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Crohn's DiseasePhase 3NCT02038920

Phase III Study of MLN0002 (300 mg) in Treatment of Crohn's Disease

A Phase 3 study testing Vedolizumab in people with Crohn's Disease, run by Takeda at 56 sites in Japan.

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

This study is a phase 3, multicenter, randomized, double-blinded, placebo-controlled, parallel-group study to examine the efficacy, safety, and pharmacokinetics of vedolizumab (MLN0002) in induction and maintenance therapy in Japanese participants with moderately or severely active Crohn's disease. Read more about this study

Who is it for?
Ages 15 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?
Yes, some participants may receive a placebo
How many people
157 participants
Where
56 sitesJapan
Study dates
28 Jan 2014to 21 May 2019
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 15 to 80 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • In the opinion of the investigator, participants were capable of understanding and complying with protocol requirements
  • Participants or, when applicable, participants legally acceptable representative sign and date the informed consent form prior to initiation of any study procedures
  • Participants aged 15 to 80 years (inclusive) at the time of consent
  • A nonsterilized male participant who has a female partner of child-bearing potential has to agree to use adequate contraception during the period from the signing of informed consent to 6 months after the last dose of the study drug
  • A female participant of child-bearing potential (i.e., nonsterilized or whose last regular menses was within previous 2 years) who has a nonsterilized male partner has to agree to use adequate contraception during the period from the signing of informed consent to 6 months after the last dose of the study drug
  • Participants with a diagnosis of small-intestinal, large-intestinal, or small-/large-intestinal Crohn's disease (CD) established based on the Revised Diagnostic Criteria for Crohn's disease issued by Research Group for Intractable Inflammatory Bowel Disease Designated as Specified Disease by the Ministry of Health, Labor and Welfare of Japan (2012) at least 3 months before the start of administration of study drug
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  • Participants with baseline CDAI score of 220 to 450(inclusive) and meeting at least one of the followings:
  • C-reactive protein (CRP) at screening test is above 0.30 mg/dL
  • Participants with irregular or semicircular ulcers or multiple aphthae (10 or more) observed over an extensive area of the small or large intestine on endoscopy or imaging test within the 4 months before the start of administration of study drugs
  • Participants with longitudinal ulcers or a cobblestone appearance observed in the small or large intestine on endoscopy or imaging test within 4 months before the start of administration of study drugs
  • In case of the participants who meet any of the following criteria; participants with ≥ 8-year history of extensive or limited colitis, participants aged ≥ 50 years, or participants with a first-degree family history of colon cancer, those whom the complication of colon cancer or dysplasia was ruled out by total colonoscopy at the start of study drug administration (or the results from total colonoscopy performed within 1 year before giving consent are available)
  • Participants meeting the criteria for treatment failure below with at least one of the following agents received within previous 5 year period before giving consent
  • Corticosteroids
  • Resistance
  • Dependence
  • Intolerance
  • Immunomodulators (azathioprine, 6-mercaptopurine or methotrexate)
  • Refractory
  • Intolerance
  • Anti-tumor necrosis factor alpha (TNFα) antibodies
  • Inadequate response
  • Loss of response
  • Intolerance

Who cannot join

  • Participants with an evidence of or suspected abdominal abscess
  • Participants with a history of subtotal or total colectomy
  • Participants who have had a resection of the small intestine in at least 3 locations or have a diagnosis of short bowel syndrome
  • Participants with ileostomy, colostomy, or internal fistula, or severe intestinal stenosis
  • Participants who have a treatment history with natalizumab, efalizumab or rituximab
  • Participants who started 5-aminosalicylic acid oral drug or probiotics treatment, antimicrobials to treat Crohn's disease, or 30 mg/day or less of oral corticosteroids within 13 days before initiation of study drug administration. If these drugs were used within 14 days before initiation of study drug administration, the dosage must have been changed or their use discontinued within 13 days before the initiation of study drug administration
Show all 44Show fewer
  • Participants who had received 5-aminosalicylic acid or corticosteroid enemas/suppositories, intravenous corticosteroid injections, or more than 30 mg/day of oral corticosteroids, medications for diarrhea-predominant irritable bowel syndrome, or Chinese herbal medicine for the treatment of Crohn's disease (e.g., Daikenchuto) within 13 days before initiation of study drug administration
  • Participants who had received azathioprine, 6-mercaptopurine, or methotrexate within 27 days before initiation of study drug administration. However, this shall not apply to participants who have received these drugs for 83 or more days before initiation of the study drug administration and continued the steady dose administration of the drugs for 27 or more days before initiation of the study drug administration
  • Participants who had received cyclosporin, tacrolimus, tofacitinib or any study drugs for treatment of ulcerative colitis within 27 days before initiation of the study drug administration
  • Participants who had received adalimumab within 27 days before initiation of study drug administration or any biological drugs other than adalimumab within 55 days before initiation of study drug administration. Topical administration (such as intraocular implantation for treatment of age-related maculopacy) is allowed
  • Participants who had received any live vaccinations within 27 days before initiation of study drug administration
  • Participants who had undergone intestinal resection within 27 days before initiation of study drug administration or those anticipated to require intestinal resection during the study
  • Participants who had received leukocytapheresis or granulocyte apheresis within 27 days before initiation of the study drug administration
  • Participants who had received intravenous hyperalimentation or total enteral nutrition within the 20 days before initiation of the study drug administration or participants who are fasted
  • Participants who had received enteral nutrition at > 900 kcal/day or started enteral nutrition at <= 900 kcal/day within the 20 days before initiation of the study drug administration. Participants receiving 900 kcal/day or less of enteral nutrition for at least 21 days before initiation of the study drug administration whom these dosage was changed or the medications were discontinued within 20 days before initiation of the study drug administration
  • Participants who had been infected with Clostridium difficile, cytomegalovirus, or any other intestinal pathogen within 27 days before the first dose of the study drug
  • Participants with evidence of adenomatous colonic polyps that need to be removed at the start of study drug administration
  • Participants with a history or an complication of dysplasia of the small or large intestine
  • Participants who were suspected to have enteritis other than CD
  • Participants who were hepatitis B surface (HBs) antigen-positive or hepatitis C virus (HCV) antibody-positive at the screening. Or participants who are hepatitis B core (HBc) antibodypositive or HBs antibody positive, even though HBs antigen-negative. However, this does not apply to participants who are only HBs antibody-positive due to hepatitis B virus (HBV) vaccination, HBV-DNA-negative, HCV antigen-negative, or HCV-RNA-negative
  • Participants who had an evidence of history of tuberculosis or a suspected history of tuberculosis (including those who have findings suggesting previous tuberculosis on chest imaging procedure at the screening). However, this does not apply to participants who had completed prophylactic isoniazid, or participants who had been receiving prophylactic isoniazid for more than 21 days before the first dose of the study drug (in the latter case, the screening period are allowed to extend up to 28 days to ensure at least 21-day prophylactic isoniazid and then the study treatment is allowed to start)
  • Participants who had positive T-SPOT test or QuantiFERON test at the screening
  • Participants who had a history or complication of identified congenital or acquire immunodeficiency syndrome (eg, not-classifiable immunodeficiency, human immunodeficiency virus [HIV] infection or organ transplantation)
  • Participants who had been affected by extraintestinal infection (eg, pneumonia, sepsis, active hepatitis or pyelonephritis) within 27 days before the first dose of the study drug
  • Participants who had a treatment history with MLN0002
  • Female participants who are lactating at the screening, or have positive urine pregnancy test either at the screening or baseline
  • Participants who had serious complications in the heart, lung, liver, kidney, metabolism, gastrointestinal system, urinary system, endocrine system or blood
  • Participants who had a history of a surgery requiring general anesthesia within 27 days before the first dose of the study drug, or with a schedule of a surgery requiring hospitalization during the study period
  • Participants who had a complication or a history of malignancy. However, this does not apply to the following participants:
  • Participants who had a curative resection of localized skin basal cell carcinoma or have completed curative radiotherapy
  • Participants who had not experienced recurrence for more than 1 year since completion of a curative resection or curative radiotherapy for skin squamous cell carcinoma
  • Participants who had not experienced recurrence for more than 3 years since completion of a curative resection or curative radiotherapy for intraepithelial carcinoma of uterine cervix For participants who had a substantially distant history of malignancy (eg, 10 years or longer without recurrence since treatment completion), the investigator and the sponsor had a discussion to decide eligibility on the basis of type of malignancy and treatment applied
  • Participants who had a history or a complication of the central nervous disorder, including stroke, multiple sclerosis, brain tumor, or neurodegenerative disease.
  • Participants who had any subjective symptoms in the subjective PML checklist at the screening or baseline
  • Participants who had any of the following laboratory abnormalities at the screening;
  • Hemoglobin ≤8 g/dL
  • White blood cells ≤3,000/μL
  • Lymphocytes ≤500/μL
  • Platelets ≤100,000/μL or ≥1,200,000/μL
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3×upper limit of normal (ULN)
  • Alkaline phosphatase (ALP) ≥3×ULN
  • Creatinine ≥2×ULN
  • Participants who had a history or a complication of alcohol dependence or illicit drug use within one year before the first dose of the study drug
  • Participants who had a history or a complication of psychotic disorder that could obstruct compliance with the study procedures

Trial locations and contacts

56 sites in 1 country.

56 sites in 1 country

Japan56 sites

  • Study site

    Abiko, Chiba

  • Study site

    Adachi-ku, Tokyo

  • Study site

    Akashi, Hyōgo

  • Study site

    Asahikawa, Hokkaido

  • Study site

    Bunkyo-ku, Tokyo

  • Study site

    Chiba

  • Study site

    Chikushino-shi, Fukuoka

  • Study site

    Chiyoda-ku, Tokyo

  • Study site

    Fukui

  • Study site

    Fukuoka

  • Study site

    Fukuyama, Hiroshima

  • Study site

    Hamamatsu, Shizuoka

  • Study site

    Hatsukaichi, Hiroshima

  • Study site

    Hirosaki, Aomori

  • Study site

    Hiroshima

  • Study site

    Kagoshima

  • Study site

    Kamakura, Kanagawa

  • Study site

    Kashiwa, Chiba

  • Study site

    Kasuga, Fukuoka

  • Study site

    Kawasaki, Kanagawa

  • Study site

    Kitakyushu, Fukuoka

  • Study site

    Kochi, Kochi

  • Study site

    Kofu, Yamanashi

  • Study site

    Kumamoto

  • Study site

    Kurashiki, Okayama-ken

  • Study site

    Kyoto

  • Study site

    Matsuyama, Ehime

  • Study site

    Minato-ku, Tokyo

  • Study site

    Moriguchi, Osaka

  • Study site

    Nagasaki

  • Study site

    Nagoya, Aichi-ken

  • Study site

    Niigata

  • Study site

    Nishinomiya, Hyōgo

  • Study site

    Ōita

  • Study site

    Okayama

  • Study site

    Okinawa

  • Study site

    Osaka

  • Study site

    Ōtsu, Shiga

  • Study site

    Saga

  • Study site

    Sagamihara, Kanagawa

  • Study site

    Saitama

  • Study site

    Sakura, Chiba

  • Study site

    Sapporo, Hokkaido

  • Study site

    Sendai, Miyagi

  • Study site

    Shimotsuke, Tochigi

  • Study site

    Shinagawa-ku, Tokyo

  • Study site

    Shinjuku-ku, Tokyo

  • Study site

    Shūnan, Yamaguchi

  • Study site

    Suita, Osaka

  • Study site

    Takamatsu, Kagawa-ken

  • Study site

    Takasaki, Gunma

  • Study site

    Tokorozawa, Saitama

  • Study site

    Tomakomai, Hokkaido

  • Study site

    Toyota, Aichi-ken

  • Study site

    Wakayama

  • Study site

    Yokohama, Kanagawa

Other trials in Japan

About this study

Official title: Phase III, Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Intravenous MLN0002 (300 mg) Infusion in Induction and Maintenance Therapy in Japanese Subjects With Moderate or Severe Crohn's Disease

This study is a phase 3, multicenter, randomized, double-blinded, placebo-controlled, parallel-group study to examine the efficacy, safety, and pharmacokinetics of vedolizumab (MLN0002) in induction and maintenance therapy in Japanese participants with moderately or severely active Crohn's disease.

Read the detailed description

This is a phase 3, multicenter, randomized, double-blinded, placebo-controlled, parallel-group study to examine the efficacy, safety, and pharmacokinetics of intravenous vedolizumab (300 mg) infusion in induction and maintenance therapy in Japanese participants with moderately or severely active Crohn's disease.

Conditions
Crohn's Disease
Being tested
Vedolizumab, Vedolizumab 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.

  • VedolizumabDrug

    Also called MLN0002

    Vedolizumab IV injection

  • Vedolizumab placeboDrug

    Vedolizumab placebo-matching IV infusion

Study groups in NCT02038920
Study groupRoleWhat they receive
Induction Phase: Vedolizumab, 300 mgExperimentalVedolizumab 300 mg, intravenous (IV) infusion, once at Weeks 0, 2 and 6 in the induction phase.
Receives: Drug: Vedolizumab
Induction Phase: PlaceboPlacebo comparatorVedolizumab placebo-matching IV infusion once at Weeks 0, 2 and 6 in the induction phase.
Receives: Drug: Vedolizumab placebo
Maintenance Phase: Vedolizumab 300 mgExperimentalVedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved Crohn's Disease Activity Index (CDAI)-70 response at Week 10 and were randomized to receive vedolizumab in maintenance phase.
Receives: Drug: Vedolizumab
Maintenance Phase: PlaceboPlacebo comparatorVedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved CDAI-70 response at Week 10 and were randomized to receive placebo in maintenance phase.
Receives: Drug: Vedolizumab placebo
Maintenance Phase: Placebo ContinuationPlacebo comparatorVedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab placebo-matching in induction phase and achieved CDAI-70 response at Week 10 received placebo in maintenance phase without randomization.
Receives: Drug: Vedolizumab placebo
Open-Label: Vedolizumab 300 mgExperimentalVedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 and then every 8 weeks thereafter up to Week 94 as a maximum duration in open-label phase.
Receives: Drug: Vedolizumab

What is being measured

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

  1. Induction Phase: Percentage of Participants With Crohn's Disease Activity Index (CDAI)-100 Response

    A response to therapy is considered a decrease from baseline of at least 100 points in the CDAI score at Week 10. CDAI is scoring system for the assessment of Crohn's disease activity. The total CDAI score ranges from 0 to approximately 600, where higher scores indicate more severe disease. Index values of 150 and below are associated with quiescent disease; values above that indicate active disease.

    Measured: Week 10

  2. Maintenance Phase: Percentage of Participants With Clinical Remission

    Clinical remission is defined as the CDAI score ≤150. CDAI is 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.

    Measured: Week 60

  3. Number of Participants Who Experienced at Least One or More Treatment-Emergent Adverse Events (TEAEs)

    An Adverse event (AE) is defined as any untoward medical occurrence in a study participant who received a drug (including a study drug); it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.

    Measured: From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks)

  4. Number of Participants With TEAE Related to Body Weight (Weight Decreased)

    Reported events on this outcome measure were "Weight Decreased".

    Measured: From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks)

  5. Number of Participants With TEAE Related to Vital Signs

    Vital signs included body temperature (axilla), sitting blood pressure (after the participant has rested for at least 5 minutes), and pulse (bpm). Reported events on this outcome measure were "Pyrexia", "Body temperature increased", "Hypertension", and "Orthostatic hypotension".

    Measured: From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks)

  6. Number of Participants With TEAE Related to Electrocardiogram (ECG) [Bundle Branch Block Right]

    Reported events on this outcome measure were "Bundle Branch Block Right".

    Measured: From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks)

  7. Number of Participants With Markedly Abnormal Values of Laboratory Parameters Values

    The laboratory values outside the range (Hemoglobin <=7 g/dL, Lymphocytes <500 /microL, White Blood Cell (WBC) <2000 /microL, Platelets <7.5 10^4/microL, Neutrophils <1000 /microL, Alanine Aminotransferase (ALT) (Glutamic Pyruvic Transaminase; GPT) >3.0 U/L x upper limit of normal (ULN), Aspartate Aminotransferase (AST) (Glutamic Oxaloacetic Transaminase; GOT) >3.0 U/L x ULN, Total Bilirubin >2.0 mg/dL x ULN, Amylase >2.0 (U/L) x ULN are considered markedly abnormal.

    Measured: From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks)

Secondary outcomes (13)

  1. Induction Phase: Percentage of Participants With Clinical Remission

    Clinical remission is defined as the CDAI score ≤150. CDAI is 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.

    Measured: Week 10

  2. Induction Phase: Change From Baseline in C-reactive Protein (CRP) Values

    Measured: Baseline to Week 10

  3. Maintenance Phase: Percentage of Participants With Crohn's Disease Activity Index (CDAI)-100 Response

    A response to therapy is considered a decrease from baseline of at least 100 points in the CDAI score at Week 10. CDAI is scoring system for the assessment of Crohn's disease activity. The total CDAI score ranges from 0 to approximately 600, where higher scores indicate more severe disease. Index values of 150 and below are associated with quiescent disease; values above that indicate active disease.

    Measured: Week 60

  4. Maintenance Phase: Percentage of Participants With Durable Clinical Remission

    Durable clinical remission is defined as participants with CDAI score ≤ 150 at both Weeks 14 and 60. CDAI is scoring system for the assessment of Crohn's disease activity. The total CDAI score ranges from 0 to approximately 600, where higher scores indicate more severe disease. Index values of 150 and below are associated with quiescent disease; values above that indicate active disease.

    Measured: From Week 14 and Week 60

  5. Maintenance Phase: Percentage of Participants With Corticosteroid-free Clinical Remission

    Corticosteroid-free clinical remission is defined as participants using oral corticosteroids at baseline (Week 0) who discontinued corticosteroids and were in clinical remission (CDAI score ≤ 150) at Week 60. CDAI is scoring system for the assessment of Crohn's disease activity. The total CDAI score ranges from 0 to approximately 600, where higher scores indicate more severe disease. Index values of 150 and below are associated with quiescent disease; values above that indicate active disease.

    Measured: Week 60

  6. Serum Vedolizumab Concentration in Induction Phase

    Measured: Weeks 2, 6, 10 and 14

  7. Serum Vedolizumab Concentration in Maintenance Phase

    Measured: Weeks 2, 6, 10, 14, 22, 30 and 60

  8. Number of Participants With Anti-vedolizumab Antibodies (AVA) in Induction Phase

    Measured: Weeks 0, 10 and 16 weeks after the last dose of study drug in induction phase

  9. Number of Participants With Anti-vedolizumab Antibodies (AVA) in Maintenance Phase

    Measured: Weeks 0, 10, 30, 60 and 16 weeks after the last dose of study drug in maintenance phase

  10. Number of Participants With Anti-vedolizumab Antibodies (AVA) in Open Label Cohort

    Measured: Weeks 0, 10, 30, 62, 94 and 16 weeks after the last dose of study drug in open-label cohort

  11. Number of Participants With Neutralizing Anti-vedolizumab Antibodies (AVA) in Induction Phase

    Measured: Weeks 0, 10 and 16 weeks after the last dose of study drug in induction phase

  12. Number of Participants With Neutralizing Anti-vedolizumab Antibodies (AVA) in Maintenance Phase

    Measured: Weeks 0, 10, 30, 60 and 16 weeks after the last dose of study drug in maintenance phase

  13. Number of Participants With Neutralizing Anti-vedolizumab Antibodies (AVA) in Open Label Cohort

    Measured: Weeks 0, 10, 30, 62, 94 and 16 weeks after the last dose of study drug in open-label cohort

Timeline

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

  1. First posted17 Jan 2014 (estimated)
  2. Study start28 Jan 2014
  3. Primary completion25 Jan 2019
  4. Study completion21 May 2019

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
157 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02038920
Sponsor's protocol ID
MLN0002/CCT-001
Other IDs
U1111-1150-2688, JapicCTI-142402
Status last verified
Nov 2019
First submitted
15 Jan 2014
Last updated
9 Dec 2019
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

Publications

  • Okamoto H, Dirks NL, Rosario M, Hori T, Hibi T. Population pharmacokinetics of vedolizumab in Asian and non-Asian patients with ulcerative colitis and Crohn's disease. Intest Res. 2021 Jan;19(1):95-105. doi: 10.5217/ir.2019.09167. Epub 2020 Jul 10.

    PubMed 32635680

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 56 sites in Japan.

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 23 inclusion and 44 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 9 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 56 sites in Japan. 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?

Yes. Results are posted in the registry (first posted 9 Dec 2019). 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?

Induction Phase: Percentage of Participants With Crohn's Disease Activity Index (CDAI)-100 Response (time frame: Week 10). The study lists 7 primary outcomes in all. 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 NCT02038920, which also lists 1 linked publication.

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 9 Dec 2019.

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Clinical Trial NCT02038920 | AzTrials