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Lupus Erythematosus, SystemicPhase 2RECAST SLENCT04925934

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

A Phase 2 study testing VIB7734 in people with Lupus Erythematosus, Systemic, run by Amgen at 67 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Lupus Erythematosus, Systemic
What is being tested?
VIB7734
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
214 participants
Where
67 sitesin 11 countries
Study dates
28 May 2021to 9 Jun 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 19Show fewer
  • 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):
  • 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.

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

67 sites in 11 countries.

67 sites in 11 countries

United States17 sites

  • Emory University School of Medicine

    Atlanta, Georgia, 30322

  • Tekton Research Inc

    Austin, Texas, 78745-1485

  • NYU Langone Ambulatory Care Brooklyn Heights

    Brooklyn, New York, 11201

  • DJL Clinical Research

    Charlotte, North Carolina, 28210-8509

  • Clinical Research of West Florida Inc - Clearwater

    Clearwater, Florida, 33765-2616

  • Precision Comprehensive Clinical Research Solutions

    Colleyville, Texas, 76034-5913

  • Metroplex Clinical Research Center

    Dallas, Texas, 75231

  • Spectrum Medical, Inc

    Danville, Virginia, 24541-1222

  • Bluegrass Community Research Inc

    Lexington, Kentucky, 40504-2931

  • Feinstein Institute For Medical Research

    Manhasset, New York, 11030-3816

  • Southwest Rheumatology Research, LLC

    Mesquite, Texas, 75150

  • Paramount Medical Research and Consulting LLC

    Middleburg Heights, Ohio, 44130-3483

  • Millennium Research

    Ormond Beach, Florida, 32174

  • IRIS Research and Development LLC

    Plantation, Florida, 33324

  • SUNY Upstate Medical Center

    Syracuse, New York, 13210

  • Clinical Research of West Florida Inc - Tampa

    Tampa, Florida, 33606-1246

  • Inland Rheumatology Clinical Trials Incorporated

    Upland, California, 91786

Other trials in United States

Mexico10 sites

  • AMAF Clinical Research,S.C.

    Distrito Federal, 06760

  • Bioclinica - Centro Integral En Reumatologia Sociedad Anónima de Capital Variable

    Guadalajara, Jalisco, 44160

  • Clinica de Investigacion en Reumatologia y Obesidad

    Guadalajara, 44600

  • Centro de Estudios de Investigacion Basica Y Clinica SC

    Jalisco, 44690

  • Morales Vargas Centro de Investigacion SC

    León, Guanajuato, 37000

  • Centro Peninsular de Investigacion S.C.P

    Mérida, Yucatán, 97000

  • Centro de Investigación en Artritis y Osteoporosis

    Mexicali, Estado de Baja California, 21200

  • Consultorio de Reumatologia

    Mexico City, 07760

  • Centro de Investigación y Tratamiento Reumatológico S.C

    San Miguel, Mexico City, 11850

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

    Zapopan, Jalisco, 45030

Other trials in Mexico

Poland10 sites

  • Nasz Lekarz Osrodek Badan Klinicznych

    Bydgoszcz, 85-065

  • Centrum Medyczne Czestochowa - PRATIA

    Częstochowa, Silesian Voivodeship, 42-200

  • Centrum Medyczne Plejady

    Krakow, Lesser Poland Voivodeship, 30-363

  • Pratia MCM

    Krakow, Lesser Poland Voivodeship, 30-510

  • Centrym Medyczne AMED oddzial w Lodzi

    Lodz, Łódź Voivodeship, 91-365

  • NZOZ Lecznica MAK-MED

    Nadarzyn, Masovian Voivodeship, 05-830

  • Twoja Przychodnia - Centrum Medyczne Nowa Sol

    Nowa Sól, Lubusz Voivodeship, 67-100

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

    Poznan, Greater Poland Voivodeship, 61-545

  • Medycyna Kliniczna Marzena Waszczak-Jeka

    Warsaw, Masovian Voivodeship, 00-874

  • Centrum Medyczne AMED

    Warsaw, Masovian Voivodeship, 03-291

Other trials in Poland

Argentina7 sites

  • Consultorios Médicos Dr. Doreski

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ABP

  • Clínica Adventista Belgrano

    Estomba, Buenos Aires, C1430EGF

  • Framingham Centro Médico

    La Plata, Buenos Aires, B1902COS

  • Instituto CER S.A

    Quilmes, Buenos Aires, B1878DVB

  • Instituto de Investigaciones Clinicas Quilmes SRL

    Quilmes, Buenos Aires, B1878GEG

  • Centro Medico Privado de Reumatologia

    San Miguel de Tucumán, Tucumán Province, T4000AXL

  • Consultorio de Investigaciones Reumatologicas

    San Miguel de Tucumán, Tucumán Province, T4000AXL

Other trials in Argentina

India5 sites

  • AES - AS - Panchshil Hospital - Ahmedabad

    Ahmedabad, Gujarat, 380005

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

    Hubli, Karnataka, 580021

  • Jasleen Hospital

    Nagpur, Maharashtra, 440012

  • Krishna Institute of Medical Sciences

    Secunderabad, Andhra Pradesh, 500003

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

    Surat, Gujarat, 395010

Other trials in India

Greece4 sites

  • Athens General Hospital 'G Gennimatas

    Athens, 115 27

  • Laiko General Hospital of Athens

    Athens, 115 27

  • University General Hospital of Larissa

    Larissa, 411 10

  • Kianous Stavros

    Thessaloniki, 546 36

Other trials in Greece

Russia3 sites

  • Belyayev Clinical Hospital of the Kuzbass

    Kemerovo, 650066

  • O.M. Filatov City Clinical Hospital #15

    Moscow, 111539

  • Departmental Hospital at Smolensk Station "rzhd" JSC

    Smolensk, 214025

Other trials in Russia

Serbia3 sites

  • Institute of Rheumatology Belgrade

    Belgrade, 11000

  • Military Medical Academy

    Belgrade, 11000

  • University Clinical Center Kragujevac

    Kragujevac, 34000

Other trials in Serbia

Taiwan3 sites

  • Kaohsiung Veterans General Hospital

    Kaohsiung City, Province of China, 81362

  • National Taiwan University Hospital

    Taipei, Province of China, 100

  • Chang Gung Memorial Hospital, Linkou

    Taoyuan, Province of China, 333

Other trials in Taiwan

Ukraine3 sites

  • Limited Liability Company Medical Center Consilium

    Kyiv, 04050

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

    Poltava, 36024

  • Medical Center of LLC Modern Clinic

    Zaporizhzhya, Zaporizhzhia Oblast, 69005

Other trials in Ukraine

Spain2 sites

  • Hospital Universitario A Coruña

    A Coruña, 15006

  • Hospital Quironsalud Infanta Luisa

    Seville, 41010

Other trials in Spain

About this study

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

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.

Being tested
VIB7734, Placebo
Medical subject headings
Lupus Erythematosus, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VIB7734Drug

    Also called Daxdilimab, HZN-7734

    VIB7734

  • PlaceboOther

    Placebo

Study groups in NCT04925934
Study groupRoleWhat they receive
VIB7734 SC (dosing interval 1)ExperimentalNot described
Receives: Drug: VIB7734
VIB7734 SC (dosing interval 2)ExperimentalNot described
Receives: Drug: VIB7734
Placebo SC (dosing interval 3)Placebo comparatorNot described
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Week 48

Secondary outcomes (9)

  1. 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

    The CLASI-A evaluates erythema (0-3 [higher scores indicate more severe redness]), scale/hypertrophy (0-2 [higher scores indicate more extensive scaling/thickening]), mucous membrane lesions (0 [absent] or 1 [present]), recent hair loss (0 [absent] or 1 [present]), and non-scarring alopecia (0-3 [(higher scores indicate more extensive hair loss without scarring]) at 13 anatomical sites on the skin. Total score is calculated by summing scores across all anatomical locations for each parameter. Higher total scores indicate greater disease activity and severity in SLE. Reduction of 50% in CLASI-A score was defined by meeting all the following conditions:

    1. A ≥ 50% reduction of CLASI-A score at Week 12 as compared to baseline.
    2. No use of restricted medications beyond the protocol-allowed threshold before assessment.
    3. No discontinuation of IP.

    Measured: Week 12

  2. 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

    The SRI-4 measures reduction in SLE disease activity and it is a composite measure that includes the SLEDAI-2K, BILAG-2004, and PGA. SRI responder was defined by meeting all of the following criteria: 1) Reduction of ≥4 points from baseline in SLEDAI-2K score; 2) no new BILAG A or no more than 1 new BILAG B disease activity scores and 3) no worsening (defined as an increase of ≥0.3 points [0-3 scale] from baseline) in the PGA.

    Measured: Week 48

  3. 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

    Maintenance of OGC reduction from Week 36 to Week 48 was defined by meeting all the following criteria:

    1. Achieved an OGC dose of ≤ 7.5 mg/day prednisone or equivalent at Week 36
    2. Maintained an OGC dose of ≤ 7.5 mg/day from Week 36 through Week 48
    3. No use of restricted medications beyond the protocol-allowed threshold before assessment
    4. No discontinuation of IP before assessment

    Measured: Week 36 up to Week 48

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

    LLDAS was defined by meeting all of the following criteria:

    1. SLEDAI-2K ≤ 4, with no activity in major organ systems (renal, central nervous system, cardiopulmonary, vasculitis, fever) and no hemolytic anemia or gastrointestinal activity measured as maintaining a D (no disease activity but suggests the system had previously been affected) or E (no current or previous disease activity) score in BILAG Gastrointestinal Body System
    2. No new lupus disease activity compared with the previous
    3. Physician's Global Assessment of Disease Activity ≤ 1 on a 3-point visual analog scale from no disease activity to severe disease activity
    4. A current prednisolone (or equivalent) dose ≤ 7.5 mg daily
    5. Well-tolerated standard maintenance doses of immunosuppressive drugs and approved biological agents

    Measured: Week 48

  5. Serum Concentration of Daxdilimab

    Measured: 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

  6. Number of Participants With Anti-drug Antibodies (ADA) to Daxdilimab

    A baseline ADA-positive participant was defined as a participant who had an ADA positive sample at baseline. ADA incidence is the number of the participants ADA positive post-Baseline only or who boosted their preexisting ADA (≥ 4 × Baseline level) during the trial. Persistent positive was defined as ADA positive at ≥ 2 post-Baseline assessments (with ≥ 16 weeks between first and last positive) or positive at last post-Baseline assessment. Transient positive was defined as ADA post-Baseline positive but did not fulfill the criteria of persistent positive.

    Measured: Baseline to Week 56

  7. Change From Baseline in Plasmacytoid Dendritic Cell (pDCs) Expression in Blood

    Measured: Baseline, Week 4, Week 8, Week 12, Week 20, Week 24, Week 32, Week 36, Week 44, Week 48, Week 52, Week 56

  8. Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)

    An adverse event (AE) is any untoward medical occurrence associated with the use of an intervention in humans whether or not it is considered intervention-related. TEAEs are AEs that started on or after the first dose of IP. An AE was considered serious (SAE) if it resulted in any of the following outcomes: death, a life-threatening AE, inpatient hospitalization or prolonged existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, a congenital abnormality/birth defect, or an important medical event. AE severity was rated according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0: grade 1 (mild), grade 2 (moderate), grade 3 (severe), grade 4 (life-threatening), grade 5 (death).

    Measured: Up to Week 56

  9. Number of Participants Who Experienced AEs of Special Interest (AESI)

    An AESI is an AE of scientific and medical interest specific to understanding of the IP and may require close monitoring and collection of additional information by the Investigator. AESIs for this study included:

    1. Hypersensitivity reaction, including anaphylaxis.
    2. Severe (Grade 3 or higher) viral infections/reactivations.
    3. Opportunistic infection.
    4. Malignancy (except non-melanoma skin cancer).

    Measured: Up to Week 56

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jun 2021
  2. Study start28 May 2021
  3. Primary completion16 May 2023
  4. Study completion9 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized, double-blind, placebo-controlled, parallel-arm study
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
214 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04925934
Sponsor's protocol ID
VIB7734.P2.S1
Other IDs
2020-005528-12
Acronym
RECAST SLE
Status last verified
Jul 2024
First submitted
4 May 2021
Last updated
23 Jul 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing VIB7734 in people with Lupus Erythematosus, Systemic, run by Amgen at 67 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 67 sites in United States, Mexico, Poland, Argentina, India and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Week 48). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04925934.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2024.

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