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

Novartis

Status and phase: Terminated; Phase 2

Conditions: Crohn's Disease

Treatments: Drug: Placebo; Drug: AIN457

Study type: Interventional

Funder types: Industry

Identifiers

NCT00584740

CAIN457A2202

Details and patient eligibility

About

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

Enrollment: 59 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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59 participants in 2 patient groups, including a placebo group

AIN457

Experimental group

Description:

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

Treatment:

Drug: AIN457

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo