EUCTR2015-001555-69-PL进行中（未招募）1 期
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Multiple Ascending Dose Study (Induction Therapy) and Long-term Extension Therapy of an Anti-OX40 Monoclonal Antibody (KHK4083) in Subjects with Moderately Active Ulcerative Colitis
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
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) Subject is able and willing to comply with study procedures, dosing and visit schedules and follow-up procedures as described in the protocol and ICF;
- •2) Subject voluntarily signs/dates an IEC approved ICF in accordance with regulatory and institutional guidelines;
- •3) Male and female subjects = 18 years of age at the time of enrollment;
- •4) Subject has UC that was diagnosed at least 6 months prior to the Screening visit;
- •5) Subject has moderately active UC, defined as:
- •Total Mayo Clinic score of 4 to 9 (range: 0 to 12, with higher scores indicating more disease activity);
- •Endoscopy subscore (mMES determined by a central reader) of at least 2; and
- •Disease that extends = 15 cm from the anal verge.
- •6) Subject has had previous treatment (within 5 years prior to
- •Screening) with one or more of the following: corticosteroids,
- •immunosuppressive medications or tumor necrosis factor (TNF)
- •antagonist therapy that was unsuccessful because of a lack of efficacy response or AEs, as defined below:
- •a)corticosteroids for induction therapy of at least prednisolone equivalent of 20 mg (or oral budesonide 9 mg) oral daily for 2 weeks or injectable for 1 week, or for maintenance therapy at least two failed attempts to reduce to less than prednisolone-equivalent 10 mg (or oral budesonide 3 mg) oral daily, or a history of intolerance to corticosteroids (including but not limited to hypertension, insomnia, osteopenia, osteoporosis, hyperglycemia, infection or Cushing's syndrome);
- •b)Azathioprine or 6-mercaptopurine of at least 1.5 mg/kg/day or 0.75 mg/kg/day, respectively, for 8 weeks, or a history of intolerance to either agent (including but not limited to nausea, vomiting, abdominal pain, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) elevations, thiopurine methyltransferase genetic mutation, or infection);
- •c)Tumor necrosis factor-alpha antagonists for induction therapy with approved anti-TNF products including, but not limited to, infliximab 5 mg/kg IV for 2 doses at least 2 weeks apart, adalimumab 160 mg SC followed by at least 80 mg SC at least 2 weeks apart, and golimumab 200 mg SC followed by at least 100 mg at least 2 weeks apart and anti-TNF biosimilar products with approved dosages for 2 doses at least 2 weeks apart; or as maintenance therapy for recurrence of symptoms despite continued
- •dosing, or history of intolerance (including but not limited to infusion or injection reactions, demyelination or infection).
- •7) Female subjects who are considered to be women of childbearing potential (WOCBP) must have a negative pregnancy test at Screening and Baseline. WOCBP must agree to use effective contraception, defined as oral contraceptives with one barrier method, or tubal ligation with one barrier method or double barrier method (condom plus spermicide
- •or diaphragm plus spermicide) during the study and for at least 6 months after the last dose of investigational product. Subjects are considered to not be of childbearing potential if they are = 50 years of age and without menses for 24 consecutive months and have a follicle stimulating hormone level > 25 mIU/mL (or in postmenopausal range per local laboratory standards); or have undergone a hysterectomy
- •and/or a bilateral salpingo-oophorectomy.
- •Egg donation is not permitted while on study medication and for at least 6 months after the last dose of study medication.
- •8) Male subjects (including those who have had a vasectomy) must use adequate contraception (e.g., latex condom, non-l
排除标准
- •1) Subject, who is judged by the Inv to be inappropriate for this study;
- •2) Medical history of clinically significant (as determined by Inv or Sponsor) cardiac, renal, hepatic/biliary, pulmonary or other medical condition or is not generally in good health; Subjects with history of immunologic, autoimmune or chronic inflammatory disorders (e.g.,
- •uveitis, rheumatoid arthritis, ankylosing spondylitis or spondyloarthritis, psoriasis) other than UC or autoimmune connective tissue diseases (e.g., systemic lupus erythematosus, systemic sclerosis) and are well controlled may be included into the trial after consultancy with medical
- •monitor. Subjects with thyroid disorders, vitiligo, or alopecia are eligible for inclusion.
- •3) Subject's UC had failed to respond to: a) 2 or more biologic treatments with different mechanisms of action (e.g infliximab and vedolizumab), or b) 3 or more anti-TNF biologics (e.g. infliximab, adalimumab and golimumab)
- •4) Requires prescription treatment for UC, except for stable, oral treatment of UC:
- •Aminosalicylates for at least 14d prior to Screening visit; and/or •Glucocorticoids for at least 14d prior to Screening visit and/or •Azathioprine up to 3 mg/kg/d or 6-mercaptopurine up to 1.5 mg/kg/d for total period of at least 12 wk, including 4 wk of stable treatment,
- •prior to Screening visit.
- •5) Received any of the following treatments within the specified time
- •prior to Baseline visit: •Natalizumab, efalizumab or rituximab or other lymphocyte-depleting
- •treatments, including but not limited, to alkylating agents and total lymphoid irradiation at any time •TNF antagonists within 8 wk, or 5 halflives (not exceeding 12 wk) •Vedolizumab within 16 wk •Methotrexate, cyclosporine, mycophenolate, tacrolimus, thalidomide, or other immune
- •altering drugs within 4 wk •5-ASA enema, or steroid enema or suppository use within 2 wk and/or •Investigational agents within 8 wk or 5 half-lives, whichever is longer.
- •6) Recent, suspected or confirmed symptomatic stenosis of the colon, abdominal bscess, ischemic colitis based on clinical or radiographic data; or suspected, confirmed or history of toxic megacolon; or any colonic resection, subtotal or total colectomy, ileostomy, or colostomy; or any previous surgery for UC or an anticipated requirement for surgery
- •7) Known colonic dysplasia, adenomas or polyposis;
- •8) Major surgery within 4 weeks prior to Screening or anticipated requirement for major surgery;
- •9) Enteric pathogens detected on stool analysis; or C difficile infection within 8 wk prior to Screening; or intestinal pathogen infection detected within 4 wk prior to Screening;
- •10) Any of the following laboratory values •Platelet count < 100,000/mm3•Neutrophils < 1500/mm3 •Serum creatinine = 1.6 mg/dL (= 144.4 µmol/L) •Alkaline phosphatase > 3 times ULN •Aspartate aminotransferase or ALT > 2 times ULN •Total bilirubin > 2 mg/dL, unless due to Gilbert's Syndrome •Serum albumin < 3 g/dL • Hemoglobin < 9 g/dL •Glycated serum hemoglobin A1c = 9%.
- •11) Clinically significant cardiac disease; unstable angina pectoris; myocardial infarction within 6m or post angioplasty or stenting within 6m; uncontrolled hypertension; or clinically significant abnormality, eg cardiac arrhythmia, on 12-lead ECG at Screening;
- •12) Pregnant or breastfeeding;
- •13) Has had a major immunologic reaction
- •14) Hep B core antibody or surface antigen +ve at Screening and/or Hep C antibody +ve with detectable RNA at Screening;
- •15) History of HIV positivity, tests
研究者
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