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

Ведущий спонсор: Viela Bio

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.

• Lupus Erythematosus, Systemic

Тип вмешательства: Drug

Название вмешательства: VIB7734

Описание: VIB7734

Тип вмешательства: Other

Название вмешательства: Placebo

Описание: Placebo

Этикетка Arm Group: Placebo SC (dosing interval 3)

Критерии:

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

Пол:

All

Минимальный возраст:

18 Years

Максимальный возраст:

70 Years

Здоровые волонтеры:

No

Фамилия: Horizon Therapeutics

Телефон: 1-866-479-6742

Argentina

Greece

Mexico

Poland

Spain

Ukraine

United States

2022-01-01

Тип: Sponsor

• Lupus Erythematosus, Systemic

Метка: VIB7734 SC (dosing interval 1)

Тип: Experimental

Метка: VIB7734 SC (dosing interval 2)

Тип: Experimental

Метка: Placebo SC (dosing interval 3)

Тип: Placebo Comparator

Распределение: Randomized

Модель вмешательства: Parallel Assignment

Описание модели вмешательства: Randomized, double-blind, placebo-controlled, parallel-arm study

Первичное назначение: Treatment

Маскировка: Double (Participant, Investigator)