EUCTR2017-003359-43-HR进行中（未招募）1 期
A Phase 2a, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 As Induction And Open Label Extension Treatment In Subjects With Moderate To Severe Crohn's Disease
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 255
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
入选标准
- •1. Male and/or female subjects (including Women of Child Bearing Potential (WOCBP)) ?18 years to ?75 years of age at the time of informed consent. For subjects in Korea: Male and/or female subjects ?19 years to ?5 years of age at the time of informed consent.
- •2. Documented diagnosis of ileal, ileocolonic, or colonic CD with a minimum disease duration of 3 months, as determined by endoscopic and histopathology assessment.
- •3. Endoscopic (central reading) confirmation of active disease with total SES-CD total score of at least 7 (?7)). For isolated ileal disease, SES-CD total score should be at least 4 (?4).
- •4. An average daily liquid/soft stool frequency (SF) ?2.5 or daily abdominal pain (AP) score ?2.0.
- •5. Must have inadequate response to, loss of response to, or intolerance to at least one conventional therapy for CD:
- •Steroids;
- •Immunosuppressants (azathioprine [AZA], 6-MP, or methotrexate [MTX]);
- •Anti-TNF inhibitors (infliximab, adalimumab, or certolizumab);
- •Anti-integrin inhibitors (eg, vedolizumab);
- •Anti-IL-12/23 inhibitor (ustekinumab).
- •However, this inclusion should be met only after the usual clinical practice in each center has been fulfilled, which may involve administration of more than one line of previous treatment.
- •Note: Further guidance information related to this inclusion criteria can be found in the protocol
- •6. Subjects currently receiving the following treatment for CD are eligible providing they have been on stable doses as described below:
- •Oral corticosteroids (prednisone or equivalent up to 25 mg/day; budesonide up to 9 mg/day). Stable dose for at least 2 weeks prior to baseline. If oral corticosteroids have been recently discontinued, they must have been stopped at least 2 weeks prior to baseline. Decreases in steroid use due to AEs are allowed.
- •Oral 5-ASA or sulfasalazine are allowed providing that the dose is stable for at least 4 weeks prior to baseline.
- •Crohn's disease-related antibiotics are allowed providing that the dose is stable for at least 4 weeks prior to baseline. If antibiotics are stopped prior to baseline, they must be discontinued at least 4 days prior to baseline.
- •7. Female subjects of childbearing potential must test negative for pregnancy at screening visit and baseline visit.
- •8. Female subjects considered to be of non-childbearing potential must meet at least 1 of the following criteria:
- •a. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed with a serum follicle-stimulating hormone (FSH) level confirming the postmenopausal state;
- •b. Have undergone a documented hysterectomy and/or bilateral oophorectomy;
- •c. Have medically confirmed ovarian failure.
- •All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.
- •9. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
- •10. Willing and able to comply with s
排除标准
- •1. Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, diverticular disease, ulcerative colitis (UC), or clinical findings suggestive of UC.
- •2. Presence of active (draining) fistulae or intra-abdominal or perineal abscesses.
- •3. Strictures with obstructive symptoms.
- •4. Short bowel syndrome.
- •5. History of bowel perforation requiring surgical intervention within the past 12 months.
- •6. Previous bowel surgery resulting in an existing stoma. Subjects who have a j-pouch are excluded, as a j-pouch can result in a stoma.
- •7. History of bowel surgery within 6 months prior to baseline.
- •8. Subjects considered in imminent need for surgery or with elective surgery scheduled to occur during the study.
- •9. Subjects displaying clinical signs of fulminant colitis or toxic megacolon.
- •10. Subjects with primary sclerosing cholangitis.
- •11. Subjects with evidence of colonic adenomas, dysplasia or neoplasia. However, subjects with prior history of adenomatous polyps or any adenomatous polyps identified on screening will be eligible if the polyps have been completely removed and the subjects are free of polyps at baseline per the assessment of the investigator based on the screening colonoscopy.
- •12. Subjects receiving the following therapies within the time period described below or expected to receive any of these therapies during the study period:
- •a. >9 mg/day of oral budesonide or >25 mg/day of prednisone or equivalent oral systemic corticosteroid dose within 2 weeks prior to baseline.
- •b. IV, IM (parenteral), or topical (rectal) treatment of 5-ASA or corticosteroid enemas/suppositories within 2 weeks prior to baseline.
- •c. Azathioprine, 6-mercaptopurine, or methotrexate within 2 weeks prior to baseline.
- •d. Anti-TNF inhibitors (or biosimilars thereof) as described below:
- •Infliximab within 8 weeks prior to baseline;
- •Adalimumab within 8 weeks prior to baseline;
- •Certolizumab within 8 weeks prior to baseline;
- •e. Anti-integrin inhibitors (eg, vedolizumab) within 8 weeks prior to baseline.
- •f. Ustekinumab within 8 weeks prior to baseline.
- •g. Interferon therapy within 8 weeks prior to baseline.
- •h. Subjects with prior treatment with lymphocyte-depleting agents/therapies within 1 year prior to baseline (eg, CamPath® [alemtuzumab], alkylating agents [eg, cyclophosphamide or chlorambucil], total lymphoid irradiation, etc).
- •i. Subjects who have received rituximab or other selective B lymphocyte-depleting agents within 1 year prior to baseline.
- •j. Subjects previously receiving leukocyte apheresis, including selective lymphocyte, monocyte, or granulocyte apheresis, or plasma exchange within 6 months prior to baseline.
- •k. Other marketed immunosuppressants or biologics with immunomodulatory properties within 3 months prior to baseline.
- •l. Subjects who have received other JAK inhibitors within 3 months prior to baseline.
- •m. Subjects who have not responded to or have been intolerant of other JAK inhibitors.
- •n. Other investigational procedures(s) or product(s
研究者
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