Completed

STA-5326 Safety and Tolerability in Moderate Crohn's Disease

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What is being tested

Data Collection

Who is being recruted

Crohn Disease+3

+ Digestive System Diseases

+ Gastroenteritis

From 18 to 65 Years
+14 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1 & 2
Interventional
Study Start: February 2004
See protocol details

Summary

Principal SponsorSynta Pharmaceuticals Corp.
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2004

Actual date on which the first participant was enrolled.

This clinical trial focuses on Crohn's Disease, a condition that causes inflammation in the digestive tract. The study aims to test a new drug called STA-5326 on patients with moderate Crohn's Disease, specifically those with CDAI scores between 220 and 450. The main goal is to understand if this drug is safe and well-tolerated by these patients, potentially paving the way for improved treatment options for this condition.

Official TitleA Phase I/IIa Trial of STA-5326 in Crohn's Disease Patients With CDAI Scores of 220-450
NCT00088062
Principal SponsorSynta Pharmaceuticals Corp.
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

48 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Crohn DiseaseDigestive System DiseasesGastroenteritisGastrointestinal DiseasesIntestinal DiseasesInflammatory Bowel Diseases

Criteria

8 inclusion criteria required to participate
Patients 18-65 years old
Crohn's Disease for 6 months
CDAI scores between 220-450
/- 5-ASA, stable dose for > 2 weeks
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6 exclusion criteria prevent from participating
Surgical bowel resection within 90 days
Patients who have had methotrexate, cyclosporine, or other experimental drug within 3 months of screening
Pregnancy, breast feeding
History of total proctocolectomy with stoma. Previous ileocolectomy would not be a contraindication to the study
Show More Criteria

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 18 locations

Suspended

Advanced Clinical Therapeutics

Tucson, United StatesOpen Advanced Clinical Therapeutics in Google Maps
Suspended

Advanced Clinical Research Institute

Anaheim, United States
Suspended

Venture Research Institute, LLC

North Miami Beach, United States
Suspended

Shafran Gastoenterology Center

Winter Park, United States
Completed18 Study Centers