Trial Outcomes & Findings for A Study of PRCL-02 in Moderate to Severe Chronic Plaque Psoriasis (NCT NCT03614078)
NCT ID: NCT03614078
Last Updated: 2020-03-30
Results Overview
Following 12 weeks of treatment. The Psoriasis Area and Severity Index (PASI) scores the severity of disease on a scale from 0 to 72 (where a score of 72 indicates extreme disease severity). PASI 75 indicates 75% improvement from baseline to Week 12 in the Psoriasis Area and Severity Index
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
92 participants
Primary outcome timeframe
Baseline to week 12
Results posted on
2020-03-30
Participant Flow
Participant milestones
| Measure |
PRCL-02 25 Milligrams (mg)
Loading dose of 150 mg followed by a once daily maintenance dose commencing on Day 2 and continuing for 12 weeks
PRCL-02: Oral tablets
|
PRCL-02 50 mg
Loading dose of 300 mg followed by a once daily maintenance dose commencing on Day 2 and continuing for 12 weeks
PRCL-02: Oral tablets
|
Placebo
Loading dose followed by a once daily maintenance dose at matching treatment levels, commencing on Day 2 and continuing for 12 weeks
Placebo: Oral tablets
|
|---|---|---|---|
|
Overall Study
STARTED
|
31
|
30
|
31
|
|
Overall Study
COMPLETED
|
28
|
23
|
26
|
|
Overall Study
NOT COMPLETED
|
3
|
7
|
5
|
Reasons for withdrawal
| Measure |
PRCL-02 25 Milligrams (mg)
Loading dose of 150 mg followed by a once daily maintenance dose commencing on Day 2 and continuing for 12 weeks
PRCL-02: Oral tablets
|
PRCL-02 50 mg
Loading dose of 300 mg followed by a once daily maintenance dose commencing on Day 2 and continuing for 12 weeks
PRCL-02: Oral tablets
|
Placebo
Loading dose followed by a once daily maintenance dose at matching treatment levels, commencing on Day 2 and continuing for 12 weeks
Placebo: Oral tablets
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
3
|
|
Overall Study
Participant Did Not Return for Visit
|
0
|
1
|
0
|
|
Overall Study
High Neutrophils
|
0
|
0
|
2
|
|
Overall Study
Patient Did Not Meet Eligibility
|
1
|
0
|
0
|
|
Overall Study
Exacerbation of Psoriasis
|
0
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
2
|
0
|
|
Overall Study
Dizziness and Rash
|
0
|
1
|
0
|
Baseline Characteristics
A Study of PRCL-02 in Moderate to Severe Chronic Plaque Psoriasis
Baseline characteristics by cohort
| Measure |
PRCL-02 25 Milligrams (mg)
n=31 Participants
Loading dose of 150 mg followed by a once daily maintenance dose commencing on Day 2 and continuing for 12 weeks
PRCL-02: Oral tablets
|
PRCL-02 50 mg
n=30 Participants
Loading dose of 300 mg followed by a once daily maintenance dose commencing on Day 2 and continuing for 12 weeks
PRCL-02: Oral tablets
|
Placebo
n=31 Participants
Loading dose followed by a once daily maintenance dose at matching treatment levels, commencing on Day 2 and continuing for 12 weeks
Placebo: Oral tablets
|
Total
n=92 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
88 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
92 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
87 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
9 participants
n=5 Participants
|
7 participants
n=7 Participants
|
6 participants
n=5 Participants
|
22 participants
n=4 Participants
|
|
Region of Enrollment
Ukraine
|
9 participants
n=5 Participants
|
10 participants
n=7 Participants
|
15 participants
n=5 Participants
|
34 participants
n=4 Participants
|
|
Region of Enrollment
Slovakia
|
13 participants
n=5 Participants
|
13 participants
n=7 Participants
|
10 participants
n=5 Participants
|
36 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to week 12Population: Intent to treat population
Following 12 weeks of treatment. The Psoriasis Area and Severity Index (PASI) scores the severity of disease on a scale from 0 to 72 (where a score of 72 indicates extreme disease severity). PASI 75 indicates 75% improvement from baseline to Week 12 in the Psoriasis Area and Severity Index
Outcome measures
| Measure |
PRCL-02 25 Milligrams (mg)
n=30 Participants
Loading dose of 150 mg followed by a once daily maintenance dose commencing on Day 2 and continuing for 12 weeks
PRCL-02: Oral tablets
|
PRCL-02 50 mg
n=29 Participants
Loading dose of 300 mg followed by a once daily maintenance dose commencing on Day 2 and continuing for 12 weeks
PRCL-02: Oral tablets
|
Placebo
n=31 Participants
Loading dose followed by a once daily maintenance dose at matching treatment levels, commencing on Day 2 and continuing for 12 weeks
Placebo: Oral tablets
|
|---|---|---|---|
|
Percentage of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement
|
4 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline up to week 18Population: Safety population
Following 12 weeks of treatment
Outcome measures
| Measure |
PRCL-02 25 Milligrams (mg)
n=31 Participants
Loading dose of 150 mg followed by a once daily maintenance dose commencing on Day 2 and continuing for 12 weeks
PRCL-02: Oral tablets
|
PRCL-02 50 mg
n=30 Participants
Loading dose of 300 mg followed by a once daily maintenance dose commencing on Day 2 and continuing for 12 weeks
PRCL-02: Oral tablets
|
Placebo
n=31 Participants
Loading dose followed by a once daily maintenance dose at matching treatment levels, commencing on Day 2 and continuing for 12 weeks
Placebo: Oral tablets
|
|---|---|---|---|
|
Number of Participants With Any Treatment Emergent Adverse Event
|
14 Participants
|
12 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Predose and 1, 2, 4, 8, 336, 672, 1008, 1344 hours post dose, on Day 84Population: Pharmacokinetic (PK) evaluable
Steady state after 12 weeks of treatment
Outcome measures
| Measure |
PRCL-02 25 Milligrams (mg)
n=24 Participants
Loading dose of 150 mg followed by a once daily maintenance dose commencing on Day 2 and continuing for 12 weeks
PRCL-02: Oral tablets
|
PRCL-02 50 mg
n=20 Participants
Loading dose of 300 mg followed by a once daily maintenance dose commencing on Day 2 and continuing for 12 weeks
PRCL-02: Oral tablets
|
Placebo
Loading dose followed by a once daily maintenance dose at matching treatment levels, commencing on Day 2 and continuing for 12 weeks
Placebo: Oral tablets
|
|---|---|---|---|
|
Area Under the Concentration Time Curve (AUC0-τ)
|
165000 h*mg/mL
Geometric Coefficient of Variation 627
|
439000 h*mg/mL
Geometric Coefficient of Variation 492
|
—
|
SECONDARY outcome
Timeframe: Predose and 1, 2, 4, 8, 336, 672, 1008, 1344 hours post dose, on Day 84Population: Pharmacokinetic (PK) evaluable
Steady state after 12 weeks of treatment
Outcome measures
| Measure |
PRCL-02 25 Milligrams (mg)
n=24 Participants
Loading dose of 150 mg followed by a once daily maintenance dose commencing on Day 2 and continuing for 12 weeks
PRCL-02: Oral tablets
|
PRCL-02 50 mg
n=20 Participants
Loading dose of 300 mg followed by a once daily maintenance dose commencing on Day 2 and continuing for 12 weeks
PRCL-02: Oral tablets
|
Placebo
Loading dose followed by a once daily maintenance dose at matching treatment levels, commencing on Day 2 and continuing for 12 weeks
Placebo: Oral tablets
|
|---|---|---|---|
|
Maximum Observed Drug Concentration (Cmax)
|
984 ng/mL
Geometric Coefficient of Variation 200
|
2220 ng/mL
Geometric Coefficient of Variation 139
|
—
|
SECONDARY outcome
Timeframe: Predose and 1, 2, 4, 8, 336, 672, 1008, 1344 hours post dose, on Day 84Population: Pharmacokinetic (PK) evaluable
Steady state after 12 weeks of treatment
Outcome measures
| Measure |
PRCL-02 25 Milligrams (mg)
n=24 Participants
Loading dose of 150 mg followed by a once daily maintenance dose commencing on Day 2 and continuing for 12 weeks
PRCL-02: Oral tablets
|
PRCL-02 50 mg
n=20 Participants
Loading dose of 300 mg followed by a once daily maintenance dose commencing on Day 2 and continuing for 12 weeks
PRCL-02: Oral tablets
|
Placebo
Loading dose followed by a once daily maintenance dose at matching treatment levels, commencing on Day 2 and continuing for 12 weeks
Placebo: Oral tablets
|
|---|---|---|---|
|
Time to Reach Maximum Observed Drug Concentration (Tmax)
|
2.0 hours
Interval 0.0 to 8.12
|
4.00 hours
Interval 0.0 to 358.0
|
—
|
Adverse Events
PRCL-02 25 Milligrams (mg)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
PRCL-02 50 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PRCL-02 25 Milligrams (mg)
n=31 participants at risk
Loading dose of 150 mg followed by a once daily maintenance dose commencing on Day 2 and continuing for 12 weeks
PRCL-02: Oral tablets
|
PRCL-02 50 mg
n=30 participants at risk
Loading dose of 300 mg followed by a once daily maintenance dose commencing on Day 2 and continuing for 12 weeks
PRCL-02: Oral tablets
|
Placebo
n=31 participants at risk
Loading dose followed by a once daily maintenance dose at matching treatment levels, commencing on Day 2 and continuing for 12 weeks
Placebo: Oral tablets
|
|---|---|---|---|
|
Infections and infestations
Measles
|
3.2%
1/31 • 20 weeks
|
0.00%
0/30 • 20 weeks
|
0.00%
0/31 • 20 weeks
|
Other adverse events
| Measure |
PRCL-02 25 Milligrams (mg)
n=31 participants at risk
Loading dose of 150 mg followed by a once daily maintenance dose commencing on Day 2 and continuing for 12 weeks
PRCL-02: Oral tablets
|
PRCL-02 50 mg
n=30 participants at risk
Loading dose of 300 mg followed by a once daily maintenance dose commencing on Day 2 and continuing for 12 weeks
PRCL-02: Oral tablets
|
Placebo
n=31 participants at risk
Loading dose followed by a once daily maintenance dose at matching treatment levels, commencing on Day 2 and continuing for 12 weeks
Placebo: Oral tablets
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
3.2%
1/31 • 20 weeks
|
6.7%
2/30 • 20 weeks
|
0.00%
0/31 • 20 weeks
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthritis
|
0.00%
0/31 • 20 weeks
|
0.00%
0/30 • 20 weeks
|
6.5%
2/31 • 20 weeks
|
|
Musculoskeletal and connective tissue disorders
Recurrent psoriatic arthritis
|
0.00%
0/31 • 20 weeks
|
0.00%
0/30 • 20 weeks
|
6.5%
2/31 • 20 weeks
|
|
Nervous system disorders
Dizziness
|
6.5%
2/31 • 20 weeks
|
6.7%
2/30 • 20 weeks
|
0.00%
0/31 • 20 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER