Overview

This trial is active, not recruiting.

Condition ulcerative colitis
Treatments vedolizumab, vedolizumab placebo
Phase phase 3
Sponsor Takeda
Start date March 2014
End date April 2018
Trial size 278 participants
Trial identifier NCT02039505, JapicCTI-142403, MLN0002/CCT-101, U1111-1151-6762

Summary

This study is a phase 3, multicenter, randomized, double-blinded, placebo-controlled, parallel-group study to examine the efficacy, safety, and pharmacokinetics of MLN0002 (Vedolizumab) in induction and maintenance therapy in Japanese patients with moderately or severely active ulcerative colitis.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Intravenous Vedolizumab (300 mg) administered at Weeks 0, 2, and 6 and every 8 weeks thereafter.
vedolizumab MLN0002
Vedolizumab intravenous injection
(Placebo Comparator)
Vedolizumab Placebo. Intravenous infusion at Weeks 0, 2, and 6 and every 8 weeks thereafter
vedolizumab placebo
Vedolizumab placebo

Primary Outcomes

Measure
Induction phase: Clinical response at Week 10
time frame: At week 10
Maintenance Phase: Clinical remission at Week 60
time frame: At Week 60
Advrse Events
time frame: From baseline to 16 weeks after the last dose of study drug
Body Weight
time frame: From baseline to 16 weeks after the last dose of study drug
Vital signs
time frame: From baseline to 16 weeks after the last dose of study drug
Electrocardiogram (ECG)
time frame: From baseline to 16 weeks after the last dose of study drug
Clinical laboratory test (bloodbiochemistry, hematology, and urinalysis)
time frame: From baseline to 16 weeks after the last dose of study drug

Secondary Outcomes

Measure
Induction Phase: Clinical remission at Week 10
time frame: at Week 10
Induction Phase: Mucosal healing at Week 10
time frame: At Week 10
Maintenance Phase: Durable clinical response
time frame: At Week 10 and Week 60
Maintenance Phase: Mucosal healing at Week 60
time frame: At week 60
Maintenance Phase: Durable clinical remission
time frame: At Week 10 and Week 60
Maintenance Phase: Corticosteroid-free clinical remission at Week 60
time frame: At Week 60
Serum Vedolizumab concentration
time frame: From Week 2 to Week 60
Human anti-human antibody (HAHA)
time frame: From baseline to 16 weeks after the last dose of study drug
Neutralizing antibody
time frame: From baseline to 16 weeks after the last dose of study drug

Eligibility Criteria

Male or female participants from 15 years up to 80 years old.

Inclusion Criteria: 1. Patients aged 15 to 80 years (inclusive) at the time of consent 2. Patients with a diagnosis of total or left-sided colitis established based on the Revised Diagnostic Criteria for Ulcerative Colitis 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 6 months before the start of administration of study drug. 3. Patients with moderately or severely active ulcerative colitis as determined by baseline complete Mayo score of 6 to 12 (inclusive) with an endoscopic subscore of ≥2 4. In case of the patients who meet any of the following criteria; patients with ≥8-year history of total or left-sided colitis, patients aged ≥ 50 years, or patients 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). 5. Patients meeting the criteria for treatment failure below with at least one of the following agents received within the previous 5 year period before giving consent. Corticosteroids - Resistance - Dependence - Intolerance Immunomodulators (azathioprine or 6-mercaptopurine) - Refractory - Intolerance Anti-TNFα antibodies - Inadequate response - Loss of response - Intolerance Exclusion Criteria: - 1. Patients whose partial Mayo score decrease by 3 points or more between screening and the start of study drug administration 2. Patients with an evidence of or suspected abdominal abscess or toxic megacolon 3. Patients with a history of subtotal or total colectomy 4. Patients with ileostomy, colostomy,or fistula, or severe intestinal stenosis 5. Patients who started 5-aminosalicylic acid oral drug or probiotics treatment 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 6. Patients who have 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 ulcerative colitis (e.g., Daikenchuto) within 13 days before initiation of the study drug administration 7. Patients who have received an antidiarrheal drug for at 4 or more days consecutively within 13 days before initiation of the study drug administration or an antidiarrheal drug within 7 days before initiation of the study drug administration 8. Patients who have received azathioprine or 6-mercaptopurine within 27 days before initiation of the study drug administration. However, this shall not apply to patients 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 9. Patients who have received cyclosporin, tacrolimus, methotrexate, or tofacitinib or any study drugs for treatment of ulcerative colitis within 27 days before initiation of the study drug administration 10. Patients who have received adalimumab within 27 days before initiation of the study drug administration or any biological drugs other than adalimumab within 55 days before initiation of the study drug administration. Topical administration (such as intraocular implantation for treatment of age-related maculopacy) is allowed 11. Patients who have received any live vaccinations within 27 days before initiation of study drug administration 12. Patients who have undergone intestinal resection within 27 days before initiation of study drug administration or those anticipated to require intestinal resection during the study 13. Patients who have received leukocytapheresis or granulocyte apheresis within 27 days before initiation of the study drug administration 14. Patients with an evidence of adenomatous colonic polyps that need to be removed at the start of study drug administration 15. Patients with a history or a complication of colonic mucosal dysplasia

Additional Information

Official title Phase III, Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel-group Study to Examine the Efficacy, Safety, and Pharmacokinetics of Intravenous MLN0002 (300 mg) Infusion in Induction and Maintenance Therapy in Japanese Patients With Moderately or Severely Active Ulcerative Colitis
Description This study 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 patients with moderately or severely active ulcerative colitis/
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Takeda.