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
- Conditions
- Systemic Lupus Erythematosus (SLE)MedDRA version: 21.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2020-005528-12-ES
- Lead Sponsor
- Viela Bio, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 195
1. Age = 18 years to = 70 years at the time of signing the ICF.
2. Willing and able to understand and provide written informed consent prior to any study-related procedures and to comply with all study requirements and complete study assessments.
3. Fulfill the 2019 European League Against Rheumatism/American College of Rheumatology Classification Criteria for SLE.
4. Disease duration of at least 6 months from the time of diagnosis at the time of signing ICF.
5. 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.
• 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
• PGA score = 1 on a 0 to 3 VAS at Screening.
6. 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.
• Anti-Smith antibodies elevated to above normal.
7. Ongoing treatment for SLE defined as (a) or (b):
a. 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):
i. Antimalarial
ii. Azathioprine (AZA) or 6-mercaptopurine (6-MP)
iii. Leflunomide
iv. Mycophenolate mofetil (MMF) or mycophenolic acid (MPA)
v. Methotrexate (MTX) (participants must be on concomitant folic or folinic acid supplementation if using MTX)
vi. Voclosporin (if approved for treatment)
vii. GCs are permitted but not required if a participant is receiving at least one other medication listed above. If GCs are used in combination with allowed DMARDs or immunosuppressants, they must be at an average daily dose of PO prednisone = 40 mg (or prednisone equivalent) for a minimum of 2 weeks prior to Screening and at a stable dose for a minimum of 2 weeks prior to Screening. In addition, the dose of OGC must be kept stable for a minimum of 2 weeks prior to Randomization. Daily dosing or alternate day dosing of PO prednisone (or prednisone equivalent) is allowed.
b. Treatment with OGC monotherapy (without the concomitant use of DMARDs or immunosuppressants):
i. Average daily dose of PO prednisone = 10 mg but = 40 mg (or prednisone equivalent) for a minimum of 4 weeks prior to Screening and at a stable dose for a minimum of 2 weeks prior to Screening. In addition, the dose of OGC must be kept stable for a minimum of 2 weeks prior to Randomization. Daily dosing or alternate day dosing of PO prednisone (or prednisone equivalent) is allowed.
8. Women of childbearing potential must have a negative urine pregnancy test at Randomization. Women of childbearing potential are defined as those who are not surgically sterile or those who are not postmenopausal.
Women of childbearing potential who are sexually active with a non-sterilized male partner must agree to use a highly effective method
1. Individuals involved in the conduct of the study, their employees, or immediate family members of such individuals.
2. Any condition that, in the opinion of the Investigator, would interfere with evaluation of the IP or interpretation of participant safety or study results.
3. History of allergy, hypersensitivity reaction, or anaphylaxis to any component of the IP or to a previous mAb or human Ig therapy.
4. Participation in another clinical study with an investigational drug within 4 weeks prior to Day 1 or within 5 published half-lives, whichever is longer.
5. 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.
6. History of drug or alcohol abuse that, in the opinion of the Investigator, might affect participant safety or compliance with visits, or interfere with other study assessments.
7. Major surgery within 8 weeks prior to Screening or elective surgery planned from Screening through Day 393.
8. Spontaneous or induced abortion, still or live birth, or pregnancy = 4 weeks prior to Screening.
9. Known history of a primary immunodeficiency or an underlying condition such as known HIV infection, a positive result for HIV infection per central laboratory, splenectomy, or any underlying condition that in the opinion of the Investigator significantly predisposes the participant to infection.
10. At Screening, any of the following per central laboratory:
• Aspartate aminotransferase (AST) > 2.5× upper limit of normal (ULN)
• Alanine aminotransferase (ALT) > 2.5× ULN
• Total bilirubin > 1.5× ULN (unless due to Gilbert’s syndrome)
• Serum IgG < 600 mg/dL (or < 6 g/L)
• Neutrophil count < 1000/µL (or < 1.0×109/L) or < 500/µL (< 0.5×109/L) if due to active SLE
• Platelet count < 50,000/µL (or < 50×109/L) or < 25,000/µL (< 25×109/L) if due to active SLE
• Hemoglobin < 8 g/dL (or < 80 g/L) or < 7 g/dL (< 70 g/L) if due to active SLE
• Glycosylated hemoglobin > 8% (or > 0.08)
• Total lymphocyte count < 200 cells/mm3
• Glomerular filtration rate < 30 mL/min/1.73 m2
• Spot UPCr > 3 mg/mg
11. Confirmed positive test for hepatitis B serology defined as:
• Hepatitis B surface antigen, or
• Hepatitis B core antibody AND hepatitis B virus DNA detected above the lower limit of quantitation by reflex testing by the central laboratory at Screening.
12. Positive test for hepatitis C virus antibody.
13. Active TB, or a positive IFN-gamma release assay test at Screening, unless documented history of appropriate treatment for active or latent TB.
14. Any severe herpes virus family infection at any time prior to Randomization, including, but not limited to, disseminated herpes, herpes encephalitis, recent recurrent herpes zoster, or ophthalmic herpes.
15. Any herpes zoster, CMV, or Epstein-Barr virus infection that was not completely resolved 12 weeks prior to Randomization.
16. Any of the following within 30 days prior to signing the ICF and though Randomization:
• Clinically significant active infection in the opinion of the Investigator, including ongoing, and chronic infection requiring antibiotics or antiviral medication.
• Any infection requiring hospitalization or treatment with IV anti-infectives.
• A participant with a documented positive SARS-CoV-2 test may be rescreened at least 2 weeks after a positive test if the participant is asymptomatic and at least 3 weeks after symptomatic COVID-19 illness.
17. Opportunistic infection requiring hospit
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method