A Phase 1/2 interventional study of AIN457 and Placebo in Plaque Psoriasis, sponsored by Novartis Pharmaceuticals. Completed. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-04-10.
Sponsored by Novartis Pharmaceuticals · Phase 1/2, Interventional, and Basic science
This is a two-arm, parallel group, double-blind, placebo-controlled proof-of-concept study comparing 3 mg/kg of AIN457 to placebo. Subjects with a diagnosis of moderate to severe stable plaque psoriasis will be randomized to receive either AIN457 or placebo. AIN457 or placebo will be administered by single infusion at baseline and subjects will be observed for up to 26 weeks following the infusion.
1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.
This study's enrollment of 36 is below the median of 70 across 1,447 interventional studies indexed under Psoriasis.
Browse Psoriasis studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Diagnosis of plaque psoriasis for at least 6 months prior to screening. The patients must meet both of the following criterion:
Exclusion Criteria:
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.
Other protocol-defined inclusion/exclusion criteria may apply
AIN457A 3mg/kg was administered intravenously as a single dose.
Biological: AIN457
Placebo was administered intravenously as a single dose.
Drug: Placebo
single infusion of 3 mg/kg
single infusion of placebo
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Mean Score
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.
Time frame: Baseline, Week 4
Percentage of Participants With Change From Baseline in Investigators Global Assessment (IGA) Score
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.
Time frame: Baseline, Week 4
Pharmacokinetics of AIN457: Time to Reach the Maximum Concentration After Drug Administration (Tmax)
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.
Time frame: Day 182
Pharmacokinetics of AIN457: Observed Maximum Serum Concentration Following Drug Administration (Cmax)
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.
Time frame: 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)
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.
Time frame: Day 182
Pharmacokinetics of AIN457: Volume of Distribution During the Terminal Phase Following Intravenous Elimination (Vz)
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.
Time frame: Day 182
Pharmacokinetics of AIN457: Systemic Clearance From Serum Following Intravenous Administration (CL)
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.
Time frame: Day 182
Pharmacokinetics of AIN457: Terminal Elimination Half-life (T1/2)
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.
Time frame: Day 182
| Milestone | AIN457 | Placebo |
|---|---|---|
| Started | 18 | 18 |
| Completed | 18 | 18 |
| Not completed | 0 | 0 |
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.
| Percentage change in PASI mean score | AIN457 | Placebo |
|---|---|---|
| Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Mean Score | 58 | 4 |
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.
| days | AIN457 |
|---|---|
| Pharmacokinetics of AIN457: Time to Reach the Maximum Concentration After Drug Administration (Tmax) | 0.11 (0.08 to 0.17) |
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.
| ug/mL | AIN457 |
|---|---|
| Pharmacokinetics of AIN457: Observed Maximum Serum Concentration Following Drug Administration (Cmax) | 74.5 ± 13.1 |
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*ug/mL | AIN457 |
|---|---|
| AUClast | 1532 ± 343 |
| AUCinf | 1629 ± 361 |
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.
| Liters | AIN457 |
|---|---|
| Pharmacokinetics of AIN457: Volume of Distribution During the Terminal Phase Following Intravenous Elimination (Vz) | 7.31 ± 1.72 |
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.
| Liters/day | AIN457 |
|---|---|
| Pharmacokinetics of AIN457: Systemic Clearance From Serum Following Intravenous Administration (CL) | 0.18 ± 0.05 |
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.
| Percentage of participants | AIN457 | Placebo |
|---|---|---|
| Change in IGA score = -1 | 5.6 | 11.1 |
| Change in IGA score = 0 | 11.1 | 77.8 |
| Change in IGA score = 1 | 33.3 | 11.1 |
| Change in IGA score = 2 | 44.4 | 0 |
| Change in IGA score = 3 | 5.6 | 0 |
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 | AIN457 |
|---|---|
| Pharmacokinetics of AIN457: Terminal Elimination Half-life (T1/2) | 29.2 ± 6.4 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| AIN457A | — | 1/18 (5.6%) | 9/18 (50%) |
| Placebo | — | 0/18 (0%) | 8/18 (44.4%) |
| Event | AIN457A | Placebo |
|---|---|---|
| Cardiac failure congestiveCardiac disorders | 1/18 | 0/18 |
| Event | AIN457A | Placebo |
|---|---|---|
| FatigueGeneral disorders | 2/18 | 1/18 |
| Blood cholesterol increasedInvestigations | 2/18 | 0/18 |
| Blood glucose increasedInvestigations | 2/18 | 1/18 |
| Blood triglycerides increasedInvestigations | 2/18 | 2/18 |
| HypertensionVascular disorders | 2/18 | 1/18 |
| Corneal degenerationEye disorders | 0/18 | 1/18 |
| Abdominal distensionGastrointestinal disorders | 0/18 | 1/18 |
| NauseaGastrointestinal disorders | 1/18 | 0/18 |
| Oedema peripheralGeneral disorders | 1/18 | 0/18 |
| Fungal infectionInfections and infestations | 1/18 | 0/18 |
| Age, Continuous(Years) | AIN457 | Placebo | Total |
|---|---|---|---|
| Mean | 50.7 ± 8.73 | 50.9 ± 12.04 | 50.8 ± 10.37 |
| Sex: Female, Male(Participants) | AIN457 | Placebo | Total |
|---|---|---|---|
| Female | 11 | 13 | 24 |
| Male | 7 | 5 | 12 |
No study locations are listed for this record.
This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Novartis Pharmaceuticals