Trial Outcomes & Findings for Safety and Efficacy Study of CF101 to Treat Psoriasis (NCT NCT00428974)
NCT ID: NCT00428974
Last Updated: 2023-02-08
Results Overview
PASI scale is sum of redness, thickness, and scale scores, ranging from 0 (no disease) to 72 (most severe possible score); lower scores, i..e., negative change from baseline, indicate improvement
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
76 participants
Primary outcome timeframe
12 weeks minus baseline
Results posted on
2023-02-08
Participant Flow
Participant milestones
| Measure |
CF101 1 mg Twice Daily (BID)
Oral tablets given every 12 hours for 12 weeks
|
CF101 2 mg BID
Oral tablets given every 12 hours for 12 weeks
|
CF101 4 mg BID
Oral tablets given every 12 hours for 12 weeks
|
Placebo
Oral tablets given every 12 hours for 12 weeks
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
25
|
17
|
15
|
19
|
|
Overall Study
COMPLETED
|
17
|
17
|
14
|
16
|
|
Overall Study
NOT COMPLETED
|
8
|
0
|
1
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy Study of CF101 to Treat Psoriasis
Baseline characteristics by cohort
| Measure |
CF101 1 mg Twice Daily (BID)
n=24 Participants
Oral tablets given every 12 hours for 12 weeks
|
CF101 2 mg BID
n=17 Participants
Oral tablets given every 12 hours for 12 weeks
|
CF101 4 mg BID
n=15 Participants
Oral tablets given every 12 hours for 12 weeks
|
Placebo
n=19 Participants
Oral tablets given every 12 hours for 12 weeks
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
17 Participants
n=483 Participants
|
66 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
9 Participants
n=36 Participants
|
|
Age, Continuous
|
51.5 years
STANDARD_DEVIATION 12.0 • n=93 Participants
|
48.4 years
STANDARD_DEVIATION 10.2 • n=4 Participants
|
45.3 years
STANDARD_DEVIATION 12.1 • n=27 Participants
|
51.2 years
STANDARD_DEVIATION 10.4 • n=483 Participants
|
49.5 years
STANDARD_DEVIATION 11.2 • n=36 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
17 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
14 Participants
n=483 Participants
|
58 Participants
n=36 Participants
|
|
Region of Enrollment
Israel
|
24 participants
n=93 Participants
|
17 participants
n=4 Participants
|
15 participants
n=27 Participants
|
19 participants
n=483 Participants
|
75 participants
n=36 Participants
|
PRIMARY outcome
Timeframe: 12 weeks minus baselinePASI scale is sum of redness, thickness, and scale scores, ranging from 0 (no disease) to 72 (most severe possible score); lower scores, i..e., negative change from baseline, indicate improvement
Outcome measures
| Measure |
CF101 1 mg Twice Daily (BID)
n=24 Participants
Oral tablets given every 12 hours for 12 weeks
|
CF101 2 mg BID
n=17 Participants
Oral tablets given every 12 hours for 12 weeks
|
CF101 4 mg BID
n=15 Participants
Oral tablets given every 12 hours for 12 weeks
|
Placebo
n=19 Participants
Oral tablets given every 12 hours for 12 weeks
|
|---|---|---|---|---|
|
Change From Baseline (CFB) in Psoriasis Area and Severity Index (PASI) Score
|
-0.67 Scores on a scale
Standard Deviation 8.9
|
-8.8 Scores on a scale
Standard Deviation 7.0
|
-4.1 Scores on a scale
Standard Deviation 7.8
|
-2.7 Scores on a scale
Standard Deviation 9.4
|
SECONDARY outcome
Timeframe: 12 weeksPGA is a scale from 0 (clear, no disease) to 5 (most severe score); patients who improve to 0 (clear) or 1 (minimal disease) are tabulated in this outcome
Outcome measures
| Measure |
CF101 1 mg Twice Daily (BID)
n=24 Participants
Oral tablets given every 12 hours for 12 weeks
|
CF101 2 mg BID
n=17 Participants
Oral tablets given every 12 hours for 12 weeks
|
CF101 4 mg BID
n=15 Participants
Oral tablets given every 12 hours for 12 weeks
|
Placebo
n=19 Participants
Oral tablets given every 12 hours for 12 weeks
|
|---|---|---|---|---|
|
The Number of Patients Who Achieve a Score of "Almost Clear" or "Clear" by Physician's Global Assessment (PGA)
|
0 Number of treated patients
|
4 Number of treated patients
|
1 Number of treated patients
|
2 Number of treated patients
|
Adverse Events
CF101 1 mg Twice Daily (BID)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
CF101 2 mg BID
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
CF101 4 mg BID
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CF101 1 mg Twice Daily (BID)
n=24 participants at risk
Oral tablets given every 12 hours for 12 weeks
|
CF101 2 mg BID
n=17 participants at risk
Oral tablets given every 12 hours for 12 weeks
|
CF101 4 mg BID
n=15 participants at risk
Oral tablets given every 12 hours for 12 weeks
|
Placebo
n=19 participants at risk
Oral tablets given every 12 hours for 12 weeks
|
|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/24 • 14 weeks
All adverse events were collected and verbatim terms were coded via MedDRA dictionary
|
0.00%
0/17 • 14 weeks
All adverse events were collected and verbatim terms were coded via MedDRA dictionary
|
0.00%
0/15 • 14 weeks
All adverse events were collected and verbatim terms were coded via MedDRA dictionary
|
5.3%
1/19 • Number of events 1 • 14 weeks
All adverse events were collected and verbatim terms were coded via MedDRA dictionary
|
Other adverse events
| Measure |
CF101 1 mg Twice Daily (BID)
n=24 participants at risk
Oral tablets given every 12 hours for 12 weeks
|
CF101 2 mg BID
n=17 participants at risk
Oral tablets given every 12 hours for 12 weeks
|
CF101 4 mg BID
n=15 participants at risk
Oral tablets given every 12 hours for 12 weeks
|
Placebo
n=19 participants at risk
Oral tablets given every 12 hours for 12 weeks
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
8.3%
2/24 • Number of events 2 • 14 weeks
All adverse events were collected and verbatim terms were coded via MedDRA dictionary
|
0.00%
0/17 • 14 weeks
All adverse events were collected and verbatim terms were coded via MedDRA dictionary
|
0.00%
0/15 • 14 weeks
All adverse events were collected and verbatim terms were coded via MedDRA dictionary
|
0.00%
0/19 • 14 weeks
All adverse events were collected and verbatim terms were coded via MedDRA dictionary
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/24 • 14 weeks
All adverse events were collected and verbatim terms were coded via MedDRA dictionary
|
0.00%
0/17 • 14 weeks
All adverse events were collected and verbatim terms were coded via MedDRA dictionary
|
0.00%
0/15 • 14 weeks
All adverse events were collected and verbatim terms were coded via MedDRA dictionary
|
5.3%
1/19 • Number of events 1 • 14 weeks
All adverse events were collected and verbatim terms were coded via MedDRA dictionary
|
|
General disorders
Chills
|
0.00%
0/24 • 14 weeks
All adverse events were collected and verbatim terms were coded via MedDRA dictionary
|
0.00%
0/17 • 14 weeks
All adverse events were collected and verbatim terms were coded via MedDRA dictionary
|
0.00%
0/15 • 14 weeks
All adverse events were collected and verbatim terms were coded via MedDRA dictionary
|
5.3%
1/19 • Number of events 1 • 14 weeks
All adverse events were collected and verbatim terms were coded via MedDRA dictionary
|
|
Ear and labyrinth disorders
Otitis externa
|
0.00%
0/24 • 14 weeks
All adverse events were collected and verbatim terms were coded via MedDRA dictionary
|
5.9%
1/17 • Number of events 1 • 14 weeks
All adverse events were collected and verbatim terms were coded via MedDRA dictionary
|
0.00%
0/15 • 14 weeks
All adverse events were collected and verbatim terms were coded via MedDRA dictionary
|
0.00%
0/19 • 14 weeks
All adverse events were collected and verbatim terms were coded via MedDRA dictionary
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
0.00%
0/24 • 14 weeks
All adverse events were collected and verbatim terms were coded via MedDRA dictionary
|
0.00%
0/17 • 14 weeks
All adverse events were collected and verbatim terms were coded via MedDRA dictionary
|
6.7%
1/15 • Number of events 1 • 14 weeks
All adverse events were collected and verbatim terms were coded via MedDRA dictionary
|
0.00%
0/19 • 14 weeks
All adverse events were collected and verbatim terms were coded via MedDRA dictionary
|
|
Renal and urinary disorders
Urine oxalate
|
0.00%
0/24 • 14 weeks
All adverse events were collected and verbatim terms were coded via MedDRA dictionary
|
0.00%
0/17 • 14 weeks
All adverse events were collected and verbatim terms were coded via MedDRA dictionary
|
6.7%
1/15 • Number of events 1 • 14 weeks
All adverse events were collected and verbatim terms were coded via MedDRA dictionary
|
0.00%
0/19 • 14 weeks
All adverse events were collected and verbatim terms were coded via MedDRA dictionary
|
|
Reproductive system and breast disorders
Uterine bleeding
|
0.00%
0/24 • 14 weeks
All adverse events were collected and verbatim terms were coded via MedDRA dictionary
|
0.00%
0/17 • 14 weeks
All adverse events were collected and verbatim terms were coded via MedDRA dictionary
|
6.7%
1/15 • Number of events 1 • 14 weeks
All adverse events were collected and verbatim terms were coded via MedDRA dictionary
|
0.00%
0/19 • 14 weeks
All adverse events were collected and verbatim terms were coded via MedDRA dictionary
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place