AzTrials
AzTrials

Crohn's DiseasePhase 3NCT00048113

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

A Phase 3 study testing Alicaforsen in people with Crohn's Disease, run by Ionis Pharmaceuticals, Inc. at 30 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Crohn's Disease
What is being tested?
Alicaforsen
How many people
150 participants
Where
30 sitesin 2 countries
Study dates
10 Jan 2001to 27 Apr 2002
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

30 sites in 2 countries.

30 sites in 2 countries

United States27 sites

  • Study site

    Arvada, Colorado

  • Study site

    Baltimore, Maryland

  • Study site

    Buffalo, New York

  • Study site

    Chevy Chase, Maryland

  • Study site

    Chicago, Illinois

  • Study site

    Cincinnati, Ohio

  • Study site

    Cleveland, Ohio

  • Study site

    Detroit, Michigan

  • Study site

    Greensboro, North Carolina

  • Study site

    Hamilton, Ohio

  • Study site

    Jacksonville, Florida

  • Study site

    Lexington, Kentucky

  • Study site

    Lincoln, Nebraska

  • Study site

    Little Rock, Arkansas

  • Study site

    Louisville, Kentucky

  • Study site

    Madison, Wisconsin

  • Study site

    Metairie, Louisiana

  • Study site

    Mexico, Missouri

  • Study site

    Milwaukee, Wisconsin

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Orange, California

  • Study site

    Portland, Oregon

  • Study site

    Raleigh, North Carolina

  • Study site

    Rochester, New York

  • Study site

    San Diego, California

  • Study site

    Tacoma, Washington

  • Study site

    Winter Park, Florida

Other trials in United States

Canada3 sites

  • Study site

    Edmonton, Alberta

  • Study site

    Québec

  • Study site

    Vancouver, British Columbia

Other trials in Canada

About this study

Official title: ISIS 2302-CS20, 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

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.

Conditions
Crohn's Disease
Being tested
Alicaforsen
Keywords
Crohn's
Medical subject headings
Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AlicaforsenDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Oct 2002 (estimated)
  2. Study start10 Jan 2001
  3. Primary completion27 Apr 2002
  4. Study completion27 Apr 2002

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Masking
Double blind
Enrolment
150 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00048113
Sponsor's protocol ID
ISIS 2302-CS20
Status last verified
Oct 2007
First submitted
24 Oct 2002
Last updated
5 Dec 2022
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Alicaforsen in people with Crohn's Disease, run by Ionis Pharmaceuticals, Inc. at 30 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00048113.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in