EUCTR2018-001272-37-BG进行中（未招募）1 期
A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Induction Therapy with 2 Doses of TD-1473 in Subjects with Moderately-to-Severely Active Crohn’s Disease - Efficacy and Safety of TD-1473 in Crohn’s Disease
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 160
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
- •Inclusion Criteria for Induction:
- •1. Subject is willing and able to provide written, signed informed consent at Screening Part 1 prior to start of any study-related procedures
- •2. Subject is a male or female at least 18 years of age at the time of Screening
- •3. Subject has a diagnosis of CD with involvement of at least the ileum or any portion of the colon at a minimum, diagnosed by radiology, endoscopy, and/or histology at least 3 months prior to Screening. The report of a previous diagnostic exam (endoscopy, radiology, and/or pathology) must be reviewed by the investigator and included in the source documents.
- •4. Subjects must have up-to-date colorectal cancer screening as per locally adopted guidelines (e.g., if subject has had = 8 years of disease involving >30% of the colon, surveillance biopsies or chromoendoscopy should be performed if either is indicated as per locally adopted guidelines but has not been performed within the 12 months prior to Screening). If indicated, the surveillance biopsies (if = 10) and chromoendoscopy need to be performed during Screening Stage 2 ileocolonoscopy after recording of a full ileocolonoscopy has been completed to avoid dye or biopsy related bleeding artifact on the recorded images.)
- •5. Subject has CDAI score = 220 and = 450
- •6. Subject has a SES-CD score of = 3 with ulceration (corresponding to a score of =1) in at least 1 of the 5 ileocolonic segments on the Ulcerated Surface subscore of the SES CD, as assessed by central reading, during Screening
- •a.Up to approximately 10% of the study population will have SES-CD score of between 3 and 5, inclusive, with the presence of ulceration in any 1 of the 5 ileocolonic segments, all other subjects (approximately
- •90% of the study population) will require an SES-CD score of = 6 (= 4 if isolated ileal disease) with ulceration (corresponding to a score of = 1) in at least 1 of the 5 ileocolonic segments on the Ulcerated Surface subscore of the SES-CD
- •7. Subject is corticosteroid-dependent or had intolerance or inadequate response to any of the following: aminosalicylates, corticosteroids, immunomodulators (azathioprine, 6-mercaptopurine, or methotrexate), or biologics (anti-TNF anti-IL- 12/IL-23 therapy, or anti-integrin)
- •NOTE: For subjects in Portugal, subject must have had intolerance or
- •inadequate response to biologics
- •8. If subject is currently receiving an oral corticosteroid, subject is eligible if:
- •a. the subject has been on corticosteroid for a minimum of 4 weeks prior to Day 1 AND
- •b. the dose is equivalent to or less than prednisone 25 mg/day or budesonide 9 mg/day or beclomethasone at 5 mg/day AND
- •c. the dose is stable for at least 2 weeks prior to Screening Stage 2 AND
- •d. the subject is willing to continue on the same dose as warranted until Week 8
- •9. If subject is currently receiving oral aminosalicylate (including, but not limited to sulfasalazine or mesalamine), the subject is eligible provided the subject has been on a stable dose for = 4 weeks prior to Day 1 and is willing to stay on the same dose as warranted until Week 12
- •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 140
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1. Subject with a confirmed or suspected diagnosis or history of primary sclerosing cholangitis (PSC)
- •2. Subject has had extensive colonic resection (i.e., more than half of colon), subtotal or total colectomy, intestinal resection within 6 months of Screening, > 2 small bowel resections or carries a diagnosis of short bowel syndrome or currently has an ostomy
- •3. Subject has a history of unresected colonic mucosal dysplasia or history of resected high-grade colonic dysplasia within 3 years prior to Screening. Subjects will not be excluded from the study because of a pathology finding of indefinite dysplasia with reactive atypia or because of adenomas that have been completely resected
- •4. Medications of exclusion below must be discontinued within the timeframe specified (if applicable)
- •azathioprine, 6-mercaptopurine, or methotrexate taken within the 14 days prior to Day 1
- •anti-TNFs (e.g., adalimumab, infliximab, golimumab, etanercept, certolizumab, or biosimilars) taken within the 60 days or 5 half-lives, whichever is longer, prior to Day 1
- •intravenous corticosteroids within the 14 days prior to Day 1
- •rectal mesalamine or corticosteroid (i.e., enemas or suppositories) taken within the 14 days prior to Day 1
- •prior exposure to vedolizumab, ustekinumab, mycophenolic acid, tacrolimus, sirolimus, or cyclosporine taken within 60 days or 5 half-lives, whichever is longer prior to Day 1
- •Any prior exposure to natalizumab, rituximab, efalizumab, fingolimod, cyclophosphamide, or thalidomide
- •NSAIDs taken on a regular (more than 3 times per week, on average) basis (regular use of aspirin = 325 mg per day for cardiovascular protection is allowed).
- •anakinra or any other immune-modifying biologic agent taken within 90 days, prior to Day 1
- •A JAK inhibitor (e.g., tofacitinib) within 60 days prior to Day 1
- •5. Prior exposure to an approved JAK inhibit that was stopped due to intolerance or lack of efficacy. This does not include subjects with prior exposure to another JAK inhibitor that was stopped for any other reason (e.g., loss/lack of insurance coverage or end of study)
- •6. Subject has participated in another clinical trial of an investigational drug (or medical device) within 30 days prior to Screening or 5x the half-life of the investigational drug, whichever is longer, or is currently participating in another trial of an investigational drug (or medical device)
- •7. Subject has had inadequate response (i.e. either primary or secondary non-response) to = 3 biologic agents of 3 different mechanisms of action (i.e., anti-TNF, anti-integrin, and anti-IL12/23)
- •8. Subject is positive for:
- •a. hepatitis B virus (HBV) surface antigen
- •b. hepatitis B virus core antibody (unless subject has positive hepatitis B surface antibody and undetectable serum hepatitis B DNA)
- •c. hepatitis C virus (HCV) antibody unless: a) there is evidence of undetectable viral load measured twice six months apart after completion of treatment regimen and b) viral load during Screening is undetectable
- •d. hepatitis E Immunoglobumin M (IgM) antibody
- •e. human immunodeficiency virus (HIV) antibody
- •9. The subject has or may have untreated active or latent TB as evidenced by any of the following:
- •a. Two indeterminate or two positive QuantiFERON®-TB Gold result within 90 days prior to screening or during the Screening Period, without having completed an adequate treatment for latent or active TB before Screening OR
- •b. Chest X-ray or equivalent chest imagi
研究者
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