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TAK-018 for Crohn's Disease

Phase 2
Waitlist Available
Research Sponsored by Millennium Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at weeks 3, 6, 12, 18, 26 and 30
Awards & highlights

Study Summary

This study is evaluating whether a drug may help reduce the recurrence of inflammation in the intestines of individuals with Crohn's disease.

Eligible Conditions
  • Crohn's Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at weeks 3, 6, 12, 18, 26 and 30
This trial's timeline: 3 weeks for screening, Varies for treatment, and at weeks 3, 6, 12, 18, 26 and 30 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants With Endoscopic Recurrence of CD as Assessed by Rutgeerts Grading Scale at Week 26
Secondary outcome measures
Ctrough: Observed Plasma Trough Concentrations of TAK-018
Percentage of Participants With Fecal Calprotectin (FCP) >135 Microgram Per Gram (mcg/g) at Weeks 3, 6, 12, 18, 26 and 30

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: TAK-018 1.5 g High DoseExperimental Treatment1 Intervention
TAK-018 1.5 g, tablets, orally, BID for up to 26.1 weeks.
Group II: TAK-018 0.30 g Low DoseExperimental Treatment1 Intervention
TAK-018 0.30 gram (g), tablets, orally, BID for up to 31.7 weeks.
Group III: PlaceboPlacebo Group1 Intervention
TAK-018 placebo-matching tablets, orally, twice daily (BID) for up to 27.7 weeks.

Find a Location

Who is running the clinical trial?

Millennium Pharmaceuticals, Inc.Lead Sponsor
404 Previous Clinical Trials
46,880 Total Patients Enrolled
Takeda Development Center Americas, Inc.Industry Sponsor
56 Previous Clinical Trials
11,996 Total Patients Enrolled
TakedaLead Sponsor
1,202 Previous Clinical Trials
4,178,228 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study of TAK-018 in Preventing the Recurrence of Crohn's Disease After Surgery
2020. "A Study of TAK-018 in Preventing the Recurrence of Crohn's Disease After Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03943446.
~7 spots leftby Apr 2025
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