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Trial record 47 of 762 for:    plaque | "Psoriasis"

Phase II Efficacy Study Looking at a Single-dose of One of Three Dose Levels of AIN457 in Patients With Chronic Plaque-type Psoriasis

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ClinicalTrials.gov Identifier: NCT00770965
Recruitment Status : Completed
First Posted : October 10, 2008
Results First Posted : February 18, 2015
Last Update Posted : March 12, 2018
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Chronic Plaque Psoriasis
Interventions Biological: AIN457
Biological: Placebo
Enrollment 80

Recruitment Details A total of 80 participants were enrolled into the study. However, due to audit findings at one site, all 65 participants enrolled at the site were excluded from the planned efficacy analyses. As a result, efficacy could not be analyzed due to an insufficient number of participants. The safety set included participants from all other sites.
Pre-assignment Details  
Arm/Group Title AIN457 0.3 mg/kg AIN457 1.0 mg/kg AIN457 3.0 mg/kg Placebo
Hide Arm/Group Description Participants received AIN457 0.3 mg/kg IV on Day 1. Participants received AIN457 1.0 mg/kg IV on Day 1. Participants received AIN457 3.0 mg/kg IV on Day 1. Participants received placebo to AIN457A IV on day 1.
Period Title: Safety Set
Started 2 4 4 5
Completed 2 4 3 4
Not Completed 0 0 1 1
Reason Not Completed
Withdrawal by Subject             0             0             0             1
Protocol deviation             0             0             1             0
Period Title: Excluded Set
Started 18 16 16 15
Completed 3 3 2 2
Not Completed 15 13 14 13
Reason Not Completed
Administrative problems             14             12             12             10
Withdrawal by Subject             1             1             2             3
Arm/Group Title AIN457 0.3 mg/kg AIN457 1.0 mg/kg AIN457 3.0 mg/kg Placebo Total
Hide Arm/Group Description Participants received AIN457 0.3 mg/kg IV on Day 1. Participants received AIN457 1.0 mg/kg IV on Day 1. Participants received AIN457 3.0 mg/kg IV on Day 1. Participants received placebo to AIN457A IV on day 1. Total of all reporting groups
Overall Number of Baseline Participants 2 4 4 5 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2 participants 4 participants 4 participants 5 participants 15 participants
53.5  (9.19) 53.3  (11.79) 51.5  (8.35) 52.4  (14.05) 52.5  (10.38)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 4 participants 4 participants 5 participants 15 participants
Female
1
  50.0%
2
  50.0%
1
  25.0%
3
  60.0%
7
  46.7%
Male
1
  50.0%
2
  50.0%
3
  75.0%
2
  40.0%
8
  53.3%
1.Primary Outcome
Title Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores
Hide Description This study was not powered for efficacy. Due to audit findings at one site, which included 65 participants, all participants enrolled at the site were excluded from the planned efficacy analyses. As a result, efficacy could not be analyzed due to an insufficient number of participants.
Time Frame baseline, week 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AIN457 0.3 mg/kg AIN457 1.0 mg/kg AIN457 3.0 mg/kg Placebo
Hide Arm/Group Description:
Participants received AIN457 0.3 mg/kg IV on Day 1.
Participants received AIN457 1.0 mg/kg IV on Day 1.
Participants received AIN457 3.0 mg/kg IV on Day 1.
Participants received placebo to AIN457A IV on day 1.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Change From Baseline in PASI
Hide Description This study was not powered for efficacy. Due to audit findings at one site, which included 65 participants, all participants enrolled at site were excluded from the planned efficacy analyses. As a result, efficacy could not be analyzed due to an insufficient number of participants.
Time Frame baseline, weeks 12, 14, 16, 20, 24, 28 and 32
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AIN457 0.3 mg/kg AIN457 1.0 mg/kg AIN457 3.0 mg/kg Placebo
Hide Arm/Group Description:
Participants received AIN457 0.3 mg/kg IV on Day 1.
Participants received AIN457 1.0 mg/kg IV on Day 1.
Participants received AIN457 3.0 mg/kg IV on Day 1.
Participants received placebo to AIN457A IV on day 1.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Investigator Global Assessment (IGA) Scores
Hide Description This study was not powered for efficacy. Due to audit findings at one site, which included 65 participants, all participants enrolled at the site were excluded from the planned efficacy analyses. As a result, efficacy could not be analyzed due to an insufficient number of participants.
Time Frame baseline, day 1, weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AIN457 0.3 mg/kg AIN457 1.0 mg/kg AIN457 3.0 mg/kg Placebo
Hide Arm/Group Description:
Participants received AIN457 0.3 mg/kg IV on Day 1.
Participants received AIN457 1.0 mg/kg IV on Day 1.
Participants received AIN457 3.0 mg/kg IV on Day 1.
Participants received placebo to AIN457A IV on day 1.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title AIN457 0.3 mg/kg AIN457 1 mg/kg AIN457 3 mg/kg Placebo
Hide Arm/Group Description AIN457 0.3 mg/kg AIN457 1 mg/kg AIN457 3 mg/kg Placebo
All-Cause Mortality
AIN457 0.3 mg/kg AIN457 1 mg/kg AIN457 3 mg/kg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
AIN457 0.3 mg/kg AIN457 1 mg/kg AIN457 3 mg/kg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/20 (5.00%)   1/20 (5.00%)   0/20 (0.00%)   0/20 (0.00%) 
Gastrointestinal disorders         
FEMORAL HERNIA, OBSTRUCTIVE  1  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Injury, poisoning and procedural complications         
HIP FRACTURE  1  0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
AIN457 0.3 mg/kg AIN457 1 mg/kg AIN457 3 mg/kg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/20 (15.00%)   4/20 (20.00%)   5/20 (25.00%)   3/20 (15.00%) 
Gastrointestinal disorders         
ABDOMINAL PAIN  1  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
NAUSEA  1  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
NECROTISING COLITIS  1  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
VOMITING  1  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
APHTHOUS STOMATITIS  1  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%) 
GASTROOESOPHAGEAL REFLUX DISEASE  1  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%) 
General disorders         
CYST  1  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%) 
INFLUENZA LIKE ILLNESS  1  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%) 
OEDEMA PERIPHERAL  1  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Infections and infestations         
GENITAL HERPES  1  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%) 
HERPES ZOSTER  1  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%) 
NASOPHARYNGITIS  1  0/20 (0.00%)  2/20 (10.00%)  0/20 (0.00%)  1/20 (5.00%) 
SINUSITIS  1  0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%) 
TOOTH INFECTION  1  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%) 
PERIRECTAL ABSCESS  1  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%) 
PNEUMONIA  1  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%) 
Injury, poisoning and procedural complications         
BACK INJURY  1  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%) 
Metabolism and nutrition disorders         
HYPERTRIGLYCERIDAEMIA  1  0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%) 
Musculoskeletal and connective tissue disorders         
ARTHRALGIA  1  0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%) 
MUSCLE SPASMS  1  0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
MELANOCYTIC NAEVUS  1  0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%) 
Nervous system disorders         
DIZZINESS  1  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%) 
HEADACHE  1  0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  1/20 (5.00%) 
MIGRAINE  1  0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%) 
Psychiatric disorders         
DEPRESSION  1  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
INSOMNIA  1  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
PHARYNGOLARYNGEAL PAIN  1  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%) 
SINUS CONGESTION  1  1/20 (5.00%)  2/20 (10.00%)  0/20 (0.00%)  0/20 (0.00%) 
Skin and subcutaneous tissue disorders         
PSORIASIS  1  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
RASH  1  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%) 
Vascular disorders         
HYPERTENSION  1  2/20 (10.00%)  1/20 (5.00%)  1/20 (5.00%)  0/20 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
Results Point of Contact
Name/Title: Study Director
Organization: Novartis
Phone: 862-778-8300
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00770965     History of Changes
Other Study ID Numbers: CAIN457A2204
First Submitted: October 9, 2008
First Posted: October 10, 2008
Results First Submitted: February 2, 2015
Results First Posted: February 18, 2015
Last Update Posted: March 12, 2018