Efficacy, Safety and Tolerability of AIN457 in Moderate to Severe Active Crohn's Disease

NCT ID: NCT00584740

Last Updated: 2015-03-31

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2010-08-31

Brief Summary

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

Conditions

Crohn's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

AIN457

AIN457 10 mg/kg was given as an intravenous infusion at day 1 and day 22.

Group Type: EXPERIMENTAL

AIN457

Intervention Type: DRUG

10 mg/kg

Placebo

Matching placebo to AIN457 was given as an infusion at day 1 and day 22.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching placebo to AIN457

Interventions

AIN457

10 mg/kg

Intervention Type: DRUG

Placebo

Matching placebo to AIN457

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

NOVARTIS

Role: PRINCIPAL_INVESTIGATOR

Novartis investigator site

Locations

Novartis Investigative Site

Berlin, , Germany

Novartis Investigative Site

Stuttgart, , Germany

Countries

Germany

Other Identifiers

CAIN457A2202

Identifier Type: -

Identifier Source: org_study_id