Crohn's DiseasePhase 2NCT00072943
A Humanized Anti-Interferon-γ Monoclonal Antibody (HuZAF) for Moderate to Severe Crohn's Disease
A Phase 2 study testing anti-Interferon-gamma monoclonal antibody in people with Crohn's Disease and Colitis, run by Facet Biotech at 19 sites in 2 countries.
Trial summary
The purpose of the HARMONY study is to assess the safety and efficacy of an investigational drug called HuZAF, in patients with moderate to severe Crohn's disease (CD). HuZAF is a humanized anti-Interferon-gamma (anti-IFN-γ) monoclonal antibody, which binds and blocks IFN-γ, a protein in the immune system that is… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Crohn's Disease, Colitis, Intestinal Disease
- What is being tested?
- anti-Interferon-gamma monoclonal antibody
- How many people
- 175 participants
- Where
- 19 sitesin 2 countries
- Study dates
- Mar 2002to Apr 2004
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
- 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
Trial locations and contacts
19 sites in 2 countries.
19 sites in 2 countries
United States15 sites
Advanced Clinical Research Institute
Anaheim, California, 92801
Atlanta Gastroenterology Associates
Atlanta, Georgia, 30342
Massachusetts General Hospital, Gastrointestinal Unit
Boston, Massachusetts, 02114
Carolina Digestion Health Associates
Charlottesville, North Carolina, 28211
University of Virginia Health System
Charlottesville, Virginia, 22908
Doctor's Office
Chicago, Illinois, 60637-1426
Consultants for Clinical Research
Cincinnati, Ohio, 45219
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Gainesville VA Medical Center
Gainesville, Florida, 32608
Houston Medical Research Associates
Houston, Texas, 77090
University of Kentucky Medical Center, Division of Digestive Disease & Nutrition
Lexington, Kentucky, 40536
Gastroenterology Specialities P.C.
Lincoln, Nebraska, 68503
Doctor's Office
Orange, California, 92868
University Pittsburgh Medical Center, Division of Gastroenterology, Hepatology and Nutrition, Inflammatory Bowel Disease Center
Pittsburgh, Pennsylvania, 15261
Waterside Clinical Research Services, Inc.
West Palm Beach, Florida, 33407
Canada4 sites
Queen Elizabeth II Health Science Center, McKenzie Building, Pathology
Halifax, Nova Scotia, B3H 1V8
London Health Science Center, University Campus
London, Ontario, N6A 5A5
Vancouver General Hospital, Dept. of Medicine
Vancouver, British Columbia, V5Z 1M9
Health Science Centre
Winnipeg, Manitoba, R3A 1R9
About this study
Official title: 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
The purpose of the HARMONY study is to assess the safety and efficacy of an investigational drug called HuZAF, in patients with moderate to severe Crohn's disease (CD). HuZAF is a humanized anti-Interferon-gamma (anti-IFN-γ) monoclonal antibody, which binds and blocks IFN-γ, a protein in the immune system that is involved in inflammation. Antibodies are proteins normally produced by our immune system to help fight off foreign substances. Scientists have been able to make therapeutic humanized monoclonal antibodies, similar to the antibodies in our bodies, to target diseases.
Read the detailed description
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.
- Conditions
- Crohn's Disease, Colitis, Intestinal Disease, Gastrointestinal Disease, Digestive System Disease
- Being tested
- anti-Interferon-gamma monoclonal antibody
- Keywords
- Crohn's Disease, Colitis, Monoclonal antibody therapy, anti-interferon gamma
- Medical subject headings
- Crohn Disease, Colitis, Intestinal Diseases, Gastrointestinal Diseases, Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-Interferon-gamma monoclonal antibodyDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2003 (estimated)
- Study startMar 2002
- Primary completionApr 2004
- Study completionApr 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 175 participants
Sponsor and investigators
- Lead sponsor
- Facet Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00072943
- Sponsor's protocol ID
- 707
- Status last verified
- Mar 2012
- First submitted
- 12 Nov 2003
- Last updated
- 13 Mar 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00072943
- Acronym / sponsor ID
- 707
- Conditions
- Crohn's Disease, Colitis, Intestinal Disease, Gastrointestinal Disease, Digestive System Disease
- Keywords
- Crohn's Disease, Colitis, Monoclonal antibody therapy, anti-interferon gamma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants
- Lead sponsor
- Facet BiotechIndustry (pharma, biotech, devices)
- Study start
- Mar 2002
- Primary completion
- Apr 2004 (actual)
- Study completion
- Apr 2004 (actual)
- First posted
- 17 Nov 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the HARMONY study is to assess the safety and efficacy of an investigational drug called HuZAF, in patients with moderate to severe Crohn's disease (CD). HuZAF is a humanized anti-Interferon-gamma (anti-IFN-γ) monoclonal antibody, which binds and blocks IFN-γ, a protein in the immune system that is involved in inflammation. Antibodies are proteins normally produced by our immune system to help fight off foreign substances. Scientists have been able to make therapeutic humanized monoclonal antibodies, similar to the antibodies in our bodies, to target diseases.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anti-Interferon-gamma monoclonal antibody | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2012.
- Crohn's and Colitis Foundation of AmericaLink provided by the sponsor.
- Harmony StudyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
19 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing anti-Interferon-gamma monoclonal antibody in people with Crohn's Disease and Colitis, run by Facet Biotech at 19 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2012.