Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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17 January 2022 |
Main ID: |
EUCTR2017-002350-36-HU |
Date of registration:
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19/04/2018 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A 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.
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Scientific title:
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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 |
Date of first enrolment:
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14/06/2018 |
Target sample size:
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270 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-002350-36 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: yes Other: no Number of treatment arms in the trial: 8
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Bulgaria
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Germany
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Greece
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Hungary
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Ireland
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Israel
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Italy
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Netherlands
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Poland
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Russian Federation
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Serbia
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Spain
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Ukraine
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United Kingdom
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United States
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Contacts
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Name:
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Trial Information Support Line-TISL
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Address:
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Grenzacherstrasse 124
4070
Basel
Switzerland |
Telephone:
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Email:
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global.rochegenentechtrials@roche.com |
Affiliation:
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Genentech Inc. c/o F. Hoffmann-La Roche Ltd |
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Name:
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Trial Information Support Line-TISL
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Address:
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Grenzacherstrasse 124
4070
Basel
Switzerland |
Telephone:
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Email:
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global.rochegenentechtrials@roche.com |
Affiliation:
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Genentech Inc. c/o F. Hoffmann-La Roche Ltd |
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Key inclusion & exclusion criteria
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Inclusion criteria: - Age 18-80 years
- Diagnosis of UC
- Moderate to severely active UC, defined by the Mayo Clinic Score
- Inadequate response, loss of response, or intolerance to prior immunosuppressant treatment and and/or corticosteroid treatment
- Use of highly effective contraception as defined by the protocol
Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 243 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 27
Exclusion criteria: - History of psoriasis or psoriatic arthritis; any other inflammatory skin disorders requiring oral corticosteroids, immunosuppressants, or biological therapy within the previous year and primary sclerosing cholangitis
- History of cancer as defined by the protocol
- Significant uncontrolled comorbidity, such as cardiac, pulmonary, renal, hepatic, endocrine, or GI 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 and toxic megacolon within 12 months prior to screening
- Suspicion of ischemic colitis, radiation colitis, or microscopic colitis
- Current fistula or history of fistula, current pericolonic abscess and Stricture (stenosis) of the colon
- History or current evidence of unresectable colonic mucosal dysplasia and high-grade colonic mucosal dysplasia
- Prior treatment with vedolizumab, etrolizumab, natalizumab, efalizumab, or any other anti-integrin agents and rituximab
- Use of prohibited therapies as defined by the protocol prior to randomization
- Evidence or treatment of infections or history of infections as defined by the protocol
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
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Ulcerative colitis (UC) MedDRA version: 20.1
Level: LLT
Classification code 10045365
Term: Ulcerative colitis
System Organ Class: 100000004856
MedDRA version: 20.1
Level: LLT
Classification code 10033007
Term: Other ulcerative colitis
System Organ Class: 100000004856
MedDRA version: 20.1
Level: LLT
Classification code 10045366
Term: Ulcerative colitis, unspecified
System Organ Class: 100000004856
MedDRA version: 20.1
Level: LLT
Classification code 10066678
Term: Acute ulcerative colitis
System Organ Class: 100000004856
MedDRA version: 20.0
Level: LLT
Classification code 10075635
Term: Acute hemorrhagic ulcerative colitis
System Organ Class: 100000004856
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Intervention(s)
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Product Name: n.a. Product Code: UTTR1147A/RO7021610 (Active) Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: n.a. Current Sponsor code: RO7021610 Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use
Trade Name: Entyvio 300mg Product Code: RO7246311 Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: Vedolizumab CAS Number: 943609-66-3 Current Sponsor code: RO7246311 Other descriptive name: VEDOLIZUMAB Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300- Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use
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Primary Outcome(s)
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Secondary Objective: • To evaluate the efficacy of UTTR1147A compared with placebo and compared with vedolizumab based on sustained remission, clinical response, endoscopic healing, endoscopic remission, UC bowel movement/abdominal signs and symptoms, and patient-reported health-related quality of life (QOL) • To evaluate the safety of UTTR1147A compared with placebo and compared with vedolizumab • To characterize the pharmacokinetics of UTTR1147A in patients with UC • To evaluate the immune response to UTTR1147A
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Timepoint(s) of evaluation of this end point: 1. At Week 8
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Primary end point(s): 1. Clinical remission
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Main Objective: • To evaluate the efficacy of UTTR1147A compared with placebo and compared with vedolizumab based on clinical remission
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Secondary Outcome(s)
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Secondary end point(s): 1. Sustained remission
2. Clinical response
3. Endoscopic healing
4. Endoscopic remission
5. Change from baseline in ulcerative colitis bowel movement signs and symptoms, as assessed by Ulcerative Colitis-Patient-Reported Outcome Signs and Symptoms score (UC PRO/SS)
6. Change from baseline in UC abdominal signs and symptoms, as assessed by UC PRO/SS score
7. Change from baseline in patient-reported health related QOL, as assessed by Inflammatory Bowel Disease Questionnaire score
8. Occurrence and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events scale
9. Change in targeted vital signs, physical findings, and clinical laboratory test results during and following study drug administration
10. Serum concentration of UTTR1147A at specified time points
11. Presence of anti-drug antibody (ADA) during the study relative to the presence of ADAs at baseline
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Timepoint(s) of evaluation of this end point: 1-4: At Weeks 8 and 30
5-7: Baseline to Weeks 8 and 30
8-9: Up to 40 months
10: At Weeks 0, 1, 2, 4, 8, 14, 22, 26 (safety follow-up visit [4 weeks after the last dose of study drug]) and at unscheduled visit or disease evaluation or early termination
11: At Weeks 0, 2, 4, 8,14,22,30 (safety follow-up visit [8 weeks after the last dose of study drug]) and at unscheduled visit or disease evaluation or early termination
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Secondary ID(s)
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GA39925
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2017-002350-36-DE
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Source(s) of Monetary Support
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Genentech Inc. c/o F. Hoffmann-La Roche Ltd
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Ethics review
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Status: Approved
Approval date: 06/06/2018
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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