A Study on the Safety of TAK-279 and Whether it Can Reduce Inflammation in the Bowel of Participants With Moderately to Severely Active Ulcerative Colitis

Part of paid clinical trials in Los Angeles, California.

Sponsor
Takeda
Study ID
NCT06254950
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • TAK-279 — DRUG
    TAK-279 capsules.
  • Placebo — DRUG
    TAK-279 placebo-matching capsules.

Study Details

The main aim of this study is to learn if TAK-279 reduces bowel inflammation and symptoms compared to placebo. Another aim is to compare any medical problems that participants have when they take TAK-279 or placebo and how well the participants tolerate any problems. The participants will take capsules of either TAK-279 or placebo for up to 3 months (12 weeks). Then all the participants will receive TAK-279 for the rest of the treatment part of the study (1 year or 52 weeks). During the study, participants will visit their study clinic several times.

Key Dates

Start date
Mar 29, 2024
Status verified
May 2026
Primary completion
Sep 30, 2026
Completion
Aug 4, 2027

Study Design

Enrollment
207 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: TAK-279 Dose 1
    TAK-279, capsules, orally at Dose 1 up to Week 12 followed by either Dose 1 or Dose 2 up to week 52 based on the response.
  • Experimental: TAK-279 Dose 2
    TAK-279, capsules, orally at Dose 2 up to Week 12 followed by either Dose 1 or Dose 2 up to week 52 based on the response.
  • Placebo Comparator: Placebo
    TAK-279 matching placebo capsules, orally, for 12 weeks followed by TAK-279 capsules, orally either Dose 1 or Dose 2 up to Week 52 based on the response.

Primary Outcome Measure

Percentage of Participants Achieving Clinical Remission at Week 12 Based on Modified Mayo Score (mMS) [ Time Frame: Week 12 ]

Locations (16)

FacilityCityStateZIPSite coordinators
GastroIntestinal BioSciencesLos AngelesCalifornia90067-
United Medical DoctorsMurrietaCalifornia92563-
West Central Gastroenterology, LLP, d/b/a/ Gastro FloridaClearwaterFlorida33762-
Auzmer ResearchLakelandFlorida33813-
GI PROS, Inc.NaplesFlorida34102-
USF Health Morsani Center for Advanced HealthcareTampaFlorida33612-
Emory University Hospital, The Emory ClinicAtlantaGeorgia30322-
Atlanta Center For Gastroenterology, P.C.DecaturGeorgia30033-
University Of LouisvilleLouisvilleKentucky40202-
Woodholme Gastroenterology AssociatesGlen BurnieMaryland21061-
Las Vegas Medical ResearchLas VegasNevada89113-
University GastroenterologyProvidenceRhode Island02904-
Gastroenterology Associates, PAGreenvilleSouth Carolina29607-
Novel Research, LLCBellaireTexas77401-
Tyler Research Institute, LLCTylerTexas75701-
University of Washington Medical CenterSeattleWashington98195-

Find similar trials in Los Angeles, CA

By condition
Ulcerative colitis
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
GastroIntestinal BioSciences· Los Angeles, CAUnited Medical Doctors· Murrieta, CAWest Central Gastroenterology, LLP, d/b/a/ Gastro Florida· Clearwater, FLAuzmer Research· Lakeland, FLGI PROS, Inc.· Naples, FLUSF Health Morsani Center for Advanced Healthcare· Tampa, FL

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