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AIN457 Regimen Finding Study in Patients With Moderate to Severe Psoriasis

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Novartis

Status and phase

Completed
Phase 2

Conditions

Chronic Plaque-type Psoriasis

Treatments

Drug: Placebo
Drug: AIN457A
Drug: AIN457

Study type

Interventional

Funder types

Industry

Identifiers

NCT00941031
CAIN457A2211
2008-007525-39 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment

404 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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
  • At screening and randomization, chronic plaque-type psoriasis considered inadequately controlled by:

    • topical treatment and/or
    • phototherapy and/or
    • previous systemic therapy

Exclusion criteria

  • 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
  • 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 design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

404 participants in 4 patient groups, including a placebo group

Induction Single Dose
Experimental group
Description:
Induction with single injection - "Single": secukinumab (AIN457) 150 mg s.c. administered at Week 1, Baseline through Week 12
Treatment:
Drug: AIN457
Induction Monthly Dose
Experimental group
Description:
Induction with monthly injections - "Monthly": secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 5, 9, Baseline through Week 12
Treatment:
Drug: AIN457A
Drug: AIN457A
Induction Early Loading Dose
Experimental group
Description:
Early loading induction - "Early": secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 2, 3, 5, Baseline through Week 12
Treatment:
Drug: AIN457A
Drug: AIN457A
Placebo Dose
Placebo Comparator group
Description:
Placebo administered at weeks 1, 2, 3, 5, 9, Baseline through Week 12
Treatment:
Drug: Placebo

Trial contacts and locations

62

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Data sourced from clinicaltrials.gov

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