Clinical trial NCT00584740: Efficacy, Safety and Tolerability of AIN457 in Moderate to Severe Active Crohn's Disease
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Proof-of-concept Study to Assess the Efficacy, Safety and Tolerability of Two Single iv Infusions of AIN457 10 mg/kg (Anti IL-17 Monoclonal Antibody) in Patients With Moderate to Severe Active Crohn's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Crohn's Disease
Keywords: Crohn's disease, moderate, severe, active, AIN457
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-01-02
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess the safety and efficacy of AIN457 in patients with moderate to severe active Crohn's disease.


Eligibility criteria: Inclusion Criteria:

* Male or female; 18-75 years old
* Diagnosis of Crohn's disease for at least 3 months prior to screening
* Confirmation of Crohn's disease by endoscopic or imaging examination
* Moderately active Crohn's disease at baseline, defined as:
* CDAI ≥220 and ≤450
* Active disease despite prior treatment with corticosteroids for at least 2 weeks, or immunosuppressants for at least 3 months. Treatment with azathioprine, 6-MP or MTX is allowed but must have been on a stable dose for at least 10 weeks, corticosteroids are allowed but must have been on a stable doses of prednisolone not exceeding 40 mg for two weeks prior to baseline. Immunosuppressants other than those listed above, such as cyclosporine, tacrolimus and mycophenolate, are not allowed and must be stopped (wash-out periods defined in the protocol);

Exclusion Criteria:

* Body Mass Index \>34
* Positive PPD tuberculin skin test or QuantiFeron test
* Any subject with evidence of active pulmonary disease or evidence of latent tuberculosis or fungal infection at screening or within past 3 months
* Symptoms associated with active bowel structuring disease and pre-stenotic dilation on radiographs
* Fistulizing disease if complicated by sepsis and/or untreated abscess
* Multiple bowel surgeries and clinically important short bowel syndrome defined as an inability to maintain caloric intake
* Use of certain medications as specified in the protocol
* Clinical improvement due to other Crohn's therapy

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Mean Change From Baseline in Crohns Disease Activity Index (CDAI) Score
timeFrame: 6 weeks
Secondary outcomes:
measure: Percentage of Participants Achieving Remission and/or Response
timeFrame: 6 weeks
measure: Percentage of Participants Achieving Remission
timeFrame: 6 weeks
measure: Percentage of Participants Achieving Response
timeFrame: 6 weeks
measure: Mean Change From Baseline in CDAI Score
timeFrame: baseline, 2 weeks, 4 weeks
measure: Area Under CDAI Curve
timeFrame: 10 weeks
measure: Percentage of Participants Maintaining Remission
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Stuttgart
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis investigator site
name: NOVARTIS
role: PRINCIPAL_INVESTIGATOR
References: