AsthmaPhase 2NCT00024544
Pilot Study in Patients With Symptomatic Steroid-Naive Asthma
A Phase 2 study testing anti-IL-4 monoclonal antibody (pascolizumab) in people with Asthma, run by Facet Biotech at 18 sites in United States.
Trial summary
The purpose of the study is to evaluate an investigational medication to treat chronic asthma. The research is being conducted at 20 clinical research sites in the US and is open to both men and women ages 18 to 70 years. Participants in the study will have a number of visits to a research site over an 8-month period. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Asthma
- What is being tested?
- anti-IL-4 monoclonal antibody (pascolizumab)
- How many people
- 120 participants
- Where
- 18 sitesUnited States
- Study dates
- Aug 2001to Feb 2003
- 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
Who may be able to join
- At least a 6-month history of asthma
- No use of inhaled, oral or injectable steroids for at least 1 month prior to enrollment
Who cannot join
- Patients with > 10 pack years of smoking history or smoking within 12 months of study enrollment
- No significant disease other than asthma
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Respiratory Therapy and Pulmonary Clinical Research Brigham & Women's Hospital
Boston, Massachusetts, 02115
National Jewish Medical and Research Center
Denver, Colorado, 80206
Valley Clinical Research Center
Easton, Pennsylvania, 18045
Clinical Trials North Houston
Houston, Texas, 77090
Allergy, Asthma, and Dermatology Research Center, LLC
Lake Oswego, Oregon, 97035
Allergy Research Foundation
Los Angeles, California, 90025
University of Wisconsin Medical School
Madison, Wisconsin, 53792
Clinical Research Institute
Minneapolis, Minnesota, 55402
Southern California Research
Mission Viejo, California, 92691
ICSL Clinical Studies
Normal, Illinois, 61761
New England Clinical Studies
North Dartmouth, Massachusetts, 02747
Center for Allergy, Asthma and Immunology, Creighton University
Omaha, Nebraska, 68131
Clinical Trials of Orange Cnty., Inc.
Orange, California, 92868
Princeton Center for Clinical Research
Princeton, New Jersey, 08540
Allergy Associates Medical Group, Inc.
San Diego, California, 92120
Allergy and Asthma Associates Santa Clara Valley Research Center
San Jose, California, 95117
The Clinical Research Center, LLC
St Louis, Missouri, 63141
Bensch Research Associates
Stockton, California, 95207
About this study
Official title: A Phase I/II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Pilot Study of SB 240683 in Patients With Symptomatic Steroid-Naive Asthma
The purpose of the study is to evaluate an investigational medication to treat chronic asthma. The research is being conducted at 20 clinical research sites in the US and is open to both men and women ages 18 to 70 years. Participants in the study will have a number of visits to a research site over an 8-month period. All study-related care and medication is provided to qualified participants at no cost. This includes all visits, examinations and laboratory work.
- Conditions
- Asthma
- Being tested
- anti-IL-4 monoclonal antibody (pascolizumab)
- Keywords
- asthma, anti-IL-4 monoclonal antibody, pascolizumab
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-IL-4 monoclonal antibody (pascolizumab)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2001 (estimated)
- Study startAug 2001
- Primary completionFeb 2003
- Study completionFeb 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- 120 participants
Sponsor and investigators
- Lead sponsor
- Facet Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00024544
- Sponsor's protocol ID
- 683-803
- Status last verified
- Mar 2012
- First submitted
- 19 Sep 2001
- Last updated
- 7 Mar 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Pilot Study of SB 240683 in Patients With Symptomatic Steroid-Naive Asthma
- ClinicalTrials.gov ID
- NCT00024544
- Acronym / sponsor ID
- 683-803
- Conditions
- Asthma
- Keywords
- asthma, anti-IL-4 monoclonal antibody, pascolizumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants
- Lead sponsor
- Facet BiotechIndustry (pharma, biotech, devices)
- Study start
- Aug 2001
- Primary completion
- Feb 2003 (actual)
- Study completion
- Feb 2003 (actual)
- First posted
- 20 Sep 2001 (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 study is to evaluate an investigational medication to treat chronic asthma. The research is being conducted at 20 clinical research sites in the US and is open to both men and women ages 18 to 70 years. Participants in the study will have a number of visits to a research site over an 8-month period. All study-related care and medication is provided to qualified participants at no cost. This includes all visits, examinations and laboratory work.
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
Key inclusion criteria (2 listed)
- At least a 6-month history of asthma
- No use of inhaled, oral or injectable steroids for at least 1 month prior to enrollment
Key exclusion criteria (2 listed)
- Patients with > 10 pack years of smoking history or smoking within 12 months of study enrollment
- No significant disease other than asthma
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-IL-4 monoclonal antibody (pascolizumab) | 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 7 Mar 2012.
Related trials for Asthma
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingObservational study
Construction and Validation of an Impulse Oscillometry (IOS)-Based Platform for Screening, Diagnosis, and Management of Chronic Airway Diseases
Chronic Obstructive Pulmonary Disease (COPD), Asthma (Diagnosis)
RecruitingObservational study
Swiss Severe Asthma Register
Severe Asthma
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Severe Asthma
Asthma
RecruitingPhase 2
Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adults With Uncontrolled Asthma on Medium-to-High Dose Inhaled Corticosteroids
Asthma
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.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing anti-IL-4 monoclonal antibody (pascolizumab) in people with Asthma, run by Facet Biotech at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. 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 7 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 18 sites in United States. 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 7 Mar 2012.