A Study of Long-term Effects of Vedolizumab Subcutaneous in Adults With Ulcerative Colitis and Crohn's Disease

Phase 3

Completed

Conditions: Colitis, Ulcerative
Crohn's Disease

Interventions: Drug: Vedolizumab SC

Registration Number: NCT02620046

Lead Sponsor: Takeda

Brief Summary: The main aim of the study is to check for long-term side effects of Vedolizumab Subcutaneous (also known as Vedolizumab SC) in people with ulcerative colitis (UC) and Crohn's disease (CD). Vedolizumab SC will be given as an injection just under the skin. This type of injection is called a subcutaneous injection or SC for short. Another aim of the study is to collect information on whether the participant's condition remains under control or improves during and after treatment with Vedolizumab SC.

Participants who previously took part in studies MLN0002SC-3027 or MLN0002SC-3031 will be invited to visit the study clinic. At this visit, the study doctor will check if each participant can take part in this study.

For those who can take part, participants will receive a subcutaneous injection of vedolizumab SC either once a week or once every 2 weeks. How often each participant receives vedolizumab SC will depend on their results from the previous study and on how active their condition is. Participants might be able to self-inject vedolizumab SC after being trained by the study doctors. During this study, the dose of vedolizumab SC might be increased for participants whose condition worsens.

Participants will continue treatment with vedolizumab SC until it is approved in their particular country, the participant decides to stop treatment, or the sponsor stops the study. If the sponsor stops the study before vedolizumab SC is approved in all countries, the sponsor will make sure all affected participants will have access to vedolizumab SC outside of the study.

After their final dose of vedolizumab SC, participants will visit the clinic 18 weeks later for a final check-up. Then, the clinic will telephone the participants 6 months after their final dose of vedolizumab SC to check if they have any health problems.

Detailed Description: The drug being tested in this study is called vedolizumab subcutaneous (vedolizumab SC). Vedolizumab SC is being tested to assess its long-term safety and effectiveness in treating participants with UC or CD. This study will look at the long-term side effects and response/remission of UC and CD in participants who received vedolizumab SC in a prior vedolizumab SC study.

The study will enroll up to 692 patients. All participants enrolled in this study will have previously participated in the MLN0002SC-3027 or MLN0002SC-3031 study. Participants who completed the Maintenance Period (Week 52) in their previous study, or who did not achieve a clinical response at Week 6 but who did achieve a clinical response at Week 14 after having received a third vedolizumab IV infusion at Week 6 in their previous study, will receive open-label vedolizumab SC 108 mg, once every 2 weeks (Q2W). Participants who withdrew early from the Maintenance Period of their previous study due to disease worsening or need for rescue medications will receive open-label vedolizumab SC 108 mg, once every week (QW). Participants receiving SC 108 mg Q2W who experience treatment failure (disease worsening or need for rescue medications while in the current study will be dose escalated to vedolizumab SC 108 mg QW.

This multi-center trial will be conducted worldwide. Participation in this vedolizumab SC study will continue until vedolizumab SC becomes commercially available, the participant withdraws from the study, or the sponsor decides to close the study. Participants will make multiple visits to the clinic, plus a final visit 18 weeks after last dose of study drug for a follow-up assessment. Participants will also participate in a long-term safety follow-up, by phone, at 6 months after the last dose of study drug.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 746

Inclusion Criteria

Prior participation in Study MLN0002SC-3027 or MLN0002SC-3031, and, in the opinion of the investigator, tolerated the study drug well. Early withdrawal from Study MLN0002SC-3027 or MLN0002SC-3031 must have been due to treatment failure during the Maintenance Period.

Exclusion Criteria

Surgical intervention for IBD during or after participation in Study MLN0002SC-3027 or MLN0002SC-3031, or at any time during this study.
Chronic or severe infection, or, any new, unstable, or uncontrolled cardiovascular, pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, neurologic, oncologic, or other medical disorder developed during or after participation in a prior vedolizumab study that, in the opinion of the investigator, would confound the study results or compromise participant safety.
Withdrawal from Study MLN0002SC-3027 or MLN0002SC-3031 due to a study-drug related adverse event (AE).

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ulcerative Colitis: Vedolizumab 108 mg	Vedolizumab SC	Participants with ulcerative colitis (UC) who completed the Maintenance Phase in MLN0002SC-3027 (Week 52 assessment) or who did not achieve a clinical response at Week 6 in MLN0002SC-3027 but who did achieve a clinical response at Week 14 of the parent study after having received a third vedolizumab IV infusion at Week 6 in the parent study received vedolizumab SC 108 mg Q2W in this study whereas who withdrew early from the Maintenance Phase (at Week 14 onwards) in MLN0002SC-3027 due to disease worsening or need for rescue medications received vedolizumab SC 108 mg QW.
Crohn's Disease: Vedolizumab 108 mg	Vedolizumab SC	Participants with Crohn's disease (CD) who completed the Maintenance Phase in MLN0002SC-3031 (Week 52 assessment) or who did not achieve a clinical response at Week 6 in MLN0002SC-3031 but who did achieve a clinical response at Week 14 of the parent study after having received a third vedolizumab IV infusion at Week 6 in the parent study received vedolizumab SC 108 mg Q2W in this study whereas who withdrew early from the Maintenance Phase (at Week 14 onwards) in MLN0002SC-3031 due to disease worsening or need for rescue medications received vedolizumab SC 108 mg QW.

Primary Outcome Measures

Name	Time	Method
Number of Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs Adjusted by Duration of Participant's Exposure to Long-term Vedolizumab Treatment	Up to 97.9 months	A TEAE was defined as an adverse event (AE) that started or worsened on or after study Day 1 (defined as day first dosed) and no more than 18 weeks after the last dose of study drug. An SAE was defined as any untoward medical occurrence that occurs at any dose and resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was an important medical event such as acute liver failure, pulmonary hypertension, or confirmed or suspected transmission of an infectious agent by a medicinal product. Participant years is defined as the total exposure-time of the participants in the respective treatment group. Incidence per 100 participant years is defined as (Number of participants with events\*100/participant years). As per planned analysis, data for this outcome measure is grouped and presented per disease condition.

Secondary Outcome Measures

Name	Time	Method
Number of Adverse Events of Special Interest (AESIs) Adjusted by Duration of Participant's Exposure to Long-term Vedolizumab Treatment	Up to 97.9 months	AESIs included hypersensitivity reactions (including injections site reactions), serious infections, malignancies, hepatotoxicity (abnormal liver function test) and progressive multifocal leukoencephalopathy (PML). Participant years is defined as the total exposure-time of the participants in the respective treatment group. Incidence per 100 participant years is defined as (Number of participants with events\*100/participant years). As per planned analysis, data for this outcome measure is grouped and presented per disease condition.
Number of Participants With Ulcerative Colitis Achieving Partial Mayo Scoring Clinical Response at Week 48	Week 48	Clinical response is defined as a decrease in the partial Mayo score of at least 2 points and ≥25% from baseline, with an accompanying decrease in rectal bleeding subscore of ≥1 point from baseline or absolute rectal bleeding subscore of ≤1 point. As per planned analysis, data for this outcome measure is grouped and presented for participants with ulcerative colitis.
Number of Participants With Crohn's Disease Achieving Clinical Response Based on Harvey-Bradshaw Index (HBI) Scores at Week 48	Week 48	Clinical response is defined as a decrease in HBI score of ≥3 points from baseline in CD participants (randomized early terminator CD participants only \[defined as randomized CD participants withdrawn from the parent study between Week 6 and Week 52\]). As per planned analysis, data for this outcome measure is grouped and presented for participants with Crohn's disease.
Number of Participants With Crohn's Disease Achieving Clinical Remission Based on Harvey-Bradshaw Index (HBI) Scores	Week 48	Clinical remission is defined as total HBI score of ≤4 points. As per planned analysis, data for this outcome measure is grouped and presented for participants with Crohn's disease.
Number of Participants With Ulcerative Colitis Achieving Clinical Remission Based on Partial Mayo Score	Week 48	Clinical remission is defined as a partial Mayo score of ≤2 with no individual subscore \>1. As per planned analysis, data for this outcome measure is grouped and presented for participants with ulcerative colitis.

Trial Locations

Locations (301): Arizona Arthritis & Rheumatology Research, PLLC
🇺🇸
Phoenix, Arizona, United States
Arkansas Primary Care Clinic, PA
🇺🇸
Little Rock, Arkansas, United States
Rocky Mountain Clinical Research, LLC
🇺🇸
Wheat Ridge, Colorado, United States
Medical Research Center of Connecticut, LLC
🇺🇸
Hamden, Connecticut, United States
Middlesex Gastroenterology Associates
🇺🇸
Middletown, Connecticut, United States
Nature Coast Clinical Research, LLC
🇺🇸
Inverness, Florida, United States
Florida Center for Gastroenterology
🇺🇸
Largo, Florida, United States
L & L Research Choices, Inc.
🇺🇸
Miami, Florida, United States
Gastroenterology Group of Naples
🇺🇸
Naples, Florida, United States
BRCR Medical Center, Inc.
🇺🇸
Pembroke Pines, Florida, United States
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Arizona Arthritis & Rheumatology Research, PLLC
🇺🇸Phoenix, Arizona, United States