PsoriasisPhase 2NCT01045577
A Double-blind, Placebo-controlled, Randomized, Parallel-group Study to Evaluate the Activity of Oral AB1010 in Adults Patients With Moderate to Severe Chronic Plaque Psoriasis
A Phase 2 study testing Masitinib in people with Psoriasis, run by AB Science.
Trial summary
A double-blind, placebo-controlled, randomized, parallel-group study to evaluate the activity of oral AB1010 in adults patients with moderate to severe chronic plaque psoriasis Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- Masitinib
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Sep 2005to Feb 2008
- 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
- Male or female outpatients aged 18 to 75 years with chronic plaque psoriasis
- Plaque psoriasis covering ≥ 10% BSA
- Disease duration ≥ 6 months
- PASI ≥ 12.0 at screening
Who cannot join
- Guttate, erythrodermic or pustular psoriasis as sole or predominant form of the disease
- Clinically significant psoriasis flare during screening or at time of enrollment
- Systemic therapy for psoriasis or systemic immunosuppressive therapy for other indications within 28 days prior to enrollment
- Topical treatment for psoriasis within 14 days prior to enrollment
- Use of CYP3A4 moderate and strong inhibitors within 4 weeks prior to randomization
- Active current bacterial, viral (including hepatitis B and C, HIV, EBV, CMV, herpes zoster, herpes simplex), fungal, mycobacterium, protozoan, or other infection
About this study
A double-blind, placebo-controlled, randomized, parallel-group study to evaluate the activity of oral AB1010 in adults patients with moderate to severe chronic plaque psoriasis
Read the detailed description
To evaluate the activity of oral AB1010, administered at two dose levels during 12 weeks to patients with moderate to severe chronic plaque psoriasis, assessed on :
i)Body Surface Area (BSA), Psoriasis Area and Severity Index (PASI), Overall Lesion Severity (OLS), Physician's Global Assessment (PGA) and Patient's Global Psoriasis Assessment (PGPA) ii)clinical and biological safety parameters iii) pharmacokinetic profile of AB1010
- Conditions
- Psoriasis
- Being tested
- Masitinib, Placebo
- Keywords
- Severe Psoriasis, Kinase Inhibitor, Masitinib
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MasitinibDrug
6 mg/kg/day
MasitinibDrug
3 mg/kg/day
PlaceboDrug
Placebo matching masitinib (3 mg/kg/day and 6 mg/kg/day)
| Study group | Role | What they receive |
|---|---|---|
| Masitinib (AB1010) | Active comparator | Masitinib (AB1010) Receives: Drug: Masitinib |
| Placebo mactching masitinib | Placebo comparator | Placebo matching masitinib Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in BSA after 12 weeks of treatment
Measured: 12 weeks
Secondary outcomes (3)
Percentage change from baseline in PASI score, proportion of patients reaching a 90%, 75% or 50% improvement in PASI score after 12 weeks of treatment; time to and duration of first occurrence in PASI 50, 75 and 90
Measured: 12 weeks
Proportion of patients achieving an OLS rating of Minimal or Clear after 12 weeks
Measured: 12 weeks
Percentage change from baseline in PGA and PGPA after 12 weeks of treatment
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2010 (estimated)
- Study startSep 2005
- Primary completionJan 2006
- Study completionFeb 2008
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.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- AB Science
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean-Paul ORTONNE, MD, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01045577
- Sponsor's protocol ID
- AB04029
- Status last verified
- Dec 2018
- First submitted
- 8 Jan 2010
- Last updated
- 10 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-controlled, Randomized, Parallel-group Study to Evaluate the Activity of Oral AB1010 in Adults Patients With Moderate to Severe Chronic Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT01045577
- Acronym / sponsor ID
- AB04029
- Conditions
- Psoriasis
- Keywords
- Severe Psoriasis, Kinase Inhibitor, Masitinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- AB ScienceIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Primary completion
- Jan 2006 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 11 Jan 2010 (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.
A double-blind, placebo-controlled, randomized, parallel-group study to evaluate the activity of oral AB1010 in adults patients with moderate to severe chronic plaque psoriasis
Detailed description
To evaluate the activity of oral AB1010, administered at two dose levels during 12 weeks to patients with moderate to severe chronic plaque psoriasis, assessed on :
i)Body Surface Area (BSA), Psoriasis Area and Severity Index (PASI), Overall Lesion Severity (OLS), Physician's Global Assessment (PGA) and Patient's Global Psoriasis Assessment (PGPA) ii)clinical and biological safety parameters iii) pharmacokinetic profile of AB1010
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Masitinib (AB1010) | Active comparator | Drug: MasitinibMasitinib (AB1010) |
| Placebo mactching masitinib | Placebo comparator | Drug: PlaceboPlacebo matching masitinib |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female outpatients aged 18 to 75 years with chronic plaque psoriasis
- Plaque psoriasis covering ≥ 10% BSA
- Disease duration ≥ 6 months
- PASI ≥ 12.0 at screening
Key exclusion criteria (6 listed)
- Guttate, erythrodermic or pustular psoriasis as sole or predominant form of the disease
- Clinically significant psoriasis flare during screening or at time of enrollment
- Systemic therapy for psoriasis or systemic immunosuppressive therapy for other indications within 28 days prior to enrollment
- Topical treatment for psoriasis within 14 days prior to enrollment
- Use of CYP3A4 moderate and strong inhibitors within 4 weeks prior to randomization
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 |
|---|---|---|
| Masitinib6 mg/kg/day | Drug | Masitinib (AB1010) |
| Masitinib3 mg/kg/day | Drug | Masitinib (AB1010) |
| PlaceboPlacebo matching masitinib (3 mg/kg/day and 6 mg/kg/day) | Drug | Placebo mactching masitinib |
Primary outcome
Change from baseline in BSA after 12 weeks of treatment
Time frame: 12 weeks
3 secondary outcomes
Percentage change from baseline in PASI score, proportion of patients reaching a 90%, 75% or 50% improvement in PASI score after 12 weeks of treatment; time to and duration of first occurrence in PASI 50, 75 and 90
Time frame: 12 weeks
Proportion of patients achieving an OLS rating of Minimal or Clear after 12 weeks
Time frame: 12 weeks
Percentage change from baseline in PGA and PGPA after 12 weeks of treatment
Time frame: 12 weeks
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 10 Dec 2018.
Related trials for Psoriasis
Active, not recruitingPhase 1
Safety and Pharmacokinetics of LPX-TI641 in Rheumatoid Arthritis and Psoriatic Arthritis
Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA)
RecruitingObservational study
Glucocorticoid-induced Osteoporosis in Patients With Chronic Inflammatory Rheumatic Diseases or Psoriasis
Osteoporosis, Inflammatory Rheumatism
RecruitingPhase 1
A Study of HL40626S Tablets in Healthy Adults
Skin Disease, Immune System Disease
RecruitingObservational study
Metabolic Profiling of Immune Responses in Immune-mediated Diseases
Primary Immunodeficiency, Psoriasis
Active, not recruitingObservational study
Efficacy and Flexibility of Tildrakizumab Treatment in Patients With Moderate-to-severe Plaque Psoriasis and High Disease Burden
Psoriasis, Moderate to Severe Psoriasis
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.
Jean-Paul ORTONNE, MD principal investigator
Centre Hospitalier Universitaire de Nice
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Masitinib in people with Psoriasis, run by AB Science.
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 6 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 10 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Change from baseline in BSA after 12 weeks of treatment (time frame: 12 weeks). 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 10 Dec 2018.