Completed

A Phase II, Double-Blind, Placebo-Controlled Study to Determine the Safety and Efficacy of a Humanized Anti-Interferon-γ Monoclonal Antibody (HuZAF) Administered to Patients With Moderate to Severe Crohn's Disease

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What is being tested

Data Collection

Who is being recruted

Colitis+5

+ Colonic Diseases

+ Crohn Disease

From 18 to 70 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: March 2002
See protocol details

Summary

Principal SponsorFacet Biotech
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2002

Actual date on which the first participant was enrolled.

Participants will be randomized, assigned by chance, to one of five treatment groups consisting of: four groups differing in the amount of study drug given and one placebo group. The initial dose of study drug will be given intravenously, injected into a vein in the arm. Four weeks later, three subsequent doses of study drug will be given subcutaneously, through the skin, every four weeks for three doses. Patients will be followed for approximately six months after receiving their final dose.

Official TitleA Phase II, Double-Blind, Placebo-Controlled Study to Determine the Safety and Efficacy of a Humanized Anti-Interferon-γ Monoclonal Antibody (HuZAF) Administered to Patients With Moderate to Severe Crohn's Disease 
NCT00072943
Principal SponsorFacet Biotech
Last updated: January 14, 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

175 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 70 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

ColitisColonic DiseasesCrohn DiseaseDigestive System DiseasesGastroenteritisGastrointestinal DiseasesIntestinal DiseasesInflammatory Bowel Diseases

Criteria

* Patients 18-70 years old * Patients with moderate to severe Crohn's disease * Patients who have had Crohn's disease for at least 6 months * Patients who have previously been treated for Crohn's disease

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 19 locations

Suspended

Advanced Clinical Research Institute

Anaheim, United StatesSee the location
Suspended

Doctor's Office

Orange, United States
Suspended

Gainesville VA Medical Center

Gainesville, United States
Suspended

Waterside Clinical Research Services, Inc.

West Palm Beach, United States
Completed19 Study Centers