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

Crohn's Disease Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00584740
• Other study ID #: CAIN457A2202
• Status: Terminated
• Phase: Phase 2
• First received: December 21, 2007
• Last updated: March 24, 2015
• Start date: August 2008
• Est. completion date: August 2010

Study information

• Verified date: March 2015
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 59
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Drug:
• AIN457
10 mg/kg
• Placebo
Matching placebo to AIN457

Locations

Country	Name	City	State
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Stuttgart

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change From Baseline in Crohns Disease Activity Index (CDAI) Score	The Crohns Disease Activity Index or CDAI is a research tool used to quantify the symptoms of patients with Crohns disease. Participants were asked to record on a paper diary the frequency of stools, abdominal pain and general well-being on a daily basis. In addition to the diary data, the investigator assessed the following for the calculation of CDAI score: arthritis/arthralgia, iritis/uveitis, erythema nodosum/pyoderma gangrenousum/aphthous stomatitis, anal fissure/fistula/abscess, other fistula; fever; use of antidiarrheal; abdominal mass; hematocrit; body weight. The CDAI score is the sum of the products of each item multiplied by its weighting factor. CDAI ranges from 0 to >=600, where remission of Crohn's disease is defined as CDAI < 150, and severe disease is defined as CDAI > 450. A negative change in mean score indicates improvement.	6 weeks	No
Secondary	Percentage of Participants Achieving Remission and/or Response	Remission or response was defined as CDAI < 150 points or CDAI reduction from baseline of at least 70 points.	6 weeks	No
Secondary	Percentage of Participants Achieving Remission	Remission was defined as CDAI < 150 points.	6 weeks	No
Secondary	Percentage of Participants Achieving Response	Response was defined as CDAI reduction of at least 70 points from baseline.	6 weeks	No
Secondary	Mean Change From Baseline in CDAI Score	The Crohns Disease Activity Index or CDAI is a research tool used to quantify the symptoms of patients with Crohns disease. Participants were asked to record on a paper diary the frequency of stools, abdominal pain and general well-being on a daily basis. In addition to the diary data, the investigator assessed the following for the calculation of CDAI score: arthritis/arthralgia, iritis/uveitis, erythema nodosum/pyoderma gangrenousum/aphthous stomatitis, anal fissure/fistula/abscess, other fistula; fever; use of antidiarrheal; abdominal mass; hematocrit; body weight. The CDAI score is the sum of the products of each item multiplied by its weighting factor. CDAI ranges from 0 to >=600, where remission of Crohn's disease is defined as CDAI < 150, and severe disease is defined as CDAI > 450. A negative change in mean score indicates improvement.	baseline, 2 weeks, 4 weeks	No
Secondary	Area Under CDAI Curve	The Crohns Disease Activity Index or CDAI is a research tool used to quantify the symptoms of patients with Crohns disease. Participants were asked to record on a paper diary the frequency of stools, abdominal pain and general well-being on a daily basis. In addition to the diary data, the investigator assessed the following for the calculation of CDAI score: arthritis/arthralgia, iritis/uveitis, erythema nodosum/pyoderma gangrenousum/aphthous stomatitis, anal fissure/fistula/abscess, other fistula; fever; use of antidiarrheal; abdominal mass; hematocrit; body weight. The CDAI score is the sum of the products of each item multiplied by its weighting factor. CDAI ranges from 0 to >=600, where remission of Crohn's disease is defined as CDAI < 150, and severe disease is defined as CDAI > 450. An area under the CDAI response curve analysis was performed with a starting point from week 4.	10 weeks	No
Secondary	Percentage of Participants Maintaining Remission	Remission was defined as CDAI < 150 points.	10 weeks	No