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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-004997-32 | EudraCT Number |
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This study was terminated early by the Sponsor based on the interim analysis of Study GA39925 (NCT03558152) that showed low efficacy of UTTR1147A in ulcerative colitis. Development of the drug in this indication has been terminated.
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UTTR1147A | Drug | UTTR1147A will be administered based on disease status, as described in the protocol. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Inclusion Criteria for Study Entry:
Inclusion Criteria for Study Entry and Study Re-Entry:
Exclusion Criteria:
Exclusion Criteria for Study Entry:
Exclusion Criteria for Study Entry and Study Re-Entry:
Exclusion Criterion for Study Re-Entry:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carolina Digestive Diseases | Greenville | North Carolina | 27834 | United States | ||
| MHAT Saint Karidad EAD |
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).
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This is a single-arm open-label extension study. There is only one arm.
All 143 patients were included in the intent-to-treat (ITT) population, with 128 patients allocated to study treatment and 15 patients that were not treated.
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| ID | Title | Description |
|---|---|---|
| FG000 | UTTR1147A | Participants enrolled in the extension study either received efmarodocokin alfa treatment (60 μg/kg intravenously [IV] every 4 weeks [Q4W]) or if they were in remission, underwent observation for up to 2 years (through Week 104), as determined based on the patient's disease status at the time of their last endoscopy in the parent study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 26, 2021 |
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| Plovdiv |
| 4000 |
| Bulgaria |
| Multiprofile Hospital for Active Treatment Hadji Dimitar OOD | Sliven | 8800 | Bulgaria |
| LLC ARENSIA Exploratory Medicine | Tbilisi | 0112 | Georgia |
| Gastroenterologische Spezialpraxis-Berlin-Karlshorst | Berlin | 10318 | Germany |
| Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden | Dresden | 01307 | Germany |
| Universitatsklinikum Schleswig Holstein; Klinik fur Allgemeine Innere Medizin | Kiel | 24105 | Germany |
| St. Marien Krankenhaus; Med. Klinik | Ludwigshafen | 67067 | Germany |
| Iatriko Palaiou Falirou; Gastrointestinal Department | Palaió Fáliro | 175 62 | Greece |
| EUROMEDICA General Clinic of Thessaloniki; Gastroenterology Department | Thessaloniki | 54645 | Greece |
| Portiuncula Hospital, Ballinasloe | Co Galway | Ireland |
| Complesso Integrato Columbus | Rome | Lazio | 00168 | Italy |
| ASST di Monza - Azienda Ospedaliera San Gerardo; U.O. Farmacia -Settore A - Corpo Posteriore | Monza | Lombardy | 20900 | Italy |
| Istituto Clinico Humanitas | Rozzano (MI) | Lombardy | 20089 | Italy |
| Azienda Ospedaliera Di Padova | Padova | Veneto | 35128 | Italy |
| ICS ARENSIA Exploratory Medicine | Chisinau | MD-2025 | Moldova |
| SPZOZ Uniwersytecki SK nr 1 im N. Barlickiego UM w Lodzi; Oddz. Klin. Gastroenter. Og. i Onk. | ?ód? | 90-153 | Poland |
| Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy; Centrum Endoskopii Zabiegowej | Bydgoszcz | 85-168 | Poland |
| AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Czestochowie | Cz?stochowa | 42-202 | Poland |
| AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdansku | Gda?sk | 80-382 | Poland |
| AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Katowicach | Katowice | 40-040 | Poland |
| ETG Kielce | Kielce | 25-355 | Poland |
| Gastromed SPK Niepubliczny Zaklad Opieki Zdrowotnej | Lublin | 20-582 | Poland |
| Klimed Marek Klimkiewicz | Piotrkow Trybunalski | 97-300 | Poland |
| Synexus - Poznan | Poznan | 60-702 | Poland |
| Clinical Research Center Sp. z o.o. MEDIC-R Spó?ka Komandytowa | Późna | 61-731 | Poland |
| Endoskopia Sp. z o.o. | Sopot | 81-756 | Poland |
| Centrum Zdrowia MDM | Warsaw | 00-635 | Poland |
| WIP Warsaw IBD Point Profesor Kierkus | Warsaw | 00-728 | Poland |
| Przychodnia EuroMediCare | Wroc?aw | 50-220 | Poland |
| Melita Medical | Wroc?aw | 50-449 | Poland |
| Synexus - Wroclaw | Wroclaw | 50-088 | Poland |
| North-West State Medical University n.a. I.I. Mechnikov | Saint Petersburg | Sankt-Peterburg | 191015 | Russia |
| Saint Martyr Elizabeth City Hospital | Saint Petersburg | Sankt-Peterburg | 195257 | Russia |
| Irkutsk Research Centre Hospital of Siberian department of Russian Academy of Science | Irkutsk | 664033 | Russia |
| Medical University Reaviz | Samara | 443011 | Russia |
| KBC Dr Dragisa Misovic Dedinje | Belgrade | 11000 | Serbia |
| University Hospital Medical Center Bezanijska kosa | Belgrade | 11080 | Serbia |
| Clinical Center Kragujevac; Clinic Of Psychiatry | Kragujevac | 34000 | Serbia |
| General Hospital Vrsac | Vršac | 26300 | Serbia |
| Clinical Hospital Centre Zemun | Zemun | 11080 | Serbia |
| General Hospital Djordje Joanovic - Zrenjanin | Zrenjanin | 23000 | Serbia |
| Hospital Universitario de Torrejon | Torrejón de Ardoz | Madrid | 28850 | Spain |
| Regional Municipal Institution Chernivtsi Regional Clinical Hospital | Chernivtsi | Chernihiv Governorate | 58005 | Ukraine |
| Medical Centre of PE First Private Clinic | Zhytomyr | Crimean Regional Governmenta | 10008 | Ukraine |
| Ternopil University Hospital; Regional Center of Gastroenterology with Hepatology | Ternopil | Katerynoslav Governorate | 46002 | Ukraine |
| Municipal Institution Zaporizhzhia Regional Clinical Hospital of Zaporizhzhia Regional Council | Zaporizhzhia | Kharkiv Governorate | 69600 | Ukraine |
| Medical Center of LLC Medical Clinic Blagomed | Kyiv | KIEV Governorate | 01001 | Ukraine |
| Medical Center of Limited Liability Company ?Harmoniya krasy? | Kyiv | KIEV Governorate | 01135 | Ukraine |
| Medical Center of LLC Medical Center Dopomoga Plus | Kyiv | KIEV Governorate | 02000 | Ukraine |
| Medical Center of Edelweiss Medics LLC | Kyiv | KIEV Governorate | 02002 | Ukraine |
| Synexus Affiliate - MC of LLC Medbud-Clinic | Kyiv | KIEV Governorate | 03037 | Ukraine |
| Med Center of International Institute of Clinical Trials LLC; Medical Center "OK!Clinic+" | Kyiv | KIEV Governorate | 2091 | Ukraine |
| Clinic of SRI of Invalid Rehab. (ESTC) of VNMU n.a. M.I.Pyrohov | Vinnytsia | Podolia Governorate | 21029 | Ukraine |
| Transcarpathian Regional Clinical Hospital n.a. A. Novak; Rheumatology Department | Uzhhorod | 88000 | Ukraine |
| Medical Center of Diaservice LLC; Division of clinical trials conduct, Department #3 | Zaporizhzhia | 69035 | Ukraine |
| Kings College Hospital | London | SW9 8RR | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
|
|
There was only 1 arm in this study. The protocol was written with this single group receiving treatment based upon remission status.
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| ID | Title | Description |
|---|---|---|
| BG000 | UTTR1147A | Participants enrolled in the extension study either received efmarodocokin alfa treatment (60 μg/kg intravenously [IV] every 4 weeks [Q4W]) or if they were in remission, underwent observation for up to 2 years (through Week 104), as determined based on the patient's disease status at the time of their last endoscopy in the parent study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| |||||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | Years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Number | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | The safety-evaluable population comprised 128 patients who received at least one dose of the study drug. There was only 1 arm in this open label extension study. Treatment was available to all study participants if they lost remission. | Posted | Count of Participants | Participants | Up to 2 years |
|
|
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From baseline up to 2 years
The safety-evaluable population comprised 128 patients who received at least one dose of the study drug.There was only one arm of this study, however there was a subset of patients who received the IMP. This subset is defined here as the safety evaluable population.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | UTTR1147A 60 | Participants received treatment with UTTR1147A until clinical remission was achieved. | 0 | 128 | 9 | 128 | 52 | 128 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA version 25.0 | Systematic Assessment |
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| COVID-19 pneumonia | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
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| Clostridium difficile infection | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
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| Amylase increased | Investigations | MedDRA version 25.0 | Systematic Assessment |
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| Lipase increased | Investigations | MedDRA version 25.0 | Systematic Assessment |
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| Venous thrombosis limb | Vascular disorders | MedDRA version 25.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 25.0 | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | MedDRA version 25.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA version 25.0 | Systematic Assessment |
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The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800-821-8590 | genentech@druginfo.com |
| Jul 11, 2023 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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