A Dose Ranging Study of AIN457 in Patients With Moderate to Severe Chronic Plaque-type Psoriasis

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Novartis ( Novartis Pharmaceuticals )

ClinicalTrials.gov Identifier:

NCT01071252

First received: February 18, 2010

Last updated: February 12, 2015

Last verified: February 2015

History of Changes

Results First Received: January 28, 2015

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Chronic Plaque-type Psoriasis
Interventions:	Drug: AIN457 Drug: Placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
AIN457 1x25mg	AIN457 25mg Subcutaneously as a single dose
AIN457 3x25mg	AIN457 25mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
AIN457 3x75mg	AIN457 75mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
AIN457 3x150mg	AIN457 150mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
Placebo	Placebo subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)

Participant Flow: Overall Study

	AIN457 1x25mg	AIN457 3x25mg	AIN457 3x75mg	AIN457 3x150mg	Placebo
STARTED	29	26	21	27	22
COMPLETED	14	16	17	20	11
NOT COMPLETED	15	10	4	7	11
unsatisfactory therapeutic effect	4	6	2	0	6
Withdrawal by Subject	8	2	1	2	3
administrative problems	1	1	0	2	1
Lost to Follow-up	1	0	1	2	0
Adverse Event	1	1	0	1	0
Death	0	0	0	0	1

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
AIN457 1x25mg	AIN457 25mg Subcutaneously as a single dose
AIN457 3x25mg	AIN457 25mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
AIN457 3x75mg	AIN457 75mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
AIN457 3x150mg	AIN457 150mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
Placebo	Placebo subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
Total	Total of all reporting groups

Baseline Measures

	AIN457 1x25mg	AIN457 3x25mg	AIN457 3x75mg	AIN457 3x150mg	Placebo	Total
Number of Participants [units: participants]	29	26	21	27	22	125
Age [units: years] Mean (Standard Deviation)	46.1 (12.65)	46.3 (13.43)	45.8 (12.36)	45.4 (11.64)	45.9 (10.88)	45.9 (12.07)
Gender [units: participants]
Female	9	4	7	6	8	34
Male	20	22	14	21	14	91

Outcome Measures

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1. Primary:

Percentage of Participants of Reponders of Psoriasis Area and Severity Index (PASI) 75 Achievement at Week 13 [ Time Frame: week 13 ]

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2. Secondary:

Percentage of Participants With Investigator’s Global Assessment (IGA) Response [ Time Frame: Week 2, 3, 5, 9, 13, 17, 21, 25, 29, 33, 37 ]

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3. Secondary:

Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) [ Time Frame: Week 2, 3, 5, 9, 13, 17, 21, 25, 29, 33, 37 ]

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4. Secondary:

To Assess the Time to Relapse [ Time Frame: 37 weeks ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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More Information

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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 agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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 Pharmaceuticals
phone: 862-778-8300

Responsible Party:	Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:	NCT01071252 History of Changes
Other Study ID Numbers:	CAIN457A2220 2009-016807-42
Study First Received:	February 18, 2010
Results First Received:	January 28, 2015
Last Updated:	February 12, 2015
Health Authority:	United States: Food and Drug Administration Canada: Health Canada Iceland: Icelandic Medicines Control Agency Estonia: The State Agency of Medicine Latvia: Agency of Medicines Japan: Pharmaceuticals and Medical Devices Agency

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