Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03558152
Recruitment Status : Recruiting
First Posted : June 15, 2018
Last Update Posted : January 12, 2021
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: UTTR1147A Drug: UTTR1147A Placebo Drug: Vedolizumab Drug: Vedolizumab Placebo Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : October 26, 2018
Estimated Primary Completion Date : August 11, 2021
Estimated Study Completion Date : January 12, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Vedolizumab

Arm Intervention/treatment
Experimental: Arm 1a: UTTR1147A Dose Level 1 (Part A) + UTTR1147A (Part B)

Part A: UTTR1147A dose level 1 and Vedolizumab Placebo.

Part B: UTTR1147A maintenance dose and Vedolizumab Placebo.

Drug: UTTR1147A
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.
Other Names:
  • Efmarodocokin alfa
  • RO7021610
  • RG7880
  • IL-22Fc

Drug: Vedolizumab Placebo
The matching placebo to vedolizumab (Vedolizumab Placebo) will be administered IV.

Experimental: Arm 1b: UTTR1147A Dose Level 1 (Part A) + Placebo (Part B)

Part A: UTTR1147A dose level 1 and Vedolizumab Placebo.

Part B: UTTR1147A Placebo and Vedolizumab Placebo.

Drug: UTTR1147A
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.
Other Names:
  • Efmarodocokin alfa
  • RO7021610
  • RG7880
  • IL-22Fc

Drug: UTTR1147A Placebo
The matching placebo to UTTR1147A (UTTR1147A Placebo) will be administered IV.

Drug: Vedolizumab Placebo
The matching placebo to vedolizumab (Vedolizumab Placebo) will be administered IV.

Experimental: Arm 2a: UTTR1147A Dose Level 2 (Part A) + UTTR1147A (Part B)

Part A: UTTR1147A dose level 2 and Vedolizumab Placebo.

Part B: UTTR1147A maintenance dose and Vedolizumab Placebo.

Drug: UTTR1147A
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.
Other Names:
  • Efmarodocokin alfa
  • RO7021610
  • RG7880
  • IL-22Fc

Drug: Vedolizumab Placebo
The matching placebo to vedolizumab (Vedolizumab Placebo) will be administered IV.

Experimental: Arm 2b: UTTR1147A Dose Level 2 (Part A) + Placebo (Part B)

Part A: UTTR1147A dose level 2 and Vedolizumab Placebo.

Part B: UTTR1147A Placebo and Vedolizumab Placebo.

Drug: UTTR1147A
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.
Other Names:
  • Efmarodocokin alfa
  • RO7021610
  • RG7880
  • IL-22Fc

Drug: UTTR1147A Placebo
The matching placebo to UTTR1147A (UTTR1147A Placebo) will be administered IV.

Drug: Vedolizumab Placebo
The matching placebo to vedolizumab (Vedolizumab Placebo) will be administered IV.

Experimental: Arm 3a: UTTR1147A Dose Level 3 (Part A) + UTTR1147A (Part B)

Part A: UTTR1147A dose level 3 and Vedolizumab Placebo.

Part B: UTTR1147A maintenance dose and Vedolizumab Placebo.

Drug: UTTR1147A
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.
Other Names:
  • Efmarodocokin alfa
  • RO7021610
  • RG7880
  • IL-22Fc

Drug: Vedolizumab Placebo
The matching placebo to vedolizumab (Vedolizumab Placebo) will be administered IV.

Experimental: Arm 3b: UTTR1147A Dose Level 3 (Part A) + Placebo (Part B)

Part A: UTTR1147A dose level 3 and Vedolizumab Placebo.

Part B: UTTR1147A Placebo and Vedolizumab Placebo.

Drug: UTTR1147A
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.
Other Names:
  • Efmarodocokin alfa
  • RO7021610
  • RG7880
  • IL-22Fc

Drug: UTTR1147A Placebo
The matching placebo to UTTR1147A (UTTR1147A Placebo) will be administered IV.

Drug: Vedolizumab Placebo
The matching placebo to vedolizumab (Vedolizumab Placebo) will be administered IV.

Active Comparator: Arm 4: Vedolizumab
Parts A and B: Vedolizumab and UTTR1147A Placebo.
Drug: UTTR1147A Placebo
The matching placebo to UTTR1147A (UTTR1147A Placebo) will be administered IV.

Drug: Vedolizumab
Vedolizumab will be administered IV, as specified in the prescribing information.
Other Name: Entyvio

Placebo Comparator: Arm 5: Placebo
Parts A and B: UTTR1147A Placebo and Vedolizumab Placebo.
Drug: UTTR1147A Placebo
The matching placebo to UTTR1147A (UTTR1147A Placebo) will be administered IV.

Drug: Vedolizumab Placebo
The matching placebo to vedolizumab (Vedolizumab Placebo) will be administered IV.




Primary Outcome Measures :
  1. Percentage of Participants with Clinical Remission at Week 8 [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Percentage of Participants with Sustained Remission [ Time Frame: At Weeks 8 and 30 ]
  2. Percentage of Participants with Clinical Response at Weeks 8 and 30 [ Time Frame: At Weeks 8 and 30 ]
  3. Percentage of Participants with Endoscopic Healing at Weeks 8 and 30 [ Time Frame: At Weeks 8 and 30 ]
  4. Percentage of Participants with Endoscopic Remission at Weeks 8 and 30 [ Time Frame: At Weeks 8 and 30 ]
  5. Change From Baseline in UC Bowel Movement Signs and Symptoms at Weeks 8 and 30, as Assessed by Ulcerative Colitis Patient-Reported Outcome Signs and Symptoms (UC-PRO/SS) Score [ Time Frame: Baseline to Weeks 8 and 30 ]
    The UC-PRO/SS is a 9-item questionnaire containing two domains: bowel movement signs and symptoms (6 items) and abdominal symptoms (3 items). An average score is calculated for each domain; a higher score indicates worse symptoms.

  6. Change From Baseline in UC Abdominal Signs and Symptoms at Weeks 8 and 30, as Assessed by Ulcerative Colitis Patient-Reported Outcome Signs and Symptoms (UC-PRO/SS) Score [ Time Frame: Baseline to Weeks 8 and 30 ]
    The UC-PRO/SS is a 9-item questionnaire containing two domains: bowel movement signs and symptoms (6 items) and abdominal symptoms (3 items). An average score is calculated for each domain; a higher score indicates worse symptoms.

  7. Change From Baseline in Patient-Reported Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Weeks 8 and 30 [ Time Frame: Baseline to Weeks 8 and 30 ]
    The IBDQ is a 32-item questionnaire containing four domains: bowel symptoms (10 items), systemic symptoms (5 items), emotional function (12 items), and social function (5 items). The items are scored on a 7-point Likert scale; a higher score indicating better health-related quality of life.

  8. Percentage of Participants with Adverse Events [ Time Frame: Up to 30 weeks ]
  9. Percentage of Participants with Presence of Anti-Drug Antibodies (ADA) at Baseline and After Drug Administration [ Time Frame: At Baseline, Weeks 2, 4, 8, 14, 22, and 30 (up to 30 weeks) ]
  10. Maximum Serum Concentration (Cmax) of UTTR1147A [ Time Frame: Postdose at Baseline and Week 8 ]
  11. Minimum Serum Concentration (Cmin) of UTTR1147A [ Time Frame: Predose in Part A: at Weeks 4 and 8; in Part B: Weeks 14 and 22; and at Week 26 (up to 26 weeks) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03558152


Contacts
Layout table for location contacts
Contact: Reference Study ID: GA39925 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global-roche-genentech-trials@gene.com

Locations
Show Show 169 study locations
Sponsors and Collaborators
Genentech, Inc.
Investigators
Layout table for investigator information
Study Director: Clinical Trials Hoffmann-La Roche
Layout table for additonal information
Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT03558152    
Other Study ID Numbers: GA39925
2017-002350-36 ( EudraCT Number )
First Posted: June 15, 2018    Key Record Dates
Last Update Posted: January 12, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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).


Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Vedolizumab
Gastrointestinal Agents