Back to resultsA Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared With Placebo and With Vedolizumab in Participants With Moderate to Severe Ulcerative Colitis (UC)
Primary Purpose
Ulcerative Colitis
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
UTTR1147A
UTTR1147A Placebo
Vedolizumab
Vedolizumab Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Ulcerative Colitis
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of UC
- Confirmation of moderately to severely active UC, defined by the Mayo Clinic Score
- Inadequate response, loss of response, or intolerance to prior immunosuppressant treatment (i.e., azathioprine, 6-mercaptopurine, methotrexate, or tumor necrosis factor [TNF] inhibitors [maximum of 2 prior TNF inhibitors]) and/or corticosteroid treatment
- Use of highly effective contraception as defined by the protocol
Exclusion Criteria:
- History of psoriasis or psoriatic arthritis; any other inflammatory skin disorders requiring oral corticosteroids, immunosuppressants, or biological therapy within the previous year; or primary sclerosing cholangitis
- History of cancer as defined by the protocol
- Significant uncontrolled comorbidity, such as cardiac, pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders (excluding UC)
- Prior extensive colonic resection, subtotal or total colectomy, or proctocolectomy, or planned surgery for UC
- Diagnosis of indeterminate colitis or granulomatous (Crohn's) colitis or toxic megacolon within 12 months prior to screening
- Suspicion of ischemic colitis, radiation colitis, or microscopic colitis
- Current fistula or history of fistula, pericolonic abscess and stricture (stenosis) of the colon
- History or current evidence of unresectable colonic mucosal dysplasia or history of high-grade colonic mucosal dysplasia
- Prior treatment with UTTR1147A
- Prior treatment with vedolizumab, etrolizumab, natalizumab, efalizumab, or any other anti-integrin agents
- Prior treatment with rituximab
- Use of prohibited therapies, as defined by the protocol, prior to randomization
- Congenital or acquired immune deficiency
- Evidence or treatment of infections or history of infections, as defined by the protocol
Sites / Locations
- Carolina Digestive Diseases
- University of Utah School of Medicine; Gastroenterology Division
- MHAT Saint Karidad EAD
- Multiprofile Hospital for Active Treatment Hadji Dimitar OOD
- LLC ARENSIA Exploratory Medicine
- Gastroenterologische Spezialpraxis-Berlin-Karlshorst
- Universitaetsklinikum Carl Gustav Carus TU Dresden
- Universitatsklinikum Schleswig-Holstein
- St. Marien Krankenhaus; Med. Klinik
- Universitätsklinikum Ulm; Klinik für Innere Medizin II
- Iatriko Palaiou Falirou; Gastrointestinal Department
- EUROMEDICA General Clinic of Thessaloniki; Gastroenterology Department
- Magyar Honvédség Egészségügyi Központ; Országos Haemophilia Központ
- Portiuncula Hospital, Ballinasloe
- Shaare Zedek Medical Center; Bait Vagan
- Policlinico Universitario Campus Biomedico Di Roma
- Complesso Integrato Columbus
- ASST di Monza - Azienda Ospedaliera San Gerardo; U.O. Farmacia -Settore A - Corpo Posteriore
- Istituto Clinico Humanitas
- Azienda Ospedaliera Di Padova
- ICS ARENSIA Exploratory Medicine
- SPZOZ Uniwersytecki SK nr 1 im N. Barlickiego UM w Lodzi; Oddz. Klin. Gastroenter. Og. i Onk.
- Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy; Centrum Endoskopii Zabiegowej
- Synexus Polska Sp. z o.o. Oddzial w Czestochowie
- Synexus Polska Sp. z o.o. Oddzial w Gdansku
- Synexus - Katowice
- Economicus - NZOZ ALL-MEDICUS; Zaklad Gastroenterologii
- ETG Kielce
- Gastromed SPK Niepubliczny Zaklad Opieki Zdrowotnej
- Klimed Marek Klimkiewicz
- Synexus Polska Sp. z o.o. Oddzial w Poznaniu
- Clinical Research Center Sp. z o.o. MEDIC-R Spó?ka Komandytowa
- Endoskopia Sp. z o.o.
- Gastromed Kopon Zmudzinski i
- Centrum Zdrowia MDM
- Jaroslaw Kierkus Prywatna Prakyka Lekarska
- Przychodnia EuroMediCare
- Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
- Melita Medical
- Saint Martyr Elizabeth City Hospital
- Irkutsk Research Centre Hospital of Siberian department of Russian Academy of Science
- Rostov State Medical University; Cardiorheumatology Department
- Medical University Reaviz
- North-West State Medical University n.a. I.I. Mechnikov
- Clinical Hospital Center Zvezdara
- KBC Dr Dragisa Misovic Dedinje
- University Hospital Medical Center Bezanijska kosa
- Clinical Center Kragujevac; Clinic Of Psychiatry
- General Hospital Vrsac
- Clinical Hospital Centre Zemun
- General Hospital Djordje Joanovic - Zrenjanin
- Hospital de Gran Canaria Dr. Negrin; Servicio de Aparato Digestivo
- Hospital Universitario de Torrejon
- Regional Municipal Institution Chernivtsi Regional Clinical Hospital; Gastroenterology department
- Medical Centre of PE First Private Clinic
- Ternopil University Hospital; Regional Center of Gastroenterology with Hepatology
- City Clinical Hospital #1; Department of Gastroenterology
- Municipal Institution Zaporizhzhia Regional Clinical Hospital of Zaporizhzhia Regional Council
- ME Dnipropetrovsk Regional Clinical Hospital n.a. I.I Mechnykov Dnipropetrovsk Regional Council
- Treatment and Diagnostic Center of LLC MRT Elit
- Medical Center of LLC Medical Clinic Blagomed
- Medical Center of Limited Liability Company ?Harmoniya krasy?
- Medical Center of LLC Medical Center Dopomoga Plus
- Medical Center of Edelweiss Medics LLC
- Synexus Affiliate - MC of LLC Medbud-Clinic
- Med Center of International Institute of Clinical Trials LLC; Medical Center "OK!Clinic+"
- Medical Center of LLC Diaservis
- Clinic of SRI of Invalid Rehab. (ESTC) of VNMU n.a. M.I.Pyrohov
- Medical Center of LLC Medical Center Family Medicine Clinic; Endoscopy & Gastroenterology
- Transcarpathian Regional Clinical Hospital n.a. A. Novak; Rheumatology Department
- Medical Center of Diaservice LLC; Division of clinical trials conduct, Department #3
- Kings College Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Active Comparator
Placebo Comparator
Arm Label
Arm 1a: UTTR1147A Dose Level 1 (Part A) + UTTR1147A (Part B)
Arm 1b: UTTR1147A Dose Level 1 (Part A) + Placebo (Part B)
Arm 2a: UTTR1147A Dose Level 2 (Part A) + UTTR1147A (Part B)
Arm 2b: UTTR1147A Dose Level 2 (Part A) + Placebo (Part B)
Arm 3a: UTTR1147A Dose Level 3 (Part A) + UTTR1147A (Part B)
Arm 3b: UTTR1147A Dose Level 3 (Part A) + Placebo (Part B)
Arm 4: Vedolizumab
Arm 5: Placebo
Arm Description
Part A: UTTR1147A dose level 1 and Vedolizumab Placebo. Part B: UTTR1147A maintenance dose and Vedolizumab Placebo.
Part A: UTTR1147A dose level 1 and Vedolizumab Placebo. Part B: UTTR1147A Placebo and Vedolizumab Placebo.
Part A: UTTR1147A dose level 2 and Vedolizumab Placebo. Part B: UTTR1147A maintenance dose and Vedolizumab Placebo.
Part A: UTTR1147A dose level 2 and Vedolizumab Placebo. Part B: UTTR1147A Placebo and Vedolizumab Placebo.
Part A: UTTR1147A dose level 3 and Vedolizumab Placebo. Part B: UTTR1147A maintenance dose and Vedolizumab Placebo.
Part A: UTTR1147A dose level 3 and Vedolizumab Placebo. Part B: UTTR1147A Placebo and Vedolizumab Placebo.
Parts A and B: Vedolizumab and UTTR1147A Placebo.
Parts A and B: UTTR1147A Placebo and Vedolizumab Placebo.
Outcomes
Primary Outcome Measures
Percentage of Participants With Clinical Remission at Week 8
Clinical remission is defined as modified Mayo Clinic Score (mMCS) <= 2 with Mayo rectal bleeding subscore = 0, Mayo stool frequency subscore <=1 and Centrally read endoscopic score <= 1. Patients were classified as Non-Remitters if Week 8 assessments were missing or patient received permitted/ prohibited Rescue Therapy prior to assessment.
Secondary Outcome Measures
Percentage of Participants With Sustained Remission
Sustained remission is defined as clinical remission at both Week 8 and Week 30, where clinical remission is defined as modified Mayo Clinic Score (mMCS) <= 2 with Mayo rectal bleeding subscore = 0, Mayo stool frequency subscore <=1 and Centrally read endoscopic score <= 1.
Patients were classified as Non-Remitters at Week 8 or at Week 30 if assessments were missing or patient received permitted/prohibited Rescue Therapy prior to assessment
Maximum Serum Concentration (Cmax) of UTTR1147A
Minimum Serum Concentration (Cmin) of UTTR1147A
Percentage of Participants With Clinical Response at Week 8
Clinical response is defined as achieving clinical remission or as meeting both of the following criteria: A >= 3-point decrease from baseline in modified Mayo Clinic Score (mMCS); A >= 1-point decrease from baseline in rectal bleeding subscore or a rectal bleeding subscore of 0 or 1.
Patients were classified as Non-Responders if assessments were missing or patient received permitted/prohibited Rescue Therapy prior to assessment.
NOTE: An Outcome Measure Description has not been entered.
Percentage of Participants With Clinical Response at Week 30
Clinical response is defined as achieving clinical remission or as meeting both of the following criteria: A >= 3-point decrease from baseline in modified Mayo Clinic Score (mMCS); A >= 1-point decrease from baseline in rectal bleeding subscore or a rectal bleeding subscore of 0 or 1.
Patients were classified as Non-Responders if assessments were missing or patient received permitted/prohibited Rescue Therapy prior to assessment.
Percentage of Participants With Endoscopic Healing at Week 8
Endoscopic healing is defined as a Mayo endoscopic subscore <= 1. Patients were classified as Non-Responders if assessments were missing or patient received permitted/prohibited Rescue Therapy prior to assessment.
Percentage of Participants With Endoscopic Healing at Week 30
Endoscopic healing is defined as a Mayo endoscopic subscore <= 1. Patients were classified as Non-Responders if assessments were missing or patient received permitted/prohibited Rescue Therapy prior to assessment.
Percentage of Participants With Endoscopic Remission at Week 8
Endoscopic remission is defined as a Mayo endoscopic subscore of 0. Patients were classified as Non-Responders if assessments were missing or patient received permitted/prohibited Rescue Therapy prior to assessment.
Percentage of Participants With Endoscopic Remission at Week 30
Endoscopic remission is defined as a Mayo endoscopic subscore of 0. Patients were classified as Non-Responders if assessments were missing or patient received permitted/prohibited Rescue Therapy prior to assessment.
Change From Baseline in UC Bowel Movement Signs and Symptoms at Week 8, as Assessed by Ulcerative Colitis Patient-Reported Outcome Signs and Symptoms (UC-PRO/SS) Score
The UC-PRO is being reported in three domains; two domains are key endpoints and reported as UC-PRO Signs and Symptoms (UC-PRO/SS). The bowel domain score ranges from 0-27, with a higher score indicating a worse disease state.
Change From Baseline in UC Bowel Movement Signs and Symptoms at Week 30, as Assessed by Ulcerative Colitis Patient-Reported Outcome Signs and Symptoms (UC-PRO/SS) Score
The UC-PRO is being reported in three domains; two domains are key endpoints and reported as UC-PRO Signs and Symptoms (UC-PRO/SS). The bowel domain score ranges from 0-27, with a higher score indicating a worse disease state.
Change From Baseline in UC Abdominal Signs and Symptoms at Week 8, as Assessed by Ulcerative Colitis Patient-Reported Outcome Signs and Symptoms (UC-PRO/SS) Score
The UC-PRO is being reported in three domains; two domains are key endpoints and reported as UC-PRO Signs and Symptoms (UC-PRO/SS). The functional (abdominal symptoms) domain score ranges from 0-12, with a higher score indicating a worse disease state.
Change From Baseline in UC Abdominal Signs and Symptoms at Week 30, as Assessed by Ulcerative Colitis Patient-Reported Outcome Signs and Symptoms (UC-PRO/SS) Score
The UC-PRO is being reported in three domains; two domains are key endpoints and reported as UC-PRO Signs and Symptoms (UC-PRO/SS). The functional (abdominal symptoms) domain score ranges from 0-12, with a higher score indicating a worse disease state.
Change From Baseline in Patient-Reported Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 8
The IBDQ score is a Total Score summed up from across all 32 questions on the questionnaire. The Total Score range is from 32 to 224 with higher scores representing a better quality of life.
Change From Baseline in Patient-Reported Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 30
The IBDQ score is a Total Score summed up from across all 32 questions on the questionnaire. The Total Score range is from 32 to 224 with higher scores representing a better quality of life.
Percentage of Participants With Adverse Events
Percentage of Participants With Presence of Anti-Drug Antibodies (ADA) at Baseline and After Drug Administration
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03558152
Brief Title
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared With Placebo and With Vedolizumab in Participants With Moderate to Severe Ulcerative Colitis (UC)
Official Title
A Phase II, Randomized, Parallel-Group, Double-Blind, Double-Dummy, Placebo-Controlled, Multicenter Study To Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared With Placebo and Compared With Vedolizumab in Patients With Moderate to Severe Ulcerative Colitis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
October 26, 2018 (Actual)
Primary Completion Date
December 15, 2021 (Actual)
Study Completion Date
December 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genentech, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study is designed to evaluate the efficacy, safety, and pharmacokinetics of UTTR1147A compared with vedolizumab and with placebo in the treatment of participants with moderate to severe UC. This study will consist of two parts, Part A and Part B. Part A will test the induction of clinical remission and Part B will test the durability of clinical remission.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
195 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1a: UTTR1147A Dose Level 1 (Part A) + UTTR1147A (Part B)
Arm Type
Experimental
Arm Description
Part A: UTTR1147A dose level 1 and Vedolizumab Placebo.
Part B: UTTR1147A maintenance dose and Vedolizumab Placebo.
Arm Title
Arm 1b: UTTR1147A Dose Level 1 (Part A) + Placebo (Part B)
Arm Type
Experimental
Arm Description
Part A: UTTR1147A dose level 1 and Vedolizumab Placebo.
Part B: UTTR1147A Placebo and Vedolizumab Placebo.
Arm Title
Arm 2a: UTTR1147A Dose Level 2 (Part A) + UTTR1147A (Part B)
Arm Type
Experimental
Arm Description
Part A: UTTR1147A dose level 2 and Vedolizumab Placebo.
Part B: UTTR1147A maintenance dose and Vedolizumab Placebo.
Arm Title
Arm 2b: UTTR1147A Dose Level 2 (Part A) + Placebo (Part B)
Arm Type
Experimental
Arm Description
Part A: UTTR1147A dose level 2 and Vedolizumab Placebo.
Part B: UTTR1147A Placebo and Vedolizumab Placebo.
Arm Title
Arm 3a: UTTR1147A Dose Level 3 (Part A) + UTTR1147A (Part B)
Arm Type
Experimental
Arm Description
Part A: UTTR1147A dose level 3 and Vedolizumab Placebo.
Part B: UTTR1147A maintenance dose and Vedolizumab Placebo.
Arm Title
Arm 3b: UTTR1147A Dose Level 3 (Part A) + Placebo (Part B)
Arm Type
Experimental
Arm Description
Part A: UTTR1147A dose level 3 and Vedolizumab Placebo.
Part B: UTTR1147A Placebo and Vedolizumab Placebo.
Arm Title
Arm 4: Vedolizumab
Arm Type
Active Comparator
Arm Description
Parts A and B: Vedolizumab and UTTR1147A Placebo.
Arm Title
Arm 5: Placebo
Arm Type
Placebo Comparator
Arm Description
Parts A and B: UTTR1147A Placebo and Vedolizumab Placebo.
Intervention Type
Drug
Intervention Name(s)
UTTR1147A
Other Intervention Name(s)
Efmarodocokin alfa, RO7021610, RG7880, IL-22Fc
Intervention Description
UTTR1147A will be administered intravenously (IV) at dose levels 1, 2, or 3 in Part A, and at the maintenance dose level in Part B, per the respective arm descriptions.
Intervention Type
Drug
Intervention Name(s)
UTTR1147A Placebo
Intervention Description
The matching placebo to UTTR1147A (UTTR1147A Placebo) will be administered IV.
Intervention Type
Drug
Intervention Name(s)
Vedolizumab
Other Intervention Name(s)
Entyvio
Intervention Description
Vedolizumab will be administered IV, as specified in the prescribing information.
Intervention Type
Drug
Intervention Name(s)
Vedolizumab Placebo
Intervention Description
The matching placebo to vedolizumab (Vedolizumab Placebo) will be administered IV.
Primary Outcome Measure Information:
Title
Percentage of Participants With Clinical Remission at Week 8
Description
Clinical remission is defined as modified Mayo Clinic Score (mMCS) <= 2 with Mayo rectal bleeding subscore = 0, Mayo stool frequency subscore <=1 and Centrally read endoscopic score <= 1. Patients were classified as Non-Remitters if Week 8 assessments were missing or patient received permitted/ prohibited Rescue Therapy prior to assessment.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Percentage of Participants With Sustained Remission
Description
Sustained remission is defined as clinical remission at both Week 8 and Week 30, where clinical remission is defined as modified Mayo Clinic Score (mMCS) <= 2 with Mayo rectal bleeding subscore = 0, Mayo stool frequency subscore <=1 and Centrally read endoscopic score <= 1.
Patients were classified as Non-Remitters at Week 8 or at Week 30 if assessments were missing or patient received permitted/prohibited Rescue Therapy prior to assessment
Time Frame
At Weeks 8 and 30
Title
Maximum Serum Concentration (Cmax) of UTTR1147A
Time Frame
Days 1 - 29, Visit: Day 57
Title
Minimum Serum Concentration (Cmin) of UTTR1147A
Time Frame
Days 1 - 29, Visit: Day 57
Title
Percentage of Participants With Clinical Response at Week 8
Description
Clinical response is defined as achieving clinical remission or as meeting both of the following criteria: A >= 3-point decrease from baseline in modified Mayo Clinic Score (mMCS); A >= 1-point decrease from baseline in rectal bleeding subscore or a rectal bleeding subscore of 0 or 1.
Patients were classified as Non-Responders if assessments were missing or patient received permitted/prohibited Rescue Therapy prior to assessment.
NOTE: An Outcome Measure Description has not been entered.
Time Frame
At Week 8
Title
Percentage of Participants With Clinical Response at Week 30
Description
Clinical response is defined as achieving clinical remission or as meeting both of the following criteria: A >= 3-point decrease from baseline in modified Mayo Clinic Score (mMCS); A >= 1-point decrease from baseline in rectal bleeding subscore or a rectal bleeding subscore of 0 or 1.
Patients were classified as Non-Responders if assessments were missing or patient received permitted/prohibited Rescue Therapy prior to assessment.
Time Frame
At Week 30
Title
Percentage of Participants With Endoscopic Healing at Week 8
Description
Endoscopic healing is defined as a Mayo endoscopic subscore <= 1. Patients were classified as Non-Responders if assessments were missing or patient received permitted/prohibited Rescue Therapy prior to assessment.
Time Frame
At Week 8
Title
Percentage of Participants With Endoscopic Healing at Week 30
Description
Endoscopic healing is defined as a Mayo endoscopic subscore <= 1. Patients were classified as Non-Responders if assessments were missing or patient received permitted/prohibited Rescue Therapy prior to assessment.
Time Frame
At Week 30
Title
Percentage of Participants With Endoscopic Remission at Week 8
Description
Endoscopic remission is defined as a Mayo endoscopic subscore of 0. Patients were classified as Non-Responders if assessments were missing or patient received permitted/prohibited Rescue Therapy prior to assessment.
Time Frame
At Week 8
Title
Percentage of Participants With Endoscopic Remission at Week 30
Description
Endoscopic remission is defined as a Mayo endoscopic subscore of 0. Patients were classified as Non-Responders if assessments were missing or patient received permitted/prohibited Rescue Therapy prior to assessment.
Time Frame
At Week 30
Title
Change From Baseline in UC Bowel Movement Signs and Symptoms at Week 8, as Assessed by Ulcerative Colitis Patient-Reported Outcome Signs and Symptoms (UC-PRO/SS) Score
Description
The UC-PRO is being reported in three domains; two domains are key endpoints and reported as UC-PRO Signs and Symptoms (UC-PRO/SS). The bowel domain score ranges from 0-27, with a higher score indicating a worse disease state.
Time Frame
At Week 8
Title
Change From Baseline in UC Bowel Movement Signs and Symptoms at Week 30, as Assessed by Ulcerative Colitis Patient-Reported Outcome Signs and Symptoms (UC-PRO/SS) Score
Description
The UC-PRO is being reported in three domains; two domains are key endpoints and reported as UC-PRO Signs and Symptoms (UC-PRO/SS). The bowel domain score ranges from 0-27, with a higher score indicating a worse disease state.
Time Frame
At Week 30
Title
Change From Baseline in UC Abdominal Signs and Symptoms at Week 8, as Assessed by Ulcerative Colitis Patient-Reported Outcome Signs and Symptoms (UC-PRO/SS) Score
Description
The UC-PRO is being reported in three domains; two domains are key endpoints and reported as UC-PRO Signs and Symptoms (UC-PRO/SS). The functional (abdominal symptoms) domain score ranges from 0-12, with a higher score indicating a worse disease state.
Time Frame
At Week 8
Title
Change From Baseline in UC Abdominal Signs and Symptoms at Week 30, as Assessed by Ulcerative Colitis Patient-Reported Outcome Signs and Symptoms (UC-PRO/SS) Score
Description
The UC-PRO is being reported in three domains; two domains are key endpoints and reported as UC-PRO Signs and Symptoms (UC-PRO/SS). The functional (abdominal symptoms) domain score ranges from 0-12, with a higher score indicating a worse disease state.
Time Frame
At Week 30
Title
Change From Baseline in Patient-Reported Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 8
Description
The IBDQ score is a Total Score summed up from across all 32 questions on the questionnaire. The Total Score range is from 32 to 224 with higher scores representing a better quality of life.
Time Frame
At Week 8
Title
Change From Baseline in Patient-Reported Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 30
Description
The IBDQ score is a Total Score summed up from across all 32 questions on the questionnaire. The Total Score range is from 32 to 224 with higher scores representing a better quality of life.
Time Frame
At Week 30
Title
Percentage of Participants With Adverse Events
Time Frame
Up to 30 weeks
Title
Percentage of Participants With Presence of Anti-Drug Antibodies (ADA) at Baseline and After Drug Administration
Time Frame
Baseline up to 30
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of UC
Confirmation of moderately to severely active UC, defined by the Mayo Clinic Score
Inadequate response, loss of response, or intolerance to prior immunosuppressant treatment (i.e., azathioprine, 6-mercaptopurine, methotrexate, or tumor necrosis factor [TNF] inhibitors [maximum of 2 prior TNF inhibitors]) and/or corticosteroid treatment
Use of highly effective contraception as defined by the protocol
Exclusion Criteria:
History of psoriasis or psoriatic arthritis; any other inflammatory skin disorders requiring oral corticosteroids, immunosuppressants, or biological therapy within the previous year; or primary sclerosing cholangitis
History of cancer as defined by the protocol
Significant uncontrolled comorbidity, such as cardiac, pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders (excluding UC)
Prior extensive colonic resection, subtotal or total colectomy, or proctocolectomy, or planned surgery for UC
Diagnosis of indeterminate colitis or granulomatous (Crohn's) colitis or toxic megacolon within 12 months prior to screening
Suspicion of ischemic colitis, radiation colitis, or microscopic colitis
Current fistula or history of fistula, pericolonic abscess and stricture (stenosis) of the colon
History or current evidence of unresectable colonic mucosal dysplasia or history of high-grade colonic mucosal dysplasia
Prior treatment with UTTR1147A
Prior treatment with vedolizumab, etrolizumab, natalizumab, efalizumab, or any other anti-integrin agents
Prior treatment with rituximab
Use of prohibited therapies, as defined by the protocol, prior to randomization
Congenital or acquired immune deficiency
Evidence or treatment of infections or history of infections, as defined by the protocol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Carolina Digestive Diseases
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
University of Utah School of Medicine; Gastroenterology Division
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
MHAT Saint Karidad EAD
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
Multiprofile Hospital for Active Treatment Hadji Dimitar OOD
City
Sliven
ZIP/Postal Code
8800
Country
Bulgaria
Facility Name
LLC ARENSIA Exploratory Medicine
City
Tbilisi
ZIP/Postal Code
0112
Country
Georgia
Facility Name
Gastroenterologische Spezialpraxis-Berlin-Karlshorst
City
Berlin
ZIP/Postal Code
10318
Country
Germany
Facility Name
Universitaetsklinikum Carl Gustav Carus TU Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitatsklinikum Schleswig-Holstein
City
Lubeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
St. Marien Krankenhaus; Med. Klinik
City
Ludwigshafen
ZIP/Postal Code
67067
Country
Germany
Facility Name
Universitätsklinikum Ulm; Klinik für Innere Medizin II
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Iatriko Palaiou Falirou; Gastrointestinal Department
City
Palaio Faliro
ZIP/Postal Code
175 62
Country
Greece
Facility Name
EUROMEDICA General Clinic of Thessaloniki; Gastroenterology Department
City
Thessaloniki
ZIP/Postal Code
54645
Country
Greece
Facility Name
Magyar Honvédség Egészségügyi Központ; Országos Haemophilia Központ
City
Budapest
ZIP/Postal Code
1134
Country
Hungary
Facility Name
Portiuncula Hospital, Ballinasloe
City
Co Galway
Country
Ireland
Facility Name
Shaare Zedek Medical Center; Bait Vagan
City
Jerusalem
ZIP/Postal Code
9103102
Country
Israel
Facility Name
Policlinico Universitario Campus Biomedico Di Roma
City
Roma
State/Province
Lazio
ZIP/Postal Code
00128
Country
Italy
Facility Name
Complesso Integrato Columbus
City
Roma
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
Facility Name
ASST di Monza - Azienda Ospedaliera San Gerardo; U.O. Farmacia -Settore A - Corpo Posteriore
City
Monza
State/Province
Lombardia
ZIP/Postal Code
20900
Country
Italy
Facility Name
Istituto Clinico Humanitas
City
Rozzano (MI)
State/Province
Lombardia
ZIP/Postal Code
20089
Country
Italy
Facility Name
Azienda Ospedaliera Di Padova
City
Padova
State/Province
Veneto
ZIP/Postal Code
35128
Country
Italy
Facility Name
ICS ARENSIA Exploratory Medicine
City
Chisinau
ZIP/Postal Code
MD-2025
Country
Moldova, Republic of
Facility Name
SPZOZ Uniwersytecki SK nr 1 im N. Barlickiego UM w Lodzi; Oddz. Klin. Gastroenter. Og. i Onk.
City
?ód?
ZIP/Postal Code
90-153
Country
Poland
Facility Name
Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy; Centrum Endoskopii Zabiegowej
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
Facility Name
Synexus Polska Sp. z o.o. Oddzial w Czestochowie
City
Cz?stochowa
ZIP/Postal Code
42-202
Country
Poland
Facility Name
Synexus Polska Sp. z o.o. Oddzial w Gdansku
City
Gda?sk
ZIP/Postal Code
80-382
Country
Poland
Facility Name
Synexus - Katowice
City
Katowice
ZIP/Postal Code
40-040
Country
Poland
Facility Name
Economicus - NZOZ ALL-MEDICUS; Zaklad Gastroenterologii
City
Katowice
ZIP/Postal Code
40-660
Country
Poland
Facility Name
ETG Kielce
City
Kielce
ZIP/Postal Code
25-355
Country
Poland
Facility Name
Gastromed SPK Niepubliczny Zaklad Opieki Zdrowotnej
City
Lublin
ZIP/Postal Code
20-582
Country
Poland
Facility Name
Klimed Marek Klimkiewicz
City
Piotrków Trybunalski
ZIP/Postal Code
97-300
Country
Poland
Facility Name
Synexus Polska Sp. z o.o. Oddzial w Poznaniu
City
Pozna?
ZIP/Postal Code
60-702
Country
Poland
Facility Name
Clinical Research Center Sp. z o.o. MEDIC-R Spó?ka Komandytowa
City
Pozna?
ZIP/Postal Code
61-731
Country
Poland
Facility Name
Endoskopia Sp. z o.o.
City
Sopot
ZIP/Postal Code
81-756
Country
Poland
Facility Name
Gastromed Kopon Zmudzinski i
City
Toru?
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Centrum Zdrowia MDM
City
Warszawa
ZIP/Postal Code
00-635
Country
Poland
Facility Name
Jaroslaw Kierkus Prywatna Prakyka Lekarska
City
Warszawa
ZIP/Postal Code
00-728
Country
Poland
Facility Name
Przychodnia EuroMediCare
City
Wroc?aw
ZIP/Postal Code
50-220
Country
Poland
Facility Name
Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
City
Wroc?aw
ZIP/Postal Code
50-381
Country
Poland
Facility Name
Melita Medical
City
Wroc?aw
ZIP/Postal Code
50-449
Country
Poland
Facility Name
Saint Martyr Elizabeth City Hospital
City
Sankt-peterburg
State/Province
Sankt Petersburg
ZIP/Postal Code
195257
Country
Russian Federation
Facility Name
Irkutsk Research Centre Hospital of Siberian department of Russian Academy of Science
City
Irkutsk
ZIP/Postal Code
664033
Country
Russian Federation
Facility Name
Rostov State Medical University; Cardiorheumatology Department
City
Rostov-na-Donu
ZIP/Postal Code
344022
Country
Russian Federation
Facility Name
Medical University Reaviz
City
Samara
ZIP/Postal Code
443011
Country
Russian Federation
Facility Name
North-West State Medical University n.a. I.I. Mechnikov
City
St. Petersburg
ZIP/Postal Code
191015
Country
Russian Federation
Facility Name
Clinical Hospital Center Zvezdara
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
KBC Dr Dragisa Misovic Dedinje
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
University Hospital Medical Center Bezanijska kosa
City
Belgrade
ZIP/Postal Code
11080
Country
Serbia
Facility Name
Clinical Center Kragujevac; Clinic Of Psychiatry
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
General Hospital Vrsac
City
Vrsac
ZIP/Postal Code
26300
Country
Serbia
Facility Name
Clinical Hospital Centre Zemun
City
Zemun
ZIP/Postal Code
11080
Country
Serbia
Facility Name
General Hospital Djordje Joanovic - Zrenjanin
City
Zrenjanin
ZIP/Postal Code
23000
Country
Serbia
Facility Name
Hospital de Gran Canaria Dr. Negrin; Servicio de Aparato Digestivo
City
Las Palmas de Gran Canaria
State/Province
LAS Palmas
ZIP/Postal Code
35010
Country
Spain
Facility Name
Hospital Universitario de Torrejon
City
Torrejon de Ardoz
State/Province
Madrid
ZIP/Postal Code
28850
Country
Spain
Facility Name
Regional Municipal Institution Chernivtsi Regional Clinical Hospital; Gastroenterology department
City
Chernivtsi
State/Province
Chernihiv Governorate
ZIP/Postal Code
58001
Country
Ukraine
Facility Name
Medical Centre of PE First Private Clinic
City
Zhytomir
State/Province
Crimean Regional Governmenta
ZIP/Postal Code
10008
Country
Ukraine
Facility Name
Ternopil University Hospital; Regional Center of Gastroenterology with Hepatology
City
Ternopil
State/Province
Katerynoslav Governorate
ZIP/Postal Code
46002
Country
Ukraine
Facility Name
City Clinical Hospital #1; Department of Gastroenterology
City
Vinnytsia
State/Province
Kharkiv Governorate
ZIP/Postal Code
21029
Country
Ukraine
Facility Name
Municipal Institution Zaporizhzhia Regional Clinical Hospital of Zaporizhzhia Regional Council
City
Zaporizhzhia
State/Province
Kharkiv Governorate
ZIP/Postal Code
69600
Country
Ukraine
Facility Name
ME Dnipropetrovsk Regional Clinical Hospital n.a. I.I Mechnykov Dnipropetrovsk Regional Council
City
Dnipro
State/Province
KIEV Governorate
ZIP/Postal Code
49005
Country
Ukraine
Facility Name
Treatment and Diagnostic Center of LLC MRT Elit
City
Kropyvnytskyi
State/Province
KIEV Governorate
ZIP/Postal Code
25005
Country
Ukraine
Facility Name
Medical Center of LLC Medical Clinic Blagomed
City
Kyiv
State/Province
KIEV Governorate
ZIP/Postal Code
01001
Country
Ukraine
Facility Name
Medical Center of Limited Liability Company ?Harmoniya krasy?
City
Kyiv
State/Province
KIEV Governorate
ZIP/Postal Code
01135
Country
Ukraine
Facility Name
Medical Center of LLC Medical Center Dopomoga Plus
City
Kyiv
State/Province
KIEV Governorate
ZIP/Postal Code
02000
Country
Ukraine
Facility Name
Medical Center of Edelweiss Medics LLC
City
Kyiv
State/Province
KIEV Governorate
ZIP/Postal Code
02002
Country
Ukraine
Facility Name
Synexus Affiliate - MC of LLC Medbud-Clinic
City
Kyiv
State/Province
KIEV Governorate
ZIP/Postal Code
03037
Country
Ukraine
Facility Name
Med Center of International Institute of Clinical Trials LLC; Medical Center "OK!Clinic+"
City
Kyiv
State/Province
KIEV Governorate
ZIP/Postal Code
2091
Country
Ukraine
Facility Name
Medical Center of LLC Diaservis
City
Zaporizhzhia
State/Province
KIEV Governorate
ZIP/Postal Code
69076
Country
Ukraine
Facility Name
Clinic of SRI of Invalid Rehab. (ESTC) of VNMU n.a. M.I.Pyrohov
City
Vinnytsia
State/Province
Podolia Governorate
ZIP/Postal Code
21029
Country
Ukraine
Facility Name
Medical Center of LLC Medical Center Family Medicine Clinic; Endoscopy & Gastroenterology
City
Dnipr
State/Province
Polissya Okruha
ZIP/Postal Code
49600
Country
Ukraine
Facility Name
Transcarpathian Regional Clinical Hospital n.a. A. Novak; Rheumatology Department
City
Uzhgorod
ZIP/Postal Code
88000
Country
Ukraine
Facility Name
Medical Center of Diaservice LLC; Division of clinical trials conduct, Department #3
City
Zaporizhzhia
ZIP/Postal Code
69035
Country
Ukraine
Facility Name
Kings College Hospital
City
London
ZIP/Postal Code
SW9 8RR
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).
For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
Learn more about this trial
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared With Placebo and With Vedolizumab in Participants With Moderate to Severe Ulcerative Colitis (UC)
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