ISIS 2302-CS22, A 6-Week, Active-Controlled Clinical Study to Evaluate the Effectiveness of Alicaforsen (ISIS 2302) in Patients With Mild to Moderate Active Ulcerative Colitis

December 1, 2022 updated by: Ionis Pharmaceuticals, Inc.

ISIS 2302-CS22, Phase II, Double-Blinded, Active-Controlled Study of Alicaforsen (ISIS 2302) Enema, an Antisense Inhibitor of ICAM-1, for the Treatment of Patients With Mild to Moderate Active Ulcerative Colitis (Left-Sided Colitis or Pancolitis With Left Sided Disease Flare)

This is a multi-center trial to test the safety, efficacy and tolerability of alicaforsen (ISIS 2302), a new type of drug called an antisense drug, in patients with mild to moderate active Ulcerative Colitis (UC). Alicaforsen is designed to reduce the production of a specific protein, called ICAM-1, a substance that plays a significant role in the increase of inflammation and is likely to be involved in inflammatory bowel diseases such as ulcerative colitis. The ISIS 2302-CS22 study will examine the effects of one of two dosages of alicaforsen delivered by enema over a six-week period as compared to an active control, mesalamine enema (The probability of receiving the alicaforsen formulation is 2:1). The primary objective of this study is to evaluate the percentage reduction in DAI at Week 6.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria

Patients must meet the following criteria at screening to be eligible for enrollment:

  • Age greater than or equal to 18 years
  • Diagnosis of ulcerative colitis of at least 6 months duration
  • Current left-sided flare, defined as activity in the colon 5-50 cm from the anal verge, extending at least 15 cm proximal to the anal verge and confirmed by endoscopic evaluation within 14 days of baseline visit.
  • Baseline DAI score of 4-10 including abnormal endoscopic score

  • On at least one or more of the following treatments for ulcerative colitis prior to baseline visit:

    1. Stable background oral mesalamine therapy for greater than or equal to 30 days, and/or
    2. Stable background mercaptopurine for greater than or equal to 60 days prior to baseline, and/or
    3. Stable azathiprine therapy for greater than or equal to 60 days prior to baseline
  • Written informed consent prior to performing screening evaluations.

Exclusion criteria

Patients who meet any of the following criteria at screening are not eligible for enrollment:

  • Bowel stricture, toxic megacolon, colonic dysplasia, adenoma or carcinoma
  • Uncontrolled hematologic, renal, hepatic, metabolic, psychiatric, CNS, pulmonary or cardiovascular disease, or sufficient level of disease that could interfere with the patient's ability to comply with protocol participation
  • Enteric pathogens or presence of Clostridium difficile toxin in stool
  • History of colon resection
  • Major surgical procedure within one month of baseline visit
  • Steroid or mesalamine enema within 14 days of baseline visit
  • Systemic steroids (including ACTH) within 30 days of baseline visit
  • Tumor necrosis factor-alpha (TNF-α) inhibitor treatment within 90 days of baseline visit
  • Non-steroidal anti-inflammatory agents (NSAIDs), including cyclooxygenase-2 (COX-2) inhibitors, within 14 days of baseline visit
  • Methotrexate, cyclosporin or thalidomide within 90 days of baseline visit
  • Any active infection currently requiring treatment
  • Malignancy within 5 years except for squamous cell or basal cell cancers of the skin
  • Current infectious, ischemic, or immunological disease with gastrointestinal involvement
  • ISIS 2302 treatment within 12 months of baseline visit
  • History of allergy to mesalamine
  • Treatment with an investigational or off-label drug within 90 days of screening or currently in long-term follow up for another investigational treatment protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ionis Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2002

Primary Completion (Actual)

March 24, 2005

Study Completion (Actual)

March 24, 2005

Study Registration Dates

First Submitted

June 25, 2003

First Submitted That Met QC Criteria

June 26, 2003

First Posted (Estimate)

June 27, 2003

Study Record Updates

Last Update Posted (Actual)

December 5, 2022

Last Update Submitted That Met QC Criteria

December 1, 2022

Last Verified

October 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISIS 2302-CS22

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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