Ulcerative ColitisPhase 2NCT01461317
Study to Evaluate the Long-term Safety of Etrolizumab in Participants With Moderate to Severe Ulcerative Colitis
A Phase 2 study testing Etrolizumab in people with Ulcerative Colitis, run by Genentech, Inc. at 40 sites in 11 countries.
Trial summary
This study is an open-label extension (OLE) trial to evaluate the safety and tolerability of etrolizumab in participants with moderate to severe ulcerative colitis (UC) who were enrolled in the Phase II Study ABS4986g (NCT01336465) and meet the eligibility criteria for entry in the OLE study. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Etrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 40 sitesin 11 countries
- Study dates
- 29 Nov 2011to 7 Aug 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All participants (placebo or active) who were previously enrolled in the Phase II study (ABS4986g) and fulfill any of the following criteria:
- Participants who have not obtained a clinical response in the Phase II study (ABS4986g) by Week 10 (the end of the Phase II treatment phase) may enter this OLE trial at any time after Week 10 and up to and including Week 28
- Participants who have a clinical response in the Phase II study (ABS4986g) at Week 10 but have had a flare of UC between Week 10 and Week 28
- Males and females with reproductive potential must be willing to use a highly effective method of contraception, vaginal ring, intrauterine device, physical barrier, or vasectomized partner) from study start to a minimum of 4 months (approximately 5 half-lives)
- Concomitant immunosuppressive therapy must be tapered within 6 weeks after enrollment in this OLE study
- Participants must have tapered completely off oral corticosteroids within 24 weeks of enrollment to this OLE study
Who cannot join
- Participants who did not complete through Week 10 of the Phase II study (ABS4986g)
- Pregnancy or lactation
- Any new malignancy within the past 6 months
- Any new (since enrolling in the Phase II study [ABS4986g]), significant, uncontrolled, co- morbidity, such as neurological, cardiac, pulmonary, renal, hepatic, endocrine, or gastrointestinal (GI) disorders
- Any new clinically significant signs or symptoms of infection as judged by the investigator
- Any abnormal laboratory values recorded at the last visit completed in the Phase II study (ABS4986g)
Trial locations and contacts
40 sites in 11 countries.
40 sites in 11 countries
United States5 sites
Atlanta Gastroenterology Associates
Atlanta, Georgia, 30342
Consultants for Clin. Rsrch
Cincinnati, Ohio, 45219
Long Island Clin Rsch Asc, LLP
Great Neck, New York, 11021
University of California, San Diego
La Jolla, California, 92037
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
Germany5 sites
CAMPUS VIRCHOW-KLINIKUM; Charité Centrum 13; Med. Klinik Abt. Hepatologie u. Gastroenterologie
Berlin, 13353
Med. Hochschule Hannover; Gastroenterologie
Hanover, 30625
Universitatsklinikum Schleswig Holstein; Klinik fur Allgemeine Innere Medizin
Kiel, 24105
Facharzt für Gastroenterologie
Minden, 32423
Univ klinikum Ulm; Medizin Zentrum Innere Medizin I
Ulm, 89081
Israel5 sites
Rambam Medical Center
Haifa, 3109601
Shaare Zedek Medical Center
Jerusalem, 9103102
Shaare Zedek Medical Ctr; Dept. of Gastroenterology
Jerusalem, 9103102
The Chaim Sheba Medical Center; Multiple Sclerosis Center
Ramat Gan, 5262100
Tel Aviv Sourasky Medical Ctr; Gastroenterology Department
Tel Aviv, 6423900
Australia4 sites
St Vincent's Hospital Melbourne; Department of Gastroenterology
Fitzroy, Victoria, 3065
The Canberra Hospital
Garran, Australian Capital Territory, 2065
Alfred Hospital
Melbourne, Victoria, 3004
Royal Melbourne Hospital; Gastroenterology
Parkville, Victoria, 3050
Canada4 sites
London Health Sciences Centre; Victoria Hospital
London, Ontario, N6A 4G5
London Health Sciences Centre
London, Ontario, N6A 4L6
GI Research Institute
Vancouver, British Columbia, V6Z 2K5
Toronto Digest. Disease Asso.
Woodbridge, Ontario, L4L 4Y7
Czechia4 sites
Poliklinika Iii, Hk; Hepatogatroenterolgy
Hradec Králové, 500 12
Oblastni nemocnice Nachod a.s.; Endoskopicke centrum
Náchod, 547 69
Fakultni nemocnice Ostrava
Ostrava - Poruba, 708 52
Krajska nemocnice Tomase Bati
Zlín, 762 75
New Zealand4 sites
Middlemore Hospital
Auckland
University of Otago, Christchurch
Christchurch, 8011
Dunedin Hospital; Otago District Health Board
Dunedin, 9054
Shakespeare Specialist Group
Takapuna, 0620
Belgium3 sites
Imeldaziekenhuis
Bonheiden, 2820
UZ Gent
Ghent, 9000
UZ Leuven Gasthuisberg
Leuven, 3000
Hungary3 sites
ENDOMEDIX Kft; Gasztroenterológia Budapest
Budapest, 1073
Pannónia Klinika Magánorvosi
Budapest, 1136
Petz Aladar County Hosp; 1St Dept. of Internal Med.
Győr, 9024
United Kingdom2 sites
St. Mark's Hospital; Inflammatory Bowel Disease Unit
Harrow, HA1 3UJ
Royal Victoria Infirmary
Newcastle upon Tyne, NE1 4LP
About this study
Official title: A Phase II Open-Label Extension Study to Evaluate the Long-Term Safety of Etrolizumab in Patients With Moderate to Severe Ulcerative Colitis
This study is an open-label extension (OLE) trial to evaluate the safety and tolerability of etrolizumab in participants with moderate to severe ulcerative colitis (UC) who were enrolled in the Phase II Study ABS4986g (NCT01336465) and meet the eligibility criteria for entry in the OLE study.
- Conditions
- Ulcerative Colitis
- Being tested
- Etrolizumab
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtrolizumabDrug
Participants will receive etrolizumab at a dose of 100 mg.
| Study group | Role | What they receive |
|---|---|---|
| Etrolizumab | Experimental | Etrolizumab 100 milligrams (mg) subcutaneous (SC) administration every 4 weeks during the treatment period of up to 240 weeks. Receives: Drug: Etrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
Measured: Baseline up to approximately Week 246
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Etrolizumab
Measured: Baseline up to approximately Week 246 (assessed at predose (Hour 0) at baseline, Weeks 4, 8, 12, and every 12 weeks thereafter up to Week 252, 12 weeks after last dose [up to approximately Week 246])
Secondary outcomes (1)
Serum Concentrations of Etrolizumab
Measured: Predose (Hour 0) at baseline, Weeks 4, 8, 12, and every 12 weeks thereafter up to approximately Week 246; 12 weeks after last dose (up to approximately Week 246)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2011 (estimated)
- Study start29 Nov 2011
- Primary completion7 Aug 2016
- Study completion7 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01461317
- Sponsor's protocol ID
- GA27927
- Other IDs
- 2011-003409-36
- Status last verified
- Feb 2020
- First submitted
- 12 Oct 2011
- Last updated
- 10 Feb 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2020. 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 of Etrolizumab in Patients With Moderate to Severe Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT01461317
- Acronym / sponsor ID
- GA27927
- Conditions
- Ulcerative Colitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Nov 2011 (actual)
- Primary completion
- 7 Aug 2016 (actual)
- Study completion
- 7 Aug 2016 (actual)
- First posted
- 28 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is an open-label extension (OLE) trial to evaluate the safety and tolerability of etrolizumab in participants with moderate to severe ulcerative colitis (UC) who were enrolled in the Phase II Study ABS4986g (NCT01336465) and meet the eligibility criteria for entry in the OLE study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Etrolizumab | Experimental | Drug: EtrolizumabEtrolizumab 100 milligrams (mg) subcutaneous (SC) administration every 4 weeks during the treatment period of up to 240 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- All participants (placebo or active) who were previously enrolled in the Phase II study (ABS4986g) and fulfill any of the following criteria:
- Participants who have not obtained a clinical response in the Phase II study (ABS4986g) by Week 10 (the end of the Phase II treatment phase) may enter this OLE trial at any time after Week 10 and up to and including Week 28
- Participants who have a clinical response in the Phase II study (ABS4986g) at Week 10 but have had a flare of UC between Week 10 and Week 28
- Males and females with reproductive potential must be willing to use a highly effective method of contraception, vaginal ring, intrauterine device, physical barrier, or vasectomized partner) from study start to a minimum of 4 months (approximately 5 half-lives)
- Concomitant immunosuppressive therapy must be tapered within 6 weeks after enrollment in this OLE study
Key exclusion criteria (6 listed)
- Participants who did not complete through Week 10 of the Phase II study (ABS4986g)
- Pregnancy or lactation
- Any new malignancy within the past 6 months
- Any new (since enrolling in the Phase II study [ABS4986g]), significant, uncontrolled, co- morbidity, such as neurological, cardiac, pulmonary, renal, hepatic, endocrine, or gastrointestinal (GI) disorders
- Any new clinically significant signs or symptoms of infection as judged by the investigator
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 |
|---|---|---|
| EtrolizumabParticipants will receive etrolizumab at a dose of 100 mg. | Drug | Etrolizumab |
Primary outcome
Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
Time frame: Baseline up to approximately Week 246
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Etrolizumab
Time frame: Baseline up to approximately Week 246 (assessed at predose (Hour 0) at baseline, Weeks 4, 8, 12, and every 12 weeks thereafter up to Week 252, 12 weeks after last dose [up to approximately Week 246])
1 secondary outcome
Serum Concentrations of Etrolizumab
Time frame: Predose (Hour 0) at baseline, Weeks 4, 8, 12, and every 12 weeks thereafter up to approximately Week 246; 12 weeks after last dose (up to approximately Week 246)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2020.
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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
Genentech, Inc.
40 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Etrolizumab in people with Ulcerative Colitis, run by Genentech, Inc. at 40 sites in 11 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 6 inclusion and 6 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: finished, as of the sponsor's last update on 10 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in United States, Germany, Israel, Australia, Canada and 6 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) (time frame: Baseline up to approximately Week 246). The study lists 2 primary outcomes in all. 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 10 Feb 2020.