2024-520098-12-00招募中2 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study With an Open-Label Extension Evaluating the Efficacy and Safety of VENT-03 in Adult Participants With Active Cutaneous Lupus Erythematosus With or Without Systemic Lupus Erythematosus
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 13
- 试验地点
- 18
- 主要终点
- Change from baseline in CLASI-A score on Day 28
研究概览
简要总结
Evaluate the effect of VENT-03 on disease severity as measured by Cutaneous Lupus Erythematosus Disease Area and Severity Index activity (CLASI-A) activity score
研究设计
- 分配方式
- Not Applicable
- 主要目的
- A Phase 2a Of Vent-03 In Participants With Active Cutaneous Lupus Erythematosus
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Male or female participants of age 18 to 70 years, inclusive.
- •Body weight within the range of 40 to 110 kg (88 to 242 lbs), (inclusive).
- •Has provided written informed consent
- •Participants of childbearing potential, participants who are not post-menopausal or surgically sterile must agree to use a highly effective method of contraception from ≥ 30 days prior to dosing through 30 days after the last IMP administration.
- •Participants (or partners of POCBP) who can produce sperm must use a highly effective methods of contraception from ≥ 30 days prior to dosing through 90 days after the last IMP administration. Participants who can produce sperm must agree to not donate sperm through 90 days after the last IMP administration.*
- •Participant is, per the investigator’s assessment, reliable and willing to be available for the duration of the study and is willing and able to perform and follow all study procedures and requirements.
- •Cutaneous lupus at Screening
排除标准
- •Has any clinical condition or clinically significant abnormality at Screening that in the opinion of the Investigator would interfere with evaluation of the IMP, affect participant safety, or interpretation of study results
- •Use of any restricted medications within the stated washout period
- •Intra-articular, intramuscular or IV glucocorticosteroids within 6 weeks prior to Day 1
- •Any live or attenuated vaccine within 8 weeks prior to signing the ICF or Bacillus Calmette-Guerin (BCG) vaccine within 1 year prior to Day
- •Administration of killed vaccines is acceptable;
- •Blood transfusion within 4 weeks prior to Day
- •Patient is taking a strong inhibitor or inducer of CYP2C8 or CYP1A2 Patient is taking a strong inhibitor of the BCRP transporter Patient is taking a narrow therapeutic index medication that is a substrate of CYP2C8 or CYP2C9 Patient is taking a narrow therapeutic index medication that is a substrate of the BCRP, OAT1, OAT3, OATP1B1 or OATP1B3 transporters
- •Has drug induced lupus, rather than “idiopathic” lupus.
- •History of, or current, inflammatory joint or skin disease other than SLE and cutaneous lupus, including other autoimmune that, in the opinion of the Investigator, could interfere with disease activity assessments
- •Diagnosis of mixed connective tissue disease or any history of overlap syndromes of SLE or systemic sclerosis (SSc) within 1 year prior to signing the ICF
- •History of, or current diagnosis of, a clinically significant non SLE-related vasculitis syndrome. Vasculitis due to SLE is permissible.
- •Active severe or unstable neuropsychiatric SLE
- •Participant is involved with the conduct of the study, or is an employee, or immediate family member of individuals involved with the conduct of the study.
- •Active severe SLE-driven renal disease
- •History or current diagnosis of catastrophic or severe anti-phospholipid syndrome within 1 year prior to Day
- •History of any non-lupus disease that has required treatment with oral or parenteral corticosteroids for more than a total of 2 weeks within the last 24 weeks prior to Day
- •Known history of a primary (HIV)
- •Latent or active tuberculosis (TB)
- •Confirmed positive test on hepatitis B serology
- •Positive test for hepatitis C antibody
- •History of any severe herpes infection
- •Herpes zoster
- •Opportunistic infection requiring hospitalization.
- •Had a major surgery within 8 weeks before Day 1 or elective major surgery planned during thestudy period.
- •Cancer screening result suspicious for malignancy or history of cancer within 2 years prior to Day 1
- •Pregnant or nursing.
- •Known hypersensitivity to any components of the VENT-03 formulation.
- •Poor venous access.
- •Currently enrolled in any other interventional clinical trial involving an investigational product within 30 days or 5 half-lives (whichever is longer) prior to dosing or enrolled in any other type of medical research.
- •History of alcohol or substance use disorder in the 12 months prior to Screening or positive drug test at Screening.
- •Regular use of > 1 nonsteroidal anti-inflammatory drug (NSAID) within 2 weeks prior to Day 1 or receipt of fluctuating doses of a NSAID within 2 weeks prior to Day 1.
结局指标
主要结局
Change from baseline in CLASI-A score on Day 28
Change from baseline in CLASI-A score on Day 28
次要结局
- Treatment-emergent adverse events (TEAEs), vital signs, electrocardiogram (ECG), physical examination, and safety laboratory assessments Change from baseline in MXA immunostaining in lesional skin biopsy Plasma concentrations and PK parameters of VENT-03
研究者
Xavier Valencia, MD
Scientific
Ventus Therapeutics U.S. Inc.
研究点 (18)
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