Crohn's Disease
TAK-279 for Adults With Moderately to Severely Active Crohn’s Disease
This phase 2 study compares three oral doses of TAK-279 with placebo in adults with moderately to severely active Crohn’s disease, assessing bowel inflammation, symptoms, quality of life, and medical problems during treatment.
Registry title: A Study on the Safety of TAK-279 and Whether it Can Reduce Inflammation in the Bowel of Participants With Moderately to Severely Active Crohn's Disease
26 recruiting U.S. sites ↓Study at a glance
- Age
- 18 Years–75 Years
- Treatment
- TAK-279 or Placebo
- Design
- Randomized · Double
- Central study contact
- Takeda Contact+1-877-825-3327medinfoUS@takeda.com
- Sponsor
- Takeda
Research question
After 12 weeks, how do three doses of TAK-279 compare with placebo for reducing bowel inflammation and ulcers, and what medical problems occur with each treatment?
Participant snapshot
Who the study is looking for
- The study is looking for adults ages 18 through 75; in South Korea, participants must be at least 19.
- The study is looking for people diagnosed with Crohn’s disease for at least 30 days.
- The study is looking for people whose Crohn’s disease is moderately to severely active by endoscopy and the Crohn’s Disease Activity Index.
- The study is looking for people who had an inadequate response, lost response, or could not tolerate at least one conventional, biologic, or advanced Crohn’s therapy.
Participation overview
What participation may involve
Participants take oral study capsules, undergo assessments of Crohn’s disease activity and bowel inflammation, report symptoms and quality of life, and are monitored for medical problems. What participation may involve: - Take oral TAK-279 capsules or placebo-matching capsules according to the assigned group. - Undergo endoscopic assessment of bowel inflammation and ulcers, including evaluation with the Simple Endoscopic Score for Crohn’s Disease. - Complete assessments covering stool frequency, abdominal pain, bowel urgency, quality of life, and fatigue. - Attend a safety follow-up period after treatment. The registry reports 52 weeks of TAK-279 treatment and an overall study duration of approximately 60 weeks, including a 4-week safety follow-up. The registry reports 15 visits to the study clinic.
Study interventions
What participants may receive or do
- TAK-279: TAK-279, also called zasocitinib in the registry, is provided as oral capsules in one of three dose groups.
- Placebo: The placebo consists of oral capsules made to match TAK-279. It is used as the study control and also as matching capsules in two TAK-279 dose groups.
Study design
How the comparison works
This is a phase 2, multicenter study with four parallel induction groups: three TAK-279 dose groups and one placebo group. During induction, participants are randomly assigned in a 1:1:1:1 ratio to one of the three TAK-279 dose groups or placebo. Participants and investigators are not told the assigned treatment during the study unless disclosure is urgently medically necessary. The study uses a parallel placebo group to compare outcomes and medical problems with those in the three TAK-279 dose groups. The reported 1:1:1:1 induction assignment means one of the four groups receives placebo alone; matching placebo capsules are also used in two TAK-279 groups.
Reported activities
Procedures and tests
- Endoscopy is used to examine the bowel for inflammation and ulcers.
- The Simple Endoscopic Score for Crohn’s Disease assesses ulcers, other inflammatory lesions, affected intestinal surface, and narrowing.
- The Crohn’s Disease Activity Index is used to assess clinical disease activity and response.
- A daily patient diary records stool frequency, abdominal pain, and whether bowel urgency occurred in the past 24 hours.
- The 32-item Inflammatory Bowel Disease Questionnaire assesses bowel function, emotional status, systemic symptoms, and social function.
- The 13-item Functional Assessment of Chronic Illness Therapy–Fatigue questionnaire assesses fatigue.
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- Participants must be ages 18 through 75; the minimum age in South Korea is 19.
- A Crohn’s disease diagnosis must have been present for at least 30 days.
- Crohn’s disease must be confirmed as moderately to severely active using both the Simple Endoscopic Score for Crohn’s Disease and the Crohn’s Disease Activity Index.
- Participants must have had an inadequate response, lost response, or intolerance to at least one conventional, biologic, or advanced Crohn’s therapy.
Possible reasons someone may not be able to join
- People with indeterminate, microscopic, ischemic, infectious, or radiation colitis; diverticular disease associated with colitis; or ulcerative colitis are excluded.
- People with Crohn’s disease complications that might require surgery during the study are excluded.
- People who currently have an ostomy are excluded.
- People who have failed three or more classes of advanced therapies are excluded.
Important unknowns
What the record does not make clear
- The registry reports 15 clinic visits but does not give their timing or describe what happens at each visit.
- The record does not state which current Crohn’s medicines may continue during the study.
- The record does not provide medication washout requirements or timing.
- The record does not explain what treatment is available if Crohn’s disease worsens during the study.
- The record confirms endoscopic assessment, including an outcome at week 12, but does not provide the complete number, timing, preparation, sedation, or biopsy requirements.
- The record does not state which study-related or routine-care costs are covered or billed to insurance.
- The record does not state whether participants receive compensation.
- The record does not state whether transportation, lodging, meals, or parking are reimbursed.
- The record reports clinic visits but does not say whether any visits or assessments can be completed remotely.
- The record does not describe access to TAK-279 after study participation ends.
- The study is listed as recruiting overall, but listed locations have differing statuses and a specific site’s current availability must be confirmed.
Before contacting the site
Questions for the study team
- What is the complete visit schedule, and what procedures occur at each of the 15 clinic visits?
- How many endoscopies are required, when are they scheduled, and will they involve sedation or biopsies?
- Which current Crohn’s treatments may continue, and are any medication washout periods required?
- What happens if symptoms or bowel inflammation worsen during the study?
- After the 12-week induction period, which treatment would I receive, and would the assignment remain blinded?
- Which study-related costs are covered, is compensation offered, and is travel support available?
- Is the nearest listed site actively enrolling, and can any visits or follow-up be completed remotely?
Before changing care
Questions for your gastroenterologist
- How stable is my Crohn’s disease now, and what risks would treatment changes or a washout create in my situation?
- What approved treatment alternatives are reasonable for me before I consider contacting this study?
- Could my Crohn’s complications, prior treatment history, or current ostomy status conflict with the study’s main criteria?
- How should my routine Crohn’s monitoring and care be coordinated with the research team?
- If my disease worsens during the study, what medical plan should the research team and your office coordinate?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
About this study
Crohn's disease (CD) is a long-lasting condition causing inflammation that can affect any part of the gut. The purpose of this study is to evaluate the efficacy and safety of TAK-279 versus placebo in participants with moderately to severely active Crohn's disease (CD). The main aim of this study is to learn if the 3 different doses of TAK-279 reduce bowel inflammation and ulcers in the bowel compared to the placebo after 12 weeks of treatment. Another aim is to compare any medical problems that participants have when they take TAK-279 or placebo and how well the participants tolerate medical problems. An endoscopy will be used to check the bowel for inflammation. The participants will be treated with TAK-279 for 52 weeks (1 year). During the study, participants will visit their study clinic 15 times.
The drug being tested in this study is TAK-279. TAK-279 is being tested to treat participants with moderately to severely active Crohn's disease. The study will look at the efficacy and safety of TAK-279. The study will enroll approximately 268 participants. During the Induction Period participants will be randomly assigned to one of the following treatment groups in a ratio of 1:1:1:1 to receive TAK-279 or placebo which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need): 1. TAK-279 Dose 1 2. TAK-279 Dose 2 3. TAK-279 Dose 3 4. Placebo This multi-center trial will be conducted globally. The overall study duration is approximately 60 weeks including a 4-week safety follow-up period.
Study design and administration
- Organization
- Takeda
- Organization class
- Industry
- Organization study ID
- TAK-279-CD-2001
- Lead sponsor
- Takeda
- Sponsor class
- Industry
- Enrollment type
- Estimated
- Allocation
- Randomized
- Intervention model
- Parallel
- Primary purpose
- Treatment
- Masking
- Double
- Who is masked
- Participant, Investigator
- Standard age groups
- Adult, Older Adult
Study arms
Experimental
TAK-279 Dose 1
Participants will be randomized to receive TAK-279 Dose 1 capsules with TAK-279 placebo-matching capsule orally.
Interventions: Drug: TAK-279, Drug: Placebo
Experimental
TAK-279 Dose 2
Participants will be randomized to receive TAK-279 Dose 2 capsules with TAK-279 placebo-matching capsule orally.
Interventions: Drug: TAK-279, Drug: Placebo
Experimental
TAK-279 Dose 3
Participants will be randomized to receive TAK-279 Dose 3 capsules orally.
Interventions: Drug: TAK-279
Experimental
Placebo
Participants will be randomized to receive TAK-279 placebo-matching capsules orally.
Interventions: Drug: Placebo
Interventions
Drug
TAK-279
TAK-279 capsules.
Drug
Placebo
TAK-279 placebo-matching capsules.
Eligibility
18 Years–75 Years
All
Not accepted
Inclusion criteria (3)
- Male or female aged 18-75 years old with diagnosis of CD for at least 30 days. In South Korea, the age requirement for adult participants is \>=19 years of age.Registry-derived · unreviewed
- Confirmed diagnosis of moderately to severely active CD assessed by SES-CD and CDAI.Registry-derived · unreviewed
- Participants must have had an inadequate response to, loss of response to, or intolerance to at least one or more conventional, biologic, or advanced therapy for CD.Registry-derived · unreviewed
Exclusion criteria (4)
- Participants with indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, and diverticular disease associated with colitis, and/or ulcerative colitis.Registry-derived · unreviewed
- Have complications of CD that might require surgery during the study.Registry-derived · unreviewed
- Participants with a current ostomy.Registry-derived · unreviewed
- Participants who have failed 3 or more classes of advanced therapies.Registry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
Primary outcome
Percentage of Participants With Endoscopic Response Based on Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 12
Time frame: Week 12
Endoscopic response is defined by decrease in SES-CD \>50% from baseline (or for participants with isolated ileal disease, SES-CD \<=4 or at least a 2-point reduction from baseline). SES-CD evaluates 4 endoscopic variables (the intestinal surface affected by ulcers, the intestinal surface affected by other inflammatory lesions, the presence of ulcers, and the presence of narrowing).
Secondary outcome
Percentage of Participants Achieving Clinical Remission Based on the Crohn's Disease Activity Index (CDAI) at Week 12
Time frame: Week 12
Clinical remission is defined as a CDAI score of \<150 points.
Secondary outcome
Percentage of Participants With a Clinical Response Based on the CDAI at Week 12
Time frame: Week 12
Clinical response is defined as \>=100-point decrease from Baseline in CDAI score.
Secondary outcome
Percentage of Participants Achieving Endoscopic Remission Based on SES-CD at Week 12.
Time frame: Week 12
Endoscopic remission as per SES-CD is defined as SES-CD score \<=4 or \<=2 for ileal disease, no subscore \>1.
Secondary outcome
Percentage of Participants Achieving Clinical Remission in 2-item Patient-reported Outcome Measure (PRO2) at Week 12
Time frame: Week 12
Clinical remission based on PRO2 is defined as average daily liquid or very soft stool frequency (SF) score \<=2.8 and not worse than baseline and average daily abdominal pain (AP) score \<=1 and not worse than baseline.
Secondary outcome
Percentage of Participants With a Clinical Response in PRO2 at Week 12
Time frame: Week 12
Clinical response based on PRO2 is defined as \>=30% decrease in average daily very soft or liquid stools and/ or \>=30% decrease in average AP from baseline.
Secondary outcome
Percentage of Participants With no Bowel Urgency at Week 12
Time frame: Week 12
Bowel urgency is assessed using a 1-item daily patient diary that asks participants to indicate if they had an urgent bowel movement (when they felt the need to rush to the toilet to avoid an accident) in the past 24 hours. Response options, "Yes" or "No" will be coded as numeric values.
Secondary outcome
Percentage of Participants With Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score >=170 at Week 12
Time frame: Week 12
The IBDQ is a 32-item questionnaire that measures 4 dimensions: bowel function, emotional status, systemic symptoms, and social function. Within dimensions, each question will be assessed on a 7-point Likert scale. Each domain score is the sum of 8 responses each ranging from 1 to 7, where 1 indicates worst function and 7 the best. The total score ranges from 32 to 224, with higher scores representing better quality of life.
Secondary outcome
Change from Baseline in Health-related Quality of Life (HRQoL) as per IBDQ Total Score at Week 12
Time frame: Baseline to Week 12
The IBDQ is a 32-item questionnaire that measures 4 dimensions: bowel function, emotional status, systemic symptoms, and social function. Within dimensions, each question will be assessed on a 7-point Likert scale. Each domain score is the sum of 8 responses each ranging from 1 to 7, where 1 indicates worst function and 7 the best. The total score ranges from 32 to 224, with higher scores representing better quality of life.
Secondary outcome
Change from Baseline in Fatigue as per Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 12
Time frame: Baseline to Week 12
FACIT-Fatigue questionnaire contains 13 fatigue-related questions. The responses to the 13 items on the FACIT-Fatigue questionnaire are each measured on a 5-point Likert scale, where 0=Not at all, 1=A little bit, 2=Somewhat, 3=Quite a bit and 4=Very much. The total score ranges from 0 to 52. High scores represent less fatigue.
Recruiting locations in the United States
United Medical Doctors
RecruitingMurrieta, California, 92563, United States
Site Contact951-566-5229drhongpi@unitedmd.com
John Hong
UCI Health
RecruitingOrange, California, 92868, United States
Site Contact714-456-5694rfearn@hs.uci.edu
Robert Fearn
West Central Gastroenterology, LLP, d/b/a/ Gastro Florida
RecruitingClearwater, Florida, 33762, United States
Site Contact727-347-0005lmweiss@gastrofl.com
Lawrence Michael Weiss
Auzmer Research
RecruitingLakeland, Florida, 33813, United States
Site Contact208-346-8900nausaf@auzmer.com
John Ligeon
Wellness Clinical Research
RecruitingMiami Lakes, Florida, 33016, United States
Site Contact786-483-7856lucky@wellnessclinicalresearch.com
Lucky Flores
GI PROS, Inc.
RecruitingNaples, Florida, 34102, United States
Site Contact239-649-1336rphillips212@comcast.net
Raymond Phillips
AdventHealth (Florida Hospital) Medical Group
Not Yet RecruitingOrlando, Florida, 32804, United States
Site Contact843-876-8282jennifer.semineriodiehl.md@adventhealth.com
Jennifer Seminerio-Diehl
USF Health Morsani Center for Advanced Healthcare
RecruitingTampa, Florida, 33612, United States
Site Contactmsrosari@usf.edu
Michelle Rosario
Emory University Hospital, The Emory Clinic
RecruitingAtlanta, Georgia, 30322, United States
Site Contactheba.iskandar@emoryhealthcare.org
Heba Iskandar
Atlanta Center For Gastroenterology, P.C.
RecruitingDecatur, Georgia, 30033, United States
Site Contact404-512-3280dbrausher@acgaec.com
David Rausher
The University of Iowa Hospitals & Clinics
RecruitingIowa City, Iowa, 52242, United States
Site Contact319-384-6336steven-polyak@uiowa.edu
Steven Polyak
University of Kansas Medical Center
Not Yet RecruitingKansas City, Kansas, 66160, United States
Site Contactsaurabhkapur15@gmail.com
Saurabh Kapur
University Of Louisville
RecruitingLouisville, Kentucky, 40202, United States
Site Contact502-852-6991gerald.dryden@louisville.edu
Gerald Dryden
Woodholme Gastroenterology Associates
RecruitingGlen Burnie, Maryland, 21061, United States
Site Contact410-863-4899konwueme@woodholmegi.com
Kenolisa Onwueme
BVL Clinical Research
RecruitingLiberty, Missouri, 64068, United States
Site Contactc.bartalos@bvlresearch.com
Christopher Bartalos
Las Vegas Medical Research
RecruitingLas Vegas, Nevada, 89128, United States
Site Contact702-750-0000cstone@nevadagastro.com
Christian Stone
Icahn School of Medicine at Mount Sinai (ISMMS) - The Mount Sinai Hospital (MSH)
RecruitingNew York, New York, 10029, United States
Site Contact917-538-2158adam.steinlauf@mssm.edu
Adam Steinlauf
Rochester Clinical Research
RecruitingRochester, New York, 14609, United States
Site Contact585-329-9644jgoldstein@rcrclinical.com
Jonathan Goldstein
Great Lakes Gastroenterology Research, LLC
RecruitingMentor, Ohio, 44060, United States
Site Contact440-205-1225kfriedenberg@thectnx.com
Keith Friedenberg
University Gastroenterology Providence
RecruitingProvidence, Rhode Island, 02904, United States
Site Contactlisa.mueller@gialliance.com
Lisa Mueller
Gastroenterology Associates, PA
RecruitingGreenville, South Carolina, 29615, United States
Site Contact910-488-3857mbarnesmd@gastroassociates.com
Matthew Barnes
Novel Research, LLC
RecruitingBellaire, Texas, 77401, United States
Site Contact281-491-9779sana@novelresearch.net
Moazzam Sana
One of a Kind Clinical research Center TX LLC
Not Yet RecruitingKingwood, Texas, 77339, United States
Site Contactsguha@hrgastro.com
Sushovan Guha
Southern Star Research Institute, LLC
RecruitingSan Antonio, Texas, 78229, United States
Site Contact210-581-2812js_bull@yahoo.com
Jeff Bullock
Tyler Research Institute, LLC
RecruitingTyler, Texas, 75701, United States
Site Contact903-630-6211aarond@tylerri.com
George Duvall
University of Washington Medical Center
RecruitingSeattle, Washington, 98195, United States
Site Contact206-543-3500scottl@medicine.washington.edu
Scott Lee
This study also lists 162 locations outside the United States. They are not shown here.
Central study contacts
Registry dates
- First posted
- Jan 31, 2024
- Primary completion
- Sep 18, 2026
- Overall completion
- Jul 23, 2027
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.