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Alicaforsen (ISIS 2302) in Patients With Active Crohn's Disease

Primary Purpose

Crohn's Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Alicaforsen
Sponsored by
Ionis Pharmaceuticals, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria Age >/= 12 years Weight >/= 36 kg CDAI score of 220 - 400 Documentation of Crohn's disease activity by endoscopy, biopsy or imaging in the last 2 years No TNF-α inhibitor treatment for three months prior to first study drug infusion Exclusion Criteria Known severe, fixed, symptomatic stenosis of the small or large intestine with significant dilation Extensive external fistulization (> 3 external fistulae which are expressible with gentle compression); colostomy or ileostomy Active infection, including infectious colitis, or infection with HIV, Hepatitis B or Hepatitis C Malignancy within 3 years or poorly controlled medical illness Requires intravenous heparin therapy or with a history of a bleeding problem

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 29, 2002
Last Updated
August 11, 2022
Sponsor
Ionis Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00048295
Brief Title
Alicaforsen (ISIS 2302) in Patients With Active Crohn's Disease
Official Title
ISIS 2302-CS21, Phase 3 Double-Masked, Placebo-Controlled Study of Alicaforsen (ISIS 2302), an Antisense Inhibitor of ICAM-1, for the Treatment of Patients With Active Crohn's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
May 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Ionis Pharmaceuticals, Inc.

4. Oversight

5. Study Description

Brief Summary
ISIS 2302 is an antisense oligonucleotide drug that reduces the production of a specific protein called intercellular adhesion molecule (ICAM-1), a substance that plays a significant role in the increase of inflammation. People with Crohn's disease have been shown to over-produce ICAM-1 in their gut tissues. Alicaforsen works by blocking ICAM-1 messenger RNA, the "instruction" molecule that is required for the production of ICAM-1 protein. This trial will examine effects of alicaforsen delivered by 2-hour intravenous infusion over a four-week period, compared to a placebo. Patients may remain on stable background 5-ASA, antibiotic, or immunosuppressive drugs, and prednisone (or equivalent) at </= 30 mg per day.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Masking
Double
Allocation
Randomized
Enrollment
150 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Alicaforsen

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Age >/= 12 years Weight >/= 36 kg CDAI score of 220 - 400 Documentation of Crohn's disease activity by endoscopy, biopsy or imaging in the last 2 years No TNF-α inhibitor treatment for three months prior to first study drug infusion Exclusion Criteria Known severe, fixed, symptomatic stenosis of the small or large intestine with significant dilation Extensive external fistulization (> 3 external fistulae which are expressible with gentle compression); colostomy or ileostomy Active infection, including infectious colitis, or infection with HIV, Hepatitis B or Hepatitis C Malignancy within 3 years or poorly controlled medical illness Requires intravenous heparin therapy or with a history of a bleeding problem
Facility Information:
City
Kortrijk
Country
Belgium
City
Roeselare
Country
Belgium
City
Hradic Kralove 2
Country
Czechia
City
Olomouc
Country
Czechia
City
Prague
Country
Czechia
City
Praha
Country
Czechia
City
Usti nad Orlici
Country
Czechia
City
Minden
Country
Germany
City
Munster
Country
Germany
City
Torino
Country
Italy
City
Krakow
Country
Poland
City
Szczecin
Country
Poland
City
Warszawa
Country
Poland
City
Wroclaw
Country
Poland
City
Barcelona
Country
Spain
City
Valencia
Country
Spain

12. IPD Sharing Statement

Links:
URL
http://www.centerwatch.com
Description
Type "ISIS 2302" in search box
URL
http://www.acurian.com
Description
Type "ISIS 2302" in search box, then click on "Crohn's Disease Alicaforsen Investigation"

Learn more about this trial

Alicaforsen (ISIS 2302) in Patients With Active Crohn's Disease

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