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

• Sponsor: Novartis Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00770965
• Collaborator: (none)
• Enrollment: 80
• Locations: 5
• Arms: 4
• Actual Duration (Months): 12.2
• Patients Per Site: 16
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief Summary

This is an exploratory, 4 arm, parallel group, placebo-controlled study comparing three doses of AIN457 to placebo. Subjects with a diagnosis of moderate to severe chronic plaque psoriasis will be randomized to receive either AIN457 at one of the three doses studied or placebo.

Condition or Disease	Intervention/Treatment	Phase
Chronic Plaque Psoriasis	Biological: AIN457; Biological: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Phase II Single Dose, Randomized, Double-blind, Multi-center, Parallel-group, Placebo-controlled Study to Assess the Efficacy of Three Dose Levels of AIN457 in Patients With Chronic Plaque-type Psoriasis
• Actual Study Start Date: Sep 10, 2008
• Actual Primary Completion Date: Sep 17, 2009
• Actual Study Completion Date: Sep 17, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AIN457 0.3 mg/kg Participants received AIN457 0.3 mg/kg IV on Day 1.	Biological: AIN457
Experimental: AIN457 1.0 mg/kg Participants received AIN457 1.0 mg/kg IV on Day 1.	Biological: AIN457
Experimental: AIN457 3.0 mg/kg Participants received AIN457 3.0 mg/kg IV on Day 1.	Biological: AIN457
Placebo Comparator: Placebo Participants received placebo to AIN457A IV on day 1.	Biological: Placebo

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores [baseline, week 4]

   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.

Secondary Outcome Measures

1. Change From Baseline in PASI [baseline, weeks 12, 14, 16, 20, 24, 28 and 32]

   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.

2. Investigator Global Assessment (IGA) Scores [baseline, day 1, weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Diagnosis of plaque psoriasis for at least 6 months prior to screening. The patients must meet all of the following criterion:

1. Coverage of the body surface area (BSA) of 10% or more with plaques

2. A score of 3 or more on the IGA (Investigator Global Assessment) scale

3. A PASI score of at least 12 at baseline;

Exclusion Criteria:

• Have forms of psoriasis other than the required "plaque psoriasis"

• Women of childbearing potential

• Recent use of investigational drugs or treatment with other biological therapies (wash-out periods required)

• Previous treatment with this investigational drug

• Subjects with active or history of clinically significant cardiac, kidney or liver abnormalities

Other protocol-defined inclusion/exclusion criteria may have applied.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigative Site	Santa Monica	California	United States	90404
2	Novartis Investigative Site	Louisville	Kentucky	United States	40217
3	Novartis Investigative Site	High Point	North Carolina	United States	27262
4	Novartis Investigative Site	Duncansville	Pennsylvania	United States	16634
5	Novartis Investigative Site	Nashville	Tennessee	United States	37215

Sponsors and Collaborators

• Novartis Pharmaceuticals

Investigators

• Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
• Principal Investigator: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT00770965
• Other Study ID Numbers: CAIN457A2204
• First Posted: Oct 10, 2008
• Last Update Posted: Mar 12, 2018
• Last Verified: Feb 1, 2018

• Keywords provided by Novartis Pharmaceuticals: Plaque psoriasis, skin condition, thickening, flaking, skin disease, autoimmune disease
• Additional relevant MeSH terms: Psoriasis

Study Results

Participant Flow

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.

Arm/Group Title	AIN457 0.3 mg/kg	AIN457 1.0 mg/kg	AIN457 3.0 mg/kg	Placebo
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
Period Title: Safety Set
STARTED	18	16	16	15
COMPLETED	3	3	2	2
NOT COMPLETED	15	13	14	13

Baseline Characteristics

Arm/Group Title	AIN457 0.3 mg/kg	AIN457 1.0 mg/kg	AIN457 3.0 mg/kg	Placebo	Total
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 Participants	2	4	4	5	15
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	53.5 (9.19)	53.3 (11.79)	51.5 (8.35)	52.4 (14.05)	52.5 (10.38)
Sex: Female, Male (Count of Participants)
Female	1 50%	2 50%	1 25%	3 60%	7 46.7%
Male	1 50%	2 50%	3 75%	2 40%	8 53.3%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	AIN457 0.3 mg/kg	AIN457 1.0 mg/kg	AIN457 3.0 mg/kg	Placebo
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.
Measure Participants	0	0	0	0

2. Secondary Outcome

Title	Change From Baseline in PASI
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	AIN457 0.3 mg/kg	AIN457 1.0 mg/kg	AIN457 3.0 mg/kg	Placebo
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.
Measure Participants	0	0	0	0

3. Secondary Outcome

Title	Investigator Global Assessment (IGA) Scores
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	AIN457 0.3 mg/kg	AIN457 1.0 mg/kg	AIN457 3.0 mg/kg	Placebo
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.
Measure Participants	0	0	0	0

Adverse Events

Arm/Group Title	AIN457 0.3 mg/kg		AIN457 1 mg/kg		AIN457 3 mg/kg		Placebo
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 (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	AIN457 0.3 mg/kg		AIN457 1 mg/kg		AIN457 3 mg/kg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/20 (5%)		1/20 (5%)		0/20 (0%)		0/20 (0%)
Gastrointestinal disorders
FEMORAL HERNIA, OBSTRUCTIVE	1/20 (5%)		0/20 (0%)		0/20 (0%)		0/20 (0%)
Injury, poisoning and procedural complications
HIP FRACTURE	0/20 (0%)		1/20 (5%)		0/20 (0%)		0/20 (0%)
Other (Not Including Serious) Adverse Events
	AIN457 0.3 mg/kg		AIN457 1 mg/kg		AIN457 3 mg/kg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/20 (15%)		4/20 (20%)		5/20 (25%)		3/20 (15%)
Gastrointestinal disorders
ABDOMINAL PAIN	1/20 (5%)		0/20 (0%)		0/20 (0%)		0/20 (0%)
NAUSEA	1/20 (5%)		0/20 (0%)		0/20 (0%)		0/20 (0%)
NECROTISING COLITIS	1/20 (5%)		0/20 (0%)		0/20 (0%)		0/20 (0%)
VOMITING	1/20 (5%)		0/20 (0%)		0/20 (0%)		0/20 (0%)
APHTHOUS STOMATITIS	0/20 (0%)		0/20 (0%)		1/20 (5%)		0/20 (0%)
GASTROOESOPHAGEAL REFLUX DISEASE	0/20 (0%)		0/20 (0%)		1/20 (5%)		0/20 (0%)
General disorders
CYST	0/20 (0%)		0/20 (0%)		0/20 (0%)		1/20 (5%)
INFLUENZA LIKE ILLNESS	0/20 (0%)		0/20 (0%)		1/20 (5%)		0/20 (0%)
OEDEMA PERIPHERAL	1/20 (5%)		0/20 (0%)		0/20 (0%)		0/20 (0%)
Infections and infestations
GENITAL HERPES	0/20 (0%)		0/20 (0%)		0/20 (0%)		1/20 (5%)
HERPES ZOSTER	0/20 (0%)		0/20 (0%)		0/20 (0%)		1/20 (5%)
NASOPHARYNGITIS	0/20 (0%)		2/20 (10%)		0/20 (0%)		1/20 (5%)
SINUSITIS	0/20 (0%)		1/20 (5%)		0/20 (0%)		0/20 (0%)
TOOTH INFECTION	0/20 (0%)		0/20 (0%)		0/20 (0%)		1/20 (5%)
PERIRECTAL ABSCESS	0/20 (0%)		0/20 (0%)		1/20 (5%)		0/20 (0%)
PNEUMONIA	0/20 (0%)		0/20 (0%)		0/20 (0%)		1/20 (5%)
Injury, poisoning and procedural complications
BACK INJURY	0/20 (0%)		0/20 (0%)		0/20 (0%)		1/20 (5%)
Metabolism and nutrition disorders
HYPERTRIGLYCERIDAEMIA	0/20 (0%)		1/20 (5%)		0/20 (0%)		0/20 (0%)
Musculoskeletal and connective tissue disorders
ARTHRALGIA	0/20 (0%)		1/20 (5%)		0/20 (0%)		0/20 (0%)
MUSCLE SPASMS	0/20 (0%)		1/20 (5%)		0/20 (0%)		0/20 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MELANOCYTIC NAEVUS	0/20 (0%)		1/20 (5%)		0/20 (0%)		0/20 (0%)
Nervous system disorders
DIZZINESS	0/20 (0%)		0/20 (0%)		1/20 (5%)		0/20 (0%)
HEADACHE	0/20 (0%)		1/20 (5%)		0/20 (0%)		1/20 (5%)
MIGRAINE	0/20 (0%)		1/20 (5%)		0/20 (0%)		0/20 (0%)
Psychiatric disorders
DEPRESSION	1/20 (5%)		0/20 (0%)		0/20 (0%)		0/20 (0%)
INSOMNIA	0/20 (0%)		0/20 (0%)		1/20 (5%)		0/20 (0%)
Respiratory, thoracic and mediastinal disorders
PHARYNGOLARYNGEAL PAIN	0/20 (0%)		0/20 (0%)		1/20 (5%)		0/20 (0%)
SINUS CONGESTION	1/20 (5%)		2/20 (10%)		0/20 (0%)		0/20 (0%)
Skin and subcutaneous tissue disorders
PSORIASIS	1/20 (5%)		0/20 (0%)		0/20 (0%)		0/20 (0%)
RASH	1/20 (5%)		0/20 (0%)		0/20 (0%)		0/20 (0%)
Vascular disorders
HYPERTENSION	2/20 (10%)		1/20 (5%)		1/20 (5%)		0/20 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.