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A Phase 2 of VIB7734 for the Treatment of Moderate to Severely Active SLE (RECAST SLE)

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ClinicalTrials.gov Identifier: NCT04925934
Recruitment Status : Recruiting
First Posted : June 14, 2021
Last Update Posted : June 14, 2021
Sponsor:
Information provided by (Responsible Party):
Viela Bio

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.

Condition or disease Intervention/treatment Phase
Lupus Erythematosus, Systemic Drug: VIB7734 Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 195 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, double-blind, placebo-controlled, parallel-arm study
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Estimated Study Start Date : June 24, 2021
Estimated Primary Completion Date : July 1, 2023
Estimated Study Completion Date : October 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arm Intervention/treatment
Experimental: VIB7734 SC (dosing interval 1) Drug: VIB7734
VIB7734

Experimental: VIB7734 SC (dosing interval 2) Drug: VIB7734
VIB7734

Placebo Comparator: Placebo SC (dosing interval 3) Other: Placebo
Placebo




Primary Outcome Measures :
  1. Proportion of Participants who achieve BICLA and OGC (oral glucocorticoid) reduction response at Week 48 [ Time Frame: Week 48 ]
    Participants will have BICLA (BILAG 2004 Index-Based Combined Lupus Assessment) and oral glucocorticoid assessment at week 48.


Secondary Outcome Measures :
  1. 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 [ Time Frame: 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.

  2. 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 [ Time Frame: Week 48 ]
    The SRI-4 (SLE Responder Index) is defined as meeting all criteria compared to baseline, (e.g. no worsening of symptoms).

  3. 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 [ Time Frame: Week 36 to Week 48 ]
  4. Proportion of Participants achieving LLDAS (Lupus Low Disease Activity State) at Week 48 [ Time Frame: 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.


Other Outcome Measures:
  1. Number of Participants who experience AEs, SAEs, AESIs [ Time Frame: Baseline through Week 60 ]
    Safety evaluation will occur throughout the study.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

    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

Exclusion Criteria:

  • Any condition that, in the opinion of the Investigator, would interfere with the evaluation of the IP or interpretation of participant safety or study results
  • 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
  • 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
  • History of cancer within the past 5 years, except:
  • In situ carcinoma of the cervix and Cutaneous basal cell
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04925934


Contacts
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Contact: Horizon Therapeutics 1-866-479-6742 clinicaltrials@horizontherapeutics.com

Locations
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United States, Florida
Clinical Research of West Florida Inc - Clearwater Recruiting
Clearwater, Florida, United States, 33765-2616
Contact: Maartje Brucculeri       mbrucculeri@crwf.com   
Principal Investigator: Robert Levin, MD         
Clinical Research of West Florida Inc - Tampa Recruiting
Tampa, Florida, United States, 33606-1246
Contact: Courtney Bryan       cbryan@crwf.com   
Principal Investigator: Edgard Janer, MD         
United States, Kentucky
Bluegrass Community Research Inc Recruiting
Lexington, Kentucky, United States, 40504-2931
Contact: Judy Edwards       bcr.net@att.net   
Principal Investigator: Alexander Brown, MD         
United States, North Carolina
DJL Clinical Research Recruiting
Charlotte, North Carolina, United States, 28210-8509
Contact: Audrey Droppelman       audrey.droppelman@djlresearch.com   
Principal Investigator: Emily Box, MD         
Medication Management LLC Recruiting
Greensboro, North Carolina, United States, 27408-7099
Contact: Tiffany Holley       tiffany.holley@emailmm.com   
Principal Investigator: Tauseef Syed, MD         
United States, Ohio
Paramount Medical Research and Consulting LLC Recruiting
Middleburg Heights, Ohio, United States, 44130-3483
Contact: Jackie Wittenmyer       jwittenmyer5@yahoo.com   
Principal Investigator: Isam Diab, MD         
United States, Texas
Tekton Research Inc Recruiting
Austin, Texas, United States, 78745-1485
Contact: Rita Yankyera       RYankyera@tektonresearch.com   
Principal Investigator: Paul Pickrell, MD         
Precision Comprehensive Clinical Research Solutions Recruiting
Colleyville, Texas, United States, 76034-5913
Contact: Shruti Parulekar       shrutiparulekar@pccrsolutions.com   
Principal Investigator: Dhiman Basu, MD         
United States, Virginia
Spectrum Medical, Inc Recruiting
Danville, Virginia, United States, 24541-1222
Contact: Tisha McMillon       tisha.mcmillon@spectrummed.com   
Principal Investigator: Sharukh Shroff, MD         
Sponsors and Collaborators
Viela Bio
Investigators
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Study Director: Neema Dhungana Horizon Therapeutics
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Responsible Party: Viela Bio
ClinicalTrials.gov Identifier: NCT04925934    
Other Study ID Numbers: VIB7734.P2.S1
2020-005528-12 ( EudraCT Number )
First Posted: June 14, 2021    Key Record Dates
Last Update Posted: June 14, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases