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)

NCT03558152 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: GA399252017-002350-36
• Study Type: interventional
• Target: 195
• Locations: 16 countries
• Sites: 72

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.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• 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.

  8 weeks

Secondary Outcomes (17)

• Percentage of Participants With Sustained Remission

  At Weeks 8 and 30

• Maximum Serum Concentration (Cmax) of UTTR1147A

  Days 1 - 29, Visit: Day 57

• Minimum Serum Concentration (Cmin) of UTTR1147A

  Days 1 - 29, Visit: Day 57

• Percentage of Participants With Clinical Response at Week 8

  At Week 8

• Percentage of Participants With Clinical Response at Week 30

  At Week 30

Study Arms (8)

Arm 1a: UTTR1147A Dose Level 1 (Part A) + UTTR1147A (Part B)

EXPERIMENTAL

Part A: UTTR1147A dose level 1 and Vedolizumab Placebo. Part B: UTTR1147A maintenance dose and Vedolizumab Placebo.

Drug: UTTR1147A; Drug: Vedolizumab Placebo

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

EXPERIMENTAL

Part A: UTTR1147A dose level 1 and Vedolizumab Placebo. Part B: UTTR1147A Placebo and Vedolizumab Placebo.

Drug: UTTR1147A; Drug: UTTR1147A Placebo; Drug: Vedolizumab Placebo

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

EXPERIMENTAL

Part A: UTTR1147A dose level 2 and Vedolizumab Placebo. Part B: UTTR1147A maintenance dose and Vedolizumab Placebo.

Drug: UTTR1147A; Drug: Vedolizumab Placebo

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

EXPERIMENTAL

Part A: UTTR1147A dose level 2 and Vedolizumab Placebo. Part B: UTTR1147A Placebo and Vedolizumab Placebo.

Drug: UTTR1147A; Drug: UTTR1147A Placebo; Drug: Vedolizumab Placebo

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

EXPERIMENTAL

Part A: UTTR1147A dose level 3 and Vedolizumab Placebo. Part B: UTTR1147A maintenance dose and Vedolizumab Placebo.

Drug: UTTR1147A; Drug: Vedolizumab Placebo

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

EXPERIMENTAL

Part A: UTTR1147A dose level 3 and Vedolizumab Placebo. Part B: UTTR1147A Placebo and Vedolizumab Placebo.

Drug: UTTR1147A; Drug: UTTR1147A Placebo; Drug: Vedolizumab Placebo

Arm 4: Vedolizumab

ACTIVE COMPARATOR

Parts A and B: Vedolizumab and UTTR1147A Placebo.

Drug: UTTR1147A Placebo; Drug: Vedolizumab

Arm 5: Placebo

PLACEBO COMPARATOR

Parts A and B: UTTR1147A Placebo and Vedolizumab Placebo.

Drug: UTTR1147A Placebo; Drug: Vedolizumab Placebo

Interventions

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.

Also known as: Efmarodocokin alfa, RO7021610, RG7880, IL-22Fc

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)

UTTR1147A Placebo DRUG

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

Arm 1b: UTTR1147A Dose Level 1 (Part A) + Placebo (Part B); Arm 2b: UTTR1147A Dose Level 2 (Part A) + Placebo (Part B); Arm 3b: UTTR1147A Dose Level 3 (Part A) + Placebo (Part B); Arm 4: Vedolizumab; Arm 5: Placebo

Vedolizumab DRUG

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

Also known as: Entyvio

Arm 4: Vedolizumab

Vedolizumab Placebo DRUG

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

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 5: Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (72)

Carolina Digestive Diseases

Greenville, North Carolina, 27834, United States

Location

University of Utah School of Medicine; Gastroenterology Division

Salt Lake City, Utah, 84132, United States

Location

MHAT Saint Karidad EAD

Plovdiv, 4000, Bulgaria

Location

Multiprofile Hospital for Active Treatment Hadji Dimitar OOD

Sliven, 8800, Bulgaria

Location

LLC ARENSIA Exploratory Medicine

Tbilisi, 0112, Georgia

Location

Gastroenterologische Spezialpraxis-Berlin-Karlshorst

Berlin, 10318, Germany

Location

Universitaetsklinikum Carl Gustav Carus TU Dresden

Dresden, 01307, Germany

Location

St. Marien Krankenhaus; Med. Klinik

Ludwigshafen, 67067, Germany

Location

Universitatsklinikum Schleswig-Holstein

Lübeck, 23538, Germany

Location

Universitätsklinikum Ulm; Klinik für Innere Medizin II

Ulm, 89081, Germany

Location

Iatriko Palaiou Falirou; Gastrointestinal Department

Palaió Fáliro, 175 62, Greece

Location

EUROMEDICA General Clinic of Thessaloniki; Gastroenterology Department

Thessaloniki, 54645, Greece

Location

Magyar Honvédség Egészségügyi Központ; Országos Haemophilia Központ

Budapest, 1134, Hungary

Location

Portiuncula Hospital, Ballinasloe

Co Galway, Ireland

Location

Shaare Zedek Medical Center; Bait Vagan

Jerusalem, 9103102, Israel

Location

Policlinico Universitario Campus Biomedico Di Roma

Rome, Lazio, 00128, Italy

Location

Complesso Integrato Columbus

Rome, Lazio, 00168, Italy

Location

ASST di Monza - Azienda Ospedaliera San Gerardo; U.O. Farmacia -Settore A - Corpo Posteriore

Monza, Lombardy, 20900, Italy

Location

Istituto Clinico Humanitas

Rozzano (MI), Lombardy, 20089, Italy

Location

Azienda Ospedaliera Di Padova

Padua, Veneto, 35128, Italy

Location

ICS ARENSIA Exploratory Medicine

Chisinau, MD-2025, Moldova

Location

SPZOZ Uniwersytecki SK nr 1 im N. Barlickiego UM w Lodzi; Oddz. Klin. Gastroenter. Og. i Onk.

?ód?, 90-153, Poland

Location

Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy; Centrum Endoskopii Zabiegowej

Bydgoszcz, 85-168, Poland

Location

Synexus Polska Sp. z o.o. Oddzial w Czestochowie

Cz?stochowa, 42-202, Poland

Location

Synexus Polska Sp. z o.o. Oddzial w Gdansku

Gda?sk, 80-382, Poland

Location

Synexus - Katowice

Katowice, 40-040, Poland

Location

Economicus - NZOZ ALL-MEDICUS; Zaklad Gastroenterologii

Katowice, 40-660, Poland

Location

ETG Kielce

Kielce, 25-355, Poland

Location

Gastromed SPK Niepubliczny Zaklad Opieki Zdrowotnej

Lublin, 20-582, Poland

Location

Klimed Marek Klimkiewicz

Piotrkow Trybunalski, 97-300, Poland

Location

Synexus Polska Sp. z o.o. Oddzial w Poznaniu

Późna, 60-702, Poland

Location

Clinical Research Center Sp. z o.o. MEDIC-R Spó?ka Komandytowa

Późna, 61-731, Poland

Location

Endoskopia Sp. z o.o.

Sopot, 81-756, Poland

Location

Gastromed Kopon Zmudzinski i

Toru?, 87-100, Poland

Location

Centrum Zdrowia MDM

Warsaw, 00-635, Poland

Location

Jaroslaw Kierkus Prywatna Prakyka Lekarska

Warsaw, 00-728, Poland

Location

Przychodnia EuroMediCare

Wroc?aw, 50-220, Poland

Location

Synexus Polska Sp. z o.o. Oddzial we Wroclawiu

Wroc?aw, 50-381, Poland

Location

Melita Medical

Wroc?aw, 50-449, Poland

Location

Saint Martyr Elizabeth City Hospital

Saint Petersburg, Sankt-Peterburg, 195257, Russia

Location

Irkutsk Research Centre Hospital of Siberian department of Russian Academy of Science

Irkutsk, 664033, Russia

Location

Rostov State Medical University; Cardiorheumatology Department

Rostov-on-Don, 344022, Russia

Location

North-West State Medical University n.a. I.I. Mechnikov

Saint Petersburg, 191015, Russia

Location

Medical University Reaviz

Samara, 443011, Russia

Location

Clinical Hospital Center Zvezdara

Belgrade, 11000, Serbia

Location

KBC Dr Dragisa Misovic Dedinje

Belgrade, 11000, Serbia

Location

University Hospital Medical Center Bezanijska kosa

Belgrade, 11080, Serbia

Location

Clinical Center Kragujevac; Clinic Of Psychiatry

Kragujevac, 34000, Serbia

Location

General Hospital Vrsac

Vršac, 26300, Serbia

Location

Clinical Hospital Centre Zemun

Zemun, 11080, Serbia

Location

General Hospital Djordje Joanovic - Zrenjanin

Zrenjanin, 23000, Serbia

Location

Hospital de Gran Canaria Dr. Negrin; Servicio de Aparato Digestivo

Las Palmas de Gran Canaria, LAS Palmas, 35010, Spain

Location

Hospital Universitario de Torrejon

Torrejón de Ardoz, Madrid, 28850, Spain

Location

Regional Municipal Institution Chernivtsi Regional Clinical Hospital; Gastroenterology department

Chernivtsi, Chernihiv Governorate, 58001, Ukraine

Location

Medical Centre of PE First Private Clinic

Zhytomyr, Crimean Regional Governmenta, 10008, Ukraine

Location

Ternopil University Hospital; Regional Center of Gastroenterology with Hepatology

Ternopil, Katerynoslav Governorate, 46002, Ukraine

Location

City Clinical Hospital #1; Department of Gastroenterology

Vinnytsia, Kharkiv Governorate, 21029, Ukraine

Location

Municipal Institution Zaporizhzhia Regional Clinical Hospital of Zaporizhzhia Regional Council

Zaporizhzhia, Kharkiv Governorate, 69600, Ukraine

Location

ME Dnipropetrovsk Regional Clinical Hospital n.a. I.I Mechnykov Dnipropetrovsk Regional Council

Dnipro, KIEV Governorate, 49005, Ukraine

Location

Treatment and Diagnostic Center of LLC MRT Elit

Kropyvnytskyi, KIEV Governorate, 25005, Ukraine

Location

Medical Center of LLC Medical Clinic Blagomed

Kyiv, KIEV Governorate, 01001, Ukraine

Location

Medical Center of Limited Liability Company ?Harmoniya krasy?

Kyiv, KIEV Governorate, 01135, Ukraine

Location

Medical Center of LLC Medical Center Dopomoga Plus

Kyiv, KIEV Governorate, 02000, Ukraine

Location

Medical Center of Edelweiss Medics LLC

Kyiv, KIEV Governorate, 02002, Ukraine

Location

Synexus Affiliate - MC of LLC Medbud-Clinic

Kyiv, KIEV Governorate, 03037, Ukraine

Location

Med Center of International Institute of Clinical Trials LLC; Medical Center "OK!Clinic+"

Kyiv, KIEV Governorate, 2091, Ukraine

Location

Medical Center of LLC Diaservis

Zaporizhzhia, KIEV Governorate, 69076, Ukraine

Location

Clinic of SRI of Invalid Rehab. (ESTC) of VNMU n.a. M.I.Pyrohov

Vinnytsia, Podolia Governorate, 21029, Ukraine

Location

Medical Center of LLC Medical Center Family Medicine Clinic; Endoscopy & Gastroenterology

Dnipr, Polissya Okruha, 49600, Ukraine

Location

Transcarpathian Regional Clinical Hospital n.a. A. Novak; Rheumatology Department

Uzhhorod, 88000, Ukraine

Location

Medical Center of Diaservice LLC; Division of clinical trials conduct, Department #3

Zaporizhzhia, 69035, Ukraine

Location

Kings College Hospital

London, SW9 8RR, United Kingdom

Location

Related Publications (1)

• Danese S, Rothenberg ME, Lim JJ, Ding HT, McBride JM, Chen Y, Dash A, Mar JS, Keir M, Peyrin-Biroulet L, Panes J, Colombel JF, Feagan B, Valentine JF, Schreiber S. A Randomized Phase II Study of Efmarodocokin Alfa, an interleukin-22 Agonist, Versus Vedolizumab in Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2025 Jul;23(8):1387-1397. doi: 10.1016/j.cgh.2024.11.013. Epub 2024 Dec 16.

  PMID: 39694207 DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

vedolizumab

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2018
• First Posted: June 15, 2018
• Study Start: October 26, 2018
• Primary Completion: December 15, 2021
• Study Completion: December 15, 2021
• Last Updated: April 14, 2023
• Results First Posted: April 14, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share

Locations

GE (1); IL (1); US (2); SE (7); RU (5); GB (1); DE (5); ES (2); UA (18); IT (5); BU (2); GR (2); MO (1); PL (18); IE (1); HU (1)