Study of VIB7734 for the Treatment of Moderate to Severely Active SLE

NCT ID: NCT04925934

Last Updated: 2024-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 214 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-28
• Study Completion Date: 2023-06-09

Brief Summary

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of VIB7734 for the Treatment of Moderate to Severely Active Systemic Lupus Erythematosus in approximately 195 participants. The study duration will be 48 weeks, with a safety follow-up through week 56.There will be 3 parallel arms - 2 active treatment and 1 placebo.

Conditions

Lupus Erythematosus, Systemic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

VIB7734 SC (dosing interval 1)

Group Type: EXPERIMENTAL

VIB7734

Intervention Type: DRUG

VIB7734

VIB7734 SC (dosing interval 2)

Group Type: EXPERIMENTAL

VIB7734

Intervention Type: DRUG

VIB7734

Placebo SC (dosing interval 3)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo

Interventions

VIB7734

VIB7734

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: OTHER

Other Intervention Names

Daxdilimab; HZN-7734

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years to ≤ 70 years
• Willing and able to understand and provide written informed consent.
• Fulfill the 2019 European League Against Rheumatism/American College of Rheumatology Classification Criteria for SLE
• Disease duration of at least 6 months
• Active SLE as indicated by presence of all the following:

1. SLEDAI-2K total score ≥ 6 at Screening, excluding fever, SLE headache, or organic brain syndrome.

2. SLEDAI-2K total score ≥ 4, excluding points attributable to any urine or laboratory results, immunologic measures, fever, SLE headache, or organic brain syndrome at Screening and Baseline (Day 1).

3. At least one of the following BILAG 2004 Index levels of disease at Screening:

• BILAG A disease in ≥ 1 organ system
• BILAG B disease in ≥ 2 organ systems d. PGA score ≥ 1 on a 0 to 3 visual analog scale (VAS) at Screening

Have at least one of the following at Screening per central lab:

• ANA ≥ 1:80
• Anti-dsDNA antibodies elevated to above normal range as established by the central laboratory (ie, positive results)
• Anti-Smith antibodies elevated to above normal (ie, positive results) Ongoing treatment for SLE

1. Treatment with one or more disease-modifying anti-rheumatic drug (DMARD) or immunosuppressive medication: Any of the following medications each administered at conventional anti-rheumatic doses for treatment of SLE for at least 12 weeks before Screening (unless discontinued or dose adjusted for documented drug-related toxicity or size/weight), and at a stable dose (including route of administration) for a minimum of 8 weeks prior to Screening and maintained through Baseline (Day 1):

2. Treatment with OGC monotherapy (without the concomitant use of DMARDs or immunosuppressants):

• Average daily dose of PO prednisone ≥ 10 mg but ≤ 40 mg (or prednisone equivalent) for a minimum of 4 weeks prior to Screening and a stable dose for minimum of 2 weeks prior to Screening. The dose of OGC must be kept for a minimum of 2 weeks prior to Randomization. Daily dosing or alternate day dosing of PO prednisone or equivalent is allowed.
• Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at Randomization.
• Non-sterilized male participants who are sexually active with a woman partner of childbearing potential must agree to use a condom with spermicide from Randomization and until 3 months (approximately 5 half-lives) after receipt of the last dose.

Exclusion Criteria

• Any condition that, in the opinion of the Investigator, or the Sponsor/Central Review Committee, would interfere with the evaluation of the IP or interpretation of participant safety or study results (including borderline disease activity)
• History of allergy, hypersensitivity reaction, or anaphylaxis to any component of the IP or a previous mAb or human Ig therapy
• Active LN or active severe or unstable neuropsychiatric SLE
• Current diagnosis of non-SLE vasculitis syndrome, mixed connective tissue disease, or rheumatic (overlap) syndrome
• Participation in another clinical study with an investigational drug within 4 weeks before Day 1
• Breastfeeding or pregnant women or women who intend to become pregnant anytime from signing the ICF through 6 months after receiving the last dose of IP
• Major surgery within 8 weeks prior to Screening or elective surgery planned from Screening through Day 393.
• Spontaneous or induced abortion, still or live birth, or pregnancy ≤ 4 weeks before Screening
• Known history of a primary immunodeficiency or an underlying condition such as known human immunodeficiency virus (HIV) infection
• Hepatitis B, Hepatitis C, active TB, any severe herpes infection, clinically active infection, or opportunistic infection
• History of clinically significant cardiac disease including unstable angina; and/or myocardial infarction and/or congestive heart failure within 6 months prior to Randomization.
• History of cancer within the past 5 years except, in situ carcinoma of the cervix, cutaneous basal cell or squamous cell carcinoma with curative therapy.
• Receipt of a live-attenuated vaccine within 4 weeks before Day 1 Administration of inactivated (killed) vaccines is acceptable
• The use of immunosuppressants, biologics and DMARDS within the protocol defined washout periods

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MD

Role: STUDY_DIRECTOR

Amgen

Nisha Jain, MD

Role: STUDY_DIRECTOR

Horizon Therapeutics

Locations

Inland Rheumatology Clinical Trials Incorporated

Upland, California, United States

Clinical Research of West Florida Inc - Clearwater

Clearwater, Florida, United States

Millennium Research

Ormond Beach, Florida, United States

IRIS Research and Development LLC

Plantation, Florida, United States

Clinical Research of West Florida Inc - Tampa

Tampa, Florida, United States

Emory University School of Medicine

Atlanta, Georgia, United States

Bluegrass Community Research Inc

Lexington, Kentucky, United States

NYU Langone Ambulatory Care Brooklyn Heights

Brooklyn, New York, United States

Feinstein Institute For Medical Research

Manhasset, New York, United States

SUNY Upstate Medical Center

Syracuse, New York, United States

DJL Clinical Research

Charlotte, North Carolina, United States

Paramount Medical Research and Consulting LLC

Middleburg Heights, Ohio, United States

Tekton Research Inc

Austin, Texas, United States

Precision Comprehensive Clinical Research Solutions

Colleyville, Texas, United States

Metroplex Clinical Research Center

Dallas, Texas, United States

Southwest Rheumatology Research, LLC

Mesquite, Texas, United States

Spectrum Medical, Inc

Danville, Virginia, United States

Consultorios Médicos Dr. Doreski

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Clínica Adventista Belgrano

Estomba, Buenos Aires, Argentina

Framingham Centro Médico

La Plata, Buenos Aires, Argentina

Instituto CER S.A

Quilmes, Buenos Aires, Argentina

Instituto de Investigaciones Clinicas Quilmes SRL

Quilmes, Buenos Aires, Argentina

Centro Medico Privado de Reumatologia

San Miguel de Tucumán, Tucumán Province, Argentina

Consultorio de Investigaciones Reumatologicas

San Miguel de Tucumán, Tucumán Province, Argentina

Athens General Hospital 'G Gennimatas

Athens, , Greece

Laiko General Hospital of Athens

Athens, , Greece

University General Hospital of Larissa

Larissa, , Greece

Kianous Stavros

Thessaloniki, , Greece

Krishna Institute of Medical Sciences

Secunderabad, Andhra Pradesh, India

AES - AS - Panchshil Hospital - Ahmedabad

Ahmedabad, Gujarat, India

AES - AS - Unity Trauma Center and ICU - Unity Hospital - Surat

Surat, Gujarat, India

AES - AS - Sushruta Multispeciality Hospital & Research Center Pvt Ltd - Hubli

Hubli, Karnataka, India

Jasleen Hospital

Nagpur, Maharashtra, India

Centro de Investigación en Artritis y Osteoporosis

Mexicali, Estado de Baja California, Mexico

Morales Vargas Centro de Investigacion SC

León, Guanajuato, Mexico

Bioclinica - Centro Integral En Reumatologia Sociedad Anónima de Capital Variable

Guadalajara, Jalisco, Mexico

Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.

Zapopan, Jalisco, Mexico

Centro de Investigación y Tratamiento Reumatológico S.C

San Miguel, Mexico City, Mexico

Centro Peninsular de Investigacion S.C.P

Mérida, Yucatán, Mexico

AMAF Clinical Research,S.C.

Distrito Federal, , Mexico

Clinica de Investigacion en Reumatologia y Obesidad

Guadalajara, , Mexico

Centro de Estudios de Investigacion Basica Y Clinica SC

Jalisco, , Mexico

Consultorio de Reumatologia

Mexico City, , Mexico

Klinika Reumatologii i Rehabilitacji Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im W. Degi

Poznan, Greater Poland Voivodeship, Poland

Centrum Medyczne Plejady

Krakow, Lesser Poland Voivodeship, Poland

Pratia MCM

Krakow, Lesser Poland Voivodeship, Poland

Twoja Przychodnia - Centrum Medyczne Nowa Sol

Nowa Sól, Lubusz Voivodeship, Poland

NZOZ Lecznica MAK-MED

Nadarzyn, Masovian Voivodeship, Poland

Medycyna Kliniczna Marzena Waszczak-Jeka

Warsaw, Masovian Voivodeship, Poland

Centrum Medyczne AMED

Warsaw, Masovian Voivodeship, Poland

Centrum Medyczne Czestochowa - PRATIA

Częstochowa, Silesian Voivodeship, Poland

Nasz Lekarz Osrodek Badan Klinicznych

Bydgoszcz, , Poland

Centrym Medyczne AMED oddzial w Lodzi

Lodz, Łódź Voivodeship, Poland

Belyayev Clinical Hospital of the Kuzbass

Kemerovo, , Russia

O.M. Filatov City Clinical Hospital #15

Moscow, , Russia

Departmental Hospital at Smolensk Station "rzhd" JSC

Smolensk, , Russia

Institute of Rheumatology Belgrade

Belgrade, , Serbia

Military Medical Academy

Belgrade, , Serbia

University Clinical Center Kragujevac

Kragujevac, , Serbia

Hospital Universitario A Coruña

A Coruña, , Spain

Hospital Quironsalud Infanta Luisa

Seville, , Spain

Kaohsiung Veterans General Hospital

Kaohsiung City, Province of China, Taiwan

National Taiwan University Hospital

Taipei, Province of China, Taiwan

Chang Gung Memorial Hospital, Linkou

Taoyuan District, Province of China, Taiwan

Medical Center of LLC Modern Clinic

Zaporizhzhia, Zaporizhzhia Oblast, Ukraine

Limited Liability Company Medical Center Consilium

Kiyiv, , Ukraine

ME Poltava Reg.Clin.Hospital n.a.M.V.Skliphosovskyi of Poltava Reg.Council

Poltava, , Ukraine

Countries

United States; Argentina; Greece; India; Mexico; Poland; Russia; Serbia; Spain; Taiwan; Ukraine

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

2020-005528-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

VIB7734.P2.S1

Identifier Type: -

Identifier Source: org_study_id