Primary Biliary CirrhosisPhase 2NCT02135536
Phase 2b Study of NGM282 Extended Treatment in Patients With Primary Biliary Cirrhosis
A Phase 2 study testing NGM282 in people with Primary Biliary Cirrhosis, run by NGM Biopharmaceuticals, Inc at 17 sites in 3 countries.
Trial summary
The purpose of this study is to determine the safety, tolerability, and activity of extended treatment with NGM282 in patients with Primary Biliary Cirrhosis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary Biliary Cirrhosis
- What is being tested?
- NGM282
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 17 sitesin 3 countries
- Study dates
- May 2014to Feb 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
- Completion of NGM 13-0103
- Males or females, between 18 and 75 years of age, inclusive
- PBC Diagnosis consistent with AASLD and EASL guidelines
- Stable dose of UDCA
Who cannot join
- Chronic liver disease of a non-PBC etiology
- Evidence of clinically significant hepatic decompensation
Trial locations and contacts
17 sites in 3 countries.
17 sites in 3 countries
Australia9 sites
NGM Clinical Study Site 607
Adelaide, South Australia
NGM Clinical Study Site 608
Adelaide, South Australia
NGM Clinical Study Site 614
Brisbane, Queensland
NGM Clinical Study Site 601
Melbourne, Victoria
NGM Clinical Study Site 613
Melbourne, Victoria
NGM Clinical Study Site 602
Sydney, New South Wales
NGM Clinical Study Site 606
Sydney, New South Wales
NGM Clinical Study Site 609
Sydney, New South Wales
NGM Clinical Study Site 611
Sydney, New South Wales
United States6 sites
NGM Clinical Study Site 108
Coronado, California
NGM Clinical Study Site 102
Dallas, Texas
NGM Clinical Study Site 101
Detroit, Michigan
NGM Clinical Study Site 105
Durham, North Carolina
NGM Clinical Study Site 103
Phoenix, Arizona
NGM Clinical Study Site 113
San Antonio, Texas
New Zealand2 sites
NGM Clinical Study Site 401
Auckland
NGM Clinical Study Site 402
Christchurch
About this study
Official title: A Phase 2, Multi-Center Study to Evaluate Three Doses of NGM282 Administered for 24 Weeks in Patients With Primary Biliary Cirrhosis (PBC) Who Have Completed Study 13-0103
The purpose of this study is to determine the safety, tolerability, and activity of extended treatment with NGM282 in patients with Primary Biliary Cirrhosis.
- Conditions
- Primary Biliary Cirrhosis
- Being tested
- NGM282
- Medical subject headings
- Liver Cirrhosis, Biliary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NGM282Biological
NGM282
| Study group | Role | What they receive |
|---|---|---|
| NGM282 Dose 1 | Experimental | NGM282 Dose 1 Receives: Biological: NGM282 |
| NGM282 Dose 2 | Experimental | NGM282 Dose 2 Receives: Biological: NGM282 |
| NGM282 Dose 3 | Experimental | NGM282 Dose 3 Receives: Biological: NGM282 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute change in plasma ALP from Baseline to Week 12
Measured: 12 weeks
Secondary outcomes (1)
Percentage change in bilirubin, ALT, AST, and GGT from Baseline to Week 12 and Week 24
Measured: 12 weeks and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2014 (estimated)
- Study startMay 2014
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Biliary CirrhosisStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- NGM Biopharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NGM Biopharmaceuticals Australia Pty Ltd
- Responsible party
- Sponsor
- Investigators
- Stephen J Rossi, PharmD, Study director, NGM Biopharmaceuticals, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02135536
- Sponsor's protocol ID
- 14-0104
- Status last verified
- Mar 2017
- First submitted
- 8 May 2014
- Last updated
- 28 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multi-Center Study to Evaluate Three Doses of NGM282 Administered for 24 Weeks in Patients With Primary Biliary Cirrhosis (PBC) Who Have Completed Study 13-0103
- ClinicalTrials.gov ID
- NCT02135536
- Acronym / sponsor ID
- 14-0104
- Conditions
- Primary Biliary Cirrhosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- NGM Biopharmaceuticals, IncIndustry (pharma, biotech, devices)
- Collaborators
- NGM Biopharmaceuticals Australia Pty Ltd
- Study start
- May 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 12 May 2014 (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.
The purpose of this study is to determine the safety, tolerability, and activity of extended treatment with NGM282 in patients with Primary Biliary Cirrhosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NGM282 Dose 1 | Experimental | Biological: NGM282NGM282 Dose 1 |
| NGM282 Dose 2 | Experimental | Biological: NGM282NGM282 Dose 2 |
| NGM282 Dose 3 | Experimental | Biological: NGM282NGM282 Dose 3 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Completion of NGM 13-0103
- Males or females, between 18 and 75 years of age, inclusive
- PBC Diagnosis consistent with AASLD and EASL guidelines
- Stable dose of UDCA
Key exclusion criteria (2 listed)
- Chronic liver disease of a non-PBC etiology
- Evidence of clinically significant hepatic decompensation
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 |
|---|---|---|
| NGM282NGM282 | Biological | NGM282 Dose 1, NGM282 Dose 2, NGM282 Dose 3 |
Primary outcome
Absolute change in plasma ALP from Baseline to Week 12
Time frame: 12 weeks
1 secondary outcome
Percentage change in bilirubin, ALT, AST, and GGT from Baseline to Week 12 and Week 24
Time frame: 12 weeks and 24 weeks
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 28 Mar 2017.
- Related InfoLink provided by the sponsor.
Related trials for Primary Biliary Cirrhosis
Active, not recruitingPhase 3
Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC)
Primary Biliary Cirrhosis
RecruitingPhase 3
Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis
Primary Biliary Cholangitis
RecruitingPhase 3
FIREFLY Trial: Fenofibrate Intervention---Randomized Evaluation in First-Line PBC Therapy
Primary Biliary Cholangitis (PBC)
RecruitingPhase 3
Fenofibrate for Patients With Primary Biliary Cirrhosis Who Had An Inadequate Response to Ursodeoxycholic Acid
Primary Biliary Cirrhosis
RecruitingPhase 2/3
Fenofibrate in Patients With Primary Biliary Cholangitis (PBC)
Primary Biliary Cholangitis
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.
Stephen J Rossi, PharmD study director
NGM Biopharmaceuticals, Inc
17 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NGM282 in people with Primary Biliary Cirrhosis, run by NGM Biopharmaceuticals, Inc at 17 sites in 3 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 4 inclusion and 2 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 28 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Australia, United States, New Zealand. 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?
Absolute change in plasma ALP from Baseline to Week 12 (time frame: 12 weeks). 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 28 Mar 2017.