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

NCT00584740 | Terminated Phase 2 Results

• 1 other identifier: CAIN457A2202
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 2

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

Keywords

Crohn's disease, moderate, severe, active, AIN457

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Percentage of Participants Achieving Remission and/or Response

  6 weeks

• Percentage of Participants Achieving Remission

  6 weeks

• Percentage of Participants Achieving Response

  6 weeks

• Mean Change From Baseline in CDAI Score

  baseline, 2 weeks, 4 weeks

• Area Under CDAI Curve

  10 weeks

Study Arms (2)

AIN457

EXPERIMENTAL

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

Drug: AIN457

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

AIN457 DRUG

10 mg/kg

AIN457

Placebo DRUG

Matching placebo to AIN457

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (2)

Novartis Investigative Site

Berlin, 10117, Germany

Location

Novartis Investigative Site

Stuttgart, 70376, Germany

Location

MeSH Terms

Conditions

Crohn Disease; Lymphoma, Follicular; Motor Activity

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Behavior

Results Point of Contact

• Title: Study Director
• Organization: Novartis

862-778-8300

Study Officials

• NOVARTIS

  Novartis investigator site

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: January 2, 2008
• Study Start: August 1, 2008
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: March 31, 2015
• Results First Posted: March 31, 2015

Record last verified: 2015-03

Locations

DE (2)