EUCTR2018-001272-37-FR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
适应症
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 history 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 by ileocolonoscopy and confirmed on histology. 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)
- •5. Subject has CDAI score = 220 and = 450 (required in order to proceed to endoscopy during Screening Stage 2 visit)
- •6. Subject has a 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, as assessed by central reading, during Screening
- •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 integrin)
- •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 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 = 3 weeks prior to Day 1 and is willing to stay on the same dose as warranted until Week 12
- •Inclusion Criteria for ATE:
- •1. Subject has completed Induction
- •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
- •Exclusion Criteria Pertinent to GI:
- •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 colonic mucosal dysplasia. Subjects will not be excluded from the study because of a pathology finding of indefinite dysplasia with reactive atypia or because of spontaneous (non-colitis-associated) adenomas that have been completely resected
- •Exclusion Criteria Pertinent to Medications:
- •1. Medications of exclusion (Refer to Protocol Section 6.4.29 for prohibited medications) 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 shorter, 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 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, or 5 half-lives, whichever is shorter, prior to Day 1
- •2. Any prior exposure to an approved JAK inhibitor or potential exposure to an investigational JAK inhibitor
- •3. 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)
- •4. Subject has failed = 3 biologic agents of 3 different mechanisms of action (i.e., anti-TNF, anti-integrin, and anti-IL12/23)
- •Exclusion Criteria Pertinent to Infections:
- •1. 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 antibody
- •e. human immunodeficiency virus (HIV) antibody
- •2. The subject has or may have untreated active or latent TB as evidenced by any of the following:
- •a. Two indeterminate or one 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 within 90 days prior to Screening in which active or latent pulmonary TB cannot be excluded.
- •A subject who has a history of latent or active tuberculosis (TB) may be eligible for the study if criteria outlined in Protocol Section 6.4.15 are
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