An Extension Study to Evaluate the Long-Term Safety and Tolerability of UTTR1147A in Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease

NCT03650413 | Terminated Phase 2 Results FDA Drug

• 2 other identifiers: GA402092017-004997-32
• Study Type: interventional
• Target: 143
• Locations: 14 countries
• Sites: 57

Brief Summary

This study will evaluate the long-term safety and tolerability of UTTR1147A in participants with moderate to severe ulcerative colitis (UC) or Crohn's disease (CD), enrolling up to 320 participants from the parent studies: Phase Ib Study GA29469 (NCT02749630) and Phase II Study GA39925 (NCT03558152).

Conditions

Ulcerative Colitis; Crohn's Disease

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events

  Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 Scale (NCI CTCAE v4.0)

  Up to 2 years

Study Arms (1)

UTTR1147A

EXPERIMENTAL

All participants will have the opportunity to receive treatment with UTTR1147A until clinical remission is achieved. Participants will either receive treatment with UTTR1147A or undergo observation depending on disease status, as described in the protocol.

Drug: UTTR1147A

Interventions

UTTR1147A DRUG

UTTR1147A will be administered based on disease status, as described in the protocol.

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

UTTR1147A

Eligibility Criteria

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

You may qualify if:

• Prior enrollment in Study GA29469 or Study GA39925 and meeting protocol defined entry criteria
• Ability to comply with requirements of the study, in the investigator's judgment
• For women and men: use of highly effective contraception as defined by the protocol.

You may not qualify if:

• Withdrawal of consent from parent study
• Discontinuation of study drug as required by the parent study protocol
• Discontinuation of study drug and withdrawal from Study GA29469 prior to Day 85 or from Study GA39925 prior to Week 8
• Noncompliance in the parent study, specifically defined as missing scheduled visits or non-adherence with background medications and concomitant medications
• Pregnant or breastfeeding, or intending to become pregnant during the study or within 8 weeks after the final dose of study drug or within 18 weeks after the final dose of study drug from GA39925, whichever is longer
• Any new malignancy, significant uncontrolled comorbidity, such as cardiac, pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders, or signs or symptoms of infection judged by the investigator to be clinically significant since enrolling in the parent study
• Use of prohibited therapies as defined in the parent study
• Abnormal laboratory values, as defined in the protocol, recorded at the last visit in the parent study
• Use of prohibited concomitant therapy since enrolling in the extension study

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (57)

Carolina Digestive Diseases

Greenville, North Carolina, 27834, 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

Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden

Dresden, 01307, Germany

Location

Universitatsklinikum Schleswig Holstein; Klinik fur Allgemeine Innere Medizin

Kiel, 24105, Germany

Location

St. Marien Krankenhaus; Med. Klinik

Ludwigshafen, 67067, Germany

Location

Iatriko Palaiou Falirou; Gastrointestinal Department

Palaió Fáliro, 175 62, Greece

Location

EUROMEDICA General Clinic of Thessaloniki; Gastroenterology Department

Thessaloniki, 54645, Greece

Location

Portiuncula Hospital, Ballinasloe

Co Galway, Ireland

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

AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Czestochowie

Cz?stochowa, 42-202, Poland

Location

AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdansku

Gda?sk, 80-382, Poland

Location

AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Katowicach

Katowice, 40-040, 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 - Poznan

Poznan, 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

Centrum Zdrowia MDM

Warsaw, 00-635, Poland

Location

WIP Warsaw IBD Point Profesor Kierkus

Warsaw, 00-728, Poland

Location

Przychodnia EuroMediCare

Wroc?aw, 50-220, Poland

Location

Melita Medical

Wroc?aw, 50-449, Poland

Location

Synexus - Wroclaw

Wroclaw, 50-088, Poland

Location

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

Saint Petersburg, Sankt-Peterburg, 191015, Russia

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

Medical University Reaviz

Samara, 443011, Russia

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 Universitario de Torrejon

Torrejón de Ardoz, Madrid, 28850, Spain

Location

Regional Municipal Institution Chernivtsi Regional Clinical Hospital

Chernivtsi, Chernihiv Governorate, 58005, 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

Municipal Institution Zaporizhzhia Regional Clinical Hospital of Zaporizhzhia Regional Council

Zaporizhzhia, Kharkiv Governorate, 69600, 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

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

Vinnytsia, Podolia Governorate, 21029, 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

MeSH Terms

Conditions

Colitis, Ulcerative; Crohn Disease

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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2018
• First Posted: August 28, 2018
• Study Start: January 14, 2019
• Primary Completion: July 12, 2022
• Study Completion: July 12, 2022
• Last Updated: September 29, 2023
• Results First Posted: September 29, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share

Locations

DE (4); GB (1); MO (1); PL (16); SE (6); IT (4); BU (2); US (1); RU (4); GE (1); GR (2); IE (1); ES (1); UA (13)