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Clinical Trials/JPRN-jRCT2031200403
JPRN-jRCT2031200403
Completed
Phase 2

An Adaptive Phase 2, Randomized, Double Blind, Placebo Controlled Study of LY3471851 (NKTR 358) in Patients With Moderately to Severely Active Ulcerative Colitis - J1P-MC-KFAH

Masaki Takeshi0 sites20 target enrollmentMarch 8, 2021
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ConditionsColitis, Ulcerative-

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Colitis, Ulcerative
Sponsor
Masaki Takeshi
Enrollment
20
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 8, 2021
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Masaki Takeshi

Eligibility Criteria

Inclusion Criteria

  • •Have moderately to severely active ulcerative colitis (UC) as defined by a modified Mayo score (MMS) of 4 to 9 with an endoscopic subscore (ES) \>\=2, with endoscopy performed within 14 days before baseline.
  • •\-Have evidence of UC extending proximal to the rectum (with \>\=15 centimeters (cm) of involved colon).
  • •\-Have up\-to\-date colorectal cancer surveillance performed according to local standard.
  • •\-Participants are either one of the following:
  • •\-Have failed conventional treatments including inability to tolerate oral or intravenous corticosteroids or immunomodulators (6\-mercaptopurine or azathioprine or methotrexate), or history of corticosteroid dependence (an inability to successfully taper corticosteroids without return of UC) and neither failed or demonstrated intolerance to advanced therapy (eg, tumor necrosis factor (TNF) antagonists, anti\-integrin therapies, anti\-IL12/23p40 therapies, Janus kinase (JAK) inhibitor) OR,
  • •\-Have failed advanced therapies such as treatment with 1 or more advance therapies (eg, tumor necrosis factor \[TNF] antagonists, anti\-integrin therapies, anti\-IL12/23p40 therapies, Janus kinase \[JAK] inhibitor) at doses approved for the treatment of UC with documented history of failure to respond to or tolerate such treatment.
  • •\-Have had an established diagnosis of UC of \>\=3 months in duration before baseline which includes endoscopic evidence of UC and a histopathology report that supports a diagnosis of UC. Supportive endoscopy and histopathology reports must be available in the source documents.
  • •\-Women of child\-bearing potential (WOCBP) must test negative for pregnancy as indicated by a negative serum pregnancy test at the screening visit followed by a negative urine pregnancy test within 24 hours prior to first exposure to study drug.

Exclusion Criteria

  • •\-Have been diagnosed with indeterminate colitis, proctitis (colitis limited to the rectum only; less than 15 centimeter (cm) from the anal verge or Crohn's disease.
  • •\-Have received any of the following for treatment of UC: cyclosporine, tacrolimus, mycophenolate mofetil or thalidomide within 2 weeks of screening, rectally administered corticosteroids or 5\-aminosalicylic acid treatments within 2 weeks of screening.
  • •\-Have had or will need abdominal surgery for UC (for example, subtotal colectomy).
  • •\-Have failed 3 or more classes of advanced therapies approved for treatment of UC (eg, tumor necrosis factor \[TNF] antagonists, anti\-integrin therapies, anti\-IL12/23p40 therapies, Janus kinase \[JAK] inhibitor).
  • •\-Have evidence of toxic megacolon, intra\-abdominal abscess, or stricture/stenosis within the small bowel or colon.
  • •\-Have any history or evidence of cancer of the gastrointestinal tract
  • •\-Have myocardial infarction, unstable ischemic heart disease, stroke or heart failure within 12 months prior to screening.

Outcomes

Primary Outcomes

Not specified

Similar Trials

Unknown
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Patients with Active Ulcerative Colitis
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A study of LY3471851 in adult participants with moderately to severely active ulcerative colitis (UC)
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