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

Lupus Erythematosus, Systemic Clinical Trial

— RECAST SLE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04925934
• Other study ID #: VIB7734.P2.S1
• Secondary ID: 2020-005528-12
• Status: Completed
• Phase: Phase 2
• Start date: June 24, 2021
• Est. completion date: June 9, 2023

Study information

• Verified date: July 2023
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 214
• Est. completion date: June 9, 2023
• Est. primary completion date: May 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic

Intervention

Drug:
• VIB7734
VIB7734

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
Argentina	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
Argentina	Consultorio de Investigaciones Reumatologicas	San Miguel De Tucumán	Tucumán
Greece	Athens General Hospital 'G Gennimatas	Athens
Greece	Laiko General Hospital of Athens	Athens
Greece	University General Hospital of Larissa	Larisa
Greece	Kianous Stavros	Thessaloníki
India	AES - AS - Panchshil Hospital - Ahmedabad	Ahmedabad	Gujarat
India	AES - AS - Sushruta Multispeciality Hospital & Research Center Pvt Ltd - Hubli	Hubli	Karnataka
India	Jasleen Hospital	Nagpur	Maharashtra
India	Krishna Institute of Medical Sciences	Secunderabad	Andhra Pradesh
India	AES - AS - Unity Trauma Center and ICU - Unity Hospital - Surat	Surat	Gujarat
Mexico	Consultorio de Reumatologia	Ciudad de Mexico
Mexico	AMAF Clinical Research,S.C.	Distrito Federal
Mexico	Bioclinica - Centro Integral En Reumatologia Sociedad Anónima de Capital Variable	Guadalajara	Jalisco
Mexico	Clinica de Investigacion en Reumatologia y Obesidad	Guadalajara
Mexico	Centro de Estudios de Investigacion Basica Y Clinica SC	Jalisco
Mexico	Morales Vargas Centro de Investigacion SC	León	Guanajuato
Mexico	Centro Peninsular de Investigacion S.C.P	Merida	Yucatán
Mexico	Centro de Investigación en Artritis y Osteoporosis	Mexicali	Baja California
Mexico	Centro de Investigación y Tratamiento Reumatológico S.C	San Miguel	Distrito Federal
Mexico	Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.	Zapopan	Jalisco
Poland	Nasz Lekarz Osrodek Badan Klinicznych	Bydgoszcz
Poland	Centrum Medyczne Czestochowa - PRATIA	Czestochowa	Slaskie
Poland	Pratia MCM	Krakow	Malopolskie
Poland	Centrum Medyczne Plejady	Kraków	Malopolskie
Poland	Centrym Medyczne AMED oddzial w Lodzi	Lódz	Lodzkie
Poland	NZOZ Lecznica MAK-MED	Nadarzyn	Mazowieckie
Poland	Twoja Przychodnia - Centrum Medyczne Nowa Sol	Nowa Sól	Lubuskie
Poland	Klinika Reumatologii i Rehabilitacji Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im W. Degi	Poznan	Wielkopolskie
Poland	Centrum Medyczne AMED	Warszawa	Mazowieckie
Poland	Medycyna Kliniczna Marzena Waszczak-Jeka	Warszawa	Mazowieckie
Russian Federation	Belyayev Clinical Hospital of the Kuzbass	Kemerovo
Russian Federation	O.M. Filatov City Clinical Hospital #15	Moscow
Russian Federation	Departmental Hospital at Smolensk Station "rzhd" JSC	Smolensk
Serbia	Institute of Rheumatology Belgrade	Belgrade
Serbia	Military Medical Academy	Belgrade
Serbia	University Clinical Center Kragujevac	Kragujevac
Spain	Hospital Universitario A Coruña	A Coruña
Spain	Hospital Quironsalud Infanta Luisa	Sevilla
Taiwan	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	Province Of China
Ukraine	Limited Liability Company Medical Center Consilium	Kyïv
Ukraine	ME Poltava Reg.Clin.Hospital n.a.M.V.Skliphosovskyi of Poltava Reg.Council	Poltava
Ukraine	Medical Center of LLC Modern Clinic	Zaporizhzhia	Zaporiz'ka Oblast
United States	Emory University School of Medicine	Atlanta	Georgia
United States	Tekton Research Inc	Austin	Texas
United States	NYU Langone Ambulatory Care Brooklyn Heights	Brooklyn	New York
United States	DJL Clinical Research	Charlotte	North Carolina
United States	Clinical Research of West Florida Inc - Clearwater	Clearwater	Florida
United States	Precision Comprehensive Clinical Research Solutions	Colleyville	Texas
United States	Metroplex Clinical Research Center	Dallas	Texas
United States	Spectrum Medical, Inc	Danville	Virginia
United States	Bluegrass Community Research Inc	Lexington	Kentucky
United States	Feinstein Institute For Medical Research	Manhasset	New York
United States	Southwest Rheumatology Research, LLC	Mesquite	Texas
United States	Paramount Medical Research and Consulting LLC	Middleburg Heights	Ohio
United States	Millennium Research	Ormond Beach	Florida
United States	IRIS Research and Development LLC	Plantation	Florida
United States	SUNY Upstate Medical Center	Syracuse	New York
United States	Clinical Research of West Florida Inc - Tampa	Tampa	Florida
United States	Inland Rheumatology Clinical Trials Incorporated	Upland	California

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Argentina,  Greece,  India,  Mexico,  Poland,  Russian Federation,  Serbia,  Spain,  Taiwan,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants who experience AEs, SAEs, AESIs	Safety evaluation will occur throughout the study.	Baseline through Week 56
Primary	Proportion of Participants who achieve BICLA and OGC (oral glucocorticoid) reduction response at Week 48	Participants will have BICLA (BILAG 2004 Index-Based Combined Lupus Assessment) and oral glucocorticoid assessment at week 48.	Week 48
Secondary	Proportion of Participants with CLASI-A score = 10 at Baseline (Day 1) who achieve = 50% reduction from Baseline (Day 1) in CLASI-A score at Week 12	Cutaneous Lupus Erythematosus Disease Area and Severity Index will be measured at week 12. The scoring consists of 2 parts: inflammatory activity of the disease and damage done by the disease.	Week 12
Secondary	Proportion of Participants achieving an SRI-4 response and an OGC dose = 7.5 mg/day and = Baseline (Day 1) dose of prednisone or equivalent at Week 48	The SRI-4 (SLE Responder Index) is defined as meeting all criteria compared to baseline, (e.g. no worsening of symptoms).	Week 48
Secondary	Proportion of Participants at OGC dose = 10 mg prednisone or equivalent at Baseline (Day 1) who achieve an OCG of = 7.5 mg/day prednisone or equivalent at Week 36 through Week 48		Week 36 to Week 48
Secondary	Proportion of Participants achieving LLDAS (Lupus Low Disease Activity State) at Week 48	LLDAS is a composite measure of SLE disease activity that measures 5 criteria: SLEDAI-2K = 4, with no activity in major organ systems, no new lupus disease activity, PGA = 1 (scale 0 to 3), current prednisone (or equivalent) dose = 7.5 mg daily, tolerated maintenance doses of immunosuppressive drugs and approved biological agents.	Week 48