Plaque-type PsoriasisPhase 2NCT01132612

AIN457 Regimen Finding Extension Study in Participants With Moderate to Severe Psoriasis

A Phase 2 study testing AIN457 in people with Plaque-type Psoriasis, run by Novartis Pharmaceuticals at 57 sites in 7 countries.

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

The purpose of this study was to provide long term clinical data for the compound for the treatment of the indication of moderate to severe chronic plaque-type psoriasis. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Plaque-type 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: 275 participants
Where: 57 sitesin 7 countries
Study dates: 11 May 2010to 18 Oct 2016
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients who completed the core study CAIN457A2211. A patient is defined as having completed the core study if he/she completed the study up to and including visit 13 (F4) of the core study
Patients must be able to understand and communicate with the investigator and comply with the requirement of the study and must given written, signed and dated informed consent before any study assessment is performed.
Patients must be expected to benefit from the ongoing treatment with AIN457, as assessed by the patient and investigator
Male patients must consent to practice reliable contraception during the study and for 16 weeks after the last dose of study drug administration Note: Due to new data available from the toxicology studies, the need for male contraception was removed.

Who cannot join

Patients who experience a second consecutive full relapse at visit 13 ( week F4) of the core study CAIN457A2211
Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until termination of gestation, confirmed by a positive hCG laboratory test (> 5mlU/mL)
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unwilling to use effective contraception during the study and for 16 weeks after stopping treatment.

Trial locations and contacts

57 sites in 7 countries.

Country

City, postcode or hospital

57 sites in 7 countries

United States25 sites

Novartis Investigative Site
Austin, Texas, 78759
Novartis Investigative Site
Birmingham, Alabama, 35233
Novartis Investigative Site
Champaign, Illinois, 61820
Novartis Investigative Site
Charlottesville, Virginia, 22911
Novartis Investigative Site
Clinton Township, Michigan, 48038
Novartis Investigative Site
Dallas, Texas, 75204
Novartis Investigative Site
Detroit, Michigan, 48202
Novartis Investigative Site
Evansville, Indiana, 47713
Novartis Investigative Site
Henderson, Nevada, 89052
Novartis Investigative Site
High Point, North Carolina, 27262
Novartis Investigative Site
Lake Oswego, Oregon, 97035
Novartis Investigative Site
Little Rock, Arkansas, 72205
Novartis Investigative Site
Louisville, Kentucky, 40291
Novartis Investigative Site
Minneapolis, Minnesota, 55455
Novartis Investigative Site
Newnan, Georgia, 30263
Novartis Investigative Site
Omaha, Nebraska, 68131
Novartis Investigative Site
Omaha, Nebraska, 68144
Novartis Investigative Site
Pasadena, California, 91105
Novartis Investigative Site
Portland, Oregon, 97210
Novartis Investigative Site
Rochester, New York, 14623
Novartis Investigative Site
San Diego, California, 92123
Novartis Investigative Site
Snellville, Georgia, 30078
Novartis Investigative Site
Springfield, Illinois, 62703
Novartis Investigative Site
St Louis, Missouri, 63117
Novartis Investigative Site
Topeka, Kansas, 66606

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Germany13 sites

Novartis Investigative Site
Berlin, 10117
Novartis Investigative Site
Bonn, 53105
Novartis Investigative Site
Dresden, 01307
Novartis Investigative Site
Erlangen, 91054
Novartis Investigative Site
Frankfurt, 60590
Novartis Investigative Site
Göttingen, 37075
Novartis Investigative Site
Hamburg, 20354
Novartis Investigative Site
Hanover, 30625
Novartis Investigative Site
Kiel, 24105
Novartis Investigative Site
Lübeck, 23538
Novartis Investigative Site
Mainz, 55131
Novartis Investigative Site
Münster, 48149
Novartis Investigative Site
Tübingen, 72076

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Japan10 sites

Novartis Investigative Site
Bunkyo-ku, Tokyo, 113-8655
Novartis Investigative Site
Chitose, Hokkaido, 066-0021
Novartis Investigative Site
Fukuoka, Fukuoka, 814-0180
Novartis Investigative Site
Kitakyushu, Fukuoka, 807-8556
Novartis Investigative Site
Kurume, Fukuoka, 830-0011
Novartis Investigative Site
Maebashi, Gunma, 371-8511
Novartis Investigative Site
Minato-ku, Tokyo, 105-8471
Novartis Investigative Site
Nagoya, Aichi-ken, 467-8602
Novartis Investigative Site
Shinagawa-ku, Tokyo, 141 8625
Novartis Investigative Site
tabashi City, Tokyo, 173-8610

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Israel3 sites

Novartis Investigative Site
Afula, 1834111
Novartis Investigative Site
Petah Tikva, 49100
Novartis Investigative Site
Ramat Gan, 5265601

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Norway3 sites

Novartis Investigative Site
Ålesund, 6017
Novartis Investigative Site
Bergen, NO-5021
Novartis Investigative Site
Oslo, 0424

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France2 sites

Novartis Investigative Site
Nice, 06202
Novartis Investigative Site
Toulouse, 31400

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Iceland1 site

Novartis Investigative Site
Kopavogur, 201

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About this study

Official title: A Multicenter Extension Trial of Subcutaneously Administered AIN457 in Participants With Moderate to Severe Chronic Plaque-type Psoriasis

The purpose of this study was to provide long term clinical data for the compound for the treatment of the indication of moderate to severe chronic plaque-type psoriasis.

Read the detailed description

In the Proof-of-Concept study (CAIN457A2102/ NCT00669916), AIN457 was proven to be efficacious in the treatment of moderate to severe chronic plaque-type psoriasis. As a result, a phase IIb regimen finding study had been started (CAIN457A2211/NCT00941031).

The data gathered in this extension study of the core study (CAIN457A2211)was used to expand the safety database of the compound for the treatment of moderate to severe chronic plaque-type psoriasis. The participants in the extension study continued to stay on the exact same treatment regimen they were taking when completing the core study. The extension trial was first designed to provide long-term safety data of up to 100 weeks of treatment (32 weeks in the core study plus 68 weeks in the extension study (part 1)), and an additional 12 weeks of treatment-free follow-up for participants who did not continue in the extension study. Amendment 2 provided an additional 156 weeks of treatment (32 weeks in the core study plus 224 weeks in the extension study, equaling 256 weeks of total treatment (part 2)), before participants entered the 12 weeks of treatment-free follow-up. Protocol Amendment 3 extended the prolongation part of the study by up to 104 additional weeks of treatment (part 3) or until the drug was commercially available in the market of the country of participation, whichever occurred first.

Conditions: Plaque-type Psoriasis
Being tested: AIN457, Placebo
Keywords: Chronic plaque-type psoriasis, AIN457, dermatology, Moderate to severe chronic plaque-type psoriasis

What participants receive

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

AIN457Drug
AIN457A 150 mg powder for solution
PlaceboDrug
Placebo to AIN457A 150 mg powder for solution

Study groups in NCT01132612
Study group	Role	What they receive
Fixed-time interval regimen	Experimental	Secukinumab 150 mg subcutaneous (sc) administered at Week 1 (baseline) of the extension study and every 12 weeks thereafter Receives: Drug: AIN457; Drug: Placebo
Treatment at start of relapse regimen	Experimental	Placebo administered at Week 1 (baseline) of the extension study and every 12 weeks thereafter. If relapse, then switch to secukinumab 150 mg sc administered every 4 weeks Receives: Drug: AIN457; Drug: Placebo
Open-label	Experimental	Secukinumab 150 mg sc administered every 4 weeks Receives: Drug: AIN457

What is being measured

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

Number of Participants With Adverse Events, Serious Adverse Events and Deaths
Safety was assessed by frequency of adverse events including serious adverse events.
Measured: up to week 351

Secondary outcomes (2)

Number of Participants With at Least 50%, 75% or 90% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) and IGA Mod 2009 0 or 1 Response
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). 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: Extension weeks: 1, 25, 73 and 301 (too few data points were available to perform analysis at week 301)
Long-term Immunogenicity Assessed by the Number of Participants Developing Anti Secukinumab Antibodies During the Trial
Describes the number of participants tested positive for anti-secukinumab antibodies. It refers to the number of participants who had no positive values at baseline but developed them only after start of secukinumab treatment.
Measured: up to week 351

Timeline

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

11 May 201018 Oct 2016

First posted28 May 2010 (estimated)
Study start11 May 2010
Primary completion18 Oct 2016
Study completion18 Oct 2016

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 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: 275 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01132612
Sponsor's protocol ID: CAIN457A2211E1
Other IDs: 2009-017234-51, 2009
Status last verified: Dec 2017
First submitted: 19 May 2010
Last updated: 4 Jan 2018
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 Plaque-type Psoriasis trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter Extension Trial of Subcutaneously Administered AIN457 in Participants With Moderate to Severe Chronic Plaque-type Psoriasis
ClinicalTrials.gov ID: NCT01132612
Acronym / sponsor ID: CAIN457A2211E1
Conditions: Plaque-type Psoriasis
Keywords: Chronic plaque-type psoriasis, AIN457, dermatology, Moderate to severe chronic plaque-type psoriasis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 275 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 11 May 2010 (actual)
Primary completion: 18 Oct 2016 (actual)
Study completion: 18 Oct 2016 (actual)
First posted: 28 May 2010 (estimated)
Results: Posted 5 Dec 2017

Clinical summary

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

The purpose of this study was to provide long term clinical data for the compound for the treatment of the indication of moderate to severe chronic plaque-type psoriasis.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Fixed-time interval regimen	Experimental	Drug: AIN457, Drug: PlaceboSecukinumab 150 mg subcutaneous (sc) administered at Week 1 (baseline) of the extension study and every 12 weeks thereafter
Treatment at start of relapse regimen	Experimental	Drug: AIN457, Drug: PlaceboPlacebo administered at Week 1 (baseline) of the extension study and every 12 weeks thereafter. If relapse, then switch to secukinumab 150 mg sc administered every 4 weeks
Open-label	Experimental	Drug: AIN457Secukinumab 150 mg sc administered every 4 weeks

Who may qualify

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

Key inclusion criteria (4 listed)

Patients who completed the core study CAIN457A2211. A patient is defined as having completed the core study if he/she completed the study up to and including visit 13 (F4) of the core study
Patients must be able to understand and communicate with the investigator and comply with the requirement of the study and must given written, signed and dated informed consent before any study assessment is performed.
Patients must be expected to benefit from the ongoing treatment with AIN457, as assessed by the patient and investigator
Male patients must consent to practice reliable contraception during the study and for 16 weeks after the last dose of study drug administration Note: Due to new data available from the toxicology studies, the need for male contraception was removed.

Key exclusion criteria (3 listed)

Patients who experience a second consecutive full relapse at visit 13 ( week F4) of the core study CAIN457A2211
Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until termination of gestation, confirmed by a positive hCG laboratory test (> 5mlU/mL)
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unwilling to use effective contraception during the study and for 16 weeks after stopping treatment.

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
AIN457AIN457A 150 mg powder for solution	Drug	Fixed-time interval regimen, Open-label, Treatment at start of relapse regimen
PlaceboPlacebo to AIN457A 150 mg powder for solution	Drug	Fixed-time interval regimen, Treatment at start of relapse regimen

Primary outcome

Number of Participants With Adverse Events, Serious Adverse Events and Deaths
Time frame: up to week 351
Safety was assessed by frequency of adverse events including serious adverse events.

2 secondary outcomes

Number of Participants With at Least 50%, 75% or 90% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) and IGA Mod 2009 0 or 1 Response
Time frame: Extension weeks: 1, 25, 73 and 301 (too few data points were available to perform analysis at week 301)
Long-term Immunogenicity Assessed by the Number of Participants Developing Anti Secukinumab Antibodies During the Trial
Time frame: up to week 351

Results and safety

Results posted to the registry on 5 Dec 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Fixed-time Interval Regimen	46	6
Treatment at Start of Relapse Regimen	42	7
Open-label	187	17

Primary outcome: Number of Participants With Adverse Events, Serious Adverse Events and Deaths

Time frame: up to week 351. Count of participants. Unit: Participants

Measure	Fixed-time Interval Regimen n = 46	Treatment at Start of Relapse Regimen n = 42	Open-label n = 187
Adverse events	44	41	180
Serious adverse events	9	4	43
Deaths	0	0	1

Population analysed: Extension safety set: the extension safety set consisted of all participants who received at least one dose of study drug during the extension and had at least one post-baseline safety assessment during the extension.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fixed-time Interval Regimen	9 of 46 (19.6%)	42 of 46 (91.3%)	Not reported
Treatment at Start of Relapse Regimen	4 of 42 (9.5%)	35 of 42 (83.3%)	Not reported
Open-label	43 of 187 (23%)	164 of 187 (87.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for 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

57 sites in 7 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AIN457 in people with Plaque-type Psoriasis, run by Novartis Pharmaceuticals at 57 sites in 7 countries.

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 3 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 4 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 57 sites in United States, Germany, Japan, Israel, Norway and 2 more countries. 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. 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 Dec 2017). 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?

Number of Participants With Adverse Events, Serious Adverse Events and Deaths (time frame: up to week 351). 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 NCT01132612.

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 4 Jan 2018.