Psoriasis, Plaque-type PsoriasisPhase 2NCT01537432

Multiple-dose Regimen Study to Assess Effect of 12 Months of Secukinumab Treatment on Skin Response and Biomarkers in Psoriasis Patients

A Phase 2 study testing secukinumab in people with Psoriasis, Plaque-type Psoriasis, run by Novartis Pharmaceuticals at 12 sites in United States.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Psoriasis, Plaque-type Psoriasis
What is being tested?: secukinumab
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 36 participants
Where: 12 sitesUnited States
Study dates: Jan 2012to Dec 2014
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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Chronic plaque-type psoriasis diagnosed for at least 6 months
Moderate to severe psoriasis as defined by: PASI score of ≥12, IGA score of ≥3, BSA (body surface area) affected by plaque-type psoriasis of ≥10%
Chronic plaque-type psoriasis considered inadequately controlled by: topical treatment and/or; phototherapy and/or previous systemic therapy

Who cannot join

Forms of psoriasis other than chronic plaque-type
Evidence of skin conditions at the time of the screening visit (e.g., eczema) that would interfere with evaluations of the effect of the investigational product on psoriasis
History or evidence of active tuberculosis or evidence of latent tuberculosis (or other infections like Hepatitis-C/B), malignancy; active or known use of other immunosuppressive drugs (for eg: AIDs, RA, organ rejection etc.) at the screening visit
Pregnant or nursing (lactating) women

Trial locations and contacts

12 sites in 1 country.

City, postcode or hospital

12 sites in 1 country

United States12 sites

Novartis Investigative Site
Birmingham, Alabama, 35205
Novartis Investigative Site
Dallas, Texas, 75230
Novartis Investigative Site
East Windsor, New Jersey, 08520
Novartis Investigative Site
High Point, North Carolina, 27262
Novartis Investigative Site
Houston, Texas, 77030
Novartis Investigative Site
Indianapolis, Indiana, 46256
Novartis Investigative Site
New York, New York, 10065
Novartis Investigative Site
Norfolk, Virginia, 23507
Novartis Investigative Site
Pasadena, California, 91105
Novartis Investigative Site
Rochester, New York, 14623
Novartis Investigative Site
St Louis, Missouri, 63117
Novartis Investigative Site
Verona, New Jersey, 07044

Other trials in United States

About this study

Official title: Phase II Randomized Double Blinded Placebo Controlled, Multiple-dose Regimen Study to Assess the Rate of Histological Clearance and Effect on Molecular Pathways as Well as on Biomarkers of 12 Months Secukinumab 300 mg s.c. Treated Patients With Chronic Plaque-type Psoriasis

This study is designed to evaluate the proportion of patients achieving reversal of chronic plaque psoriasis at week 4 and 12 following multiple doses of secukinumab administered subcutaneously (sc) compared to placebo. Starting from week 13, all patients will receive multiple doses of secukinumab up to week 52 to study long term effects of secukinumab. Clinical endpoints including biomarker assessments, PASI, IGA and DLQI will be compared to better understand, why secukinumab may be effective in psoriasis patients.

Conditions: Psoriasis, Plaque-type Psoriasis
Being tested: secukinumab, placebo
Keywords: Psoriasis, Plaque-type psoriasis, Plaque, Secukinumab, AIN457A, PASI, DLQI, IGA
Medical subject headings: Psoriasis, Plaque, Amyloid

What participants receive

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

secukinumabDrug
secukinumab
placeboDrug
placebo comparator

Study groups in NCT01537432
Study group	Role	What they receive
placebo	Placebo comparator	placebo Receives: Drug: placebo
secukinumab	Experimental	secukinumab Receives: Drug: secukinumab

What is being measured

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

Percentage of Participants Achieving Skin Histology Response After Secukinumab Treatment From Baseline to Week 12
Histological sections of lesional and nonlesional skin biopsies at baseline and at Week 12 were examined. For each visit, each patient's lesional skin biopsy was scored for the degree of histological improvement compared to that patient's baseline disease on a five point scale; -
1 (worse) to +3 (excellent). Histological disease reversal or "excellent improvement" (histological disease reversal score = 3) was declared at the endpoint when all of the following four criteria were met.
Measured: Baseline, Week 12

Secondary outcomes (1)

Percentage of Participants Achieving Skin Histological Disease Reversal at Week 52
Histological sections of lesional and nonlesional skin biopsies at Week 52 were examined. For each visit, each patient's lesional skin biopsy was scored for the degree of histological improvement compared to that patient's baseline disease on a five point scale; -
1 (worse) to +3 (excellent). Histological disease reversal or "excellent improvement" (histological disease reversal score = 3) was declared at the endpoint when all of the following four criteria were met.
Measured: Week 52

Timeline

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

Jan 2012Dec 2014

First posted23 Feb 2012 (estimated)
Study startJan 2012
Primary completionDec 2014
Study completionDec 2014

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 Psoriasis, Plaque-type 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: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01537432
Sponsor's protocol ID: CAIN457A2223
Status last verified: Nov 2015
First submitted: 17 Feb 2012
Last updated: 5 Jan 2016
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?

See locations

RecruitingObservational study
Serum Substance P, Neuropathic Pain, and Central Sensitization Across Treatment Groups in Chronic Plaque Psoriasis
Chronic Plaque-type Psoriasis
Recruiting
Clinical Study on the Medical Devices PROXERA PSOMED 20 and PROXERA PSOMED 40 for the Treatment of Plaque Psoriasis and Non-pustular Palmoplantar Psoriasis
Plaque Type Psorisis, Non-pustular Palmoplantar Psoriasis
Not yet recruitingPhase 2/3
A Clinical Study Evaluating the Efficacy and Safety of CMS-D001 Tablets in the Treatment of Adult Patients With Moderate to Severe Plaque-type Psoriasis
Moderate to Severe Plaque Psoriasis
RecruitingPhase 2
Acupuncture With Chinese Herbal Cream Compare With Acupuncture With Calcipotriol in Plaque Psoriasis.
Plaque Type Psorisis
RecruitingObservational study
SKIN Disease Profiling by an Exploratory, pRospective, Biomarker Study in dermatoloGY Practice (SKINERGY)
Chronic Spontaneous Urticaria (CSU), Hidradenitis Suppurativa (HS)

All Psoriasis, Plaque-type Psoriasis trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase II Randomized Double Blinded Placebo Controlled, Multiple-dose Regimen Study to Assess the Rate of Histological Clearance and Effect on Molecular Pathways as Well as on Biomarkers of 12 Months Secukinumab 300 mg s.c. Treated Patients With Chronic Plaque-type Psoriasis
ClinicalTrials.gov ID: NCT01537432
Acronym / sponsor ID: CAIN457A2223
Conditions: Psoriasis, Plaque-type Psoriasis
Keywords: Psoriasis, Plaque-type psoriasis, Plaque, Secukinumab, AIN457A, PASI, DLQI, IGA
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Jan 2012
Primary completion: Dec 2014 (actual)
Study completion: Dec 2014 (actual)
First posted: 23 Feb 2012 (estimated)
Results: Posted 5 Jan 2016

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: 2

Arm	Type	Receives
placebo	Placebo comparator	Drug: placeboplacebo
secukinumab	Experimental	Drug: secukinumabsecukinumab

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Chronic plaque-type psoriasis diagnosed for at least 6 months
Moderate to severe psoriasis as defined by: PASI score of ≥12, IGA score of ≥3, BSA (body surface area) affected by plaque-type psoriasis of ≥10%
Chronic plaque-type psoriasis considered inadequately controlled by: topical treatment and/or; phototherapy and/or previous systemic therapy

Key exclusion criteria (4 listed)

Forms of psoriasis other than chronic plaque-type
Evidence of skin conditions at the time of the screening visit (e.g., eczema) that would interfere with evaluations of the effect of the investigational product on psoriasis
History or evidence of active tuberculosis or evidence of latent tuberculosis (or other infections like Hepatitis-C/B), malignancy; active or known use of other immunosuppressive drugs (for eg: AIDs, RA, organ rejection etc.) at the screening visit
Pregnant or nursing (lactating) women

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
secukinumabsecukinumab	Drug	secukinumab
placeboplacebo comparator	Drug	placebo

Primary outcome

Percentage of Participants Achieving Skin Histology Response After Secukinumab Treatment From Baseline to Week 12
Time frame: Baseline, Week 12
Histological sections of lesional and nonlesional skin biopsies at baseline and at Week 12 were examined. For each visit, each patient's lesional skin biopsy was scored for the degree of histological improvement compared to that patient's baseline disease on a five point scale; - 1 (worse) to +3 (excellent). Histological disease reversal or "excellent improvement" (histological disease reversal score = 3) was declared at the endpoint when all of the following four criteria were met.

1 secondary outcome

Percentage of Participants Achieving Skin Histological Disease Reversal at Week 52
Time frame: Week 52

Results and safety

Results posted to the registry on 5 Jan 2016, 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 300mg	24	18
Placebo	12	10

Primary outcome: Percentage of Participants Achieving Skin Histology Response After Secukinumab Treatment From Baseline to Week 12

Time frame: Baseline, Week 12. Number. Unit: percentage of participants

Measure	AIN457 300mg n = 23	Placebo n = 12
Value	56.5	0.0

AIN457 300mg vs Placebo: difference in proportions: 0.565 (95% CI 0.363 to 0.768), p <0.001, Fisher Exact

Population analysed: PharmacoDynamic PD -All patients with at least one evaluable post-treatment PD measurement and no protocol deviations with relevant impact on PD data.

1 secondary outcome is 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 300 mg	1 of 24 (4.2%)	13 of 24 (54.2%)	Not reported
Placebo	0 of 12 (0%)	8 of 12 (66.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Psoriasis, Plaque-type Psoriasis

RecruitingObservational study
Serum Substance P, Neuropathic Pain, and Central Sensitization Across Treatment Groups in Chronic Plaque Psoriasis
Chronic Plaque-type Psoriasis
Recruiting
Clinical Study on the Medical Devices PROXERA PSOMED 20 and PROXERA PSOMED 40 for the Treatment of Plaque Psoriasis and Non-pustular Palmoplantar Psoriasis
Plaque Type Psorisis, Non-pustular Palmoplantar Psoriasis
Not yet recruitingPhase 2/3
A Clinical Study Evaluating the Efficacy and Safety of CMS-D001 Tablets in the Treatment of Adult Patients With Moderate to Severe Plaque-type Psoriasis
Moderate to Severe Plaque Psoriasis
RecruitingPhase 2
Acupuncture With Chinese Herbal Cream Compare With Acupuncture With Calcipotriol in Plaque Psoriasis.
Plaque Type Psorisis
RecruitingObservational study
SKIN Disease Profiling by an Exploratory, pRospective, Biomarker Study in dermatoloGY Practice (SKINERGY)
Chronic Spontaneous Urticaria (CSU), Hidradenitis Suppurativa (HS)

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

12 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing secukinumab in people with Psoriasis, Plaque-type Psoriasis, run by Novartis Pharmaceuticals at 12 sites in United States.

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 3 inclusion and 4 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 5 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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 5 Jan 2016). 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?

Percentage of Participants Achieving Skin Histology Response After Secukinumab Treatment From Baseline to Week 12 (time frame: Baseline, Week 12). 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 NCT01537432.

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 5 Jan 2016.