Chronic Plaque PsoriasisPhase 2NCT00805480

Multiple-loading Dose Regimen Study in Patients With Chronic Plaque-type Psoriasis

A Phase 2 study testing AIN457 in people with Chronic Plaque Psoriasis, run by Novartis Pharmaceuticals.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Loading dose, four arm, double-blind, parallel group, placebo-controlled study comparing single and multiple doses of AIN457 to placebo in patients with a diagnosis of moderate to severe chronic plaque psoriasis. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Chronic Plaque Psoriasis
What is being tested?: AIN457
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 130 participants
Where: No sites listed yet
Study dates: Dec 2008to Sep 2010
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of plaque psoriasis for at least 6 months prior to screening. The patients must meet all of the following criterion:
Coverage of the body surface area (BSA) of 10% or more with plaques
A score of 3 or more on the IGA scale
A PASI score of at least 12 at baseline

Who cannot join

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 apply

About this study

Official title: Phase II Randomized, Double-blind, Multi-center, Parallel-group, Placebo-controlled Multiple-loading Dose Regimen Study to Assess the Safety, Efficacy and Duration of Response of AIN457 in Patients With Chronic Plaque-type Psoriasis.

Conditions: Chronic Plaque Psoriasis
Being tested: AIN457, Placebo
Keywords: Plaque, psoriasis, inflammatory skin disease, skin condition, thickening, flaking, scaly patches, skin disease
Medical subject headings: Plaque, Amyloid, Psoriasis, Dermatitis, Skin Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AIN457Drug
Also called Secukinumab
AIN457 was administered intravenously.
PlaceboDrug
Matching placebo to AIN457 was administered intravenously.

Study groups in NCT00805480
Study group	Role	What they receive
AIN457 3 mg/kg	Experimental	Participants randomized to this arm received AIN457 3 mg/kg on day 1, and then matching placebo on days 15 and 29. Receives: Drug: AIN457; Drug: Placebo
AIN457 10 mg/kg	Experimental	Participants randomized to this arm received AIN457 10 mg/kg on day 1, and then matching placebo on days 15 and 29. Receives: Drug: AIN457; Drug: Placebo
AIN457 10 mg/kg x3	Experimental	Participants randomized to this arm received AIN457 3 mg/kg on days 1, 15 and 29. Receives: Drug: AIN457
Placebo	Placebo comparator	Participants randomized to this arm received matching placebo to AIN457 on days 1, 15 and 29 Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores
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).
Measured: Baseline, Week 12
Percentage of Participants Who Had Not Relapsed at Any Time in the Trial
This outcome measure shows the proportion of participants in each of the AIN457 treatment groups who were relapse free throughout the study up to and including week 56.
Measured: Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 56

Secondary outcomes (3)

Percentage of Participants With at Least 50% 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).
Measured: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, end of study (EOS) (up to week 56)
Percentage of Participants With at Least 75% or 90% 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).
Measured: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, EOS (up to week 56)
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
The IGA 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, 4 = severe and 5 = very severe.
Measured: Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, EOS (up to week 56)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2008Sep 2010

First posted9 Dec 2008 (estimated)
Study startDec 2008
Primary completionSep 2010
Study completionSep 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Chronic Plaque PsoriasisStudies of the same condition, open and under way.
More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 130 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00805480
Sponsor's protocol ID: CAIN457A2212
Status last verified: Jan 2015
First submitted: 5 Dec 2008
Last updated: 10 Feb 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 4
An Open Label Trial to Evaluate Efficacy and Safety of Roflumilast 0.3% Cream for Chronic Plaque and Nail Psoriasis
Chronic Plaque Psoriasis, Nail Psoriasis
RecruitingPhase 2
Early Intervention in Plaque Psoriasis: is Bimekizumab Able to Delay Chronic Inflammation?
Psoriasis
RecruitingObservational study
Serum Substance P, Neuropathic Pain, and Central Sensitization Across Treatment Groups in Chronic Plaque Psoriasis
Chronic Plaque-type Psoriasis
Active, not recruitingPhase 3
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Participants
Psoriasis
Not yet recruitingPhase 2
Comparative Study on Unani Formulation Vs Active Control in Plaque Psoriasis
Chronic Plaque Psoriasis, Plaque Psoriasis

All Chronic Plaque Psoriasis trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase II Randomized, Double-blind, Multi-center, Parallel-group, Placebo-controlled Multiple-loading Dose Regimen Study to Assess the Safety, Efficacy and Duration of Response of AIN457 in Patients With Chronic Plaque-type Psoriasis.
ClinicalTrials.gov ID: NCT00805480
Acronym / sponsor ID: CAIN457A2212
Conditions: Chronic Plaque Psoriasis
Keywords: Plaque, psoriasis, inflammatory skin disease, skin condition, thickening, flaking, scaly patches, skin disease
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 130 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Dec 2008
Primary completion: Sep 2010 (actual)
Study completion: Sep 2010 (actual)
First posted: 9 Dec 2008 (estimated)
Results: Posted 10 Feb 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
AIN457 3 mg/kg	Experimental	Drug: AIN457, Drug: PlaceboParticipants randomized to this arm received AIN457 3 mg/kg on day 1, and then matching placebo on days 15 and 29.
AIN457 10 mg/kg	Experimental	Drug: AIN457, Drug: PlaceboParticipants randomized to this arm received AIN457 10 mg/kg on day 1, and then matching placebo on days 15 and 29.
AIN457 10 mg/kg x3	Experimental	Drug: AIN457Participants randomized to this arm received AIN457 3 mg/kg on days 1, 15 and 29.
Placebo	Placebo comparator	Drug: PlaceboParticipants randomized to this arm received matching placebo to AIN457 on days 1, 15 and 29

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (6 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AIN457Also: SecukinumabAIN457 was administered intravenously.	Drug	AIN457 10 mg/kg, AIN457 10 mg/kg x3, AIN457 3 mg/kg
PlaceboMatching placebo to AIN457 was administered intravenously.	Drug	AIN457 10 mg/kg, AIN457 3 mg/kg, Placebo

Primary outcome

Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores
Time frame: Baseline, Week 12
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).
Percentage of Participants Who Had Not Relapsed at Any Time in the Trial
Time frame: Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 56
This outcome measure shows the proportion of participants in each of the AIN457 treatment groups who were relapse free throughout the study up to and including week 56.

3 secondary outcomes

Percentage of Participants With at Least 50% Improvement From Baseline in PASI
Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, end of study (EOS) (up to week 56)
Percentage of Participants With at Least 75% or 90% Improvement From Baseline in PASI
Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, EOS (up to week 56)
Percentage of Participants in Each Investigator Global Assessment (IGA) Category
Time frame: Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, EOS (up to week 56)

Results and safety

Results posted to the registry on 10 Feb 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AIN457 3 mg/kg	30	16
AIN457 10 mg/kg	29	22
AIN457 10 mg/kg x3	31	19
Placebo	10	5

Primary outcome: Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores

Time frame: Baseline, Week 12. Mean (Standard Deviation). Unit: scores on a scale

Measure	AIN457 3 mg/kg n = 27	AIN457 10 mg/kg n = 23	AIN457 10 mg/kg x3 n = 27	Placebo n = 5
Value	-12.46 (7.668)	-13.35 (6.195)	-18.02 (6.792)	-4.18 (4.698)

Population analysed: Participants from the PD Analysis Set, who had both baseline and week 12 values, were included in the analysis. As such, the population for each treatment group is different from the PD population in the participant flow. The PD analysis set included participants who had at least one dose of study medication and had no protocol deviations.

Primary outcome: Percentage of Participants Who Had Not Relapsed at Any Time in the Trial

Time frame: Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 56. Number. Unit: Percentage of participants

Measure	AIN457 3 mg/kg n = 30	AIN457 10 mg/kg n = 25	AIN457 10 mg/kg x3 n = 29
Week 1 (n=30,25,29)	100.0	100.0	100.0
Week 2 (n=30,25,28)	100.0	100.0	96.6
Week 4 (n=30,25,27)	100.0	100.0	93.1
Week 6 (n=30,24,27)	100.0	96.0	93.1
Week 8 (n=30,24,27)	100.0	96.0	93.1
Week 10 (n=28,22,27)	93.3	88.0	93.1
Week 12 (n=23,22,27)	76.7	88.0	93.1
Week 14 (n=20,20,27)	66.7	80.0	93.1

Population analysed: PD analysis set participants (AIN457 groups only), who had not yet relapsed were included in the analysis at each time point. As a result, the number of participants at risk for relapse may decrease as the number of weeks on study increases. The PD set included participants who had at least one dose of study medication and no protocol deviations.

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AIN457 3 mg/kg	2 of 30 (6.7%)	15 of 30 (50%)	Not reported
AIN457 10 mg/kg	3 of 29 (10.3%)	22 of 29 (75.9%)	Not reported
AIN457 10 mg/kg x3	2 of 31 (6.5%)	19 of 31 (61.3%)	Not reported
Placebo	0 of 10 (0%)	3 of 10 (30%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Chronic Plaque Psoriasis

RecruitingPhase 4
An Open Label Trial to Evaluate Efficacy and Safety of Roflumilast 0.3% Cream for Chronic Plaque and Nail Psoriasis
Chronic Plaque Psoriasis, Nail Psoriasis
RecruitingPhase 2
Early Intervention in Plaque Psoriasis: is Bimekizumab Able to Delay Chronic Inflammation?
Psoriasis
RecruitingObservational study
Serum Substance P, Neuropathic Pain, and Central Sensitization Across Treatment Groups in Chronic Plaque Psoriasis
Chronic Plaque-type Psoriasis
Active, not recruitingPhase 3
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Participants
Psoriasis
Not yet recruitingPhase 2
Comparative Study on Unani Formulation Vs Active Control in Plaque Psoriasis
Chronic Plaque Psoriasis, Plaque Psoriasis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Novartis Pharmaceuticals study director

Novartis Pharmaceuticals

Novartis principal investigator

Novartis Investigator Site

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AIN457 in people with Chronic Plaque Psoriasis, run by Novartis Pharmaceuticals.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores (time frame: Baseline, Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00805480.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2015.