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Crohn's DiseasePhase 3NCT02425111

Effect of Intravenous (IV) Vedolizumab on Mucosal Healing in Crohn's Disease

A Phase 3 study testing Vedolizumab in people with Crohn's Disease, run by Takeda at 79 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate endoscopic remission at Week 26 as assessed by ileocolonoscopy. 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
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
101 participants
Where
79 sitesin 8 countries
Study dates
30 Mar 2015to 21 Feb 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
  • Signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
  • Has a diagnosis of moderately to severely active Crohn's disease (CD) at least 3 months prior to enrollment, with a Crohn's Disease Activity Index (CDAI) score of 220-450 during the Screening Period, a simple endoscopic score for Crohn's Disease (SES-CD) score of ≥7 and presence of at least one mucosal ulceration documented by recorded ileocolonoscopy at Screening assessed by the central reader.
  • Has CD with involvement of the ileum and/or colon that can be assessed by ileocolonoscopy.
  • Is male or female and aged 18 to 80 years, inclusive.
  • A male participant who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 18 weeks after last dose.
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  • A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use routinely adequate contraception from signing of informed consent throughout the duration of the study and for 18 weeks after last dose.
  • Has demonstrated an inadequate response to, loss of response to, or intolerance of at least 1 of the following agents as defined below:
  • Immunomodulators:
  • Has signs and symptoms of persistently active disease despite a history of at least one 12-week regimen of oral azathioprine (≥1.5 mg/kg) or 6-mercaptopurine (≥0.75 mg/kg), OR ii. Has a history of intolerance (including but not limited to nausea/vomiting, abdominal pain, pancreatitis, liver function test abnormalities, lymphopenia, thiopurine S-methyltransferase non wild type [where wild type is defined as thiopurine S-methyltransferase (TPMT)*1/*1], infection) to at least 1 immunomodulator.
  • Tumor necrosis factor- alpha (TNF-α) antagonists:
  • Has signs and symptoms of persistently active disease despite a history of at least 1 induction with:
  • Infliximab: 4-week regimen of 5 mg/kg, 2 doses at 2 weeks apart, OR
  • Adalimumab: 2-week regimen of 160 mg on Day 1 and 80 mg on Day 15, OR
  • Certolizumab: 4-week regimen of 400 mg initially at Weeks 0, 2, 4 OR ii. Has recurrence of symptoms during maintenance dosing following prior clinical benefit (discontinuation despite clinical benefit does not qualify), OR iii. Has a history of intolerance of infliximab, adalimumab, or certolizumab, including but not limited to, infusion-related reaction, demyelination, congestive heart failure, or infection.
  • Corticosteroids i. Signs and symptoms of persistently active disease despite a history of at least one 4-week induction regimen that included a dose equivalent to prednisone 30 mg daily orally for 2 weeks or intravenous(ly) (IV) for 1 week, OR ii. Signs and symptoms of persistently active disease despite treatment with budesonide 9 mg daily or 6 mg daily for maintenance, OR iii. At least one failed attempt to taper corticosteroids to below a dose equivalent to prednisone 10 mg daily orally, OR iv. History of intolerance to corticosteroids (including, but not limited to, Cushing's syndrome, osteopenia/osteoporosis, hyperglycemia, insomnia, and infection).
  • May be receiving a stable therapeutic dose of conventional therapies for CD (excluding other biologic agents 60 days before enrollment).
  • Has a family history of colorectal cancer, personal history of increased colorectal cancer risk, age >50 years, or other known risk factors must be up-to-date on colorectal cancer surveillance (may be performed during Screening).

Who cannot join

  • Has received a diagnosis of ulcerative colitis or indeterminate colitis.
  • Has clinical evidence of abdominal abscess.
  • Has a history of >3 small bowel resections or diagnosis of short bowel syndrome.
  • Has extensive colonic resection, ie, subtotal or total colectomy with <15 cm colon remaining.
  • Has ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.
  • Has a history or evidence of adenomatous colonic polyps that have not been removed.
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  • Has a history or evidence of colonic mucosal dysplasia.
  • Has intolerance or contraindication to undergo ileocolonoscopy.
  • Has active or latent tuberculosis, regardless of treatment history, as evidenced by any of the following:
  • History of tuberculosis (TB). b. A diagnostic TB test performed during screening that is positive, as defined by: i. A positive QuantiFERON® test or 2 successive indeterminate QuantiFERON tests OR ii. A tuberculin skin test reaction ≥10 mm (≥5 mm in participants receiving the equivalent of >15 mg/day prednisone).
  • Has chronic hepatitis B (HBV) or hepatitis C (HCV) infection.
  • Has any identified congenital or acquired immunodeficiency (eg, common variable immunodeficiency, human immunodeficiency virus [HIV] infection, organ transplantation).
  • Has evidence of active C. difficile infection or is having treatment for C. difficile infection or other intestinal pathogens during Screening.
  • Has evidence of an active infection during Screening.
  • Currently requires or has a planned surgical intervention for CD during the study.
  • Has received any investigational compound within 60 days of enrollment.
  • Has received any biologics within 60 days of enrollment.
  • Has received any live vaccinations within 30 days prior to enrollment.
  • Has conditions which, in the opinion of the investigator, may interfere with the participant's ability to comply with the study procedures.
  • Has any unstable or uncontrolled cardiovascular, pulmonary, hepatic, renal, gastrointestinal (GI), genitourinary, hematological, coagulation, immunological, endocrine/metabolic, or other medical disorder that, in the opinion of the investigator, would confound the study results or compromise participant safety.
  • Has a history of hypersensitivity or allergies to vedolizumab or its components.
  • Has had prior exposure to vedolizumab, natalizumab, efalizumab, or rituximab.
  • Had a surgical procedure requiring general anesthesia within 30 days prior to screening or is planning to undergo major surgery during the study period.
  • Has a history of malignancy, except for the following: adequately-treated nonmetastatic basal cell skin cancer; squamous cell skin cancer that has been adequately treated and that has not recurred for at least 1 year prior to Screening; and history of cervical carcinoma in situ that has been adequately treated and that has not recurred for at least 3 years prior to screening. Participants with a 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 prior to enrollment.
  • Has a history of any major neurological disorders, including stroke, multiple sclerosis, brain tumor, or neurodegenerative disease.
  • Has a positive progressive multifocal leukoencephalopathy (PML) subjective symptom checklist during Screening or prior to the administration of study drug.
  • Has any of the following laboratory abnormalities during the Screening Period:
  • Hemoglobin level <8 g/dL. ii. White blood cell (WBC) count <3*10^9/L. iii. Lymphocyte count <0.5*10^9/L. iv. Platelet count <100*10^9/L or >1200*10^9/L. v. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3*the upper limit of normal (ULN).
  • Alkaline phosphatase >3*ULN. vii. Serum creatinine >2*ULN.
  • Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year prior to enrollment.
  • Has an active psychiatric problem that, in the investigator's opinion, may interfere with compliance with study procedures.
  • Is unable to attend all the study visits or comply with study procedures.
  • If female, the participant is pregnant or lactating or intending to become pregnant before, during, or within 18 weeks after participating in this study; or intending to donate ova during such time period.
  • If male, the participant intends to donate sperm during the course of this study or for 18 weeks thereafter.
  • Is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.
  • Participants who are at sites participating in the magnetic resonance enterography (MREn) substudy may not participate if they have intolerance or contraindication to the procedure or if any of the following exclusions apply:
  • Has certain implanted medical devices, such as pacemakers or implantable cardioverter defibrillators (ICDs), or ferromagnetic metallic foreign bodies, such as shrapnel or certain tattoos.
  • Has allergy to gadolinium-based magnetic resonance (MR) IV contrast agents.
  • Has known claustrophobia.
  • Has estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m^2 at Screening.

Trial locations and contacts

79 sites in 8 countries.

79 sites in 8 countries

United States22 sites

  • Study site

    Ann Arbor, Michigan

  • Study site

    Baton Rouge, Louisiana

  • Study site

    Boston, Massachusetts

  • Study site

    Cleveland, Ohio

  • Study site

    Columbia, Maryland

  • Study site

    Gainesville, Florida

  • Study site

    Germantown, Tennessee

  • Study site

    Hamden, Connecticut

  • Study site

    Inverness, Florida

  • Study site

    La Jolla, California

  • Study site

    Macon, Georgia

  • Study site

    Maitland, Florida

  • Study site

    Manhasset, New York

  • Study site

    Miami, Florida

  • Study site

    Portland, Oregon

  • Study site

    Poughkeepsie, New York

  • Study site

    St Louis, Missouri

  • Study site

    Suwanee, Georgia

  • Study site

    Topeka, Kansas

  • Study site

    Tulsa, Oklahoma

  • Study site

    Winston-Salem, North Carolina

  • Study site

    Winter Park, Florida

Other trials in United States

Hungary14 sites

  • Study site

    Békéscsaba

  • Study site

    Budapest

  • Study site

    Debrecen

  • Study site

    Gyöngyös

  • Study site

    Gyula

  • Study site

    Jászberény

  • Study site

    Kistarcsa

  • Study site

    Miskolc

  • Study site

    Mosonmagyaróvár

  • Study site

    Pécs

  • Study site

    Szeged

  • Study site

    Székesfehérvár

  • Study site

    Szekszárd

  • Study site

    Vác

Other trials in Hungary

France12 sites

  • Study site

    Lille, Nord

  • Study site

    Lille

  • Study site

    Nantes

  • Study site

    Nice, Alpes Maritimes

  • Study site

    Nice

  • Study site

    Pessac, Gironde

  • Study site

    Pessac

  • Study site

    Reims, Marne

  • Study site

    Reims

  • Study site

    Saint-Etienne

  • Study site

    Saint-Étienne-de-Montluc, Pays de la Loire Region

  • Study site

    Toulouse

Other trials in France

Italy11 sites

  • Study site

    Bologna

  • Study site

    Florence

  • Study site

    Naples

  • Study site

    Padova

  • Study site

    Roma

  • Study site

    Rozzano, Milano

  • Study site

    Rozzano

  • Study site

    San Donato Milanese, Milano

  • Study site

    San Donato Milanese

  • Study site

    San Giovanni Rotondo, Foggia

  • Study site

    San Giovanni Rotondo

Other trials in Italy

Belgium6 sites

  • Study site

    Bonheiden

  • Study site

    Brussels

  • Study site

    Herentals

  • Study site

    Kortrijk

  • Study site

    Leuven

  • Study site

    Roeselare

Other trials in Belgium

Canada5 sites

  • Study site

    Halifax, Nova Scotia

  • Study site

    London, Ontario

  • Study site

    Vancouver, British Columbia

  • Study site

    Vaughan, Ontario

  • Study site

    Victoria, British Columbia

Other trials in Canada

Poland5 sites

  • Study site

    Bialystok

  • Study site

    Elblag

  • Study site

    Poznan

  • Study site

    Warsaw

  • Study site

    Wroclaw

Other trials in Poland

Czechia4 sites

  • Study site

    Hradec Králové

  • Study site

    Kladno

  • Study site

    Pardubice

  • Study site

    Prague

Other trials in Czechia

About this study

Official title: An Open-Label Phase 3b Study to Assess Mucosal Healing in Subjects With Moderately to Severely Active Crohn's Disease Treated With Vedolizumab IV

The purpose of this study is to evaluate endoscopic remission at Week 26 as assessed by ileocolonoscopy.

Read the detailed description

The drug being tested in this study is called vedolizumab. Vedolizumab is being tested to treat people who have Crohn's disease. This study will look at mucosal healing in people who take vedolizumab.

The study will enroll approximately 100 patients and will be conducted in 2 Parts. Part A will consist of a 26-week treatment period and all participants will receive vedolizumab 300 mg intravenously (IV) on Day 1 and at Weeks 2, 6, 14 and 22. Part B will consist of a 26-week extension treatment period and all participants will receive vedolizumab 300 mg IV at Weeks 30, 38, and 46.

This multi-center trial will be conducted worldwide. The overall time to participate in this study is approximately 70 weeks for Parts A, B and 18-Week Follow-up combined. Participants will make multiple visits to the clinic. All participants included in the study will also have a 6 month safety follow-up telephone call following his/her last dose of study drug.

Conditions
Crohn's Disease
Being tested
Vedolizumab
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.

  • VedolizumabDrug

    Also called MLN0002

    Vedolizumab intravenous injection

Study groups in NCT02425111
Study groupRoleWhat they receive
Vedolizumab 300 mgExperimentalPart A: Vedolizumab 300 mg, intravenously (IV), once on Day 1 and Weeks 2, 6, 14 and 22, followed by Part B: Vedolizumab 300 mg, intravenously (IV), once at Weeks 30, 38, and 46.
Receives: Drug: Vedolizumab

What is being measured

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

  1. Part A: Percentage of Participants Achieving Endoscopic Remission at Week 26

    Endoscopic remission is defined as a simple endoscopic score for Crohn's Disease (SES-CD) score of ≤4. The SES-CD evaluates 4 endoscopic variables (ulcer size, proportion of the surface area that is ulcerated, proportion of the surface area affected, and stenosis in 5 segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The score for each endoscopic variable is the sum of values obtained for each segment. The SES-CD total is the sum of the 4 endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease.

    Measured: Week 26

Secondary outcomes (14)

  1. Part A: Percentage of Participants Achieving Complete Mucosal Healing at Week 26

    Complete mucosal healing is defined as absence of ulceration.

    Measured: Week 26

  2. Part B: Percentage of Participants Achieving Complete Mucosal Healing at Week 52

    Complete mucosal healing is defined as absence of ulceration.

    Measured: Week 52

  3. Part A: Percentage of Participants Achieving Endoscopic Remission at Week 14

    Endoscopic remission is defined as a SES-CD score of ≤4. The SES-CD evaluates 4 endoscopic variables (ulcer size, proportion of the surface area that is ulcerated, proportion of the surface area affected, and stenosis in 5 segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The score for each endoscopic variable is the sum of values obtained for each segment. The SES-CD total is the sum of the 4 endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease.

    Measured: Week 14

  4. Part B: Percentage of Participants Achieving Endoscopic Remission at Week 52

    Endoscopic remission is defined as a SES-CD score of ≤4. The SES-CD evaluates 4 endoscopic variables (ulcer size, proportion of the surface area that is ulcerated, proportion of the surface area affected, and stenosis in 5 segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The score for each endoscopic variable is the sum of values obtained for each segment. The SES-CD total is the sum of the 4 endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease.

    Measured: Week 52

  5. Part A: Percentage of Participants With Endoscopic Response at Week 14

    Endoscopic response is defined as a reduction in SES-CD from Baseline by ≥50%. The SES-CD evaluates 4 endoscopic variables (ulcer size, proportion of the surface area that is ulcerated, proportion of the surface area affected, and stenosis in 5 segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The score for each endoscopic variable is the sum of values obtained for each segment. The SES-CD total is the sum of the 4 endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease.

    Measured: Baseline and Week 14

  6. Part A: Percentage of Participants With Endoscopic Response at Week 26

    Endoscopic response is defined as a reduction in SES-CD from Baseline by ≥50%. The SES-CD evaluates 4 endoscopic variables (ulcer size, proportion of the surface area that is ulcerated, proportion of the surface area affected, and stenosis in 5 segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The score for each endoscopic variable is the sum of values obtained for each segment. The SES-CD total is the sum of the 4 endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease.

    Measured: Baseline and Week 26

  7. Part B: Percentage of Participants With Endoscopic Response at Week 52

    Endoscopic response is defined as a reduction in SES-CD from Baseline by ≥50%. The SES-CD evaluates 4 endoscopic variables (ulcer size, proportion of the surface area that is ulcerated, proportion of the surface area affected, and stenosis in 5 segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The score for each endoscopic variable is the sum of values obtained for each segment. The SES-CD total is the sum of the 4 endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease.

    Measured: Baseline and Week 52

  8. Part A: Percentage of Participants Achieving Clinical Response at Week 10

    Clinical response is defined as Crohn's Disease Activity Index (CDAI) decrease from Baseline of ≥100 points. CDAI is a scoring system for the assessment of Crohn's Disease Activity, index values of 150 and below are associated with quiescent disease; values above that indicate active disease and values above 450 are seen with extremely severe disease.

    Measured: Baseline and Week 10

  9. Part A: Percentage of Participants Achieving Clinical Response at Week 26

    Clinical response is defined as CDAI decrease from Baseline of ≥100 points. CDAI is a scoring system for the assessment of Crohn's Disease Activity, index values of 150 and below are associated with quiescent disease; values above that indicate active disease and values above 450 are seen with extremely severe disease.

    Measured: Baseline and Week 26

  10. Part B: Percentage of Participants Achieving Clinical Response at Week 52

    Clinical response is defined as CDAI decrease from Baseline of ≥100 points. CDAI is a scoring system for the assessment of Crohn's Disease Activity, index values of 150 and below are associated with quiescent disease; values above that indicate active disease and values above 450 are seen with extremely severe disease.

    Measured: Baseline and Week 52

  11. Part A: Percentage of Participants Achieving Clinical Remission at Week 10

    Clinical remission is defined as CDAI score of ≤150 points. CDAI is a scoring system for the assessment of Crohn's Disease Activity, index values of 150 and below are associated with quiescent disease; values above that indicate active disease and values above 450 are seen with extremely severe disease.

    Measured: Week 10

  12. Part A: Percentage of Participants Achieving Clinical Remission at Week 26

    Clinical remission is defined as CDAI score of ≤150 points. CDAI is a scoring system for the assessment of Crohn's Disease Activity, index values of 150 and below are associated with quiescent disease; values above that indicate active disease and values above 450 are seen with extremely severe disease.

    Measured: Week 26

  13. Part B: Percentage of Participants Achieving Clinical Remission at Week 52

    Clinical remission is defined as CDAI score of ≤150 points. CDAI is a scoring system for the assessment of Crohn's Disease Activity, index values of 150 and below are associated with quiescent disease; values above that indicate active disease and values above 450 are seen with extremely severe disease.

    Measured: Week 52

  14. Part B: Percentage of Participants With Durable Clinical Remission

    Durable clinical remission is defined as clinical remission at both Week 26 and Week 52. Clinical remission is defined as CDAI score of ≤150 points. CDAI is a scoring system for the assessment of Crohn's Disease Activity, index values of 150 and below are associated with quiescent disease; values above that indicate active disease and values above 450 are seen with extremely severe disease. The percentage of participants assessed at Week 52 who had clinical remission at Week 26 of Part A and also had clinical remission at Week 52 is reported.

    Measured: Weeks 26 and 52

Timeline

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

  1. First posted23 Apr 2015 (estimated)
  2. Study start30 Mar 2015
  3. Primary completion2 Jun 2017
  4. Study completion21 Feb 2018

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
101 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02425111
Sponsor's protocol ID
MLN0002-3028
Other IDs
U1111-1159-5806, 2014-003509-13, 183974, 2014
Status last verified
Aug 2018
First submitted
26 Mar 2015
Last updated
14 Sep 2018
Data monitoring committee
No

Publications

  • Rimola J, Colombel JF, Bressler B, Adsul S, Siegelman J, Cole PE, Lindner D, Danese S. Magnetic Resonance Enterography Assessment of Transmural Healing with Vedolizumab in Moderate to Severe Crohn's Disease: Feasibility in the VERSIFY Phase 3 Clinical Trial. Clin Exp Gastroenterol. 2024 Jan 27;17:9-23. doi: 10.2147/CEG.S429039. eCollection 2024.

    PubMed 38298861

  • Narula N, Wong ECL, Dulai PS, Marshall JK, Jairath V, Reinisch W. Comparative Effectiveness of Biologics for Endoscopic Healing of the Ileum and Colon in Crohn's Disease. Am J Gastroenterol. 2022 Jul 1;117(7):1106-1117. doi: 10.14309/ajg.0000000000001795. Epub 2022 Apr 15.

    PubMed 35435862

  • Danese S, Sandborn WJ, Colombel JF, Vermeire S, Glover SC, Rimola J, Siegelman J, Jones S, Bornstein JD, Feagan BG. Endoscopic, Radiologic, and Histologic Healing With Vedolizumab in Patients With Active Crohn's Disease. Gastroenterology. 2019 Oct;157(4):1007-1018.e7. doi: 10.1053/j.gastro.2019.06.038. Epub 2019 Jul 4.

    PubMed 31279871

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Vedolizumab in people with Crohn's Disease, run by Takeda at 79 sites in 8 countries.

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 18 inclusion and 40 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: finished, as of the sponsor's last update on 14 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 79 sites in United States, Hungary, France, Italy, Belgium and 3 more countries. 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. 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?

Yes. Results are posted in the registry (first posted 14 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A: Percentage of Participants Achieving Endoscopic Remission at Week 26 (time frame: Week 26). 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 NCT02425111, which also lists 3 linked publications.

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 14 Sep 2018; AzTrials last refreshed its copy on 8 Nov 2026.

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