Clinical trial NCT04804540: A Study of Vedolizumab in People With Ulcerative Colitis and Crohn's Disease
Official title: A Multicenter, Single-arm, Open-label, Phase 4 Study to Evaluate the Safety and Efficacy of Vedolizumab in Indian Patients With Ulcerative Colitis and Crohn's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ulcerative Colitis
Crohn Disease
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2021-03-18
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Vedolizumab is a medicine that helps to reduce inflammation and pain in the digestive system. In this study, people with ulcerative colitis or Crohn's disease will be treated with vedolizumab. The main aim of the study is to check for side effects from vedolizumab.

At the first visit, the study doctor will check who can take part. Participants will receive vedolizumab slowly through a vein (infusion). Participants will regularly visit the clinic for up to 46 weeks for more infusions of Vedolizumab. During these visits, the study doctor will check if there are any side effects from this treatment.

Participants will visit the clinic for a final check-up up to 16 weeks after their final infusion of Vedolizumab. Clinic staff will arrange a phone call 6 months after their final infusion of Vedolizumab for a further check-up.

Detailed description: The drug being tested in this study is called vedolizumab. Vedolizumab is being tested to treat people who have active UC or CD.

The study will enroll approximately 150 patients. Participants will be assigned to the vedolizumab treatment group.

•Vedolizumab 300 mg

Vedolizumab 300 mg IV infusion will be administered once in Weeks 0, 2, 6 and 10 (CD-participants who have not shown a response can receive a dose at Week 10) during induction phase and in Weeks 14, 22, 30, 38 and 46 during maintenance phase.

This multicentre trial will be conducted in India. The overall time to participate in this study is 74 weeks. Participants will make multiple visits to the clinic, and will be contacted by telephone plus a final visit after receiving their last dose of drug for a follow-up assessment.

Eligibility criteria: Inclusion Criteria:

1. Has a diagnosis of moderately to severely active ulcerative colitis (UC) or Crohn's disease (CD) at least 3 months prior to screening, with a Full Mayo Score of 6-12 for UC and a Harvey Bradshaw Index (HBI) score of \>=8 for CD at the time of enrolment.
2. Has demonstrated, an inadequate response to, loss of response to, or intolerance to at least 1 of the following agents:

   1. Conventional therapy
   2. TNF-α alpha antagonist

Exclusion Criteria:

1. Has undergone an ileostomy, colostomy, or has known fixed symptomatic stenosis of the intestine.
2. Has active or latent tuberculosis (TB).
3. Has had a prior exposure to vedolizumab or a history of hypersensitivity or allergies to vedolizumab, natalizumab, efalizumab, or rituximab.
4. Has a positive progressive multifocal leukoencephalopathy (PML) subjective symptom checklist during screening or prior to the administration of study drug on Day 1.

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)
timeFrame: From first dose of study drug up to 24 weeks after the last dose (up to 70 weeks)
measure: Number of Participants With Adverse Drug Reactions (ADRs) and Unexpected ADRs
timeFrame: From first dose of study drug up to 24 weeks after the last dose (up to 70 weeks)
Secondary outcomes:
measure: Percentage of UC Participants With Clinical Response at Weeks 14, 30 and 46
timeFrame: At Weeks 14, 30 and 46
measure: Percentage of CD Participants With Clinical Response at Weeks 14, 30 and 46
timeFrame: At Weeks 14, 30 and 46
measure: Percentage of UC Participants With Clinical Remission at Weeks 14, 30 and 46
timeFrame: At Weeks 14, 30 and 46
measure: Percentage of CD Participants With Clinical Remission at Weeks 14, 30 and 46
timeFrame: At Weeks 14, 30 and 46
measure: Percentage of UC and CD Participants Who Discontinued Vedolizumab
timeFrame: From first dose of study drug up to Week 46
measure: Percentage of UC Participants With Mucosal Healing at Week 46
timeFrame: At Week 46
measure: Percentage of CD Participants With Mucosal Healing at Week 46
timeFrame: At Week 46
measure: Percentage of UC Participants With Endoscopic Response at Week 46
timeFrame: At Week 46
measure: Percentage of CD Participants With Endoscopic Response at Week 46
timeFrame: At Week 46
measure: Change From Baseline in Patient-reported Quality of Life (Short Inflammatory Bowel Disease Questionnaire [SIBDQ]) Scores at Weeks 14, 30, and 46
timeFrame: Baseline, Weeks 14, 30 and 46
Other outcomes:
Locations:
city: Guntur
country: India
facility: Government General Hospital
state: Andhra Pradesh
city: Guwahati
country: India
facility: Institute of Gastroenterology and Liver Disease Dispur Hospitals
state: Assam
city: Patna
country: India
facility: Indira Gandhi Institute of Medical Sciences
state: Bihar
city: New Delhi
country: India
facility: Dr. Ram Manohar Lohia Hospita Hospital
state: Delhi
city: New Delhi
country: India
facility: Maulana Azad Medical college & Associated G B Pant Hospital
state: Delhi
city: New Delhi
country: India
facility: All India Institute of Medical Sciences
state: Delhi
city: Ahmedabad
country: India
facility: Gastroplus Digestive Disease Centre Pvt.Ltd
state: Gujarat
city: Surat
country: India
facility: Surat Institute of Digestive Sciences
state: Gujarat
city: Bangalore
country: India
facility: Banglore Medical College & Research Institute
state: Karnatka
city: Nagpur
country: India
facility: Midas Multispeciality Hospital
state: Maharashtra
city: Ludhiana
country: India
facility: Dayanand Medical College and Hospital
state: Punjab
city: Coimbatore
country: India
facility: VGM Hospital- Institute of Gastroenterology
state: Tamilnadu
city: Hyderabad
country: India
facility: Asian Institute of Gastroenterology
state: Telangana
city: Secunderabad
country: India
facility: Yashoda Hospitals
state: Telangana
city: Lucknow
country: India
facility: King George's Medical University
state: Uttar Pradesh
city: Hyderabad
country: India
facility: Osmania General Hospital
city: Hyderabad
country: India
facility: Deccan College of Medical Sciences
Study officials:
affiliation: Takeda
name: Medical Director
role: STUDY_DIRECTOR
References: