Trial Outcomes & Findings for A Study of Baricitinib (LY3009104) in Participants With Primary Biliary Cholangitis Who do Not Respond or Cannot Take UDCA (NCT NCT03742973)
NCT ID: NCT03742973
Last Updated: 2020-10-14
Results Overview
Change from baseline in Alkaline Phosphatase (ALP)
TERMINATED
PHASE2
2 participants
Baseline, Week 12
2020-10-14
Participant Flow
Zero participants reported in cohort A due to protection of personal identifiable information based on enrollment futility and cohort B is not reported due to early study termination based on enrollment futility.
Participant milestones
| Measure |
Baricitinib Cohort A
Participants received 2 milligram (mg) of Baricitinib tablet orally once a day for 12 weeks.
|
Placebo Cohort A
Participants received placebo orally once a day for 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Baricitinib (LY3009104) in Participants With Primary Biliary Cholangitis Who do Not Respond or Cannot Take UDCA
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: Baseline, Week 12Population: Zero participants reported in cohort A due to protection of personal identifiable information based on enrollment futility.
Change from baseline in Alkaline Phosphatase (ALP)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 12Population: Zero participants with evaluable data was reported in cohort A due to protection of personal identifiable information based on enrollment futility.
Percentage of participants with alkaline phosphatase (ALP) \<1.67 x Upper Limit of Normal (ULN) (and at least 15% decrease from baseline) and total bilirubin level less than ULN.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Zero participants reported in cohort A due to protection of personal identifiable information based on enrollment futility.
Change from baseline in itch NRS. The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participant's itching is indicated by circling the number that best describes the worst level of itching in the past 7 days.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Zero participants reported in cohort A due to protection of personal identifiable information based on enrollment futility.
Change from baseline in fatigue NRS. The Fatigue NRS is a single-item, patient-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no fatigue" and 10 representing "as bad as you can imagine." Overall severity of a participant's fatigue is indicated by selecting the number that describes the worst level of fatigue during the past 7 days.
Outcome measures
Outcome data not reported
Adverse Events
Baricitinib Cohort A
Placebo Cohort A
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60