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NCT00063414
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
Phase 2 trial testing Alicaforsen in Ulcerative Colitis. Completed in 24 March 2005.
24 March 2005
Quick facts
| Lead sponsor | Ionis Pharmaceuticals, Inc. |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Primary purpose | treatment |
| Start date | 20 November 2002 |
| Primary completion | 24 March 2005 |
| Estimated completion | 24 March 2005 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Alicaforsen — full drug profile →
Conditions studied
- Ulcerative Colitis — all drugs for Ulcerative Colitis →
Sponsor
Ionis Pharmaceuticals, Inc. — full company profile →
Who can join
18 and older, any sex, with Ulcerative Colitis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
-
Noncoding RNA therapeutics - challenges and potential solutions.
Winkle M, El-Daly SM, Fabbri M, Calin GA. · · 2021 · cited 1123× · PMID 34145432 · DOI 10.1038/s41573-021-00219-z -
Non-Coding RNA-Targeted Therapy: A State-of-the-Art Review.
Nappi F. · · 2024 · cited 72× · PMID 38612441 · DOI 10.3390/ijms25073630 -
Landscape of small nucleic acid therapeutics: moving from the bench to the clinic as next-generation medicines.
Liu M, Wang Y, Zhang Y, Hu D, et al · · 2025 · cited 62× · PMID 40059188 · DOI 10.1038/s41392-024-02112-8 -
Biological therapy for ulcerative colitis.
Arora Z, Shen B. · · 2015 · cited 34× · PMID 25344680 · DOI 10.1093/gastro/gou070 -
Non-coding RNAs: emerging biomarkers and therapeutic targets in cancer and inflammatory diseases.
Hossam Abdelmonem B, Kamal LT, Wardy LW, Ragheb M, et al · · 2025 · cited 19× · PMID 40129920 · DOI 10.3389/fonc.2025.1534862
Verify or expand the search:
- PubMed search for NCT00063414
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Alicaforsen
Trials testing the same drug.
- NCT03473626 — Phase 1 Food Effect Study for Alicaforsen Tablets · Phase 1 · completed
- NCT02525523 — Efficacy of Alicaforsen in Pouchitis Patients Who Have Failed to Respond to at Least One Course of Antibiotics · Phase 3 · completed
- NCT00063830 — ISIS 2302-CS27, A 6-Week, Placebo-Controlled Clinical Study to Evaluate the Effectiveness of Alicaforsen (ISIS 2302) in · Phase 2 · completed
- NCT00048113 — Alicaforsen (ISIS 2302) in Patients With Active Crohn's Disease · Phase 3 · completed
Other recruiting trials for Ulcerative Colitis
Currently open trials in the same condition.
- NCT07185009 — A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Acti · Phase 3 · recruiting
- NCT07265570 — Study Evaluating ISM5411 Administered Orally to Subjects With Active Ulcerative Colitis (BETHESDA) · Phase 2 · recruiting
- NCT07223424 — Patient Preference for Subcutaneous vs. Intravenous Immune Therapy · Phase 2 · recruiting
- NCT06405087 — A Long-Term Extension Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis (UC) or Crohn's Disease (CD · Phase 3 · recruiting
- NCT07184996 — An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Activ · Phase 3 · recruiting
Other Ionis Pharmaceuticals, Inc. trials
Trials by the same sponsor.
- NCT06673069 — Hero: A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics (PK) and Pharmacodynamics (PD) of ION269 in Par · Phase 1 · terminated
- NCT06014541 — Observational Study to Characterize Biomarkers and Disease Progression in Participants With Methyl CpG Binding Protein 2 · terminated
- NCT05610280 — A Study of Olezarsen (ISIS 678354) in Participants With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease, · Phase 3 · completed
- NCT05579860 — A Study Comparing Two Subcutaneous Formulations: Vial and Autoinjector (AI) With Olezarsen, at Two Dose Levels, in Healt · Phase 1 · completed
- NCT05552326 — A Study of Olezarsen Administered Subcutaneously to Participants With Severe Hypertriglyceridemia · Phase 3 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00063414 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ionis Pharmaceuticals, Inc.
- Last refreshed: 5 December 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00063414.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing