Ulcerative ColitisPhase 2NCT03650413
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
A Phase 2 study testing UTTR1147A in people with Ulcerative Colitis and Crohn's Disease, run by Genentech, Inc. at 57 sites in 14 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ulcerative Colitis, Crohn's Disease
- What is being tested?
- UTTR1147A
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 57 sitesin 14 countries
- Study dates
- 14 Jan 2019to 12 Jul 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
57 sites in 14 countries.
57 sites in 14 countries
Poland16 sites
SPZOZ Uniwersytecki SK nr 1 im N. Barlickiego UM w Lodzi; Oddz. Klin. Gastroenter. Og. i Onk.
?ód?, 90-153
Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy; Centrum Endoskopii Zabiegowej
Bydgoszcz, 85-168
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Czestochowie
Cz?stochowa, 42-202
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdansku
Gda?sk, 80-382
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Katowicach
Katowice, 40-040
ETG Kielce
Kielce, 25-355
Gastromed SPK Niepubliczny Zaklad Opieki Zdrowotnej
Lublin, 20-582
Klimed Marek Klimkiewicz
Piotrkow Trybunalski, 97-300
Clinical Research Center Sp. z o.o. MEDIC-R Spó?ka Komandytowa
Późna, 61-731
Synexus - Poznan
Poznan, 60-702
Endoskopia Sp. z o.o.
Sopot, 81-756
Centrum Zdrowia MDM
Warsaw, 00-635
WIP Warsaw IBD Point Profesor Kierkus
Warsaw, 00-728
Przychodnia EuroMediCare
Wroc?aw, 50-220
Melita Medical
Wroc?aw, 50-449
Synexus - Wroclaw
Wroclaw, 50-088
Ukraine13 sites
Regional Municipal Institution Chernivtsi Regional Clinical Hospital
Chernivtsi, Chernihiv Governorate, 58005
Medical Center of LLC Medical Clinic Blagomed
Kyiv, KIEV Governorate, 01001
Medical Center of Limited Liability Company ?Harmoniya krasy?
Kyiv, KIEV Governorate, 01135
Medical Center of LLC Medical Center Dopomoga Plus
Kyiv, KIEV Governorate, 02000
Medical Center of Edelweiss Medics LLC
Kyiv, KIEV Governorate, 02002
Synexus Affiliate - MC of LLC Medbud-Clinic
Kyiv, KIEV Governorate, 03037
Med Center of International Institute of Clinical Trials LLC; Medical Center "OK!Clinic+"
Kyiv, KIEV Governorate, 2091
Ternopil University Hospital; Regional Center of Gastroenterology with Hepatology
Ternopil, Katerynoslav Governorate, 46002
Transcarpathian Regional Clinical Hospital n.a. A. Novak; Rheumatology Department
Uzhhorod, 88000
Clinic of SRI of Invalid Rehab. (ESTC) of VNMU n.a. M.I.Pyrohov
Vinnytsia, Podolia Governorate, 21029
Municipal Institution Zaporizhzhia Regional Clinical Hospital of Zaporizhzhia Regional Council
Zaporizhzhya, Kharkiv Governorate, 69600
Medical Center of Diaservice LLC; Division of clinical trials conduct, Department #3
Zaporizhzhya, 69035
Medical Centre of PE First Private Clinic
Zhytomyr, Crimean Regional Governmenta, 10008
Serbia6 sites
KBC Dr Dragisa Misovic Dedinje
Belgrade, 11000
University Hospital Medical Center Bezanijska kosa
Belgrade, 11080
Clinical Center Kragujevac; Clinic Of Psychiatry
Kragujevac, 34000
General Hospital Vrsac
Vršac, 26300
Clinical Hospital Centre Zemun
Zemun, 11080
General Hospital Djordje Joanovic - Zrenjanin
Zrenjanin, 23000
Germany4 sites
Gastroenterologische Spezialpraxis-Berlin-Karlshorst
Berlin, 10318
Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden
Dresden, 01307
Universitatsklinikum Schleswig Holstein; Klinik fur Allgemeine Innere Medizin
Kiel, 24105
St. Marien Krankenhaus; Med. Klinik
Ludwigshafen, 67067
Italy4 sites
ASST di Monza - Azienda Ospedaliera San Gerardo; U.O. Farmacia -Settore A - Corpo Posteriore
Monza, Lombardy, 20900
Azienda Ospedaliera Di Padova
Padova, Veneto, 35128
Complesso Integrato Columbus
Rome, Lazio, 00168
Istituto Clinico Humanitas
Rozzano (MI), Lombardy, 20089
Russia4 sites
Irkutsk Research Centre Hospital of Siberian department of Russian Academy of Science
Irkutsk, 664033
North-West State Medical University n.a. I.I. Mechnikov
Saint Petersburg, Sankt-Peterburg, 191015
Saint Martyr Elizabeth City Hospital
Saint Petersburg, Sankt-Peterburg, 195257
Medical University Reaviz
Samara, 443011
Bulgaria2 sites
MHAT Saint Karidad EAD
Plovdiv, 4000
Multiprofile Hospital for Active Treatment Hadji Dimitar OOD
Sliven, 8800
Greece2 sites
Iatriko Palaiou Falirou; Gastrointestinal Department
Palaió Fáliro, 175 62
EUROMEDICA General Clinic of Thessaloniki; Gastroenterology Department
Thessaloniki, 54645
United States1 site
Carolina Digestive Diseases
Greenville, North Carolina, 27834
About this study
Official title: A Phase II Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of UTTR1147A in Patients With Moderate to Severe Ulcerative Colitis or Crohn's Disease
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
- Being tested
- UTTR1147A
- Medical subject headings
- Colitis, Ulcerative, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UTTR1147ADrug
Also called Efmarodocokin alfa, RO7021610, RG7880, IL-22Fc
UTTR1147A will be administered based on disease status, as described in the protocol.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: UTTR1147A |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2018
- Study start14 Jan 2019
- Primary completion12 Jul 2022
- Study completion12 Jul 2022
Why it stopped: 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03650413
- Sponsor's protocol ID
- GA40209
- Other IDs
- 2017-004997-32, 2017
- Status last verified
- Sep 2023
- First submitted
- 16 Aug 2018
- Last updated
- 29 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of UTTR1147A in Patients With Moderate to Severe Ulcerative Colitis or Crohn's Disease
- ClinicalTrials.gov ID
- NCT03650413
- Acronym / sponsor ID
- GA40209
- Conditions
- Ulcerative Colitis, Crohn's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 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.
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Jan 2019 (actual)
- Primary completion
- 12 Jul 2022 (actual)
- Study completion
- 12 Jul 2022 (actual)
- First posted
- 28 Aug 2018 (actual)
- Results
- Posted 29 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UTTR1147A | Experimental | Drug: UTTR1147AAll 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UTTR1147AAlso: Efmarodocokin alfa, RO7021610, RG7880, IL-22FcUTTR1147A will be administered based on disease status, as described in the protocol. | Drug | UTTR1147A |
Primary outcome
Number of Participants With Adverse Events
Time frame: Up to 2 years
Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 Scale (NCI CTCAE v4.0)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
57 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing UTTR1147A in people with Ulcerative Colitis and Crohn's Disease, run by Genentech, Inc. at 57 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 57 sites in Poland, Ukraine, Serbia, Germany, Italy and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2023.