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Completed

NCT Number: NCT03558152

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)

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.

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

MHAT Saint Karidad EAD, Plovdiv, Bulgaria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

UTTR1147A

Drug

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

UTTR1147A Placebo

Drug

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

Vedolizumab

Drug

Vedolizumab will be administered IV, as specified in the prescribing information.

Other names: Entyvio

Vedolizumab Placebo

Drug

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

Primary outcomes

  1. Percentage of Participants With Clinical Remission at Week 8

    Time frame: 8 weeks

    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 outcomes

  1. Percentage of Participants With Sustained Remission

    Time frame: At Weeks 8 and 30

    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

  2. Maximum Serum Concentration (Cmax) of UTTR1147A

    Time frame: Days 1 - 29, Visit: Day 57

  3. Minimum Serum Concentration (Cmin) of UTTR1147A

    Time frame: Days 1 - 29, Visit: Day 57

  4. Percentage of Participants With Clinical Response at Week 8

    Time frame: 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.

  5. Percentage of Participants With Clinical Response at Week 30

    Time frame: 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.

  6. Percentage of Participants With Endoscopic Healing at Week 8

    Time frame: 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.

  7. Percentage of Participants With Endoscopic Healing at Week 30

    Time frame: 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.

  8. Percentage of Participants With Endoscopic Remission at Week 8

    Time frame: 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.

  9. Percentage of Participants With Endoscopic Remission at Week 30

    Time frame: 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.

  10. 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

    Time frame: At Week 8

    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.

  11. 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

    Time frame: At Week 30

    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.

  12. 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

    Time frame: At Week 8

    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.

  13. 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

    Time frame: At Week 30

    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.

  14. Change From Baseline in Patient-Reported Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 8

    Time frame: 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.

  15. Change From Baseline in Patient-Reported Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 30

    Time frame: 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.

  16. Percentage of Participants With Adverse Events

    Time frame: Up to 30 weeks

  17. Percentage of Participants With Presence of Anti-Drug Antibodies (ADA) at Baseline and After Drug Administration

    Time frame: Baseline up to 30

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jun 15, 2018
Registry last updated
Apr 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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