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Crohn's DiseasePhase 3NCT05837897

A Study of Vedolizumab in Adult Participants With Moderate to Severe Crohn's Disease

A Phase 3 study testing Vedolizumab IV in people with Crohn's Disease, run by Takeda at 43 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is a study to evaluate vedolizumab for injection (300 mg) as a safe and active treatment for Crohn's Disease in adults in China. Participants will receive an injection of Vedolizumab 300 mg at scheduled weeks 0, 2, and 6, and starting at week 14, every 8 weeks over 58 weeks or starting at week 18, every 4 weeks… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Crohn's Disease
What is being tested?
Vedolizumab IV
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
408 participants
Where
43 sitesChina
Study dates
16 Jun 2023to 30 May 2031
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The participant has a diagnosis of CD established at least 3 months before screening by clinical and endoscopic evidence corroborated by a histopathology report. Cases of CD established at least 6 months before randomization for which a histopathology report is not available will be considered based on the weight of evidence supporting the diagnosis and excluding other potential diagnoses, and must be discussed with the sponsor on a case-by-case basis before randomization.
  • The participant has moderately to severely active CD as determined by a 2-component patient-reported outcome (PRO2) score of 14 to 34 points and a Simple Endoscopic Score for Crohn's Disease (SES-CD) score of ≥6 (or ≥4 in cases of isolated ileitis) on screening ileocolonoscopy.
  • The participant has CD involvement of the ileum and/or colon, at a minimum.
  • A participant with extensive colitis or pancolitis of >8 years duration or limited colitis of >12 years duration must have documented evidence that a surveillance colonoscopy was performed within 12 months before initial screening (may be performed during screening if not performed in previous 12 months).
  • A participant with a family history of colorectal cancer, personal history of increased colorectal cancer risk, age >50 years, or other known risk factor must be up-to-date on colorectal cancer surveillance (may be performed during screening).
  • The participant has demonstrated an inadequate response to, loss of response to, or intolerance of at least 1 of the following agents as defined below:
Show all 9Show fewer
  • Corticosteroids.
  • Immunomodulators.
  • TNF-α antagonists.

Who cannot join

  • Gastrointestinal (GI) Exclusion Criteria:
  • The participant has evidence of abdominal abscess at the initial screening visit.
  • The participant has had extensive colonic resection, subtotal or total colectomy.
  • The participant has a history of >3 small bowel resections or diagnosis of short bowel syndrome.
  • The participant has received tube feeding, defined formula diets, or parenteral alimentation within 21 days before administration of the first dose of study drug.
  • The participant has had ileostomy, colostomy, known fixed symptomatic stenosis of the intestine, or evidence of fixed stenosis, or small bowel stenosis with prestenotic dilation.
Show all 28Show fewer
  • Within 30 days before randomization, the participant has received any of the following for the treatment of underlying disease:
  • Nonbiologic therapies (eg, cyclosporine, thalidomide) other than those specifically listed in the Permitted Medications and Treatments section.
  • An approved or investigational nonbiologic therapy in an investigational protocol.
  • The participant has received traditional Chinese medication (TCMs) within 30 days before randomization.
  • The participant has had previous exposure to approved or investigational anti-integrins including, but not limited to natalizumab, efalizumab, etrolizumab, or abrilumab (AMG-181), or mucosal vascular addressin cell adhesion molecule 1 (MAdCAM-1) antagonists, or rituximab.
  • The participant has had previous exposure to vedolizumab.
  • The participant has used topical (rectal) treatment with 5-aminosalicylic acid (5-ASA), corticosteroid enemas/suppositories or traditional Chinese medications for CD treatment within 2 weeks of the administration of the first dose of study drug.
  • The participant requires currently or is anticipated to require surgical intervention for CD during the study.
  • The participant has a history or evidence of adenomatous colonic polyps that have not been removed.
  • The participant has a history or evidence of colonic mucosal dysplasia including low or high-grade dysplasia, as well as indeterminate for dysplasia.
  • Infectious Disease Exclusion Criteria
  • The participant has evidence of active infection during the screening period.
  • The participant has evidence of treatment for Clostridioides difficile (C difficile) infection or other intestinal pathogen within, 28 days before first dose of study drug.
  • The participant has chronic hepatitis B virus (HBV) infection or chronic hepatitis C virus (HCV) infection.
  • The participant has active or latent tuberculosis (TB).
  • The participant has any identified congenital or acquired immunodeficiency (eg, common variable immunodeficiency, human immunodeficiency virus [HIV] infection, organ transplantation).
  • The participants has received any live vaccinations within 30 days before screening.
  • The participant has a clinically significant active infection (eg, pneumonia, pyelonephritis, or coronavirus disease 2019 [COVID-19]) within 30 days before screening or during screening, or has an ongoing chronic infection or any ongoing COVID-19-related symptom(s), if previously diagnosed as having COVID-19.
  • General Exclusion Criteria
  • The participant has had any surgical procedure requiring general anesthesia within 30 days before enrollment or is planning to undergo major surgery during the study period.
  • The participant has any history of malignancy, except for the following: (a) adequately-treated nonmetastatic basal cell skin cancer; (b) squamous cell skin cancer that has been adequately treated and has not recurred for at least 1 year before randomization; and (c) history of cervical carcinoma in situ that has been adequately treated and has not recurred for at least 3 years before randomization. Participants with remote history of malignancy (eg, >10 years since completion of curative therapy without recurrence) will be considered based on the nature of the malignancy and the therapy received and must be discussed with the sponsor on a case-by-case basis before randomization.
  • The participant has a history of any major neurological disorders, including stroke, multiple sclerosis, brain tumor, or neurodegenerative disease.

Trial locations and contacts

43 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Takeda Contact contact

+1-877-825-3327

medinfoUS@takeda.com

43 sites in 1 country

China43 sites, 33 recruiting

  • Peking University First Hospital - Changqiao Campus

    Beijing, Beijing Municipality, 100034

    Completed

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100191

    Site Contact, +86 15611908241, dingshigang222@163.com

    Shigang Ding

    Recruiting

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan, 410011

    Site Contact, +86 13973181426, Wxh05271@126.com

    Xuehong Wang

    Recruiting

  • Changzhou No.2 People's Hospital - Yanling Campus

    Changzhou, Jiangsu, 213200

    Site Contact, +86 13813016290, 13813016290@126.com

    Wenjia Liu

    Recruiting

  • The First People's Hospital of Foshan

    Foshan, Guangdong, 528000

    Site Contact, +86 18038863728, 13827774833@139.com

    Zhaotao Li

    Recruiting

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian, 350005

    Site Contact, +86 13178111141, wangcdhl@fjmu.edu.cn

    Chengdang Wang

    Recruiting

  • The First Affiliated Hospital, Sun Yat-sen University - Main

    Guangzhou, Guangdong, 510080

    Site Contact, +86 13302298302, chenbaili05@163.com

    Baili Chen

    Recruiting

  • Guangzhou First People's Hospital

    Guangzhou, Guangdong, 510180

    Site Contact, +86 13503060150, zhouyongjian_gz@126.com

    Yongjian Zhou

    Recruiting

  • The Second Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510260

    Site Contact, +86 15915822551, yanghui@gzhmu.edu.cn

    Hui Yang

    Recruiting

  • The Third Affiliated Hospital, Sun Yat-Sen University

    Guangzhou, Guangdong, 510630

    Completed

  • The Sixth Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510655

    Site Contact, +86 13502405878, helen_gao818@163.com

    Xiang Gao

    Recruiting

  • The 2nd Affliated Hospital of Harbin Medical University

    Haerbin, Heilongjiang, 150081

    Site Contact, +86 13030039874, qubo_1970@hotmail.com

    Bo Qu

    Recruiting

  • The First Affiliated Hospital, Zhejiang University School of Medicine - Qingchun Campus - PPDS

    Hangzhou, Zhejiang, 310003

    Site Contact, +86 13906523922, chenchunxiao12@126.com

    Chunxiao Chen

    Recruiting

  • The Second Hospital of Anhui Medical University

    Hefei, Anhui, 230601

    Site Contact, +86 18756039192, xphuay2003GCP@aliyun.com

    Xiangpeng Hu

    Recruiting

  • Huizhou Central People's Hospital

    Huizhou, Guangdong, 516001

    Site Contact, +86 13802473695, 13802473695@139.com

    Huixin Chen

    Recruiting

  • The First People's Hospital of Yunnan Province

    Kunming, Yunnan, 650100

    Site Contact, +86 13678786157, song4715@163.com

    Zhengji Song

    Recruiting

  • Lanzhou University Second Hospital

    Lanzhou, Gansu, 730030

    Site Contact, +86 13919788616, ldeyzdk@163.com

    Dekui Zhang

    Recruiting

  • The Second Affiliated Hospital of Nanchang University - Donghu Campus

    Nanchang, Jiangxi, 330008

    Site Contact, +86 13870608072, wenzhili@126.com

    Zhili Wen

    Recruiting

  • Zhongda Hospital, Affiliated to Southeast University

    Nanjing, Jiangsu, 210009

    Site Contact, njchenhong66@163.com

    Hong Chen

    Recruiting

  • Nanyang First People's Hospital

    Nanyang, Henan, 474500

    Site Contact, +86 17763310163, 2547048667@qq.com

    Chunxian Gao

    Recruiting

  • The First Affiliated Hospital of Ningbo University - Fangqiao Campus

    Ningbo, Zhejiang, 315010

    Site Contact, +86 13429362120, jiangqigua@163.com

    Qi Jiang

    Recruiting

  • Qingyuan People's Hospital

    Qingyuan, Guangdong, 511518

    Completed

  • People's Hospital of Quzhou

    Quzhou, Zhejiang, 324307

    Completed

  • Zhongshan Hospital Fudan University

    Shanghai, Shanghai Municipality, 200022

    Completed

  • Shanghai East Hospital - Main

    Shanghai, Shanghai Municipality, 200123

    Site Contact, +86 13162099450, lanzhong83@sina.com

    Lan Zhong

    Recruiting

  • Shanghai Changhai Hospital

    Shanghai, Shanghai Municipality, 200433

    Site Contact, +86 13801993592, duyiqi@hotmail.com

    Yiqi Du

    Recruiting

  • Shengjing Hospital of China Medical University - Nanhu Campus

    Shenyang, Liaoning, 110004

    Site Contact, +86 18940251666, zhengchangqing88@163.com

    Changqing Zheng

    Recruiting

  • The University of Hong Kong - Shenzhen Hospital

    Shenzhen, Guangdong, 518053

    Site Contact, +86 13632998540, wkseto@hku.hk

    Wai-Kay Seto

    Recruiting

  • The Second Hospital of Hebei Medical University - Main

    Shijiazhuang, Hebei, 50051

    Completed

  • Changshu No.2 People's Hospital

    Suzhou, Jiangsu, 215516

    Site Contact, +86 18962122430, zhulanxiang0125@163.com

    Lanxiang Zhu

    Recruiting

  • Taizhou Hospital of Zhejiang Province - Main

    Taizhou, Zhejiang, 317000

    Site Contact, +86 13750630566, maoxl@enzemed.com

    Xinli Mao

    Recruiting

  • The First People's Hospital of Wenling

    Taizhou, Zhejiang, 317599

    Site Contact, +86 13606863699, gcpxiaohua@163.com

    Haifan Yan

    Recruiting

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality, 300052

    Site Contact, +86 13602007150, gi.tmuh@sohu.com

    Bangmao Wang

    Recruiting

  • The 1st Affiliated Hospital of Wenzhou Medical University - Nanbaixiang Campus

    Wenzhou, Zhejiang, 325000

    Completed

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei, 430022

    Site Contact, +86 13035143646, houxh@medmail.com.cn

    Xiaohua Hou

    Recruiting

  • Renmin Hospital of Wuhan University - Main Campus

    Wuhan, Hubei, 430060

    Site Contact, +86 18627068700, anping_05@163.com

    Ping An

    Recruiting

  • Yijishan Hospital of Wannan Medical College

    Wuhu, Anhui, 241001

    Site Contact, +86 13956215866, hechiyi11@163.com

    Chiyi He

    Recruiting

  • Xuzhou Central Hospital

    Xuzhou, Jiangsu, 221009

    Completed

  • Yancheng No.1 People's Hospital

    Yancheng, Jiangsu, 224006

    Site Contact, +8618936296299, 196206yhm@163.com

    Hongmei Yang

    Recruiting

  • Yantai Yuhuangding Hospital

    Yantai, Shandong, 264000

    Completed

  • People's Hospital of Ningxia Hui Aotonomous Region

    Yinchuan, Ningxia, 750002

    Completed

  • Affiliated Hospital of Jiangsu University

    Zhenjiang, Jiangsu, 212001

    Site Contact, +8615862990603, peterxu1974@163.com

    Min Xu

    Recruiting

  • The Fifth Affiliated Hospital Sun Yat-Sen University

    Zhuhai, Guangdong, 519000

    Site Contact, lxf_ZDWY_GCP@163.com

    Xiaofeng Li

    Recruiting

Other trials in China

About this study

Official title: A Phase 3, Multicenter, Randomized, Parallel-Group, Double-blind, Placebo-Controlled Induction Study Followed by an Open-label Extension Period to Evaluate the Efficacy and Safety of Intravenous Vedolizumab (300 mg) Infusion Treatment in Subjects in China With Moderately to Severely Active Crohn's Disease

This is a study to evaluate vedolizumab for injection (300 mg) as a safe and active treatment for Crohn's Disease in adults in China. Participants will receive an injection of Vedolizumab 300 mg at scheduled weeks 0, 2, and 6, and starting at week 14, every 8 weeks over 58 weeks or starting at week 18, every 4 weeks over 54 weeks. There will be up to 20 study visits over 58 weeks to complete assessments.

Read the detailed description

The drug being tested in this study is called vedolizumab. Vedolizumab will be administered as an intravenous (IV) infusion in Chinese participants. This study will investigate the efficacy and safety of vedolizumab IV in participants with moderately to severely active Crohn's Disease (CD).

The study will enroll approximately 408 patients. Participants will be randomized into 2:1 in the Induction Period to receive:

  • Vedolizumab IV 300 mg
  • Placebo

All participants completing the Week 14 visit, irrespective of their response status, will continue in the OLE without unblinding of their baseline treatment group and will receive 300 mg vedolizumab once every 8 weeks (Q8W) starting from Week 14. Starting at Week 18 and throughout the remainder of the OLE, participants who are nonresponders or who have disease worsening based on the assessment by visit every 4 weeks, are eligible to receive 300 mg vedolizumab once every 4 weeks (Q4W).

This multi-center trial will be conducted in China. The overall time participants will be in this study is approximately 58 weeks. Participants will make a final safety follow-up visit at 18 weeks after the last dose of study drug. Participants will also be followed-up for a long-term follow-up safety survey after completion of or early termination from study via telephone, 6 months after last dose of study drug.

Conditions
Crohn's Disease
Being tested
Vedolizumab IV, Placebo
Keywords
Drug therapy
Medical subject headings
Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vedolizumab IVDrug

    Vedolizumab IV infusion

  • PlaceboDrug

    Vedolizumab placebo-matching IV infusion

Study groups in NCT05837897
Study groupRoleWhat they receive
Induction Period: Vedolizumab 300 mgExperimentalParticipants will receive vedolizumab 300 mg IV infusion on Days 1,15, and 43 (Weeks 0, 2, and 6) in the 14-week Induction Period.
Receives: Drug: Vedolizumab IV
Induction Period: PlaceboPlacebo comparatorParticipants will receive vedolizumab placebo-matching IV, infusion on Days 1,15, and 43 (Weeks 0, 2, and 6) in the 14-week Induction Period.
Receives: Drug: Placebo
Open-label Extension (OLE) Period: Vedolizumab 300 mgExperimentalAll participants completing the Week 14 visit, irrespective of their response status, will continue in the OLE without unblinding of their baseline treatment group and will receive vedolizumab 300 mg, IV infusion, Q8W, on Days 99, 155, 211, 267, 323, and 379 (Weeks 14, 22, 30, 38, 46 and 54). Starting from Day 127 (Week 18) until the end of OLE Period up to approximately 58 weeks, participants who are nonresponders or who have disease worsening are eligible to receive 300 mg vedolizumab Q4W.
Receives: Drug: Vedolizumab IV

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Achieving Clinical Response at Week 14

    Clinical response is defined as ≥8 point decrease in 2-component patient-reported outcome (PRO2) score from baseline. The PRO2 is constituted by abdominal pain and number of liquid stools components of the Crohn's Disease Activity Index (CDAI). The PRO-2 score is the sum of the abdominal pain and stool frequency subscores of the CDAI score. The average daily number of liquid or very soft stools and abdominal pain score (with 0 indicating no pain and 3 indicating severe pain) are weighted according to the CDAI multiplication factors (2 for stool frequency and 5 for abdominal pain).

    Measured: Up to Week 14

Secondary outcomes (7)

  1. Percentage of Participants Achieving Clinical Remission at Week 14

    Clinical remission is defined as PRO2 score <8 from baseline. The PRO2 is comprised of the stool frequency and abdominal pain components of the CDAI. The PRO-2 score is the sum of the abdominal pain and stool frequency subscores of the CDAI score. The average daily number of liquid or very soft stools and abdominal pain score (with 0 indicating no pain and 3 indicating severe pain) are weighted according to the CDAI multiplication factors (2 for stool frequency and 5 for abdominal pain).

    Measured: Up to Week 14

  2. Percentage of Participants Achieving Endoscopic Response at Week 14

    Endoscopic response is defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) reduction by ≥50%. The SES-CD evaluates 4 endoscopic variables (ulcer size, percentage of the surface area that is ulcerated, percentage of the surface area affected, and presence and type of narrowings in 5 colonic segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The score for each endoscopic variable is sum of values obtained for each segment. The SES-CD total is the sum of the 4 endoscopic variable scores from 0 to 60, where higher scores indicate more severe disease.

    Measured: Up to Week 14

  3. Percentage of Participants Achieving Both Clinical Response and Endoscopic Response at Week 14

    Clinical response:≥8 point decrease in PRO2 score from baseline. Endoscopic response:SES-CD reduction by ≥50%.PRO2:number of liquid stools and abdominal pain components of the CDAI. PRO-2 score:sum of the abdominal pain and stool frequency subscores of the CDAI score.Average daily number of liquid or very soft stools and abdominal pain score (0=no pain and 3=severe pain) are weighted according to the CDAI multiplication factors (2= stool frequency;5= abdominal pain).Negative change indicates clinical response achieved.SES-CD evaluates 4 endoscopic variables (ulcer size, percentage of the surface area that is ulcerated, percentage of the surface area affected, and presence of narrowings) in 5 colonic segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum).Score for each endoscopic variable=sum of values obtained for each segment.SES-CD total=sum of the 4 endoscopic variable scores from 0 to 60, where higher scores=more severe disease.

    Measured: Up to Week 14

  4. Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and AEs Leading to Discontinuation

    AE:any untoward medical occurrence in clinical investigation participants administered a drug;it does not necessarily have to have causal relationship with treatment.SAE:any untoward medical occurrence that:1)results in death,2)is life-threatening,3)requires inpatient hospitalization or prolongation of existing hospitalization,4)results in persistent or significant disability/incapacity,5)leads to a congenital anomaly/birth defect in offspring of participant or6)is medically important event that satisfies any of following:a)May require intervention to prevent items 1 through 5 above.b)May expose participant to danger,even though event is not immediately life threatening or fatal or does not result in hospitalization.AESI:serious infections,opportunistic infections such as progressive multifocal leukoencephalopathy(PML);liver injury;malignancies;infusion-related reactions,injection site reactions,systemic reactions,and hypersensitivity.

    Measured: From first dose up to 18 weeks after the final dose of vedolizumab (Up to approximately 78 weeks)

  5. Percentage of Participants With Abnormal Change from Baseline in Vital Sign Values

    Vital signs assessment will include body temperature, respiratory rate, blood pressure, and pulse (beats per minute). Abnormal values will be determined by the investigator.

    Measured: From first dose up to 18 weeks after the final dose of vedolizumab (Up to approximately 78 weeks)

  6. Percentage of Participants With Abnormal Change from Baseline in Laboratory Values

    Laboratory parameter assessment will include hematology, serum chemistry, and urinalysis. Abnormal values will be determined by the central lab.

    Measured: From first dose up to 18 weeks after the final dose of vedolizumab (Up to approximately 78 weeks)

  7. Percentage of Participants With Abnormal Change from Baseline in Electrocardiogram (ECG) Values

    The ECG results will be interpreted using 1 of the following categories: within normal limits, abnormal but not clinically significant, or abnormal and clinically significant. Abnormal values are determined by the investigator.

    Measured: From first dose up to 18 weeks after the final dose of vedolizumab (Up to approximately 78 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2023
  2. Study start16 Jun 2023
  3. Primary completion8 Mar 2030 (estimated)
  4. Study completion30 May 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
408 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05837897
Sponsor's protocol ID
Vedolizumab-3040
Status last verified
Oct 2026
First submitted
20 Apr 2023
Last updated
2 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Vedolizumab IV in people with Crohn's Disease, run by Takeda at 43 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Takeda Contact (+1-877-825-3327, medinfoUS@takeda.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Achieving Clinical Response at Week 14 (time frame: Up to Week 14). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05837897.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.

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