Trials Sponsors Conditions Drugs Pricing

Conditions

Plaque-type Psoriasis

Keywords

Psoriasisplaqueinflammatory skin diseasescaly patchesAIN457secukinumabModerate to severe

Outcome Measures

Primary Outcomes (2)

Percentage of Participants (Who Achieved a Partial Response Defined as ≥ 50% But < 75% Improvement in Psoriasis Area and Severity Index (PASI) After 12 Weeks of Treatment in Study AIN457A2304) With 75% Improvement From Baseline in PASI
PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).
Week 8
Percentage of Participants (Who Achieved a Partial Response Defined as ≥ 50% But < 75% Improvement in PASI After 12 Weeks of Treatment in Study AIN457A2304) With Investigator's Global Assessment Model 2011 (IGA Mod 2011) 0 or 1 Response
The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. Treatment success was defined as achievement of IGA mod 2001 score of 0 or 1.
Week 8

Secondary Outcomes (8)

Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40
Mean Percent Change From Baseline in PASI Scores
Baseline, weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40
Percentage of Participants in Each IGA Mod 2011 Score Category
Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40
Percentage of Participants Who Achieved Dermatology Life Quality Index (DLQI) of 0 or 1
Baseline, Week 8, Week 16, Week 24, Week 32,up to Week 40
Mean Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Scores
Baseline, weeks 8, 16, 24, 32 and 40
+3 more secondary outcomes

Study Arms (2)

AIN457 subcutaneous (s.c.)

EXPERIMENTAL

During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.

Drug: secukinumab 150mg

AIN457 I.V.

EXPERIMENTAL

During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.

Drug: secukinumab 10mg/kg i.v. regimen

Interventions

secukinumab 150mgDrug

secukinumab 150mg (2 injections per dose)

AIN457 subcutaneous (s.c.)

secukinumab 10mg/kg i.v. regimenDrug

secukinumab 10mg/kg i.v. regimen

AIN457 I.V.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Written Informed Consent must be obtained before any assessment is performed,
Subject must be able to understand and communicate with the investigator and comply with the requirements of the study.

Sponsors & Collaborators

Novartis Pharmaceuticals
Industrylead

Study Sites (27)

Novartis Investigative Site

Jacksonville, Florida, 32216, United States

Novartis Investigative Site

West Palm Beach, Florida, 33409, United States

Novartis Investigative Site

Boston, Massachusetts, 02111, United States

Novartis Investigative Site

St Louis, Missouri, 63117, United States

Novartis Investigative Site

Greensboro, North Carolina, 27401, United States

Novartis Investigative Site

Greer, South Carolina, 29651, United States

Novartis Investigative Site

Wels, Austria, 4600, Austria

MeSH Terms

Conditions

PsoriasisPlaque, AmyloidDermatitis

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Results Point of Contact

Title: Study Director
Organization: Novartis

Study Officials

Novartis Pharmaceuticals
Novartis Pharmaceuticals
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: OTHER
Restrictive Agreement: Yes

Enrollment

43 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

August 5, 2011

First Posted

August 9, 2011

Study Start

December 2011

Date type not reported

This date has not been verified as actual or estimated.

Efficacy and Safety of Intravenous and Subcutaneous Secukinumab in Moderate to Severe Chronic Plaque-type Psoriasis

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (8)

Study Arms (2)

AIN457 subcutaneous (s.c.)

AIN457 I.V.

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (27)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (8)

Study Arms (2)

AIN457 subcutaneous (s.c.)

AIN457 I.V.

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (27)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations