- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00669916
A Study Comparing AIN457 to Placebo in Subjects With a Diagnosis of Moderate to Severe Stable Plaque Psoriasis
Phase 2a Single-Dose, Randomized, Double Blind, Multi-Center, Parallel-Group, Placebo-Controlled Proof of Concept Study to Assess the Efficacy, Safety, Tolerability, and Population Pharmacokinetics of AIN457 in Patients With Stable Plaque-type Psoriasis
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Males or females, aged 18-69 at time of consent.
- Post menopausal or surgically sterile female patients are allowed. Male patients must be willing to use contraception method at least for 3 months following the completion of the study. Women of child-bearing potential will not be allowed to participate.
Diagnosis of plaque psoriasis for at least 6 months prior to screening. The patients must meet both of the following criterion:
- Coverage of the body surface area (BSA) of 10% or more with plaques
- A score of 3 or more on the IGA scale
- Stable plaque psoriasis at screening and randomization.
- PASI score of 12 or greater at randomization.
- Able to communicate well with the investigator, and to understand and comply with the requirements of the study. Understand and sign the written informed consent.
- Patients must have normal laboratory values for screening laboratory test results of hematological (hemoglobin, WBCs, neutrophils, platelets) and renal (serum creatinine) assessments. For the transaminases, aspartate aminotransferase and alanine aminotransferase, levels 1.5 times the upper limit of normal will be accepted. For the additional hepatic laboratory results (alkaline phosphatase, gamma-glutamyltransferase, bilirubin), patients must have non-clinically significant values.
Exclusion Criteria:
- Currently have any of the nonplaque forms of psoriasis: erythrodermic, guttate, or pustular.
- Currently have drug-induced psoriasis (new onset or exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium).
- Men who are planning to initiate a pregnancy while enrolled in the study or for 3 months following completion of the study.
- Women of child-bearing potential are not allowed in the study.
- Used any investigational drug within the previous 4 weeks.
Recent previous treatment with anti-TNF-α therapy (or other biological therapy), immunosuppressive agents such as cyclosporine, mycophenolate, pimecrolimus, or tacrolimus. The following washout period will be required for such patients to be eligible to participate in the trial.
- 2 months washout prior to screening for etanercept, adalimumab, or infliximab.
- 1 month washout prior to screening for cyclosporine, mycophenolate, tacrolimus, and any systemic immunosuppressants including, but not limited to, methotrexate, azathioprine, 6-thioguanine, mercaptopurine, and hydroxyurea
Other protocol-defined inclusion/exclusion criteria may apply
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: AIN457
AIN457A 3mg/kg was administered intravenously as a single dose.
|
single infusion of 3 mg/kg
|
Placebo Comparator: Placebo
Placebo was administered intravenously as a single dose.
|
single infusion of placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Mean Score
Time Frame: Baseline, Week 4
|
The PASI assessed the extent of psoriasis on four body surface areas (head, trunk and upper limbs) and the degree of plaque erythema, scaling and thickness.
The PASI score accounted for the extent of body surface area affected by the erythema, scaling and thickness and the severity of these measures.
The score ranged from 0 (no disease) to 72 (maximal disease) where a reduction in PASI score from baseline indicates improvement.
The percentage change was calculated by subtracting the week 4 values from the baseline values.The percentage change was calculated for each entire treatment group (not for each participant).
A positive percentage change from baseline indicates improvement.
|
Baseline, Week 4
|
Percentage of Participants With Change From Baseline in Investigators Global Assessment (IGA) Score
Time Frame: Baseline, Week 4
|
The IGA is an instrument which captured and categorized the global assessment of all clinical signs and symptoms of disease.
The investigator used all available information for the assessment, including subjective information from the participant and (where available) photographs taken at baseline.
The IGA categories were clear, almost clear, mild disease, moderate disease, severe disease and very severe disease.
This outcome measure shows the percentage of patients who experienced a category change from baseline.
Category changes of 1, 2 or 3 indicate improvement.
|
Baseline, Week 4
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetics of AIN457: Time to Reach the Maximum Concentration After Drug Administration (Tmax)
Time Frame: Day 182
|
Blood was drawn for PK analyses at baseline (prior to dosing), end of infusion, 1 hr and 2 hr after infusion, and during office visits in Weeks 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 26.
The PK samples may have been taken at any time during each office visit, following the day of study drug infusion.
This outcome measure shows the mean of all values resulting from each time point outlined above.
|
Day 182
|
Pharmacokinetics of AIN457: Observed Maximum Serum Concentration Following Drug Administration (Cmax)
Time Frame: Day 182
|
Blood was drawn for PK analyses at baseline (prior to dosing), end of infusion, 1 hr and 2 hr after infusion, and during office visits in Weeks 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 26.
The PK samples may have been taken at any time during each office visit, following the day of study drug infusion.
This outcome measure shows the mean of all values resulting from each time point outlined above.
|
Day 182
|
Pharmacokinetics of AIN457: Area Under the Serum Concentration-time Cure From Time Zero to the Time of Last Quantifiable Concentration (AUClast), Area Under the Serum Concentration-time Curve From Time Zero to (AUCinf)
Time Frame: Day 182
|
Blood was drawn for PK analyses at baseline (prior to dosing), end of infusion, 1 hr and 2 hr after infusion, and during office visits in Weeks 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 26.
The PK samples may have been taken at any time during each office visit, following the day of study drug infusion.
This outcome measure shows the mean of all values resulting from each time point outlined above.
|
Day 182
|
Pharmacokinetics of AIN457: Volume of Distribution During the Terminal Phase Following Intravenous Elimination (Vz)
Time Frame: Day 182
|
Blood was drawn for PK analyses at baseline (prior to dosing), end of infusion, 1 hr and 2 hr after infusion, and during office visits in Weeks 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 26.
The PK samples may have been taken at any time during each office visit, following the day of study drug infusion.
This outcome measure shows the mean of all values resulting from each time point outlined above.
|
Day 182
|
Pharmacokinetics of AIN457: Systemic Clearance From Serum Following Intravenous Administration (CL)
Time Frame: Day 182
|
Blood was drawn for PK analyses at baseline (prior to dosing), end of infusion, 1 hr and 2 hr after infusion, and during office visits in Weeks 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 26.
The PK samples may have been taken at any time during each office visit, following the day of study drug infusion.
This outcome measure shows the mean of all values resulting from each time point outlined above.
|
Day 182
|
Pharmacokinetics of AIN457: Terminal Elimination Half-life (T1/2)
Time Frame: Day 182
|
Blood was drawn for PK analyses at baseline (prior to dosing), end of infusion, 1 hr and 2 hr after infusion, and during office visits in Weeks 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 26.
The PK samples may have been taken at any time during each office visit, following the day of study drug infusion.
This outcome measure shows the mean of all values resulting from each time point outlined above.
|
Day 182
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CAIN457A2102
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Plaque Psoriasis
-
UCB Biopharma SRLRecruitingModerate Chronic Plaque Psoriasis | Severe Chronic Plaque Psoriasis | Mixed Guttate/Plaque PsoriasisUnited States, Canada, Puerto Rico
-
Idera Pharmaceuticals, Inc.CompletedModerate to Severe Plaque Psoriasis | Actively Extending Plaque PsoriasisUnited States
-
Fresenius Kabi SwissBioSim GmbHMerck KGaA, Darmstadt, GermanyCompletedPsoriasis | Moderate to Severe Plaque Psoriasis | Plaque Type PsoriasisUnited States, Canada, Czechia, Hungary, Russian Federation, Bulgaria, Mexico, United Kingdom, Poland, Germany, Estonia, France
-
UCB Biopharma SRLCompletedModerate to Severe Plaque Psoriasis | Chronic Plaque PsoriasisUnited States, Australia, Canada, Germany, Hungary, Korea, Republic of, Poland, Russian Federation, Taiwan
-
UCB Biopharma SRLCompletedModerate to Severe Chronic Plaque Psoriasis | Chronic Plaque PsoriasisUnited States, Australia, Belgium, Canada, Germany, Hungary, Italy, Japan, Korea, Republic of, Poland, Russian Federation, Taiwan, United Kingdom
-
UCB Biopharma SRLCompletedModerate to Severe Chronic Plaque Psoriasis | Chronic Plaque PsoriasisUnited States, Australia, Belgium, Canada, France, Germany, Netherlands, Poland, Spain, Turkey, United Kingdom
-
Biocon Biologics Inc.MEDA Pharma GmbH & Co. KG; Mylan Inc.; IQVIA Pvt. LtdCompletedHulio Interchangeability to Humira®, Comparing Pharmacokinetics, Efficacy, Safety and ImmunogenicityModerate Chronic Plaque Psoriasis | Severe Chronic Plaque PsoriasisBulgaria, Czechia, Estonia, Poland
-
UCB Biopharma SRLCompletedModerate to Severe Chronic Plaque Psoriasis | Chronic Plaque PsoriasisUnited States, Canada
-
UCB Biopharma SRLActive, not recruitingModerate to Severe Chronic Plaque Psoriasis | Chronic Plaque PsoriasisChina
-
AmgenCompletedPsoriasis-Type Psoriasis | Plaque-Type PsoriasisUnited States
Clinical Trials on AIN457
-
Novartis PharmaceuticalsTerminatedRheumatoid ArthritisUnited States, Germany, Greece, Argentina, Brazil, Colombia, Czech Republic, Dominican Republic, Guatemala, India, Italy, Japan, Korea, Republic of, Panama, Portugal, South Africa
-
Novartis PharmaceuticalsActive, not recruitingNon-radiographic Axial SpondyloarthritisChina
-
Novartis PharmaceuticalsWithdrawn
-
Novartis PharmaceuticalsRecruitingGiant Cell Arteritis | Polymyalgia RheumaticaUnited States
-
Academisch Medisch Centrum - Universiteit van Amsterdam...NovartisCompletedSpondylarthropathiesNetherlands
-
Novartis PharmaceuticalsCompletedRelapsing-remitting Multiple Sclerosis | RRMSRussian Federation, Ukraine, Czech Republic
-
Novartis PharmaceuticalsTerminatedLupus NephritisChina, Croatia, Czechia, Russian Federation, Turkey, Australia, Spain, Thailand, Argentina, United States, Denmark, Greece, Romania, Germany, Korea, Republic of, India, Brazil, Japan, Peru, Portugal, Italy, Taiwan, Vietnam, Norway, Colo... and more
-
Novartis PharmaceuticalsActive, not recruitingPsoriasisArgentina, Canada, Guatemala, Mexico, Brazil, Costa Rica, Dominican Republic, Panama
-
Novartis PharmaceuticalsCompletedPsoriasisUnited Kingdom, Ireland
-
Novartis PharmaceuticalsCompletedRheumatoid ArthritisColombia, United States, Belgium, Turkey, Thailand, Argentina, Italy, Guatemala, India, Japan, Panama, Hungary, United Kingdom, Mexico, Puerto Rico, Canada