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.

• Register: EUCTR
• Last refreshed on: 11 June 2018
• Main ID: EUCTR2017-002350-36-ES
• Date of registration: 06/06/2018
• Prospective Registration: No
• Primary sponsor: Roche Farma, S.A por delegación de Genentech, Inc.
• Public title: 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.
• Scientific 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
• Date of first enrolment: 15/04/2018
• Target sample size: 330
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-002350-36
• Study type: Interventional clinical trial of medicinal product
• Study design: 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: 10
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Bulgaria, Germany, Greece, Hungary, Ireland, Israel, Italy, Netherlands, Poland, Russian Federation, Serbia, Spain, Ukraine, United Kingdom, United States

Contacts

• Name: Trial Information Support Line-TISL
• Affiliation: Genentech Inc. c/o F. Hoffmann-La Roche Ltd

• Name: Trial Information Support Line-TISL
• Affiliation: Genentech Inc. c/o F. Hoffmann-La Roche Ltd

Key inclusion & exclusion criteria

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 300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

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

Health Condition(s) or Problem(s) studied

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

Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Intervention(s)

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

Primary Outcome(s)

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

Main Objective: • To evaluate the efficacy of UTTR1147A compared with placebo and compared with vedolizumab based on clinical remission

Timepoint(s) of evaluation of this end point: 1. At Week 10

Primary end point(s): 1. Clinical remission

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 1-4: At Weeks 10 and 30
5-7: Baseline to Weeks 10 and 30
8-9: Up to 45 months
10: At Weeks 0, 1, 2, 4, 6, 8, 10, 14, 30 and at 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, 6, 10, 22, 30 and at safety follow-up visit (8 weeks after
the last dose of study drug) and at unscheduled visit or disease evaluation or early termination

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

Secondary ID(s)

GA39925

Source(s) of Monetary Support

Genentech Inc. c/o F. Hoffmann-La Roche Ltd