Adults 18 to 75, any sex, with Primary Sclerosing Cholangitis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage Change From Baseline Through Week 24 in Serum Alkaline Phosphatase (ALP)Primary· Baseline (Day 1) to Week 24
ALP was used as a primary surrogate marker for measuring Primary Sclerosing Cholangitis disease. The percent change from Baseline was defined as 100\*(value at each visit - Baseline value)/Baseline value. The Baseline value was defined as the last non-missing value on or before the Baseline visit (Day 1). A negative percentage change from baseline indicates an improvement.
Group
Value
95% CI
Cenicriviroc 150 mg
-4.5
± 34.84
Percentage of Participants Who Normalized ALP at Week 24Secondary· Week 24
ALP was used as a primary surrogate marker for measuring Primary Sclerosing Cholangitis disease. Normalization was defined as ALP values outside of the central laboratory reference range at baseline, but within the central laboratory reference range at Week 24.
Group
Value
95% CI
Cenicriviroc 150 mg
0.0
0.83 – 1.00
Percentage of Participants Who Achieved Serum ALP of Less Than 1.5 Times Upper Limit of Normal (ULN) in Serum ALP at Week 24Secondary· Week 24
ALP was used as a primary surrogate marker for measuring Primary Sclerosing Cholangitis disease. The upper limit of normal ALP was defined according to the central laboratory reference ranges.
Group
Value
95% CI
Cenicriviroc 150 mg
10
0.68 – 0.98
Percentage of Participants Who Achieved a 50% Decrease in ALP at Week 24Secondary· Week 24
ALP was used as a primary surrogate marker for measuring Primary Sclerosing Cholangitis disease.
Group
Value
95% CI
Cenicriviroc 150 mg
0.0
0.83 – 1.00
Percentage of Participants With a Treatment-emergent Adverse Event (TEAE)Secondary· Baseline (Day 1) to Week 24
An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, regardless of whether related to the medicinal (investigational) product. A TEAE was defined as an AE with an onset that occurred after receiving treatment.
Group
Value
95% CI
Cenicriviroc 150 mg
83.3
Percentage of Participants Who Discontinued Due to a TEAESecondary· Baseline (Day 1) to Week 24
An adverse event was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, regardless of whether related to the medicinal (investigational) product. A TEAE was defined as an AE with an onset that occurred after receiving treatment.
Group
Value
95% CI
Cenicriviroc 150 mg
8.3
Adverse events — posted to ClinicalTrials.gov
Time frame: From Baseline (Day 1) to Week 24.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This is an open label, proof of concept (PoC) study of Cenicriviroc (CVC) in adult participants with Primary Sclerosing Cholangitis (PSC). The main objective of this PoC study is to assess changes in alkaline phosphatase (ALP) both individually and as a group, over 24 weeks of treatment with CVC.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT02330549 — ORION: Effects of Cenicriviroc on Insulin Sensitivity in Subjects With Prediabetes or Type 2 Diabetes Mellitus (T2DM) an
· Phase 2
· completed
Other recruiting trials for Primary Sclerosing Cholangitis
Currently open trials in the same condition.
NCT07229911 — A Study of TAK-781 in Healthy Volunteers and in Participants With Non-Cirrhotic Primary Sclerosing Cholangitis (PSC)
· Phase 1
· recruiting
NCT06905054 — Pharmacologic Approaches to Preventing Primary Sclerosing Cholangitis Recurrence After Liver Transplantation
· Phase 2
· recruiting
NCT06455280 — A Study of SIPLIZUMAB in AILD and LT Patients
· Phase 1
· recruiting
NCT06519162 — Liver-gut Axis Study Through Identification of Liver Disease-specific Microbiome
· recruiting
NCT06351696 — The Effects of Bromelain Supplement in Patients With Ulcerative Colitis
· NA
· recruiting
Other Tobira Therapeutics, Inc. trials
Trials by the same sponsor.
NCT03028740 — AURORA: A Study for the Efficacy and Safety of Cenicriviroc (CVC) for the Treatment of Liver Fibrosis in Adults With Non
· Phase 3
· terminated
NCT03059446 — Rollover Study of Cenicriviroc for the Treatment of Liver Fibrosis in Participants With Nonalcoholic Steatohepatitis
· Phase 2
· terminated
NCT02684799 — Pharmacokinetic and Safety Study of Cenicriviroc and Acid Reducing Agents When Dosed Alone or in Combination
· Phase 1
· completed
NCT02685462 — Pharmacokinetic and Safety Study of Cenicriviroc and HMG-CoA Reductase Inhibitors, Caffeine and Digoxin
· Phase 1
· completed
NCT02330549 — ORION: Effects of Cenicriviroc on Insulin Sensitivity in Subjects With Prediabetes or Type 2 Diabetes Mellitus (T2DM) an
· Phase 2
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Tobira Therapeutics, Inc.
Last refreshed: 1 October 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02653625.