Trial Outcomes & Findings for PERSEUS: Preliminary Efficacy and Safety of Cenicriviroc in Adult Participants With Primary Sclerosing Cholangitis (NCT NCT02653625)
NCT ID: NCT02653625
Last Updated: 2018-10-01
Results Overview
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.
COMPLETED
PHASE2
24 participants
Baseline (Day 1) to Week 24
2018-10-01
Participant Flow
Participant milestones
| Measure |
Cenicriviroc 150 mg
Cenicriviroc 150 mg was administered orally once daily with food in the morning for 24 weeks.
|
|---|---|
|
Overall Study
STARTED
|
24
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Cenicriviroc 150 mg
Cenicriviroc 150 mg was administered orally once daily with food in the morning for 24 weeks.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Non-compliance with Study Drug
|
1
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Suspected Drug Induced Liver Injury
|
1
|
Baseline Characteristics
PERSEUS: Preliminary Efficacy and Safety of Cenicriviroc in Adult Participants With Primary Sclerosing Cholangitis
Baseline characteristics by cohort
| Measure |
Cenicriviroc 150 mg
n=24 Participants
Cenicriviroc 150 mg was administered orally once daily with food in the morning for 24 weeks.
|
|---|---|
|
Age, Continuous
|
43.3 years
STANDARD_DEVIATION 12.93 • n=99 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
White
|
21 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic
|
22 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) to Week 24Population: ITT Population: All enrolled participants who received at least 1 dose of study treatment. Participants who did not return for any post-baseline visits were not included in the efficacy measurements. Number of participants analyzed are the participants with available data at the given time-point.
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.
Outcome measures
| Measure |
Cenicriviroc 150 mg
n=20 Participants
Cenicriviroc 150 mg was administered orally once daily with food in the morning for 24 weeks.
|
|---|---|
|
Percentage Change From Baseline Through Week 24 in Serum Alkaline Phosphatase (ALP)
|
-4.5 percentage change in ALP
Standard Deviation 34.84
|
SECONDARY outcome
Timeframe: Week 24Population: ITT Population: All enrolled participants who received at least 1 dose of study treatment. Participants who did not return for any post-baseline visits were not included in the efficacy measurements. Number of participants analyzed are the participants with available data at the given time-point.
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.
Outcome measures
| Measure |
Cenicriviroc 150 mg
n=20 Participants
Cenicriviroc 150 mg was administered orally once daily with food in the morning for 24 weeks.
|
|---|---|
|
Percentage of Participants Who Normalized ALP at Week 24
|
0.0 percentage of participants
Interval 0.83 to 1.0
|
SECONDARY outcome
Timeframe: Week 24Population: ITT Population: All enrolled participants who received at least 1 dose of study treatment. Participants who did not return for any post-baseline visits were not included in the efficacy measurements. Number of participants analyzed are the participants with available data at the given time-point.
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.
Outcome measures
| Measure |
Cenicriviroc 150 mg
n=20 Participants
Cenicriviroc 150 mg was administered orally once daily with food in the morning for 24 weeks.
|
|---|---|
|
Percentage of Participants Who Achieved Serum ALP of Less Than 1.5 Times Upper Limit of Normal (ULN) in Serum ALP at Week 24
|
10 percentage of participants
Interval 0.68 to 0.98
|
SECONDARY outcome
Timeframe: Week 24Population: ITT Population: All enrolled participants who received at least 1 dose of study treatment. Participants who did not return for any post-baseline visits were not included in the efficacy measurements. Number of participants analyzed are the participants with available data at the given time-point.
ALP was used as a primary surrogate marker for measuring Primary Sclerosing Cholangitis disease.
Outcome measures
| Measure |
Cenicriviroc 150 mg
n=20 Participants
Cenicriviroc 150 mg was administered orally once daily with food in the morning for 24 weeks.
|
|---|---|
|
Percentage of Participants Who Achieved a 50% Decrease in ALP at Week 24
|
0.0 percentage of participants
Interval 0.83 to 1.0
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Week 24Population: Safety Analysis Set: All enrolled participants who received at least 1 dose of study treatment.
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.
Outcome measures
| Measure |
Cenicriviroc 150 mg
n=24 Participants
Cenicriviroc 150 mg was administered orally once daily with food in the morning for 24 weeks.
|
|---|---|
|
Percentage of Participants With a Treatment-emergent Adverse Event (TEAE)
|
83.3 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Week 24Population: Safety Analysis Set: All enrolled participants who received at least 1 dose of study treatment.
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.
Outcome measures
| Measure |
Cenicriviroc 150 mg
n=24 Participants
Cenicriviroc 150 mg was administered orally once daily with food in the morning for 24 weeks.
|
|---|---|
|
Percentage of Participants Who Discontinued Due to a TEAE
|
8.3 percentage of participants
|
Adverse Events
Cenicriviroc 150 mg
Serious adverse events
| Measure |
Cenicriviroc 150 mg
n=24 participants at risk
Cenicriviroc 150 mg was administered orally once daily with food in the morning for 24 weeks.
|
|---|---|
|
Hepatobiliary disorders
Gallbladder polyp
|
4.2%
1/24 • From Baseline (Day 1) to Week 24
Safety Analysis Set: All enrolled participants who received at least 1 dose of study treatment.
|
Other adverse events
| Measure |
Cenicriviroc 150 mg
n=24 participants at risk
Cenicriviroc 150 mg was administered orally once daily with food in the morning for 24 weeks.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Rash
|
16.7%
4/24 • From Baseline (Day 1) to Week 24
Safety Analysis Set: All enrolled participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.3%
2/24 • From Baseline (Day 1) to Week 24
Safety Analysis Set: All enrolled participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
8.3%
2/24 • From Baseline (Day 1) to Week 24
Safety Analysis Set: All enrolled participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
3/24 • From Baseline (Day 1) to Week 24
Safety Analysis Set: All enrolled participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
8.3%
2/24 • From Baseline (Day 1) to Week 24
Safety Analysis Set: All enrolled participants who received at least 1 dose of study treatment.
|
|
General disorders
Fatigue
|
16.7%
4/24 • From Baseline (Day 1) to Week 24
Safety Analysis Set: All enrolled participants who received at least 1 dose of study treatment.
|
|
General disorders
Pyrexia
|
8.3%
2/24 • From Baseline (Day 1) to Week 24
Safety Analysis Set: All enrolled participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Dizziness
|
16.7%
4/24 • From Baseline (Day 1) to Week 24
Safety Analysis Set: All enrolled participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Headache
|
12.5%
3/24 • From Baseline (Day 1) to Week 24
Safety Analysis Set: All enrolled participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Lower respiratory tract infection
|
8.3%
2/24 • From Baseline (Day 1) to Week 24
Safety Analysis Set: All enrolled participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
3/24 • From Baseline (Day 1) to Week 24
Safety Analysis Set: All enrolled participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.3%
2/24 • From Baseline (Day 1) to Week 24
Safety Analysis Set: All enrolled participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
8.3%
2/24 • From Baseline (Day 1) to Week 24
Safety Analysis Set: All enrolled participants who received at least 1 dose of study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER