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| ID | Type | Description | Link |
|---|---|---|---|
| I1X-MC-BDAD | Other Identifier | Eli Lilly and Company |
Not provided
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The trial was terminated for several reasons, including complexities in development of LY2525623, but not because of safety concerns
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In this study, we will evaluate clinical activity, safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of 5 LY2525623 dosing groups compared to placebo in adults with plaque psoriasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 180 mg LY2525623 | Experimental |
| |
| Intravenous Placebo | Placebo Comparator |
| |
| Subcutaneous Placebo | Placebo Comparator |
| |
| 3 mg LY2525623 | Experimental |
| |
| 10 mg LY2525623 | Experimental |
| |
| 30 mg LY2525623 | Experimental |
| |
| 90 mg LY2525623 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2525623 Intravenous | Drug | administered intravenously at randomization and every 2 weeks for 6 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Scale by Week 12 | 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. | Baseline through 12 weeks |
| Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Scale at Weeks 12 and 24 | 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. | Baseline, 12 weeks, 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Relative Physician's Global Assessment (rPGA) Scale at 12 Weeks and 24 Weeks | 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. |
Not provided
Inclusion criteria:
Exclusion criteria:
Have had a clinically significant flare of psoriasis during the 12 weeks prior to randomization or a biologic agent/monoclonal antibody within the longer of 5 half lives or 12 weeks prior to dosing, had systemic treatment for psoriasis or phototherapy within 4 weeks prior to dosing, or had topical psoriasis treatment within 2 weeks prior to dosing.
Have had a vaccination within 4 to 12 weeks (depending on type) prior to or intend to have one within 4 weeks after the dosing period.
Are immunocompromised or have evidence of active infection (such as viral hepatitis and/or positive testing for tuberculosis or human immunodeficiency virus [HIV]); or have had a recent serious systemic infection (such as mononucleosis or herpes zoster).
Have a history of or current lymphoproliferative disease or malignant disease (except for resolved cervical dysplasia; or no more than 3 successfully treated basal- or squamous- cell carcinomas of the skin), or severe drug allergies/hypersensitivity.
Have a history of serious cardiac disease within 12 weeks before randomization; or have serious or unstable/uncontrolled illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, neurologic, psychiatric, immunologic, or hematologic disease and other conditions that, in the investigator's opinion, could interfere with the analyses of safety and efficacy in this study.
Have laboratory test values outside the reference range for the population or investigative site that are considered clinically significant and/or have any of the following specific abnormalities:
Have significant allergies to humanized monoclonal antibodies, or clinically significant multiple or severe drug allergies, or intolerance to topical corticosteroids
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Mobile | Alabama | 36608 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 180 mg LY2525623 | 180 mg LY2525623 administered intravenously at randomization and every 2 weeks for 6 weeks |
| FG001 | Subcutaneous Placebo | Placebo administered subcutaneously at randomization and every 2 weeks for 6 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| LY2525623 Subcutaneous | Drug | administered subcutaneously at randomization and every 2 weeks for 6 weeks |
|
|
| Placebo Intravenous | Drug | administered intravenously at randomization and every 2 weeks for 6 weeks |
|
| Placebo Subcutaneous | Drug | administered subcutaneously at randomization and every 2 weeks for 6 weeks |
|
| Baseline, 12 weeks, 24 weeks |
| Change From Baseline in the Visual Analog Scale (VAS) for Psoriatic Arthritis at 12 Weeks and 24 Weeks | 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. | Baseline, 12 weeks, 24 weeks |
| Change From Baseline in the Patient's Global Assessment of Psoriasis Scale at 12 Weeks and 24 Weeks | 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. | Baseline, 12 weeks, 24 weeks |
| Change From Baseline in the Dermatology Life Quality Index (DLQI) Score at 12 Weeks | 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. | Baseline, 12 weeks |
| Change From Baseline in the 16-Item Quick Inventory for Depressive Symptomatology-Self Report (QIDS16SRTotal) at 12 Weeks | 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. | Baseline, 12 weeks |
| Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) at 12 Weeks | 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. | Baseline, 12 weeks |
| Pharmacokinetics: Area Under the Time Concentration Curve Through 24 Weeks | 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. | Baseline through 24 weeks |
| Number of Participants Who Developed Anti-LY2525623 Antibody Results Through 24 Weeks | 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. | Baseline through 24 weeks |
| United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Peoria | Arizona | 85381 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Hot Springs | Arkansas | 71913 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Fremont | California | 94538 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Los Angeles | California | 90045 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | San Diego | California | 92123 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Santa Monica | California | 90404 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Jacksonville | Florida | 32204 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Ocala | Florida | 34471 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | South Miami | Florida | 33143 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Normal | Illinois | 61761 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Evansville | Indiana | 47714 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Indianapolis | Indiana | 46256 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Owensboro | Kentucky | 42301 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | East Windsor | New Jersey | 08520 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | South Euclid | Ohio | 44118 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Johnston | Rhode Island | 02919 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Simpsonville | South Carolina | 29681 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Houston | Texas | 77030 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Spokane | Washington | 99202 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Edmonton | Alberta | T5K 1X3 | Canada |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Moncton | New Brunswick | E1C8X3 | Canada |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Barrie | Ontario | L4M6L2 | Canada |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Markham | Ontario | L3P1A8 | Canada |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Ottawa | Ontario | K2G6E2 | Canada |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Waterloo | Ontario | N2J 1C4 | Canada |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Montreal | Quebec | H3Z2S6 | Canada |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Québec | Quebec | G1V4X7 | Canada |
| FG002 | 3 mg LY2525623 | 3 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks |
| FG003 | 30 mg LY2525623 | 30 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks |
| FG004 | 90 mg LY2525623 | 90 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 180 mg LY2525623 | 180 mg LY2525623 administered intravenously at randomization and every 2 weeks for 6 weeks |
| BG001 | Subcutaneous Placebo | Placebo administered subcutaneously at randomization and every 2 weeks for 6 weeks |
| BG002 | 3 mg LY2525623 | 3 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks |
| BG003 | 30 mg LY2525623 | 30 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks |
| BG004 | 90 mg LY2525623 | 90 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Scale by Week 12 | 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. | No participants had data analyzed due to the termination of the trial and the insufficient sample size. | Posted | Number | percentage of participants | Baseline through 12 weeks |
|
| |||||||||||||||||||||||||||||
| Primary | Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Scale at Weeks 12 and 24 | 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. | No participants had data analyzed due to the termination of the trial and the insufficient sample size. | Posted | Least Squares Mean | 95% Confidence Interval | percentage of units on a scale | Baseline, 12 weeks, 24 weeks |
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Relative Physician's Global Assessment (rPGA) Scale at 12 Weeks and 24 Weeks | 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. | No participants had data analyzed due to the termination of the trial and the insufficient sample size. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 12 weeks, 24 weeks |
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Visual Analog Scale (VAS) for Psoriatic Arthritis at 12 Weeks and 24 Weeks | 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. | No participants had data analyzed due to the termination of the trial and the insufficient sample size. | Posted | Mean | Standard Deviation | millimeters (mm) | Baseline, 12 weeks, 24 weeks |
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Patient's Global Assessment of Psoriasis Scale at 12 Weeks and 24 Weeks | 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. | No participants had data analyzed due to the termination of the trial and the insufficient sample size. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 12 weeks, 24 weeks |
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Dermatology Life Quality Index (DLQI) Score at 12 Weeks | 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. | No participants had data analyzed due to the termination of the trial and the insufficient sample size. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 12 weeks |
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the 16-Item Quick Inventory for Depressive Symptomatology-Self Report (QIDS16SRTotal) at 12 Weeks | 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. | No participants had data analyzed due to the termination of the trial and the insufficient sample size. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 12 weeks |
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) at 12 Weeks | 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. | No participants had data analyzed due to the termination of the trial and the insufficient sample size. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 12 weeks |
| |||||||||||||||||||||||||||||
| Secondary | Pharmacokinetics: Area Under the Time Concentration Curve Through 24 Weeks | 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. | No participants had data analyzed due to the termination of the trial and the insufficient sample size. | Posted | Geometric Mean | 90% Confidence Interval | nanograms per milliliter (ng/mL) | Baseline through 24 weeks |
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Developed Anti-LY2525623 Antibody Results Through 24 Weeks | 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. | No participants had data analyzed due to the termination of the trial and the insufficient sample size. | Posted | Number | participants | Baseline through 24 weeks |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 180 mg LY2525623 | 0 | 4 | 3 | 4 | |||
| EG001 | Subcutaneous Placebo | 0 | 1 | 0 | 1 | |||
| EG002 | 3 mg LY2525623 | 0 | 1 | 0 | 1 | |||
| EG003 | 30 mg LY2525623 | 0 | 1 | 1 | 1 | |||
| EG004 | 90 mg LY2525623 | 0 | 1 | 1 | 1 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry mouth | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Tiredness | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Cold sores | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Upper respiratory infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Contusion of knee | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Foreign body in eye | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Cough nonproductive | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
Study BDAD was terminated early due to non-safety related complexities in LY2525623 development. Numerical summaries and statistical comparisons for the 8 patients enrolled are not appropriate and may be scientifically/clinically misleading.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG003 | 30 mg LY2525623 | 30 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks |
| OG004 | 90 mg LY2525623 | 90 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks |
|
| OG003 | 30 mg LY2525623 | 30 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks |
| OG004 | 90 mg LY2525623 | 90 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks |
|
| OG003 |
| 30 mg LY2525623 |
30 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks |
| OG004 | 90 mg LY2525623 | 90 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 |
| OG004 | 90 mg LY2525623 | 90 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 |
| OG004 | 90 mg LY2525623 | 90 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 |
| OG004 | 90 mg LY2525623 | 90 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks |
|
| OG003 |
| 30 mg LY2525623 |
30 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks |
| OG004 | 90 mg LY2525623 | 90 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks |
|
30 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks |
| OG004 | 90 mg LY2525623 | 90 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks |
|
30 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
| OG004 | 90 mg LY2525623 | 90 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks |
|