A Study to Evaluate the Effectiveness and Safety of TD-1473 in Crohn's Disease

Overview

About this study

The purpose of this study is to evaluate the effectiveness, safety and tolerability of TD-1473 in subjects with moderately-to-severely active Crohn's Disease with up to 36 weeks of treatment.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Subject is willing and able to provide written, signed informed consent at Screening Part 1 prior to start of any study-related procedures.
  • Subject is a male or female at least 18 years of age at the time of Screening.
  • 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.
  • 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.
  • Subject has CDAI score ≥ 220 and ≤ 450 (required in order to proceed to endoscopy during Screening Stage 2 visit).
  • 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.
  • 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).
  • If subject is currently receiving an oral corticosteroid, subject is eligible if:
    • the subject has been on corticosteroid for a minimum of 4 weeks prior to Day 1; AND
    • the dose is equivalent to or less than prednisone 25 mg/day or budesonide 9 mg/day or beclomethasone at 5 mg/day; AND
    • the dose is stable for at least 2 weeks prior to Screening Stage 2; AND
    • the subject is willing to continue on the same dose as warranted until Week 8.
  • 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.
  • If subject is on antibiotics or probiotics for CD, subject must have been on the same dose for at least 2 weeks before Screening Stage 2 with stable symptoms and is willing to remain on the same dose as warranted until Week 12.
  • If subject has recently discontinued corticosteroids, these must have been stopped at least 2 weeks before endoscopy during Screening Stage 2 visit.
  • During the Study and for 7 days after receiving the last dose of the Study drug, females of childbearing potential or males capable of fathering children must agree to use highly effective birth control measures (failure rate <1% when used consistently and correctly) or agree to abstain from sexual intercourse. Females of childbearing potential must test negative for pregnancy at Screening and at Day 1.
  • All male subjects must agree to refrain from semen donation during the study and for 7 days after the last dose of study drug.
  • Subject has completed the daily diary at least 5 out of 7 days prior to Screening Stage 2.
  • Subject is able to communicate effectively with the investigator, and willing and able to comply with the study procedures, requirements and restrictions, and directions of the clinic staff.

Exclusion Criteria: 

  • Subject with current symptoms or signs suggestive of intestinal perforation, intra-abdominal or pelvic abscess, symptomatic internal fistulae, abdominal wall fistulae, or symptomatic stricture.
  • Subject with a diagnosis of indeterminate colitis, ulcerative colitis, microscopic colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, or suspected ulcerative colitis.
  • Subject with a confirmed or suspected diagnosis or history of primary sclerosing cholangitis (PSC).
  • Subject is likely to require bowel surgery or any other type of major surgery (e.g., requiring general anesthesia) during the study duration.
  • 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.
  • Subject has a history of unresected 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 adenomas that have been completely resected.
  • Subject has required enteral feeding via feeding tube or parenteral alimentation within 21 days prior to Day 1.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Talha Malik, M.D.

Open for enrollment

Contact information:

Talha Malik M.D.

(480) 301-6990

Malik.Talha@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available