Status RECRUITING

Novartis Investigative Site

Caba, Buenos Aires, Argentina

Site Status WITHDRAWN

Novartis Investigative Site

La Plata, Buenos Aires, Argentina

Site Status RECRUITING

Novartis Investigative Site

Caba, , Argentina

Site Status RECRUITING

Novartis Investigative Site

CABA, , Argentina

Site Status RECRUITING

Novartis Investigative Site

San Miguel de Tucumán, , Argentina

Site Status RECRUITING

Novartis Investigative Site

Vitória, Espírito Santo, Brazil

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Salvador, Estado de Bahia, Brazil

Site Status RECRUITING

Novartis Investigative Site

São Luís, Maranhão, Brazil

Site Status WITHDRAWN

Novartis Investigative Site

Belo Horizonte, Minas Gerais, Brazil

Site Status RECRUITING

Novartis Investigative Site

Juiz de Fora, Minas Gerais, Brazil

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Curitiba, Paraná, Brazil

Site Status WITHDRAWN

Novartis Investigative Site

Recife, Pernambuco, Brazil

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Porto Alegre, Rio Grande do Sul, Brazil

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Porto Alegre, Rio Grande do Sul, Brazil

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Santo André, São Paulo, Brazil

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Salvador, , Brazil

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Calgary, Alberta, Canada

Site Status RECRUITING

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Vancouver, British Columbia, Canada

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Winnipeg, Manitoba, Canada

Site Status ACTIVE_NOT_RECRUITING

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Etobicoke, Ontario, Canada

Site Status RECRUITING

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London, Ontario, Canada

Site Status RECRUITING

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Toronto, Ontario, Canada

Site Status RECRUITING

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Montreal, Quebec, Canada

Site Status RECRUITING

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Sherbrooke, Quebec, Canada

Site Status RECRUITING

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Santiago, RM, Chile

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Temuco, , Chile

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Hefei, Anhui, China

Site Status WITHDRAWN

Novartis Investigative Site

Guangzhou, Guangdong, China

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Guangzhou, Guangdong, China

Site Status COMPLETED

Novartis Investigative Site

Guangzhou, Guangdong, China

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Shantou, Guangdong, China

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Shenzhen, Guangdong, China

Site Status WITHDRAWN

Novartis Investigative Site

Shenzhen, Guangdong, China

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Liuchow, Guangxi, China

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Haikou, Hainan, China

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Wuhan, Hubei, China

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Wuhan, Hubei, China

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Changsha, Hunan, China

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Nanjing, Jiangsu, China

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Nanchang, Jiangxi, China

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Changchun, Jilin, China

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Shenyang, Liaoning, China

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Binzhou, Shandong, China

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Linyi, Shandong, China

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Xian, Shanxi, China

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Chengdu, Sichuan, China

Site Status COMPLETED

Novartis Investigative Site

Ningbo, Zhejiang, China

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Beijing, , China

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Chongqing, , China

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Guangzhou, , China

Site Status COMPLETED

Novartis Investigative Site

Guangzhou, , China

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Shanghai, , China

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Shanghai, , China

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Shanghai, , China

Site Status COMPLETED

Novartis Investigative Site

Medellín, Antioquia, Colombia

Site Status RECRUITING

Novartis Investigative Site

Barranquilla, Atlántico, Colombia

Site Status RECRUITING

Novartis Investigative Site

Bogota, Cundinamarca, Colombia

Site Status RECRUITING

Novartis Investigative Site

Olomouc, , Czechia

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Prague, , Czechia

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Tallinn, , Estonia

Site Status RECRUITING

Novartis Investigative Site

Tallinn, , Estonia

Site Status RECRUITING

Novartis Investigative Site

Angers, , France

Site Status WITHDRAWN

Novartis Investigative Site

Besançon, , France

Site Status RECRUITING

Novartis Investigative Site

Bordeaux, , France

Site Status RECRUITING

Novartis Investigative Site

Grenoble, , France

Site Status RECRUITING

Novartis Investigative Site

Lyon, , France

Site Status RECRUITING

Novartis Investigative Site

Marseille, , France

Site Status RECRUITING

Novartis Investigative Site

Poitiers, , France

Site Status RECRUITING

Novartis Investigative Site

Toulouse, , France

Site Status RECRUITING

Novartis Investigative Site

Vandœuvre-lès-Nancy, , France

Site Status RECRUITING

Novartis Investigative Site

Regensburg, Bavaria, Germany

Site Status WITHDRAWN

Novartis Investigative Site

Aachen, , Germany

Site Status RECRUITING

Novartis Investigative Site

Bochum, , Germany

Site Status RECRUITING

Novartis Investigative Site

Münster, , Germany

Site Status RECRUITING

Novartis Investigative Site

Guatemala City, , Guatemala

Site Status RECRUITING

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Guatemala City, , Guatemala

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Quetzaltenango, , Guatemala

Site Status RECRUITING

Novartis Investigative Site

Kwun Tong, Kowloon, Hong Kong

Site Status RECRUITING

Novartis Investigative Site

Tuenmen, , Hong Kong

Site Status RECRUITING

Novartis Investigative Site

Debrecen, Hajdu Bihar Megye, Hungary

Site Status RECRUITING

Novartis Investigative Site

Budapest, , Hungary

Site Status RECRUITING

Novartis Investigative Site

Budapest, , Hungary

Site Status RECRUITING

Novartis Investigative Site

Kaposvár, , Hungary

Site Status RECRUITING

Novartis Investigative Site

Bangalore, Karnataka, India

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Secunderabad, Telangana, India

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Lucknow, Uttar Pradesh, India

Site Status RECRUITING

Novartis Investigative Site

Chandigarh, , India

Site Status RECRUITING

Novartis Investigative Site

Cagliari, CA, Italy

Site Status WITHDRAWN

Novartis Investigative Site

Foggia, FG, Italy

Site Status RECRUITING

Novartis Investigative Site

Florence, FI, Italy

Site Status RECRUITING

Novartis Investigative Site

Milan, MI, Italy

Site Status RECRUITING

Novartis Investigative Site

Pavia, PV, Italy

Site Status RECRUITING

Novartis Investigative Site

Roma, RM, Italy

Site Status RECRUITING

Novartis Investigative Site

Torino, TO, Italy

Site Status RECRUITING

Novartis Investigative Site

Udine, UD, Italy

Site Status RECRUITING

Novartis Investigative Site

Napoli, , Italy

Site Status WITHDRAWN

Novartis Investigative Site

Kaunas, LTU, Lithuania

Site Status RECRUITING

Novartis Investigative Site

Vilnius, , Lithuania

Site Status RECRUITING

Novartis Investigative Site

Kuala Lumpur, Kuala Lumpur, Malaysia

Site Status RECRUITING

Novartis Investigative Site

Sibu, Sarawak, Malaysia

Site Status RECRUITING

Novartis Investigative Site

Kuala Terengganu, Terengganu, Malaysia

Site Status RECRUITING

Novartis Investigative Site

León, Guanajuato, Mexico

Site Status RECRUITING

Novartis Investigative Site

Monterrey, Nuevo León, Mexico

Site Status RECRUITING

Novartis Investigative Site

Oaxaca City, , Mexico

Site Status RECRUITING

Novartis Investigative Site

Querétaro, , Mexico

Site Status WITHDRAWN

Novartis Investigative Site

Querétaro, , Mexico

Site Status RECRUITING

Novartis Investigative Site

Cluj-Napoca, Cluj, Romania

Site Status RECRUITING

Novartis Investigative Site

Oradea, Jud Bihor, Romania

Site Status RECRUITING

Novartis Investigative Site

Timișoara, Timiș County, Romania

Site Status RECRUITING

Novartis Investigative Site

Râmnicu Vâlcea, Vâlcea County, Romania

Site Status WITHDRAWN

Novartis Investigative Site

Bucharest, , Romania

Site Status RECRUITING

Novartis Investigative Site

Bucharest, , Romania

Site Status RECRUITING

Novartis Investigative Site

Singapore, , Singapore

Site Status RECRUITING

Novartis Investigative Site

Singapore, , Singapore

Site Status RECRUITING

Novartis Investigative Site

Bundang Gu, Gyeonggi-do, South Korea

Site Status RECRUITING

Novartis Investigative Site

Suwon, Gyeonggi-do, South Korea

Site Status RECRUITING

Novartis Investigative Site

Daejeon, Korea, South Korea

Site Status WITHDRAWN

Novartis Investigative Site

Busan, , South Korea

Site Status RECRUITING

Novartis Investigative Site

Daegu, , South Korea

Site Status WITHDRAWN

Novartis Investigative Site

Gwangju, , South Korea

Site Status RECRUITING

Novartis Investigative Site

Seoul, , South Korea

Site Status RECRUITING

Novartis Investigative Site

Seoul, , South Korea

Site Status RECRUITING

Novartis Investigative Site

Seoul, , South Korea

Site Status WITHDRAWN

Novartis Investigative Site

Seoul, , South Korea

Site Status RECRUITING

Novartis Investigative Site

Seoul, , South Korea

Site Status RECRUITING

Novartis Investigative Site

Santiago Compostela, A Coruna, Spain

Site Status RECRUITING

Novartis Investigative Site

Barcelona, Catalonia, Spain

Site Status RECRUITING

Novartis Investigative Site

El Palmar, Murcia, Spain

Site Status WITHDRAWN

Novartis Investigative Site

Pamplona, Navarre, Spain

Site Status RECRUITING

Novartis Investigative Site

Vigo, Pontevedra, Spain

Site Status RECRUITING

Novartis Investigative Site

San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain

Site Status RECRUITING

Novartis Investigative Site

Valencia, Valencia, Spain

Site Status RECRUITING

Novartis Investigative Site

Barcelona, , Spain

Site Status RECRUITING

Novartis Investigative Site

Madrid, , Spain

Site Status COMPLETED

Novartis Investigative Site

Madrid, , Spain

Site Status RECRUITING

Novartis Investigative Site

Madrid, , Spain

Site Status RECRUITING

Novartis Investigative Site

Kaohsiung City, , Taiwan

Site Status RECRUITING

Novartis Investigative Site

Taichung, , Taiwan

Site Status RECRUITING

Novartis Investigative Site

Taichung, , Taiwan

Site Status RECRUITING

Novartis Investigative Site

Taipei, , Taiwan

Site Status RECRUITING

Novartis Investigative Site

Songkhla, Hat Yai, Thailand

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Bangkok, , Thailand

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Bangkok, , Thailand

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Bangkok, , Thailand

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Chiang Mai, , Thailand

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Bradford, West Yorkshire, United Kingdom

Site Status RECRUITING

Novartis Investigative Site

London, , United Kingdom

Site Status RECRUITING

Novartis Investigative Site

Hanoi, , Vietnam

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Ho Chi Minh City, , Vietnam

Site Status ACTIVE_NOT_RECRUITING

Countries

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United States Argentina Brazil Canada Chile China Colombia Czechia Estonia France Germany Guatemala Hong Kong Hungary India Italy Lithuania Malaysia Mexico Romania Singapore South Korea Spain Taiwan Thailand United Kingdom Vietnam

Central Contacts

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Novartis Pharmaceuticals

Role: CONTACT

Phone: 1-888-669-6682

Email: [email protected]

Novartis Pharmaceuticals

Role: CONTACT

Phone: +41613241111

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Alason Koenig

Role: primary

Reza Azadegan

Role: primary

Aima Ohiwerei

Role: primary

Ahmad Walid Roshan

Role: primary

Chenoa Vargas

Role: primary

Bosco Trinh

Role: primary

Michael D Fechter

Role: primary

Tia Wilkes

Role: primary

Niurka Colina

Role: primary

Karla Caylor

Role: primary

Victoria Givans

Role: primary

Mannai Coutermarsh

Role: primary

Jacob Seep

Role: primary

Cathryn Leggio

Role: primary

Biljana Basic-Panic

Role: primary

Priscilla Herrera

Role: primary

Maria Munoz

Role: primary

Tatiana Cordero

Role: primary

Natasha Zarrin

Role: primary

Radha Puran

Role: primary

Kelly Wettstein

Role: primary

Kathleen Escoto

Role: primary

Leksi Travitz

Role: primary

Rogel Gonzales

Role: primary

Samina Shehzad

Role: primary

Mohammad Sohail

Role: primary

Sri Cheruku

Role: primary

Azza Badr

Role: primary

Jose Restrepo

Role: primary

Sandy Owings

Role: primary

Musirah Khan

Role: primary

Kian Djamali

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2020-005830-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2023-508559-37-00

Identifier Type: OTHER

Identifier Source: secondary_id

CVAY736K12301

Identifier Type: -

Identifier Source: org_study_id