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Alicaforsen

Phase 3

Crohn's Disease | RNA therapy | Gastrointestinal |Ionis Pharmaceuticals, Inc.|Trials Updated: Dec 5, 2022

Alicaforsen development status

Highest phase Phase 3
Registered trials 6 across 2 sponsors since Oct 2002

Alicaforsen target and mechanism

Molecular targetICAM1
Target classAntisense Inhibitor
ModalityRNA therapy

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials4
Total Enrollment300

FDA Designations

No designations recorded

Alicaforsen clinical trials

Alicaforsen · 4 trials · 2 indications

Phase 3 2Phase 2 2
NCT00048295Alicaforsen (ISIS 2302) in Patients With Active Crohn's DiseaseCrohn's Disease
COMPLETED150 Analytics
NCT00048113Alicaforsen (ISIS 2302) in Patients With Active Crohn's DiseaseCrohn's Disease
COMPLETED150 Analytics
PHASE3COMPLETED
Alicaforsen (ISIS 2302) in Patients With Active Crohn's Disease
Crohn's DiseaseUnlock trial analytics
PHASE3COMPLETED
Alicaforsen (ISIS 2302) in Patients With Active Crohn's Disease
Crohn's DiseaseUnlock trial analytics

Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
PurposeTREATMENT

Interventions

NameTypeDescription
AlicaforsenDRUG -
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Eligibility Criteria

Age Range12 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites15

Inclusion Criteria 1. Age \>/= 12 years 2. Weight \>/= 36 kg 3. CDAI score of 220 - 400 4. Documentation of Crohn's disease activity by endoscopy, biopsy or imaging in the last 2 years 5. No TNF-α inhibitor treatment for three months prior to first study drug infusion Exclusion Criteria 1. Known ...

Countries:BelgiumCzechiaGermanyItalyPolandSpainUnited StatesCanada
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Frequently asked questions about Alicaforsen

What is alicaforsen used for?

Alicaforsen is an investigational RNA therapy developed for inflammatory bowel disease, specifically Crohn's disease and ulcerative colitis. It has been studied in clinical trials for patients with active forms of these gastrointestinal conditions. It is not approved for commercial use and remains in clinical development.

What does alicaforsen target?

Alicaforsen targets ICAM1, also known as intercellular adhesion molecule 1. It is an antisense inhibitor, meaning it is designed to reduce production of the ICAM1 protein. ICAM1 is involved in the inflammatory process, which is the rationale for studying alicaforsen in inflammatory bowel disease.

Who is developing alicaforsen?

Alicaforsen is being developed by Ionis Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker symbol IONS. Ionis is the sponsor of the clinical trials evaluating alicaforsen in Crohn's disease and ulcerative colitis.

What phase is alicaforsen in?

Alicaforsen has reached Phase 3 clinical development. Two Phase 3 trials were conducted in patients with active Crohn's disease, and earlier Phase 2 studies were run in ulcerative colitis. The drug is investigational and has not been approved by the FDA.

What clinical trials is alicaforsen in?

Alicaforsen has been studied in four registered trials. The Phase 3 Crohn's disease studies are NCT00048295, run in Europe, and NCT00048113, run in the United States and Canada, each enrolling 150 patients. The ulcerative colitis Phase 2 studies are NCT00063830 and NCT00063414.

Is alicaforsen the same as ISIS 2302?

Yes, alicaforsen is also known as ISIS 2302. The earlier clinical trials for ulcerative colitis and Crohn's disease were registered and titled under the ISIS 2302 name, so searches for either term refer to the same antisense drug candidate developed by Ionis Pharmaceuticals.