Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02026401




Registration number
NCT02026401
Ethics application status
Date submitted
30/12/2013
Date registered
3/01/2014
Date last updated
28/03/2017

Titles & IDs
Public title
Phase 2 Study of NGM282 in Patients With Primary Biliary Cirrhosis
Scientific title
A Phase 2, Randomized, Double Blind, Placebo Controlled, Parallel Group, Multiple Center Study to Evaluate the Safety, Tolerability, and Pharmacodynamic Activity of NGM282 in Combination With Ursodeoxycholic Acid (UDCA) Administered for 28 Days in Patients With Primary Biliary Cirrhosis
Secondary ID [1] 0 0
13-0103
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary Biliary Cirrhosis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - NGM282
Other interventions - Placebo

Experimental: NGM282 Dose 1 - NGM282 Dose 1

Experimental: NGM282 Dose 2 - NGM282 Dose 2

Placebo Comparator: Placebo - Placebo


Other interventions: NGM282


Other interventions: Placebo
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Absolute change in plasma ALP from Baseline to Day 28
Timepoint [1] 0 0
28 days
Secondary outcome [1] 0 0
Absolute change in bilirubin from Baseline to Day 28
Timepoint [1] 0 0
28 days

Eligibility
Key inclusion criteria
- Males or females, between 18 and 75 years of age, inclusive

- PBC diagnosis consistent with AASLD and EASL guidelines

- Stable dose of UDCA
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Chronic liver disease of a non-PBC etiology

- Evidence of clinically significant hepatic decompensation

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Factorial
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2014
Sample size
Target
Accrual to date
Final
45
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
NGM Clinical Study Site 602 - Sydney
Recruitment hospital [2] 0 0
NGM Clinical Study Site 606 - Sydney
Recruitment hospital [3] 0 0
NGM Clinical Study Site 609 - Sydney
Recruitment hospital [4] 0 0
NGM Clinical Study Site 611 - Sydney
Recruitment hospital [5] 0 0
NGM Clinical Study Site 614 - Brisbane
Recruitment hospital [6] 0 0
NGM Clinical Study Site 607 - Adelaide
Recruitment hospital [7] 0 0
NGM Clinical Study Site 608 - Adelaide
Recruitment hospital [8] 0 0
NGM Clinical Study Site 601 - Melbourne
Recruitment hospital [9] 0 0
NGM Clinical Study Site 604 - Melbourne
Recruitment hospital [10] 0 0
NGM Clinical Study Site 613 - Melbourne
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment postcode(s) [2] 0 0
- Brisbane
Recruitment postcode(s) [3] 0 0
- Adelaide
Recruitment postcode(s) [4] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Michigan
Country [4] 0 0
United States of America
State/province [4] 0 0
North Carolina
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas
Country [6] 0 0
United States of America
State/province [6] 0 0
Virginia

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
NGM Biopharmaceuticals, Inc
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
NGM Biopharmaceuticals Australia Pty Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine the safety, tolerability, and activity of NGM282 in
patients with Primary Biliary Cirrhosis.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02026401
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Stephen J Rossi, PharmD
Address 0 0
NGM Biopharmaceuticals, Inc
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02026401