EUCTR2017-000575-88-GB进行中（未招募）1 期
A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 305) - CARMEN CD 305
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,032
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.Subjects and/or their parent or legally authorized representative must have an understanding, ability, and willingness to fully comply with study procedures and restrictions.
- •2.Subjects must be able to voluntarily provide written, signed, and dated (personally or via a legally authorized representative) informed consent and/or assent as applicable to participate in the study.
- •3.Subjects must be between =16 and =80 years of age at the time of the signing of the informed consent/assent form. Note: Subjects <18 years of age must weigh =40 kg and must have body mass index =16.5 kg/m2.
- •4.Subjects must have active moderate to severe ileal (terminal ileum), ileocolic, or colonic CD at baseline (Visit 2) as defined by:
- •a.CDAI score between 220 and 450 (inclusive) AND
- •b.Presence of ulcerations that are characteristic to CD, as determined by a colonoscopy performed during screening, and as defined by the SES-CD >6 (SES-CD =4 for isolated ileitis) AND
- •c.Meeting the following subscores in the 2-item PRO:
- •i.Abdominal pain subscore =5 (average worst daily pain on the 11-point NRS) AND abdominal pain subscore > 2 (average daily pain on the 4point abdominal pain variable of CDAI) over the 7 most recent days out of the 10 days before colonoscopy preparation (may or may not be contiguous) AND/OR
- •ii.Average of the daily stool frequency subscore =4 of type 6/7 (very soft stools/liquid stools) as shown in the BSFS over the 7 most recent days out of the 10 days before colonoscopy preparation (may or may not be contiguous).
- •c. Presence of ulcerations that are characteristic to CD, as determined by a colonoscopy performed during screening, and as defined by the SES-CD >6 (SES-CD =4 for isolated ileitis) Note that the subject must be confirmed as meeting the CDAI score and PRO subscore requirements before a colonoscopy is done.
- •5.Subjects must have a documented diagnosis (endoscopic with histology) of CD for =3 months before screening. Documented diagnosis is defined as:
- •A biopsy report in which the description of the histological findings is consistent with the CD diagnosis AND
- •A report documenting disease duration based upon prior colonoscopy.
- •Note: If a biopsy report is not available in the source document at the
- •time of screening, a biopsy must be performed during the screening
- •colonoscopy and the histology report should be consistent with the CD
- •diagnosis. If the histology description does not support the CD diagnosis is
- •not clear at this time point, the subject should not be randomized
- •6.Subjects must be willing and able to undergo a colonoscopy during screening after all other inclusion criteria have been met.
- •7.Subjects must have had an inadequate response to, or lost response to, or had an intolerance to at least 1 conventional treatment such as sulfasalazine or mesalamine (5-ASA), glucocorticoids, immunosuppressants (AZA, 6-MP, or MTX), or anti-TNF (see to Appendix 4 of the protocol for guidance).
- •Subjects who have had an inadequate response to sulfasalazine or mesalamine should have also failed at least 1 other conventional treatment such as glucocorticoids.
排除标准
- •1.Subjects with indeterminate colitis, microscopic colitis, non-steroidal anti-inflammatory drug-induced colitis, ischemic colitis, infectious colitis, or clinical/histologic findings suggestive of ulcerative colitis.
- •2.Subjects with colonic dysplasia or neoplasia. (Subjects with prior
- •history of adenomatous polyps will be eligible if the polyps have been completely removed.)
- •3.Subjects with past medical history or presence of toxic megacolon.
- •4.Subjects with presence of enterovesical (ie, between the bowel and urinary bladder) or enterovaginal fistulae.
- •5.Subjects with current symptomatic diverticulitis or diverticulosis.
- •6.Subjects with clinically significant obstructive colonic stricture, or
- •who have a history of bowel surgery within 6 months before screening,
- •or who are likely to require surgery for CD during the treatment period. Subjects who have undergone
- •previous colonic resection or
- •ileocolectomy more than 6 months before screening must have at least 25 cm of colon remaining.
- •7.Subjects with past medical history of multiple small bowel resections resulting in clinically significant short bowel syndrome.
- •8.Subjects requiring total parenteral nutrition.
- •9.Subjects with past medical history of bowel surgery resulting in an existing or current stoma. Subjects who had a j-pouch are excluded as a j-pouch could result in a stoma.
- •10.Subjects have had prior treatment with ontamalimab (formerly PF00547659;
- •11.Subjects with known or suspected intolerance or hypersensitivity to the investigational product(s), closely related compounds, or any of the stated ingredients.
- •12.Subjects have received any nonbiologic treatment
- •with immunomodulatory properties (other than AZA, 6-MP, or MTX) or
- •continuous antibiotics (>2 weeks) for the treatment of CD within 30 days before baseline (Visit 2).
- •13.Subjects have received anti-TNF treatment within 60 days before baseline (Visit 2).
- •14.Subjects have received any biologic with
- •immunomodulatory
- •properties (other than anti-TNFs) within 90 days before baseline (Visit 2).
- •15.Subjects have ever received anti integrin/adhesion
- •molecule treatment (eg, natalizumab, vedolizumab, efalizumab, etrolizumab,
- •or any other investigational anti-integrin/adhesion
- •16.Subjects have received lymphocytes apheresis or selective monocyte
- •granulocytes apheresis within 60 days before baseline (Visit 2).
- •17.Subjects have received enteral nutrition treatment within 30 days before baseline (Visit 2).
- •18.Subjects have received parenteral or rectal glucocorticoids or rectal
- •5-ASA within 14 days before screening colonoscopy.
- •19.Subjects have taken >20 mg/day of prednisone, >9 mg/day of budesonide, or equivalent oral systemic corticosteroid dose within
- •14 days before baseline (Visit 2) or have taken =40 mg/day of prednisone or equivalent oral systemic corticosteroid dose within 6 weeks before
- •baseline (Visit 2).
研究者
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