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

NCT04925934 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: VIB7734.P2.S12020-005528-12
• Study Type: interventional
• Target: 214
• Locations: 11 countries
• Sites: 67

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants Achieving a BILAG-2004 Index-based Combined Lupus Assessment (BICLA) Response and an OGC Dose ≤ 7.5 mg/Day and ≤ Baseline Dose of Prednisone or Equivalent at Week 48

  A BICLA response required improvement in all domains affected at baseline, assessed by the BILAG 2004, no worsening of other BILAG 2004 domains, no worsening of SLEDAI-2K or PGA scores compared with baseline, no use of restricted medications beyond the protocol-allowed threshold, and no discontinuation of IP.

  Week 48

Secondary Outcomes (9)

• Number of Participants With a Cutaneous Lupus Erythematosus Disease Area and Severity Index-Activity (CLASI-A) Score ≥ 10 at Baseline Achieving ≥ 50% Reduction From Baseline in CLASI-A Score at Week 12

  Week 12

• Number of Participants Achieving an SLE Responder Index (SRI)-4 Response and an OGC Dose ≤ 7.5 mg/Day and ≤ Baseline Dose of Prednisone or Equivalent at Week 48

  Week 48

• Number of Participants With an OGC Dose ≥ 10 mg/Day of Prednisone or Equivalent at Baseline Who Maintained an OGC Dose ≤ 7.5 mg/Day From Week 36 Through Week 48

  Week 36 up to Week 48

• Number of Participants Achieving Lupus Low Disease Activity State (LLDAS) at Week 48

  Week 48

• Serum Concentration of Daxdilimab

  Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48

Study Arms (3)

VIB7734 SC (dosing interval 1)

EXPERIMENTAL

Drug: VIB7734

VIB7734 SC (dosing interval 2)

EXPERIMENTAL

Drug: VIB7734

Placebo SC (dosing interval 3)

PLACEBO COMPARATOR

Other: Placebo

Interventions

VIB7734 DRUG

VIB7734

Also known as: Daxdilimab, HZN-7734

VIB7734 SC (dosing interval 1); VIB7734 SC (dosing interval 2)

Placebo OTHER

Placebo

Placebo SC (dosing interval 3)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amgen: lead

Study Sites (67)

Inland Rheumatology Clinical Trials Incorporated

Upland, California, 91786, United States

Location

Clinical Research of West Florida Inc - Clearwater

Clearwater, Florida, 33765-2616, United States

Location

Millennium Research

Ormond Beach, Florida, 32174, United States

Location

IRIS Research and Development LLC

Plantation, Florida, 33324, United States

Location

Clinical Research of West Florida Inc - Tampa

Tampa, Florida, 33606-1246, United States

Location

Emory University School of Medicine

Atlanta, Georgia, 30322, United States

Location

Bluegrass Community Research Inc

Lexington, Kentucky, 40504-2931, United States

Location

NYU Langone Ambulatory Care Brooklyn Heights

Brooklyn, New York, 11201, United States

Location

Feinstein Institute For Medical Research

Manhasset, New York, 11030-3816, United States

Location

SUNY Upstate Medical Center

Syracuse, New York, 13210, United States

Location

DJL Clinical Research

Charlotte, North Carolina, 28210-8509, United States

Location

Paramount Medical Research and Consulting LLC

Middleburg Heights, Ohio, 44130-3483, United States

Location

Tekton Research Inc

Austin, Texas, 78745-1485, United States

Location

Precision Comprehensive Clinical Research Solutions

Colleyville, Texas, 76034-5913, United States

Location

Metroplex Clinical Research Center

Dallas, Texas, 75231, United States

Location

Southwest Rheumatology Research, LLC

Mesquite, Texas, 75150, United States

Location

Spectrum Medical, Inc

Danville, Virginia, 24541-1222, United States

Location

Consultorios Médicos Dr. Doreski

Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ABP, Argentina

Location

Clínica Adventista Belgrano

Estomba, Buenos Aires, C1430EGF, Argentina

Location

Framingham Centro Médico

La Plata, Buenos Aires, B1902COS, Argentina

Location

Instituto CER S.A

Quilmes, Buenos Aires, B1878DVB, Argentina

Location

Instituto de Investigaciones Clinicas Quilmes SRL

Quilmes, Buenos Aires, B1878GEG, Argentina

Location

Centro Medico Privado de Reumatologia

San Miguel de Tucumán, Tucumán Province, T4000AXL, Argentina

Location

Consultorio de Investigaciones Reumatologicas

San Miguel de Tucumán, Tucumán Province, T4000AXL, Argentina

Location

Athens General Hospital 'G Gennimatas

Athens, 115 27, Greece

Location

Laiko General Hospital of Athens

Athens, 115 27, Greece

Location

University General Hospital of Larissa

Larissa, 411 10, Greece

Location

Kianous Stavros

Thessaloniki, 546 36, Greece

Location

Krishna Institute of Medical Sciences

Secunderabad, Andhra Pradesh, 500003, India

Location

AES - AS - Panchshil Hospital - Ahmedabad

Ahmedabad, Gujarat, 380005, India

Location

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

Surat, Gujarat, 395010, India

Location

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

Hubli, Karnataka, 580021, India

Location

Jasleen Hospital

Nagpur, Maharashtra, 440012, India

Location

Centro de Investigación en Artritis y Osteoporosis

Mexicali, Estado de Baja California, 21200, Mexico

Location

Morales Vargas Centro de Investigacion SC

León, Guanajuato, 37000, Mexico

Location

Bioclinica - Centro Integral En Reumatologia Sociedad Anónima de Capital Variable

Guadalajara, Jalisco, 44160, Mexico

Location

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

Zapopan, Jalisco, 45030, Mexico

Location

Centro de Investigación y Tratamiento Reumatológico S.C

San Miguel, Mexico City, 11850, Mexico

Location

Centro Peninsular de Investigacion S.C.P

Mérida, Yucatán, 97000, Mexico

Location

AMAF Clinical Research,S.C.

Distrito Federal, 06760, Mexico

Location

Clinica de Investigacion en Reumatologia y Obesidad

Guadalajara, 44600, Mexico

Location

Centro de Estudios de Investigacion Basica Y Clinica SC

Jalisco, 44690, Mexico

Location

Consultorio de Reumatologia

Mexico City, 07760, Mexico

Location

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

Poznan, Greater Poland Voivodeship, 61-545, Poland

Location

Centrum Medyczne Plejady

Krakow, Lesser Poland Voivodeship, 30-363, Poland

Location

Pratia MCM

Krakow, Lesser Poland Voivodeship, 30-510, Poland

Location

Twoja Przychodnia - Centrum Medyczne Nowa Sol

Nowa Sól, Lubusz Voivodeship, 67-100, Poland

Location

NZOZ Lecznica MAK-MED

Nadarzyn, Masovian Voivodeship, 05-830, Poland

Location

Medycyna Kliniczna Marzena Waszczak-Jeka

Warsaw, Masovian Voivodeship, 00-874, Poland

Location

Centrum Medyczne AMED

Warsaw, Masovian Voivodeship, 03-291, Poland

Location

Centrum Medyczne Czestochowa - PRATIA

Częstochowa, Silesian Voivodeship, 42-200, Poland

Location

Nasz Lekarz Osrodek Badan Klinicznych

Bydgoszcz, 85-065, Poland

Location

Centrym Medyczne AMED oddzial w Lodzi

Lodz, Łódź Voivodeship, 91-365, Poland

Location

Belyayev Clinical Hospital of the Kuzbass

Kemerovo, 650066, Russia

Location

O.M. Filatov City Clinical Hospital #15

Moscow, 111539, Russia

Location

Departmental Hospital at Smolensk Station "rzhd" JSC

Smolensk, 214025, Russia

Location

Institute of Rheumatology Belgrade

Belgrade, 11000, Serbia

Location

Military Medical Academy

Belgrade, 11000, Serbia

Location

University Clinical Center Kragujevac

Kragujevac, 34000, Serbia

Location

Hospital Universitario A Coruña

A Coruña, 15006, Spain

Location

Hospital Quironsalud Infanta Luisa

Seville, 41010, Spain

Location

Kaohsiung Veterans General Hospital

Kaohsiung City, Province of China, 81362, Taiwan

Location

National Taiwan University Hospital

Taipei, Province of China, 100, Taiwan

Location

Chang Gung Memorial Hospital, Linkou

Taoyuan District, Province of China, 333, Taiwan

Location

Medical Center of LLC Modern Clinic

Zaporizhzhia, Zaporizhzhia Oblast, 69005, Ukraine

Location

Limited Liability Company Medical Center Consilium

Kiyiv, 04050, Ukraine

Location

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

Poltava, 36024, Ukraine

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

medinfo@amgen.com

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

• Nisha Jain, MD

  Horizon Therapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, placebo-controlled, parallel-arm study

Study Record Dates

• First Submitted: May 4, 2021
• First Posted: June 14, 2021
• Study Start: May 28, 2021
• Primary Completion: May 16, 2023
• Study Completion: June 9, 2023
• Last Updated: July 23, 2024
• Results First Posted: July 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

RU (3); SE (3); US (17); ME (10); PL (10); UA (3); IN (5); GR (4); ES (2); AR (7); TW (3)