Crohn's DiseasePhase 3NCT03234907
Vedolizumab Intravenous (IV) Compared to Placebo in Chinese Participants With Crohn's Disease.
A Phase 3 study testing Vedolizumab IV in people with Crohn's Disease, run by Takeda at 29 sites in China.
Trial summary
The purpose of this study is to assess the safety and efficacy of vedolizumab intravenous (IV) infusion as induction treatment in Chinese participants with moderately to severely active Crohn's disease (CD) at Week 10. 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
- 215 participants
- Where
- 29 sitesChina
- Study dates
- 3 Aug 2017to 14 Aug 2020
- 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
- Has a diagnosis of Crohn's disease (CD) established at least 3 months prior to Screening by clinical and endoscopic evidence corroborated by a histopathology report. Cases of CD established at least 6 months prior to 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 diagnosis, and must be discussed with the sponsor on a case-by-case basis prior to randomization.
- Has moderately to severely active CD as determined by a Crohn's Disease Activity Index (CDAI) score of 220 to 400 within 7 days prior to the first dose of study drug and 1 of the following:
- C-reactive protein (CRP) level >2.87 mg/L during the Screening Phase, OR
- Ileocolonoscopy with photographic documentation of a minimum of 3 nonanastomotic ulcerations (each >0.5 cm in diameter) or 10 aphtous ulcerations (involving a minimum of 10 contiguous cm of intestine) consistent with CD, within 4 months prior to randomization, OR
- Fecal calprotectin >250 μg/g stool during the Screening Phase in conjunction with computed tomography enterography (CTE), magnetic resonance enterography (MRE), contrast enhanced small bowel radiography, or wireless capsule endoscopy revealing CD ulcerations (aphthae not sufficient), within 4 months prior to Screening
- Has CD involvement of the ileum and/or colon, at a minimum.
Show all 12Show fewer
- Has 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 prior to initial screening (may be performed during Screening if not performed in previous 12 months).
- Has 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).
- Has demonstrated an inadequate response to, loss of response to, or intolerance of at least 1 of the following agents as defined below:
- Corticosteroids.
- Immunomodulators.
- Tumor necrosis factor-alpha (TNF-α) antagonists.
Who cannot join
- Has evidence of abdominal abscess at the initial Screening Visit.
- Has had extensive colonic resection, subtotal or total colectomy.
- Has a history of >3 small bowel resections or diagnosis of short bowel syndrome.
- Has had ileostomy, colostomy, known fixed symptomatic stenosis of the intestine, or evidence of fixed stenosis, or small bowel stenosis with prestenotic dilation.
- Has had previous exposure to approved or investigational anti-integrins (e.g., natalizumab, efalizumab, etrolizumab, or AMG-181), or MAdCAM-1 antagonists, or rituximab.
- Has used topical (rectal) treatment with 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.
Show all 17Show fewer
- Requires currently or is anticipated to require surgical intervention for CD during the study.
- Has a history or evidence of adenomatous colonic polyps that have not been removed.
- Has a history or evidence of colonic mucosal dysplasia including low or high-grade dysplasia, as well as indeterminate for dysplasia.
- Has a suspected or confirmed diagnosis of ulcerative colitis, indeterminate colitis, ischemic colitis, and radiation colitis.
- Has evidence of treatment for C.difficile infection or other intestinal pathogen with 28 days prior to first dose of study drug.
- Has chronic hepatitis B virus (HBV) infection or chronic hepatitis C virus (HCV) infection.
- Has active or latent tuberculosis.
- Has any identified congenital or acquired immunodeficiency (e.g., common variable immunodeficiency, human immunodeficiency virus [HIV] infection, organ transplantation).
- 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 that has not recurred for at least 1 year prior to randomization; and (c) history of cervical carcinoma in situ that has been adequately treated and that has not recurred for at least 3 years prior to randomization. Participants with remote history of malignancy (e.g., >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 randomization.
- 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 at Screening or prior to the administration of the first dose of study drug at Week 0.
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
China29 sites
Gastroenterology
Beijing, Beijing Municipality, 100050
Gastroenterology
Beijing, Beijing Municipality, 100730
Gastroenterology
Changchun, Jilin, 130000
Gastroenterology
Changsha, Hunan, 410008
Gastroenterology
Changsha, Hunan, 410011
Gastroenterology
Changsha, Hunan, 410013
Gastroenterology
Chengdu, Sichuan, 610041
Gastroenterology
Chongqing, Chongqing Municipality, 400037
Gastroenterology
Fuzhou, Fujian, 350025
Gastroenterology
Guangzhou, Guangdong, 510080
Gastroenterology
Guangzhou, Guangdong, 510515
Gastroenterology
Guangzhou, Guangdong, 510655
Gastroenterology
Hangzhou, Zhejiang, 310009
Gastroenterology
Hangzhou, Zhejiang, 310016
Gastroenterology
Hefei, Anhui, 230024
Gastroenterology
Kunming, Yunnan, 650032
Gastroenterology
Nanchang, Jiangxi, 330006
Gastroenterology
Nanjing, Jiangsu, 210008
Gastroenterology
Nanjing, Jiangsu, 210029
Gastroenterology
Shanghai, Shanghai Municipality, 200025
Gastroenterology
Shanghai, Shanghai Municipality, 200032
Gastroenterology
Shanghai, Shanghai Municipality, 200072
Gastroenterology
Shanghai, Shanghai Municipality, 200092
Gastroenterology
Shenyang, Liaoning, 110022
Gastroenterology
Wuhan, Hubei, 430000
Gastroenterology
Wuhan, Hubei, 430030
Gastroenterology
Wuhan, Hubei, 430060
Gastroenterology
Wuxi, Jiangsu, 241023
Gastroenterology
Xiamen, Fujian, 361004
About this study
Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Examine the Efficacy and Safety of Intravenous Vedolizumab (300 mg) Infusion Treatment in Chinese Subjects With Moderately to Severely Active Crohn's Disease
The purpose of this study is to assess the safety and efficacy of vedolizumab intravenous (IV) infusion as induction treatment in Chinese participants with moderately to severely active Crohn's disease (CD) at Week 10.
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 as induction and maintenance therapy in participants with moderately to severely active Crohn's Disease (CD).
The study will enroll approximately 300 moderately to severely active Chinese patients with CD.
Induction Phase: participants will be randomized 2:1 to receive:
- Vedolizumab IV 300 mg
- Placebo IV
Participants will receive vedolizumab 300 mg or matching placebo, intravenous (IV) infusion at Weeks 0, 2, and 6 in the induction phase. At Week 10, participants will be assessed for clinical response. Results of Week 10 clinical response will determine the treatment pathway in the maintenance phase.
Maintenance Phase: participants who achieved clinical response at Week 10 will continue to receive the same treatment as they received in Induction Phase; every 8 weeks (Q8W) starting at Week 14. Participants who received vedolizumab IV or placebo in the Induction Phase and did not achieve clinical response at Week 10 will receive vedolizumab every 4 weeks (Q4W) starting at Week 14.
This multi-center trial will be conducted in China. The overall time to participate in this study is 60 weeks. Participants will make multiple visits to the clinic, and will be contacted by telephone, 6 months after last dose of study drug for a long-term follow-up safety survey.
- 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
| Study group | Role | What they receive |
|---|---|---|
| Induction Phase: Placebo | Placebo comparator | Placebo, IV, infusion, once at Weeks 0, 2, and 6 in the Induction Phase. Receives: Drug: Vedolizumab IV |
| Induction Phase: Vedolizumab 300 mg | Experimental | Vedolizumab 300 milligram (mg), IV infusion, once at Weeks 0, 2, and 6 in the Induction Phase. Receives: Drug: Placebo |
| Maintenance Phase: Induction Placebo to Placebo Q4W | Placebo comparator | Participants who received placebo in the Induction Phase and achieved clinical response at Week 10 continued to receive placebo in the Maintenance Phase. Vedolizumab placebo-matching, IV infusion, once every 4 weeks (Q4W), from Week 14 to Week 58. Receives: Drug: Vedolizumab IV; Drug: Placebo |
| Maintenance Phase: Induction Placebo to Vedolizumab 300 mg Q4W | Experimental | Participants who received placebo in the Induction Phase and did not achieve clinical response at Week 10 received vedolizumab in the Maintenance Phase. Vedolizumab 300 mg, IV infusion, Q4W, from Week 14 to Week 58. Receives: Drug: Vedolizumab IV |
| Maintenance Phase: Induction Vedolizumab 300 mg to Vedolizumab 300 mg Q8W | Experimental | Participants who received vedolizumab in the Induction Phase and achieved clinical response at Week 10 continued to receive vedolizumab in the Maintenance Phase. Vedolizumab 300 mg, IV infusion, once every 8 weeks (Q8W), at Weeks 14, 22, 30, 38, 46 and 54 and vedolizumab placebo-matching, IV infusion, Q8W, at Weeks 18, 26, 34, 42, 50 and 58 to maintain double-blind. Receives: Drug: Placebo |
| Maintenance Phase: Induction Vedolizumab 300 mg to Vedolizumab 300 mg Q4W | Experimental | Participants who received vedolizumab in the Induction Phase and did not achieve clinical response at Week 10 received vedolizumab in the Maintenance Phase. Vedolizumab 300 mg, IV infusion, Q4W, from Week 14 to Week 58. Receives: Drug: Vedolizumab IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Enhanced Clinical Response in the Induction Phase at Week 10
Enhanced clinical response was defined as ≥100-point decrease from Baseline in the Crohn's Disease Activity Index (CDAI) score at Week 10. A CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days includes participant reported symptoms, physician-assessed signs, and laboratory markers. CDAI score is equal to sum of weighted scores for subjective items (number of liquid/soft stools, degree of abdominal pain, general well-being); and objective items (use of anti-diarrhoeal medication, abdominal mass, haematocrit, presence of extraintestinal manifestation, body weight). CDAI scores range approximately from 0 to 600, higher scores indicating greater disease activity.
Measured: Week 10
Secondary outcomes (1)
Percentage of Participants With Clinical Remission in the Induction Phase at Week 10
Clinical remission was defined as CDAI score of ≤150 points at Week 10. A CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days includes participant reported symptoms, physician-assessed signs, and laboratory markers. CDAI score is equal to sum of weighted scores for subjective items (number of liquid/soft stools, degree of abdominal pain, general well-being); and objective items (use of anti-diarrhoeal medication, abdominal mass, haematocrit, presence of extraintestinal manifestation, body weight). CDAI scores range approximately from 0 to 600, higher scores indicating greater disease activity
Measured: Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2017
- Study start3 Aug 2017
- Primary completion14 Aug 2020
- Study completion14 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director Clinical Science, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03234907
- Sponsor's protocol ID
- Vedolizumab-3034
- Other IDs
- U1111-1195-3932
- Status last verified
- Feb 2023
- First submitted
- 26 Jul 2017
- Last updated
- 1 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Examine the Efficacy and Safety of Intravenous Vedolizumab (300 mg) Infusion Treatment in Chinese Subjects With Moderately to Severely Active Crohn's Disease
- ClinicalTrials.gov ID
- NCT03234907
- Acronym / sponsor ID
- Vedolizumab-3034
- Conditions
- Crohn's Disease
- Keywords
- Drug therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 3 Aug 2017 (actual)
- Primary completion
- 14 Aug 2020 (actual)
- Study completion
- 14 Aug 2020 (actual)
- First posted
- 31 Jul 2017 (actual)
- Results
- Posted 21 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the safety and efficacy of vedolizumab intravenous (IV) infusion as induction treatment in Chinese participants with moderately to severely active Crohn's disease (CD) at Week 10.
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 as induction and maintenance therapy in participants with moderately to severely active Crohn's Disease (CD).
The study will enroll approximately 300 moderately to severely active Chinese patients with CD.
Induction Phase: participants will be randomized 2:1 to receive:
- Vedolizumab IV 300 mg
- Placebo IV
Participants will receive vedolizumab 300 mg or matching placebo, intravenous (IV) infusion at Weeks 0, 2, and 6 in the induction phase. At Week 10, participants will be assessed for clinical response. Results of Week 10 clinical response will determine the treatment pathway in the maintenance phase.
Maintenance Phase: participants who achieved clinical response at Week 10 will continue to receive the same treatment as they received in Induction Phase; every 8 weeks (Q8W) starting at Week 14. Participants who received vedolizumab IV or placebo in the Induction Phase and did not achieve clinical response at Week 10 will receive vedolizumab every 4 weeks (Q4W) starting at Week 14.
This multi-center trial will be conducted in China. The overall time to participate in this study is 60 weeks. Participants will make multiple visits to the clinic, and will be contacted by telephone, 6 months after last dose of study drug for a long-term follow-up safety survey.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Induction Phase: Placebo | Placebo comparator | Drug: Vedolizumab IVPlacebo, IV, infusion, once at Weeks 0, 2, and 6 in the Induction Phase. |
| Induction Phase: Vedolizumab 300 mg | Experimental | Drug: PlaceboVedolizumab 300 milligram (mg), IV infusion, once at Weeks 0, 2, and 6 in the Induction Phase. |
| Maintenance Phase: Induction Placebo to Placebo Q4W | Placebo comparator | Drug: Vedolizumab IV, Drug: PlaceboParticipants who received placebo in the Induction Phase and achieved clinical response at Week 10 continued to receive placebo in the Maintenance Phase. Vedolizumab placebo-matching, IV infusion, once every 4 weeks (Q4W), from Week 14 to Week 58. |
| Maintenance Phase: Induction Placebo to Vedolizumab 300 mg Q4W | Experimental | Drug: Vedolizumab IVParticipants who received placebo in the Induction Phase and did not achieve clinical response at Week 10 received vedolizumab in the Maintenance Phase. Vedolizumab 300 mg, IV infusion, Q4W, from Week 14 to Week 58. |
| Maintenance Phase: Induction Vedolizumab 300 mg to Vedolizumab 300 mg Q8W | Experimental | Drug: PlaceboParticipants who received vedolizumab in the Induction Phase and achieved clinical response at Week 10 continued to receive vedolizumab in the Maintenance Phase. Vedolizumab 300 mg, IV infusion, once every 8 weeks (Q8W), at Weeks 14, 22, 30, 38, 46 and 54 and vedolizumab placebo-matching, IV infusion, Q8W, at Weeks 18, 26, 34, 42, 50 and 58 to maintain double-blind. |
| Maintenance Phase: Induction Vedolizumab 300 mg to Vedolizumab 300 mg Q4W | Experimental | Drug: Vedolizumab IVParticipants who received vedolizumab in the Induction Phase and did not achieve clinical response at Week 10 received vedolizumab in the Maintenance Phase. Vedolizumab 300 mg, IV infusion, Q4W, from Week 14 to Week 58. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Has a diagnosis of Crohn's disease (CD) established at least 3 months prior to Screening by clinical and endoscopic evidence corroborated by a histopathology report. Cases of CD established at least 6 months prior to 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 diagnosis, and must be discussed with the sponsor on a case-by-case basis prior to randomization.
- Has moderately to severely active CD as determined by a Crohn's Disease Activity Index (CDAI) score of 220 to 400 within 7 days prior to the first dose of study drug and 1 of the following:
- Has CD involvement of the ileum and/or colon, at a minimum.
- Has 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 prior to initial screening (may be performed during Screening if not performed in previous 12 months).
- Has 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).
Key exclusion criteria (17 listed)
- Has evidence of abdominal abscess at the initial Screening Visit.
- Has had extensive colonic resection, subtotal or total colectomy.
- Has a history of >3 small bowel resections or diagnosis of short bowel syndrome.
- Has had ileostomy, colostomy, known fixed symptomatic stenosis of the intestine, or evidence of fixed stenosis, or small bowel stenosis with prestenotic dilation.
- Has had previous exposure to approved or investigational anti-integrins (e.g., natalizumab, efalizumab, etrolizumab, or AMG-181), or MAdCAM-1 antagonists, or rituximab.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vedolizumab IVVedolizumab IV infusion | Drug | Induction Phase: Placebo, Maintenance Phase: Induction Placebo to Placebo Q4W, Maintenance Phase: Induction Placebo to Vedolizumab 300 mg Q4W, Maintenance Phase: Induction Vedolizumab 300 mg to Vedolizumab 300 mg Q4W |
| PlaceboVedolizumab placebo-matching | Drug | Induction Phase: Vedolizumab 300 mg, Maintenance Phase: Induction Placebo to Placebo Q4W, Maintenance Phase: Induction Vedolizumab 300 mg to Vedolizumab 300 mg Q8W |
Primary outcome
Percentage of Participants With Enhanced Clinical Response in the Induction Phase at Week 10
Time frame: Week 10
Enhanced clinical response was defined as ≥100-point decrease from Baseline in the Crohn's Disease Activity Index (CDAI) score at Week 10. A CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days includes participant reported symptoms, physician-assessed signs, and laboratory markers. CDAI score is equal to sum of weighted scores for subjective items (number of liquid/soft stools, degree of abdominal pain, general well-being); and objective items (use of anti-diarrhoeal medication, abdominal mass, haematocrit, presence of extraintestinal manifestation, body weight). CDAI scores range approximately from 0 to 600, higher scores indicating greater disease activity.
1 secondary outcome
Percentage of Participants With Clinical Remission in the Induction Phase at Week 10
Time frame: Week 10
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain more information on the study, click on this link.Link provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director Clinical Science study director
Takeda
29 sites in 1 country: see every site and its status.
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 29 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 12 inclusion and 17 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 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 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?
Yes. Results are posted in the registry (first posted 21 Sep 2022). 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?
Percentage of Participants With Enhanced Clinical Response in the Induction Phase at Week 10 (time frame: Week 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Mar 2023.