Crohn's DiseasePhase 3NCT00048295
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 15 sites in 6 countries.
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
- 15 sitesin 6 countries
- Study dates
- May 2002to not given
- 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
15 sites in 6 countries.
15 sites in 6 countries
Czechia4 sites
Study site
Hradic Kralove 2
Study site
Olomouc
Study site
Prague
Study site
Ústí nad Orlicí
Poland4 sites
Study site
Krakow
Study site
Szczecin
Study site
Warsaw
Study site
Wroclaw
About this study
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
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
- 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.
- First posted30 Oct 2002 (estimated)
- Study startMay 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by Ionis Pharmaceuticals, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Ionis Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00048295
- Sponsor's protocol ID
- ISIS 2302-CS21
- Status last verified
- Aug 2022
- First submitted
- 29 Oct 2002
- Last updated
- 15 Aug 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00048295
- Acronym / sponsor ID
- ISIS 2302-CS21
- Conditions
- Crohn's Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants
- Lead sponsor
- Ionis Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2002
- First posted
- 30 Oct 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alicaforsen | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2022.
- Type "ISIS 2302" in search boxLink provided by the sponsor.
- Type "ISIS 2302" in search box, then click on "Crohn's Disease Alicaforsen Investigation"Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 6 countries: see every site and its status.
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 15 sites in 6 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 15 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Czechia, Poland, Belgium, Germany, Spain and 1 more country. 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?
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 15 Aug 2022.