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Chronic Plaque-type PsoriasisPhase 2NCT00941031

AIN457 Regimen Finding Study in Patients With Moderate to Severe Psoriasis

A Phase 2 study testing AIN457 and AIN457A in people with Chronic Plaque-type Psoriasis, run by Novartis Pharmaceuticals at 62 sites in 7 countries.

Completed

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

Official record
Search all trials

Trial summary

The purpose of the study is to determine whether, in patients with moderate to severe plaque-type psoriasis, AIN457 administered subcutaneously reduces the severity of psoriasis symptoms and the extent to which the patient's body area is affected by the disease (compared to placebo). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Plaque-type Psoriasis
What is being tested?
AIN457 and AIN457A
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
404 participants
Where
62 sitesin 7 countries
Study dates
Jul 2009to Dec 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men or women at least 18 years of age at time of consent
  • Chronic plaque-type psoriasis diagnosed for at least 6 months at time of randomization
  • At time of randomization, moderate to severe psoriasis as defined by:
  • PASI score of 12 or greater and
  • IGA score of 3 or greater and
  • Body Surface Area (BSA) affected by plaque-type psoriasis of 10 % or greater
Show all 10Show fewer
  • At screening and randomization, chronic plaque-type psoriasis considered inadequately controlled by:
  • topical treatment and/or
  • phototherapy and/or
  • previous systemic therapy

Who cannot join

  • Patients meeting any of the following criteria will be excluded from entry into the study:
  • Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis) at screening or randomization
  • Drug-induced psoriasis (i.e. new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium) and randomization
  • Ongoing use of prohibited psoriasis treatments (e.g., topical or systemic corticosteroids, UV therapy) at randomization. Washout periods detailed in the study protocol have to be adhered to
  • Ongoing use of other prohibited treatments at randomization. Washout periods detailed in the study protocol have to be adhered to. All prior concomitant medications must be on a stable dose for at least four weeks before study drug administration
  • Known immunosuppression (e.g., AIDS) at screening and / or randomization
Show all 13Show fewer
  • History or evidence of active tuberculosis at screening. All patients will be tested for tuberculosis status using a blood test (QuantiFERON®-TB Gold In-Tube). Patients with evidence of latent tuberculosis may enter the trial after sufficient treatment has been initiated according to local regulations.
  • Active systemic infections (other than common cold) during the two weeks before randomization (e.g., hepatitis)
  • At screening, history or symptoms of malignancy of any organ system (other than history of basal cell carcinoma and / or up to three squamous cell carcinomas of the skin, if successful treatment has been performed, with no signs of recurrence; actinic keratoses, if present at screening, should be treated according to standard therapy before randomization), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases
  • History of congestive heart failure (NYHA functional classification ≥III) at screening and / or randomization
  • History of severe hypersensitivity to any human or humanized biological agents (antibody or soluble receptor) at screening and / or randomization
  • Any severe, progressive or uncontrolled medical condition at randomization that in the judgment of the investigator prevents the patient from participating in the study
  • Pregnant or nursing (lactating) women

Trial locations and contacts

62 sites in 7 countries.

62 sites in 7 countries

United States29 sites

  • Novartis Investigative Site

    Austin, Texas, 78759

  • Novartis Investigative Site

    Birmingham, Alabama, 35233

  • Novartis Investigative Site

    Boston, Massachusetts, 02111

  • Novartis Investigative Site

    Champaign, Illinois, 61820

  • Novartis Investigative Site

    Charlottesville, Virginia, 22911

  • Novartis Investigative Site

    Clinton Twp., 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, 40217

  • Novartis Investigative Site

    Lynchburg, Virginia, 24501

  • Novartis Investigative Site

    Minneapolis, Minnesota, 55455

  • Novartis Investigative Site

    New York, New York, 10029

  • 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

    Philadelphia, Pennsylvania, 19104

  • 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

Other trials in United States

Germany14 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

    Leipzig, 04103

  • Novartis Investigative Site

    Lübeck, 23538

  • Novartis Investigative Site

    Mainz, 55131

  • Novartis Investigative Site

    Münster, 48149

  • Novartis Investigative Site

    Tübingen, 72076

Other trials in Germany

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

    Itabashi-ku, Tokyo, 173-8610

  • 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

Other trials in Japan

Israel3 sites

  • Novartis Investigative Site

    Afula, 18101

  • Novartis Investigative Site

    Petah Tikva, 49100

  • Novartis Investigative Site

    Ramat Gan, 52621

Other trials in Israel

Norway3 sites

  • Novartis Investigative Site

    Ålesund, 6017

  • Novartis Investigative Site

    Bergen, NO-5021

  • Novartis Investigative Site

    Oslo, 0424

Other trials in Norway

France2 sites

  • Novartis Investigative Site

    Nice, 06202

  • Novartis Investigative Site

    Toulouse, France, 31059

Other trials in France

Iceland1 site

  • Novartis Investigative Site

    Kopavogur, 201

Other trials in Iceland

About this study

Official title: A Randomized, Double-blind, Placebo Controlled, Multicenter Regimen Finding Study of Subcutaneously Administered AIN457, Assessing Psoriasis Area and Severity Index (PASI) Response in Patients With Moderate to Severe Chronic Plaque-type Psoriasis

The purpose of the study is to determine whether, in patients with moderate to severe plaque-type psoriasis, AIN457 administered subcutaneously reduces the severity of psoriasis symptoms and the extent to which the patient's body area is affected by the disease (compared to placebo).

Being tested
AIN457, AIN457A, Placebo
Keywords
Moderate to severe chronic plaque-type psoriasis, AIN457, dermatology

What participants receive

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

  • AIN457Drug

    Also called Secukinumab

  • AIN457ADrug

    Also called Secukinumab

    Induction with monthly injections - "Monthly": secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 5, 9

  • AIN457ADrug

    Also called Secukinumab

    Early loading induction - "Early": secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 2, 3, 5

  • PlaceboDrug

    Placebo - "Placebo": Placebo administered at weeks 1, 2, 3, 5, 9

Study groups in NCT00941031
Study groupRoleWhat they receive
Induction Single DoseExperimentalInduction with single injection - "Single": secukinumab (AIN457) 150 mg s.c. administered at Week 1, Baseline through Week 12
Receives: Drug: AIN457
Induction Monthly DoseExperimentalInduction with monthly injections - "Monthly": secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 5, 9, Baseline through Week 12
Receives: Drug: AIN457A
Induction Early Loading DoseExperimentalEarly loading induction - "Early": secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 2, 3, 5, Baseline through Week 12
Receives: Drug: AIN457A
Placebo DosePlacebo comparatorPlacebo administered at weeks 1, 2, 3, 5, 9, Baseline through Week 12
Receives: Drug: Placebo

What is being measured

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

  1. The Efficacy of Three Induction Regimens of AIN457 Administered Subcutaneously in Patients With Moderate to Severe Chronic Plaque-type Psoriasis With Respect to PASI 75 Achievement After 12 Weeks of Treatment, Compared to Placebo.

    Number (%) of patients achieving PASI 50, PASI 75, PASI 90, by visit and induction treatment

    Measured: 13 weeks

Secondary outcomes (2)

  1. The Efficacy of Two Maintenance Regimens of AIN457 With Respect to PASI 75 Achievement at Least Once From Week 21 to 29

    Measured: week 21 to 29

  2. The Efficacy of Three Induction Regimens of AIN457 Administered Subcutaneously With Respect Participants Who Reported Either an IGA 0 or 1 After 12 Weeks of Treatment, Compared to Placebo

    The investigator's global assessment (IGA) was used to evaluate overall psoriatic disease, with scores ranging from 0 (clear) to 5 (very severe disease). Treatment success was defined as patients who achieved IGA 0 or 1 and improvement of at least 2 points on the IGA scale compared to baseline. The IGA rating score for involvement of hands and feet ranged from 0 (clear) to 4 (severe).

    Measured: 13 weeks

Timeline

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

  1. First posted17 Jul 2009 (estimated)
  2. Study startJul 2009
  3. Primary completionDec 2010
  4. Study completionDec 2010

Resources

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
404 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00941031
Sponsor's protocol ID
CAIN457A2211
Other IDs
2008-007525-39, 2008
Status last verified
Mar 2015
First submitted
16 Jul 2009
Last updated
20 Aug 2015
Data monitoring committee
No

Publications

  • Paul C, Reich K, Gottlieb AB, Mrowietz U, Philipp S, Nakayama J, Harfst E, Guettner A, Papavassilis C; CAIN457A2211 study group. Secukinumab improves hand, foot and nail lesions in moderate-to-severe plaque psoriasis: subanalysis of a randomized, double-blind, placebo-controlled, regimen-finding phase 2 trial. J Eur Acad Dermatol Venereol. 2014 Dec;28(12):1670-5. doi: 10.1111/jdv.12359. Epub 2014 Jan 7.

    PubMed 24393602

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AIN457 and AIN457A in people with Chronic Plaque-type Psoriasis, run by Novartis Pharmaceuticals at 62 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 10 inclusion and 13 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 20 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 62 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. 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 27 Mar 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?

The Efficacy of Three Induction Regimens of AIN457 Administered Subcutaneously in Patients With Moderate to Severe Chronic Plaque-type Psoriasis With Respect to PASI 75 Achievement After 12 Weeks of Treatment, Compared to Placebo. (time frame: 13 weeks). 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 NCT00941031, which also lists 1 linked publication.

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 20 Aug 2015; AzTrials last refreshed its copy on 26 Oct 2026.

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