NCT04286789已完成1 期
A Randomized, Double-blind, Parallel, Vehicle Controlled, Repeat Dose Comparative Phase 1b Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ORTD-1 in Rheumatoid Arthritis Patients With Mild Disease Managed With DMARDs
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 3
- 主要终点
- Safety and Tolerability of ORTD-1 measured by the number of patients with adverse events
研究概览
简要总结
This is a randomized, vehicle controlled, double-blind, repeat dose comparative study in patients with rheumatoid arthritis (RA) under management with DMARDs and with persistent disease activity. The goal of this study is to evaluate the safety, tolerability and pharmacokinetics of 6 weekly repeat doses of ORTD-1.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years of age or older, males or females.
- •Diagnosed rheumatoid arthritis per the American Rheumatism Association 1987 classification criteria of at least 6 months duration.
- •Disease activity defined as:
- •erythrocyte sedimentation rate (ESR) > 24 mm or serum C-reactive protein level ≥ 1.2 times (X) the upper limit of normal (ULN), and
- •DAS28-CRP score ≥ 2.6 and < 5.1
- •Current regimen of DMARDs that may include methotrexate, sulfasalazine, hydroxychloroquine, leflunomide and/or azathioprine, alone or in combination.
- •No change in DMARD dose(s) within 4 weeks prior to Screening.
- •May be receiving a stable regimen (of at least 4 weeks duration) of concomitant NSAIDs.
- •Women of child-bearing potential (WOCBP), defined as a sexually mature woman not surgically sterilized, or not post-menopausal for at least 12 consecutive months. Female subjects must:
- •Not be lactating; not be pregnant upon enrollment.
- •Agree to use highly effective methods of birth control throughout the study. Highly effective methods of contraception include combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation by oral, intravaginal, or transdermal administration; progestogen-only hormonal contraception associated with inhibition of ovulation by oral, injectable, or implantable administration; intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; partner vasectomy; or total abstinence (only if total abstinence is an established method and lifestyle of the subject).
- •Patients already using hormonal contraception at the time of screening will be eligible but will not initiate hormonal contraception in order to participate in the study.
- •Agree to use highly effective methods of birth control for at least 6 months after the last dose of investigational product.
- •Male subjects must refrain from donating sperm or fathering a child during the study.
- •Male subjects must use barrier contraception throughout the course of the study.
- •Signed and dated informed consent.
排除标准
- •Prior therapy with any biologic therapeutic within 3 months prior to enrollment, or in the case of Rituxan (rituximab), this period must be at least 12 months.
- •History of or current clinical fibromyalgia or Juvenile Idiopathic Arthritis (JIA).
- •Positive diagnosis of SLE.
- •Patients with Type 1 or Type 2 Diabetes Mellitus.
- •Patients with psoriasis.
- •Patients with skin condition(s) or visible abnormalities at or near potential sites of injection (right and left abdomen; right and left thigh) that could mask the assessment of safety.
- •Acute illness including current or chronic infections requiring antibiotics, or symptoms of a resolving illness, within 2 weeks prior to study.
- •Any investigational drug within 3 months prior to study.
- •Patients may not be receiving systemic corticosteroid therapy with the exception of inhaled corticosteroids for the treatment of asthma.
- •Any clinically relevant abnormality as assessed by the Investigator, on screening history, physical exam, clinical laboratory, chest X-ray, or ECG, other than values consistent with rheumatoid arthritis, with the exception that liver function tests (ALP, ALT, AST) may be up to 1.5 times (X) the upper limit of normal (ULN).
- •Positive serological test for HCV, HBsAg, HBcAg, HIV.
- •QuantiFERON-positive patients may be enrolled with documented evidence that they have completed a prescribed course of antituberculous therapy.
- •History of cardiovascular disease with New York Heart Association (NYHA) functional class II or greater; or history of stroke, or uncontrolled hypertension.
- •History of lymphoproliferative disease, or organ allograft.
- •Pregnancy or lactation, or WOCBP not currently using contraceptives or male partners of WOCBP not currently using contraceptives.
- •History of cancer (except for in situ cancer, or limited stage cancer of the cervix, head and neck (squamous cell), thyroid, or skin (non-melanomatous) curatively treated with no sign of disease for > 5 years).
- •Any physical or psychological condition that might prevent complete participation in the study, in the view of the investigator.
研究组 & 干预措施
ORTD-1-Low Dose
Experimental
5.6 mg/0.45 mL of active study drug
干预措施: Low dose ORTD-1 (Drug)
Vehicle Control -Low Dose
Placebo Comparator
Vehicle (Identical formulation without the active DP)
干预措施: Low dose vehicle control (Drug)
ORTD 1-High Dose
Experimental
22.5 mg/1.8 mL of active study drug
干预措施: High dose ORTD-1 (Drug)
Vehicle Control -High Dose
Placebo Comparator
Vehicle (Identical formulation without the active DP)
干预措施: High dose vehicle control (Drug)
结局指标
主要结局
Safety and Tolerability of ORTD-1 measured by the number of patients with adverse events
时间窗: 10 weeks
Safety will be assessed throughout the duration of the study (weeks 1 through 10) by monitoring of adverse events.
次要结局
- Immunogenicity by measurement of anti-drug antibodies(Weeks 1, 3, 5, and 10)
- Cmax of ORTD-1(Week 1 through week 6)
- Serum concentration of ORTD-1 from baseline(10 weeks)
- Tmax of ORTD-1(Week 1 through week 6)
研究者
研究点 (3)
Loading locations...
相似试验
已完成
2 期
NFX-179 Topical Gel Treatment for Adults With Neurofibromatosis 1 (NF1) and Cutaneous Neurofibromas (cNF)Neurofibromatosis 1Cutaneous NeurofibromaNCT05005845NFlection Therapeutics, Inc.199
已完成
2 期
Clinical Trial of Patidegib Gel 2%, 4%, and Vehicle Applied Once or Twice Daily to Decrease the GLI1 Biomarker in Sporadic Nodular Basal Cell CarcinomasBasal Cell CarcinomasNCT02828111PellePharm, Inc.36
已完成
2 期
Safety and Efficacy Study of Topically Applied DS107 Cream in Mild to Moderate Atopic Dermatitis Patients (AD)Atopic DermatitisNCT02925793DS Biopharma327
已完成
3 期
A Randomized, Double-Blind, Vehicle-Controlled Study in Subjects With Seborrheic KeratosisSeborrheic KeratosisNCT02667275Aclaris Therapeutics, Inc.487
已完成
2 期
A Study to Determine the Efficacy and Safety of Halobetasol Propionate Lotion 0.05% in Subjects With Plaque PsoriasisPsoriasisPlaque PsoriasisNCT01610596Therapeutics, Inc.72