Vedolizumab Intravenous (IV) Compared to Placebo in Chinese Participants With Crohn's Disease.

NCT03234907 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: Vedolizumab-3034U1111-1195-3932
• Study Type: interventional
• Target: 215
• Locations: 1 country
• Sites: 29

Brief 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.

Conditions

Crohn's Disease

Keywords

Drug therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  Week 10

Secondary Outcomes (1)

• Percentage of Participants With Clinical Remission in the Induction Phase at Week 10

  Week 10

Study Arms (6)

Induction Phase: Placebo

PLACEBO COMPARATOR

Placebo, IV, infusion, once at Weeks 0, 2, and 6 in the Induction Phase.

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.

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.

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.

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.

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.

Drug: Vedolizumab IV

Interventions

Vedolizumab IV DRUG

Vedolizumab IV infusion

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

Placebo DRUG

Vedolizumab placebo-matching

Induction Phase: Vedolizumab 300 mg; Maintenance Phase: Induction Placebo to Placebo Q4W; Maintenance Phase: Induction Vedolizumab 300 mg to Vedolizumab 300 mg Q8W

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Takeda: lead

Study Sites (29)

Gastroenterology

Hefei, Anhui, 230024, China

Location

Gastroenterology

Beijing, Beijing Municipality, 100050, China

Location

Gastroenterology

Beijing, Beijing Municipality, 100730, China

Location

Gastroenterology

Chongqing, Chongqing Municipality, 400037, China

Location

Gastroenterology

Fuzhou, Fujian, 350025, China

Location

Gastroenterology

Xiamen, Fujian, 361004, China

Location

Gastroenterology

Guangzhou, Guangdong, 510080, China

Location

Gastroenterology

Guangzhou, Guangdong, 510515, China

Location

Gastroenterology

Guangzhou, Guangdong, 510655, China

Location

Gastroenterology

Wuhan, Hubei, 430000, China

Location

Gastroenterology

Wuhan, Hubei, 430030, China

Location

Gastroenterology

Wuhan, Hubei, 430060, China

Location

Gastroenterology

Changsha, Hunan, 410008, China

Location

Gastroenterology

Changsha, Hunan, 410011, China

Location

Gastroenterology

Changsha, Hunan, 410013, China

Location

Gastroenterology

Nanjing, Jiangsu, 210008, China

Location

Gastroenterology

Nanjing, Jiangsu, 210029, China

Location

Gastroenterology

Wuxi, Jiangsu, 241023, China

Location

Gastroenterology

Nanchang, Jiangxi, 330006, China

Location

Gastroenterology

Changchun, Jilin, 130000, China

Location

Gastroenterology

Shenyang, Liaoning, 110022, China

Location

Gastroenterology

Shanghai, Shanghai Municipality, 200025, China

Location

Gastroenterology

Shanghai, Shanghai Municipality, 200032, China

Location

Gastroenterology

Shanghai, Shanghai Municipality, 200072, China

Location

Gastroenterology

Shanghai, Shanghai Municipality, 200092, China

Location

Gastroenterology

Chengdu, Sichuan, 610041, China

Location

Gastroenterology

Kunming, Yunnan, 650032, China

Location

Gastroenterology

Hangzhou, Zhejiang, 310009, China

Location

Gastroenterology

Hangzhou, Zhejiang, 310016, China

Location

Related Links

• To obtain more information on the study, click on this link.

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Results Point of Contact

• Title: Study Director
• Organization: Takeda

TrialDisclosures@takeda.com

+1-877-825-3327

Study Officials

• Study Director Clinical Science

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2017
• First Posted: July 31, 2017
• Study Start: August 3, 2017
• Primary Completion: August 14, 2020
• Study Completion: August 14, 2020
• Last Updated: March 1, 2023
• Results First Posted: September 21, 2022

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

CN (29)