PsoriasisPhase 2NCT00399906
A Study of BMS-582949 in Patients With Moderate to Severe Plaque Psoriasis
A Phase 2 study testing BMS-582949 in people with Psoriasis, run by Bristol-Myers Squibb at 21 sites in 3 countries.
Trial summary
The purpose of this clinical research study is to learn if BMS-582949 alone is an effective treatment for moderate to severe psoriasis. The safety of the drug and the effectiveness of each dose will also be studied. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- BMS-582949
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 21 sitesin 3 countries
- Study dates
- Aug 2007to Apr 2009
- 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
Who may be able to join
- Males and Females (not nursing or not pregnant)
- 18-75 years of age
- Diagnosis of moderate to severe psoriasis for at least six months at the time of screening
- Subjects will require wash-out of certain therapies for the treatment of psoriasis but will be allowed to continue on certain topical therapies
Who cannot join
None listed.
Trial locations and contacts
21 sites in 3 countries.
21 sites in 3 countries
Canada12 sites
Local Institution
Calgary, Alberta, T3A 2N1
Local Institution
Edmonton, Alberta, T5K 1X3
Local Institution
Halifax, Nova Scotia, B3H 1Z4
Local Institution
Montreal, Quebec, H3H 1V4
Local Institution
Oakville, Ontario, L6J 7W5
Local Institution
Québec, Quebec, G1V 4X7
Local Institution
Saint-Léonard, Quebec, H1S 3A9
Local Institution
St. John's, Newfoundland and Labrador, A1B 3E1
Local Institution
Surrey, British Columbia, V3R 6A7
Local Institution
Toronto, Ontario, M9W 4L6
Local Institution
Waterloo, Ontario, N2J 1C4
Local Institution
Winnipeg, Manitoba, R2C 0N2
Australia5 sites
Local Institution
Carlton, Victoria, 3053
Local Institution
Greenslopes, Queensland, 4120
Local Institution
Kogarah, New South Wales, 2217
Local Institution
Malvern, Victoria, 3144
Local Institution
North Adelaide, South Australia, 5006
Mexico4 sites
Local Institution
Df, Mexico City, 06780
Local Institution
México, Aguascalientes, 20127
Local Institution
Monterrey, Nuevo León, 64060
Local Institution
Zapopan, Jalisco, 45190
About this study
Official title: A Phase IIa, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Clinical Efficacy, Safety, and Pharmacokinetics of Three Different Doses of BMS-582949 Given Orally to Subjects With Moderate to Severe Plaque Psoriasis
The purpose of this clinical research study is to learn if BMS-582949 alone is an effective treatment for moderate to severe psoriasis. The safety of the drug and the effectiveness of each dose will also be studied.
- Conditions
- Psoriasis
- Being tested
- BMS-582949, Placebo
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-582949Drug
Tablets, Oral, Once daily, 12 weeks
PlaceboDrug
Tablets, Oral, Once daily, 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| A1 | Active comparator | 10 mg Receives: Drug: BMS-582949 |
| A2 | Active comparator | 30 mg Receives: Drug: BMS-582949 |
| A3 | Active comparator | 100 mg Receives: Drug: BMS-582949 |
| P1 | Placebo comparator | 10 or 100 mg Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is the proportion of subjects achieving an IGA score of clear or almost clear at Week 12
Measured: at Week 12
Secondary outcomes (3)
Proportion of subjects achieving a PASI-50
Measured: at Week 12
Proportion of subjects achieving a PASI-75
Measured: at Week 12
Proportion of subjects achieving a PASI-90
Measured: at Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2006 (estimated)
- Study startAug 2007
- Primary completionJan 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies 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
- Who is masked
- Participant, Investigator
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00399906
- Sponsor's protocol ID
- IM119-013
- Status last verified
- Nov 2015
- First submitted
- 14 Nov 2006
- Last updated
- 7 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Clinical Efficacy, Safety, and Pharmacokinetics of Three Different Doses of BMS-582949 Given Orally to Subjects With Moderate to Severe Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT00399906
- Acronym / sponsor ID
- IM119-013
- Conditions
- Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 15 Nov 2006 (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-582949 alone is an effective treatment for moderate to severe psoriasis. The safety of the drug and the effectiveness of each dose will also be studied.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A1 | Active comparator | Drug: BMS-58294910 mg |
| A2 | Active comparator | Drug: BMS-58294930 mg |
| A3 | Active comparator | Drug: BMS-582949100 mg |
| P1 | Placebo comparator | Drug: Placebo10 or 100 mg |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males and Females (not nursing or not pregnant)
- 18-75 years of age
- Diagnosis of moderate to severe psoriasis for at least six months at the time of screening
- Subjects will require wash-out of certain therapies for the treatment of psoriasis but will be allowed to continue on certain topical therapies
Key exclusion criteria (0 listed)
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-582949Tablets, Oral, Once daily, 12 weeks | Drug | A1, A2, A3 |
| PlaceboTablets, Oral, Once daily, 12 weeks | Drug | P1 |
Primary outcome
The primary endpoint is the proportion of subjects achieving an IGA score of clear or almost clear at Week 12
Time frame: at Week 12
3 secondary outcomes
Proportion of subjects achieving a PASI-50
Time frame: at Week 12
Proportion of subjects achieving a PASI-75
Time frame: at Week 12
Proportion of subjects achieving a PASI-90
Time frame: at Week 12
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 Dec 2015.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
21 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BMS-582949 in people with Psoriasis, run by Bristol-Myers Squibb at 21 sites in 3 countries.
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 4 inclusion and 0 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 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Canada, Australia, Mexico. 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. Some participants in this study may receive a placebo. 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.
What does the primary outcome measure?
The primary endpoint is the proportion of subjects achieving an IGA score of clear or almost clear at Week 12 (time frame: at Week 12). 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 7 Dec 2015.