Trial Outcomes & Findings for A Study for Adults With Plaque Psoriasis (NCT NCT01018810)
NCT ID: NCT01018810
Last Updated: 2011-07-29
Results Overview
PASI combines extent of body-surface involvement assessments in 4 anatomical regions and severity of regional desquamation, erythema, and plaque induration/infiltration. Overall score: 0 (no psoriasis) to 72 (severe disease). Study BDAD was terminated after enrolling only 8 patients. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.
TERMINATED
PHASE2
8 participants
Baseline through 12 weeks
2011-07-29
Participant Flow
Participant milestones
| Measure |
180 mg LY2525623
180 mg LY2525623 administered intravenously at randomization and every 2 weeks for 6 weeks
|
Subcutaneous Placebo
Placebo administered subcutaneously at randomization and every 2 weeks for 6 weeks
|
3 mg LY2525623
3 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
|
30 mg LY2525623
30 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
|
90 mg LY2525623
90 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
1
|
1
|
1
|
1
|
|
Overall Study
COMPLETED
|
2
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
1
|
1
|
1
|
Reasons for withdrawal
| Measure |
180 mg LY2525623
180 mg LY2525623 administered intravenously at randomization and every 2 weeks for 6 weeks
|
Subcutaneous Placebo
Placebo administered subcutaneously at randomization and every 2 weeks for 6 weeks
|
3 mg LY2525623
3 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
|
30 mg LY2525623
30 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
|
90 mg LY2525623
90 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
|
|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Sponsor Decision
|
2
|
0
|
1
|
1
|
1
|
Baseline Characteristics
A Study for Adults With Plaque Psoriasis
Baseline characteristics by cohort
| Measure |
180 mg LY2525623
n=4 Participants
180 mg LY2525623 administered intravenously at randomization and every 2 weeks for 6 weeks
|
Subcutaneous Placebo
n=1 Participants
Placebo administered subcutaneously at randomization and every 2 weeks for 6 weeks
|
3 mg LY2525623
n=1 Participants
3 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
|
30 mg LY2525623
n=1 Participants
30 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
|
90 mg LY2525623
n=1 Participants
90 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
|
Total
n=8 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
8 Participants
n=8 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
8 Participants
n=8 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
1 participants
n=21 Participants
|
8 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline through 12 weeksPopulation: No participants had data analyzed due to the termination of the trial and the insufficient sample size.
PASI combines extent of body-surface involvement assessments in 4 anatomical regions and severity of regional desquamation, erythema, and plaque induration/infiltration. Overall score: 0 (no psoriasis) to 72 (severe disease). Study BDAD was terminated after enrolling only 8 patients. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline, 12 weeks, 24 weeksPopulation: No participants had data analyzed due to the termination of the trial and the insufficient sample size.
PASI combines body-surface assessments and severity of desquamation, erythema, and plaque induration/infiltration. Overall score:0(no psoriasis) to 72(severe disease). Percent(%) improvement=(baseline PASI-observed PASI)/baseline PASI\*100. Study BDAD was terminated after enrolling only 8 patients. Least Squares (LS) Mean Values were adjusted for time, treatment, and baseline. Given small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 12 weeks, 24 weeksPopulation: No participants had data analyzed due to the termination of the trial and the insufficient sample size.
The rPGA rates the subject's psoriasis relative to baseline as 1 (100% clearing), 2 (excellent; 75%-99% clearing), 3 (good; 50%-74% clearing), 4 (fair; 25%-49% clearing), 5 (poor; 0%-24% clearing), or 6 (worsening). Study BDAD was terminated after enrolling only 8 patients. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 12 weeks, 24 weeksPopulation: No participants had data analyzed due to the termination of the trial and the insufficient sample size.
A global estimate of pain caused by joint disease on arising made by the subject by placing a vertical mark or tick on a 100-mm VAS from not present to worse, range from 0 to 100mm. Study BDAD was terminated after enrolling only 8 patients. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 12 weeks, 24 weeksPopulation: No participants had data analyzed due to the termination of the trial and the insufficient sample size.
A scale measures patient perception of psoriatic condition with a continuous range of 0 (good) to 5 (severe). Study BDAD was terminated after enrolling only 8 patients. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: No participants had data analyzed due to the termination of the trial and the insufficient sample size.
10-item, validated questionnaire covers 6 domains. Responses range from 0 (not at all) to 3 (very much); totals range from 0 to 30 (more impairment). Study BDAD was terminated after enrolling only 8 patients. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: No participants had data analyzed due to the termination of the trial and the insufficient sample size.
A 16-item patient-rated measure of depressive symptomatology. The total score ranges from 0 to 27 with higher scores indicative of greater severity. Study BDAD was terminated after enrolling only 8 patients. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: No participants had data analyzed due to the termination of the trial and the insufficient sample size.
A 14-item questionnaire with anxiety and depression subscales; 21 maximum score. Scores of 11+ on either subscale (significant case of psychological morbidity); 8-10 (borderline); 0-7 (normal). Study BDAD was terminated after enrolling only 8 patients. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline through 24 weeksPopulation: No participants had data analyzed due to the termination of the trial and the insufficient sample size.
Area under the curve of serum drug concentration, including absolute bioavailability. Study BDAD was terminated after enrolling only 8 patients. Given the small sample size overall and in each treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline through 24 weeksPopulation: No participants had data analyzed due to the termination of the trial and the insufficient sample size.
Measures anti-LY2525263 antibody as positive or negative. Study BDAD was terminated after enrolling only 8 patients. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.
Outcome measures
Outcome data not reported
Adverse Events
180 mg LY2525623
Subcutaneous Placebo
3 mg LY2525623
30 mg LY2525623
90 mg LY2525623
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
180 mg LY2525623
n=4 participants at risk
|
Subcutaneous Placebo
n=1 participants at risk
|
3 mg LY2525623
n=1 participants at risk
|
30 mg LY2525623
n=1 participants at risk
|
90 mg LY2525623
n=1 participants at risk
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/4
|
0.00%
0/1
|
0.00%
0/1
|
100.0%
1/1 • Number of events 1
|
0.00%
0/1
|
|
General disorders
Fatigue
|
25.0%
1/4 • Number of events 1
|
0.00%
0/1
|
0.00%
0/1
|
0.00%
0/1
|
0.00%
0/1
|
|
General disorders
Tiredness
|
25.0%
1/4 • Number of events 3
|
0.00%
0/1
|
0.00%
0/1
|
0.00%
0/1
|
0.00%
0/1
|
|
Infections and infestations
Cold sores
|
25.0%
1/4 • Number of events 1
|
0.00%
0/1
|
0.00%
0/1
|
0.00%
0/1
|
0.00%
0/1
|
|
Infections and infestations
Pneumonia
|
25.0%
1/4 • Number of events 1
|
0.00%
0/1
|
0.00%
0/1
|
0.00%
0/1
|
0.00%
0/1
|
|
Infections and infestations
Sinusitis
|
25.0%
1/4 • Number of events 1
|
0.00%
0/1
|
0.00%
0/1
|
0.00%
0/1
|
0.00%
0/1
|
|
Infections and infestations
Upper respiratory infection
|
25.0%
1/4 • Number of events 1
|
0.00%
0/1
|
0.00%
0/1
|
0.00%
0/1
|
0.00%
0/1
|
|
Injury, poisoning and procedural complications
Contusion of knee
|
25.0%
1/4 • Number of events 1
|
0.00%
0/1
|
0.00%
0/1
|
0.00%
0/1
|
0.00%
0/1
|
|
Injury, poisoning and procedural complications
Foreign body in eye
|
25.0%
1/4 • Number of events 1
|
0.00%
0/1
|
0.00%
0/1
|
0.00%
0/1
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Cough nonproductive
|
25.0%
1/4 • Number of events 1
|
0.00%
0/1
|
0.00%
0/1
|
0.00%
0/1
|
0.00%
0/1
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4
|
0.00%
0/1
|
0.00%
0/1
|
0.00%
0/1
|
100.0%
1/1 • Number of events 1
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60