A Study for Adults With Plaque Psoriasis - Full Text View

Sponsor:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT01018810

Purpose

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.

Condition	Intervention	Phase
Psoriasis	Drug: LY2525623 Intravenous Drug: LY2525623 Subcutaneous Drug: Placebo Intravenous Drug: Placebo Subcutaneous	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	LY2525623 (IL-23 Antibody) Multiple-Dose Study in Adults With Plaque Psoriasis

Resource links provided by NLM:

Genetics Home Reference related topics: psoriatic arthritis

MedlinePlus related topics: Psoriasis

Drug Information available for: Immunoglobulins Globulin, Immune

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Percentage of Participants Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Scale by Week 12 [ Time Frame: Baseline through 12 weeks ] [ Designated as safety issue: No ]
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.
Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Scale at Weeks 12 and 24 [ Time Frame: Baseline, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Change From Baseline in Relative Physician's Global Assessment (rPGA) Scale at 12 Weeks and 24 Weeks [ Time Frame: Baseline, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]
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.
Change From Baseline in the Visual Analog Scale (VAS) for Psoriatic Arthritis at 12 Weeks and 24 Weeks [ Time Frame: Baseline, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]
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.
Change From Baseline in the Patient's Global Assessment of Psoriasis Scale at 12 Weeks and 24 Weeks [ Time Frame: Baseline, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]
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.
Change From Baseline in the Dermatology Life Quality Index (DLQI) Score at 12 Weeks [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
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.
Change From Baseline in the 16-Item Quick Inventory for Depressive Symptomatology-Self Report (QIDS16SRTotal) at 12 Weeks [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: Yes ]
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.
Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) at 12 Weeks [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: Yes ]
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.
Pharmacokinetics: Area Under the Time Concentration Curve Through 24 Weeks [ Time Frame: Baseline through 24 weeks ] [ Designated as safety issue: Yes ]
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.
Number of Participants Who Developed Anti-LY2525623 Antibody Results Through 24 Weeks [ Time Frame: Baseline through 24 weeks ] [ Designated as safety issue: Yes ]
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.

Enrollment:	8
Study Start Date:	December 2009
Study Completion Date:	August 2010
Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 180 mg LY2525623	Drug: LY2525623 Intravenous administered intravenously at randomization and every 2 weeks for 6 weeks Other Name: LY2525623 (IL-23 Antibody)
Placebo Comparator: Intravenous Placebo	Drug: Placebo Intravenous administered intravenously at randomization and every 2 weeks for 6 weeks
Placebo Comparator: Subcutaneous Placebo	Drug: Placebo Subcutaneous administered subcutaneously at randomization and every 2 weeks for 6 weeks
Experimental: 3 mg LY2525623	Drug: LY2525623 Subcutaneous administered subcutaneously at randomization and every 2 weeks for 6 weeks Other Name: LY2525623 (IL-23 Antibody)
Experimental: 10 mg LY2525623	Drug: LY2525623 Subcutaneous administered subcutaneously at randomization and every 2 weeks for 6 weeks Other Name: LY2525623 (IL-23 Antibody)
Experimental: 30 mg LY2525623	Drug: LY2525623 Subcutaneous administered subcutaneously at randomization and every 2 weeks for 6 weeks Other Name: LY2525623 (IL-23 Antibody)
Experimental: 90 mg LY2525623	Drug: LY2525623 Subcutaneous administered subcutaneously at randomization and every 2 weeks for 6 weeks Other Name: LY2525623 (IL-23 Antibody)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Are ambulatory and greater than or equal to 18 years of age. Females of child-bearing potential must test negative for pregnancy at the time of enrollment based on a serum pregnancy test and agree to use a highly reliable method of birth control as defined by those which result in a low failure rate(<1% per year) during the study.
Chronic psoriasis vulgaris for at least 6 months prior to randomization.
Moderate and severe (plaque) psoriasis involving at least 10% body surface area (BSA) or at least 8% BSA in subjects with severe palmar-plantar involvement at randomization.
Psoriasis Area and Severity Index (PASI) total score of at least 12 at screening.

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:
- Aspartate transaminase (AST) or alanine transaminase (ALT) >2 x the upper limit of normal (ULN; upper reference range of the central laboratory for the study)
- Hemoglobin <100 g/L (10 g/dL)
- White blood cell (WBC) <3.0 G/L (3,000/mm3)
- Neutrophils <1.5 G/L (1,500/mm3)
- Platelets <75 G/L (75,000/mm3)
- Serum creatinine >133 µmol/L (1.5 mg/dL)
- Random glucose >11.1mmol/L (200 mg/dL).
Have significant allergies to humanized monoclonal antibodies, or clinically significant multiple or severe drug allergies, or intolerance to topical corticosteroids

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01018810

Show 28 Study Locations

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director:

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

More Information

No publications provided

Responsible Party:	Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier:	NCT01018810 History of Changes
Other Study ID Numbers:	11431, I1X-MC-BDAD
Study First Received:	November 24, 2009
Results First Received:	June 1, 2011
Last Updated:	July 27, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:

Psoriasis

Additional relevant MeSH terms:

Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Antibodies

Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012