Psoriasis, Moderate to SeverePhase 2NCT00162253
Study of BMS-587101 in Patients With Moderate to Severe Psoriasis
A Phase 2 study testing BMS 587101 in people with Psoriasis, Moderate to Severe, run by Bristol-Myers Squibb at 16 sites in United States.
Trial summary
The purpose of this clinical research study is to learn if BMS-587101 is effective on the treatment of Moderate to Severe Psoriasis. The safety of this treatment will also be studied. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Psoriasis, Moderate to Severe
- What is being tested?
- BMS 587101
- How many people
- 120 participants
- Where
- 16 sitesUnited States
- Study dates
- Apr 2005to Jun 2006
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria: Otherwise healthy individuals with a diagnosis of plaque-type psoriasis at least 6 months prior to screening (subjects with concurrent psoriatic arthritis may be enrolled).
Men and Women Not of Child Bearing Potential (i.e. women who are postmenopausal or surgically sterile), women ages 18 to 75.
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Exclusion Criteria: Women of Child Bearing Potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the study.
Known or suspected infection, including infection with human immunodeficiency virus (HIV), hepatitis B or C viruses. Any recent infections requiring antibiotic treatment that completed within 4 weeks of enrollment.
Any known malignancy or history of malignancy within 5 years prior to enrollment, with the exception of basal cell or squamous cell carcinoma of the skin that has been excised with no evidence of recurrence (squamous cell carcinoma of other locations is exclusionary).
Any history of Guillane-Barre syndrome. History of keloid formation.
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Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Local Institution
Boise, Idaho
Local Institution
Columbus, Ohio
Local Institution
Dallas, Texas
Local Institution
Fridley, Minnesota
Local Institution
Greer, South Carolina
Local Institution
Miami Beach, Florida
Local Institution
New Brunswick, New Jersey
Local Institution
New York, New York
Local Institution
Philadelphia, Pennsylvania
Local Institution
Phoenix, Arizona
Local Institution
Pinellas Park, Florida
Local Institution
Portland, Oregon
Local Institution
San Diego, California
Local Institution
St Louis, Missouri
Local Institution
Tucson, Arizona
Local Institution
Winston-Salem, North Carolina
About this study
Official title: Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study of BMS-587101 in Patients With Moderate to Severe Psoriasis
The purpose of this clinical research study is to learn if BMS-587101 is effective on the treatment of Moderate to Severe Psoriasis. The safety of this treatment will also be studied.
- Conditions
- Psoriasis, Moderate to Severe
- Being tested
- BMS 587101
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS 587101Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
To estimate the clinical response in terms of the percent of subjects achieving PASI_50 in each treatment arm, and to determine whether there was a difference in PASI_50 between each BMS-587101 treatment arm and placebo
Secondary outcomes (6)
To estimate the proportion of patients achieving a PASI 75 response in each treatment arm.
To estimate the percent change (or reduction) in PASI score at 12 weeks of treatment in each treatment arm.
To estimate the proportion of patients achieving a PGA score of clear to minimal in each treatment arm.
To estimate the percent change from baseline in epidermal thickness of psoriatic lesion.
To evaluate the safety and tolerability of BMS-587101 in patients with psoriasis.
To evaluate the single- and multiple-dose pharmacokinetics of BMS-587101
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2005 (estimated)
- Study startApr 2005
- Primary completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriasis, Moderate to SevereStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- 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
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00162253
- Sponsor's protocol ID
- IM117-005
- Status last verified
- Sep 2007
- First submitted
- 9 Sep 2005
- Last updated
- 2 Mar 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study of BMS-587101 in Patients With Moderate to Severe Psoriasis
- ClinicalTrials.gov ID
- NCT00162253
- Acronym / sponsor ID
- IM117-005
- Conditions
- Psoriasis, Moderate to Severe
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 120 participants
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Apr 2005
- Primary completion
- Jun 2006 (actual)
- First posted
- 13 Sep 2005 (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 this clinical research study is to learn if BMS-587101 is effective on the treatment of Moderate to Severe Psoriasis. The safety of this treatment will also be studied.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 75 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 |
|---|---|---|
| BMS 587101 | Drug | – |
Primary outcome
To estimate the clinical response in terms of the percent of subjects achieving PASI_50 in each treatment arm, and to determine whether there was a difference in PASI_50 between each BMS-587101 treatment arm and placebo
6 secondary outcomes
To estimate the proportion of patients achieving a PASI 75 response in each treatment arm.
To estimate the percent change (or reduction) in PASI score at 12 weeks of treatment in each treatment arm.
To estimate the proportion of patients achieving a PGA score of clear to minimal in each treatment arm.
To estimate the percent change from baseline in epidermal thickness of psoriatic lesion.
To evaluate the safety and tolerability of BMS-587101 in patients with psoriasis.
To evaluate the single- and multiple-dose pharmacokinetics of BMS-587101
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2010.
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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.
16 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 BMS 587101 in people with Psoriasis, Moderate to Severe, run by Bristol-Myers Squibb at 16 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?
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: stopped early, as of the sponsor's last update on 2 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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 was stopped early. Results are not available in the source record.
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.
What does the primary outcome measure?
To estimate the clinical response in terms of the percent of subjects achieving PASI_50 in each treatment arm, and to determine whether there was a difference in PASI_50 between each BMS-587101 treatment arm and placebo. It is what the study was designed to measure, not a finding.
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 2 Mar 2010.