PsoriasisPhase 2NCT01018810
A Study for Adults With Plaque Psoriasis
A Phase 2 study testing LY2525623 Intravenous and LY2525623 Subcutaneous in people with Psoriasis, run by Eli Lilly and Company at 28 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- LY2525623 Intravenous and LY2525623 Subcutaneous
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 28 sitesin 2 countries
- Study dates
- Dec 2009to Aug 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
Show all 14Show fewer
- 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
Trial locations and contacts
28 sites in 2 countries.
28 sites in 2 countries
United States20 sites
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
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
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
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Hot Springs, Arkansas, 71913
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Houston, Texas, 77030
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Indianapolis, Indiana, 46256
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Jacksonville, Florida, 32204
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Johnston, Rhode Island, 02919
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Los Angeles, California, 90045
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Mobile, Alabama, 36608
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Normal, Illinois, 61761
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
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Owensboro, Kentucky, 42301
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Peoria, Arizona, 85381
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San Diego, California, 92123
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
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
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
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
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
Canada8 sites
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
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Edmonton, Alberta, T5K 1X3
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
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
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Montreal, Quebec, H3Z2S6
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
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
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
About this study
Official title: LY2525623 (IL-23 Antibody) Multiple-Dose Study in Adults With Plaque Psoriasis
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.
- Conditions
- Psoriasis
- Being tested
- LY2525623 Intravenous, LY2525623 Subcutaneous, Placebo Intravenous, Placebo Subcutaneous
- Keywords
- Psoriasis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY2525623 IntravenousDrug
Also called LY2525623 (IL-23 Antibody)
administered intravenously at randomization and every 2 weeks for 6 weeks
LY2525623 SubcutaneousDrug
Also called LY2525623 (IL-23 Antibody)
administered subcutaneously at randomization and every 2 weeks for 6 weeks
Placebo IntravenousDrug
administered intravenously at randomization and every 2 weeks for 6 weeks
Placebo SubcutaneousDrug
administered subcutaneously at randomization and every 2 weeks for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| 180 mg LY2525623 | Experimental | Not described Receives: Drug: LY2525623 Intravenous |
| Intravenous Placebo | Placebo comparator | Not described Receives: Drug: Placebo Intravenous |
| Subcutaneous Placebo | Placebo comparator | Not described Receives: Drug: Placebo Subcutaneous |
| 3 mg LY2525623 | Experimental | Not described Receives: Drug: LY2525623 Subcutaneous |
| 10 mg LY2525623 | Experimental | Not described Receives: Drug: LY2525623 Subcutaneous |
| 30 mg LY2525623 | Experimental | Not described Receives: Drug: LY2525623 Subcutaneous |
| 90 mg LY2525623 | Experimental | Not described Receives: Drug: LY2525623 Subcutaneous |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, 12 weeks, 24 weeks
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline through 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2009 (estimated)
- Study startDec 2009
- Primary completionMay 2010
- Study completionAug 2010
Why it stopped: The trial was terminated for several reasons, including complexities in development of LY2525623, but not because of safety concerns
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01018810
- Sponsor's protocol ID
- 11431
- Other IDs
- I1X-MC-BDAD
- Status last verified
- Jul 2011
- First submitted
- 24 Nov 2009
- Last updated
- 29 Jul 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LY2525623 (IL-23 Antibody) Multiple-Dose Study in Adults With Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT01018810
- Acronym / sponsor ID
- 11431
- Conditions
- Psoriasis
- Keywords
- Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The trial was terminated for several reasons, including complexities in development of LY2525623, but not because of safety concerns
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- May 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 25 Nov 2009 (estimated)
- Results
- Posted 30 Jun 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 180 mg LY2525623 | Experimental | Drug: LY2525623 Intravenous |
| Intravenous Placebo | Placebo comparator | Drug: Placebo Intravenous |
| Subcutaneous Placebo | Placebo comparator | Drug: Placebo Subcutaneous |
| 3 mg LY2525623 | Experimental | Drug: LY2525623 Subcutaneous |
| 10 mg LY2525623 | Experimental | Drug: LY2525623 Subcutaneous |
| 30 mg LY2525623 | Experimental | Drug: LY2525623 Subcutaneous |
| 90 mg LY2525623 | Experimental | Drug: LY2525623 Subcutaneous |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LY2525623 IntravenousAlso: LY2525623 (IL-23 Antibody)administered intravenously at randomization and every 2 weeks for 6 weeks | Drug | 180 mg LY2525623 |
| LY2525623 SubcutaneousAlso: LY2525623 (IL-23 Antibody)administered subcutaneously at randomization and every 2 weeks for 6 weeks | Drug | 10 mg LY2525623, 3 mg LY2525623, 30 mg LY2525623, 90 mg LY2525623 |
| Placebo Intravenousadministered intravenously at randomization and every 2 weeks for 6 weeks | Drug | Intravenous Placebo |
| Placebo Subcutaneousadministered subcutaneously at randomization and every 2 weeks for 6 weeks | Drug | Subcutaneous Placebo |
Primary outcome
Percentage of Participants Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Scale by Week 12
Time frame: Baseline through 12 weeks
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
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.
8 secondary outcomes
Change From Baseline in Relative Physician's Global Assessment (rPGA) Scale at 12 Weeks and 24 Weeks
Time frame: Baseline, 12 weeks, 24 weeks
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
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
Change From Baseline in the Dermatology Life Quality Index (DLQI) Score at 12 Weeks
Time frame: Baseline, 12 weeks
Change From Baseline in the 16-Item Quick Inventory for Depressive Symptomatology-Self Report (QIDS16SRTotal) at 12 Weeks
Time frame: Baseline, 12 weeks
Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) at 12 Weeks
Time frame: Baseline, 12 weeks
Pharmacokinetics: Area Under the Time Concentration Curve Through 24 Weeks
Time frame: Baseline through 24 weeks
Number of Participants Who Developed Anti-LY2525623 Antibody Results Through 24 Weeks
Time frame: Baseline through 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
28 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LY2525623 Intravenous and LY2525623 Subcutaneous in people with Psoriasis, run by Eli Lilly and Company at 28 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jun 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Scale by Week 12 (time frame: Baseline through 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2011.