EUCTR2011-005036-26-GB进行中（未招募）不适用
An Exploratory Phase IIa Study to Investigate the Biological Activity of Oral FX125L in Adult Patients with Chronic Inflammatory Disease
Funxional Therapeutics Ltd0 个研究点开始时间: 2011年10月31日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Willing and able to give written informed consent and to comply with the requirements of the study.
- •2.Male or female aged 18–77 years, inclusive.
- •3.Body mass index 18–35 kg/m2, inclusive.
- •4.Females of child-bearing potential must be using an adequate and medically acceptable contraception method.
- •5.Females of child-bearing potential must not be lactating or pregnant (negative serum beta-human chorionic gonadotropin on Screening or urine pregnancy test at Day -1 visit).
- •6.Male patients must agree not to donate sperm, and to take appropriate precautions to avoid fathering a child, throughout the study and until 90 days after the end of treatment.
- •7.Ability to produce an analysable sample of sputum at Screening. This is defined as a) a sputum plug with a weight exceeding 500 mg and b) more than 300 intact leukocytes on a cytospin slide.
- •In addition, patients must meet the inclusion criteria for a chronic inflammatory disease as follows:
- •1.Documented diagnosis of asthma at least 6 months prior to Screening or equivalent that confirms the diagnosis meets this criteria
- •2.Forced expiratory volume in 1 second =60% and =90% of predicted at Screening and Randomisation (Day -1).
- •3.Sputum eosinophilia =3% at Screening.
- •Chronic Obstructive Pulmonary Disorder:
- •1.Documented diagnosis of moderate to severe COPD, according to Global Initiative for Chronic Obstructive Lung Disease criteria, at least 6 months prior to the screening visit, and who meet the criteria for Stage II–III disease at Screening , and who meet the criteria for Stage II–III disease at Screening.
- •2.Stable disease for at least 1 month prior to Screening.
- •3.Sputum neutrophils = 40% at Screening.
- •Rheumatoid Arthritis:
- •1.Documented diagnosis of rheumatoid arthritis according to the 1996 American College or Rheumatology (ACR) / European League Against Rheumatism criteria.
- •2.Global functional class I, II or III according to the ACR 1991 revised criteria at Screening and Day -1.
- •3.At least six swollen joints and at least six tender joints during the 28-joint assessment performed at Screening and Day -1.
- •4.C-reactive protein =7.0 mg/L at Screening.
- •5.Presence of anti-cyclic citrullinated peptide antibodies >50 ELISA Units (or above the median titre among RA patients for the anti-cyclic citrullinated peptide assay used at the clinical site) at Screening.
- •1.Documented diagnosis of moderate/severe chronic plaque psoriasis for more than 6 months, and eligible for systemic treatment , or equivalent that confirms the diagnosis meets this criteria.
- •2.Plaque psoriasis covering greater than 5% of total body surface area and a Psoriasis Area and Severity Index score of 12.0 or more at Screening and Day -1.
- •3.At least one evaluable plaque psoriasis lesion with a Psoriatic Lesion Severity Sum total score (erythema, induration and scaling) of 5–12 and an induration score of 2–4 at Screening and Day -1.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 119
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 119
排除标准
- •1.Any condition, including findings in the medical history or in the pre-study assessments, which, in the opinion of the Investigator, constitute a risk or contraindication for the participation of the subject in the study, or that could interfere with the study objectives, conduct, or evaluation including, but not limited to:
- •-Any clinically significant abnormality in the results of screening safety laboratory tests.
- •-Positive test for drugs of abuse.
- •-Positive alcohol breath test.
- •-Positive results from serum tests for hepatitis B surface antigen (except if due to vaccination), hepatitis C, or HIV.
- •-History or presence of liver disease.
- •-History or presence of endocrine disorders or diseases affecting the hypothalamic-pituitary-adrenal axis, including acromegaly, growth hormone deficiency, adrenal insufficiency, Cushing’s syndrome, Grave’s Disease, Hashimoto’s Disease, uncontrolled diabetes mellitus, with the exception of idiopathic hypothyroidism in patients > 60 years.
- •-History of hypofertility.
- •-History of cancer in the preceding 5 years (except adequately treated basal cell carcinoma of the skin and squamous cell carcinoma in situ of the skin)
- •2.History or presence of drug or alcohol abuse.
- •3.History or active manifestation of a serious psychiatric illness including depression, suicidal ideation or psychosis.
- •4.Positive test for latent tuberculosis.
- •5.Requirement for immunisations or vaccinations within 7 days of any visit during the entire study period (including the screening, treatment and follow-up phases).
- •6.Previous participation in the current study, or administration of any investigational product within 12 weeks (or at least 5 times the half-life of the product, if longer) prior to entry into the study.
- •7.Acute infection requiring a visit to a doctor or hospital, or treatment with a prescription-only medication, within 2 weeks prior to Day 1.
- •8.Any condition that may affect the absorption of an orally administered drug, for example, but not limited to, ulcerative colitis or resection of the stomach or small bowel.
- •9.Required to take a proscribed drug during the study.
- •10.History of treatment with corticosteroids, whether systemic, topical or inhaled, within 1 month of screening.
- •11.History of treatment with a biological anti-inflammatory therapy within 6 months of screening.
- •12.History of exposure to FX125L.
- •Patients must not meet any exclusion criteria for at least 1 of the chronic inflammatory disease(s) for which they met the disease-specific inclusion criteria:
- •1.Received treatment with topical or oral asthma or allergy medications except ß-agonists within 4 weeks prior to Screening.
- •2.Suffer from respiratory diseases, other than asthma or allergic rhinitis, which would interfere with asthma disease assessments.
- •3.Respiratory infections within 8 weeks prior to Day 1.
- •4.Asthma exacerbation leading to hospitalisation for >2 days within the last 6 months or a hospital accident and emergency visit due to asthma exacerbation in the last 3 months.
- •1.Exacerbation of COPD requiring treatment with oral steroids or hospitalisation within 3 months prior to screening, or >2 such exacerbations with the 6 months prior to screening.
- •2.Suffer from respiratory diseases other than COPD that would interfere with COPD disease assessments.
- •3.Evidence of cor pulmonale, clinically significant pulmonary hypertension or chronic use of oxygen.
- •4.History of lung resection or lung reduction surgery.
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