Primary Sclerosing Cholangitis Clinical Trial
Official title:
A Phase 2, Randomized, Double Blind, Placebo Controlled, Parallel Group, Multiple Center Study to Evaluate the Safety, Tolerability, and Efficacy of NGM282 Administered for 12 Weeks in Patients With Primary Sclerosing Cholangitis
| NCT number | NCT02704364 |
| Other study ID # | 15-0106 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 2 |
| First received | |
| Last updated | |
| Start date | March 2016 |
| Est. completion date | June 2017 |
| Verified date | July 2018 |
| Source | NGM Biopharmaceuticals, Inc |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to determine the safety, tolerability, and activity of NGM282 in patients with Primary Sclerosing Cholangitis.
| Status | Completed |
| Enrollment | 62 |
| Est. completion date | June 2017 |
| Est. primary completion date | June 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility |
Inclusion Criteria: - Confirmed diagnosis of PSC Exclusion Criteria: - Clinically significant acute or chronic liver disease of an etiology other than PSC - Secondary or IgG4 related sclerosing cholangitis |
| Country | Name | City | State |
|---|---|---|---|
| France | NGM Clinical Study Site 301 | Paris | |
| Netherlands | NGM Clinical Study Site 402 | Amsterdam | |
| Netherlands | NGM Clinical Study Site 407 | Amsterdam | |
| Netherlands | NGM Clinical Study Site 406 | Leiden | |
| Netherlands | NGM Clinical Study Site 401 | Nijmegen | |
| Netherlands | NGM Clinical Study Site 404 | Rotterdam | |
| Netherlands | NGM Clinical Study Site 405 | Utrecht | |
| United Kingdom | NGM Clinical Study Site 505 | Birmingham | |
| United Kingdom | NGM Clinical Study Site 504 | Liverpool | |
| United Kingdom | NGM Clinical Study Site 502 | London | |
| United Kingdom | NGM Clinical Study Site 501 | Newcastle | |
| United Kingdom | NGM Clinical Study Site 503 | Norwich | |
| United States | NGM Clinical Study Site 106 | Aurora | Colorado |
| United States | NGM Clinical Study Site 111 | Charlottesville | Virginia |
| United States | NGM Clinical Study Site 120 | Cincinnati | Ohio |
| United States | NGM Clinical Study Site 113 | Dallas | Texas |
| United States | NGM Clinical Study Site 117 | Dallas | Texas |
| United States | NGM Clinical Study Site 104 | Detroit | Michigan |
| United States | NGM Clinical Study Site 116 | Durham | North Carolina |
| United States | NGM Clinical Study Site 110 | Gainesville | Florida |
| United States | NGM Clinical Study Site 119 | Houston | Texas |
| United States | NGM Clinical Study Site 109 | Indianapolis | Indiana |
| United States | NGM Clinical Study Site 102 | Kansas City | Missouri |
| United States | NGM Clinical Study Site 124 | Lakewood Ranch | Florida |
| United States | NGM Clinical Study Site 105 | Miami | Florida |
| United States | NGM Clinical Study Site 114 | Nashville | Tennessee |
| United States | NGM Clinical Study Site 103 | New York | New York |
| United States | NGM Clinical Study Site 122 | Newport News | Virginia |
| United States | NGM Clinical Study Site 101 | Norfolk | Virginia |
| United States | NGM Clinical Study Site 121 | Richmond | Virginia |
| United States | NGM Clinical Study Site 118 | Sacramento | California |
| United States | NGM Clinical Study Site 107 | Saint Louis | Missouri |
| United States | NGM Clinical Study Site 112 | San Clemente | California |
| United States | NGM Clinical Study Site 127 | San Francisco | California |
| United States | NGM Clinical Study Site 108 | Seattle | Washington |
| United States | NGM Clinical Study Site 126 | Seattle | Washington |
| United States | NGM Clinical Study Site 125 | Southlake | Texas |
| United States | NGM Clinical Study Site 115 | Washington | District of Columbia |
| Lead Sponsor | Collaborator |
|---|---|
| NGM Biopharmaceuticals, Inc |
United States, France, Netherlands, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The mean and percent change in ALP from Baseline to Week 12 | 12 weeks | ||
| Secondary | The mean and percent change in ALT from Baseline to Week 12 | 12 weeks |
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