Plaque PsoriasisPhase 2NCT00884169
Study to Investigate the Efficacy and the Safety of M518101 in Psoriasis Patients
A Phase 2 study testing M518101 in people with Plaque Psoriasis, run by Maruho Co., Ltd. at 1 site in United Kingdom.
Trial summary
This study is to investigate the efficacy and safety of M518101 in male and female plaque psoriasis patients with refractory plaques. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- M518101
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2009to Dec 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 65 years
- All sexes
- Adult, Older adult
Who may be able to join
- Who are able and willing to give signed informed consent
- Who are male or females aged between 18 and 65 years with plaque psoriasis confirmed by the Investigator.
- Who have less than 20% of body surface area (BSA) afflicted with plaques
- Who are neither pregnant nor breast-feeding, nor plan to become pregnant during the study.
Who cannot join
- Who have a history of allergy to vitamin D3 derivative preparations.
- Who have a history of relevant drug hypersensitivity.
- Who have a history of contact dermatitis induced by a topical medicine.
- Who are pregnant or lactating.
- Who have any renal or hepatic insufficiency, or clinically significant cardiac, renal or hepatic disease.
- Who have clinically relevant history or presence of any disease or surgical history other than psoriasis which is likely to affect the conduct of the study.
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- Whose serum calcium levels exceed the upper limit of reference range
- Who have used any investigational medicinal product and/or participated in any clinical study within 24 weeks
- Who have been treated with systemic therapy within 8 weeks
- Who have been treated with biologics within 12 weeks
- Who have been treated with topical therapy during the wash-out and lead-in period.
Trial locations and contacts
1 site in 1 country.
About this study
This study is to investigate the efficacy and safety of M518101 in male and female plaque psoriasis patients with refractory plaques.
- Conditions
- Plaque Psoriasis
- Being tested
- M518101, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
M518101Drug
Proper quantity twice a day
placeboDrug
Proper quantity twice a day
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of plaque psoriasis
Secondary outcomes (1)
Investigator and Patient overall assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2009 (estimated)
- Study startJul 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque 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
- Allocation
- Randomised
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Maruho Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00884169
- Sponsor's protocol ID
- M518101-EU03
- Status last verified
- Nov 2010
- First submitted
- 17 Apr 2009
- Last updated
- 3 Nov 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Investigate the Efficacy and the Safety of M518101 in Psoriasis Patients
- ClinicalTrials.gov ID
- NCT00884169
- Acronym / sponsor ID
- M518101-EU03
- Conditions
- Plaque Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Maruho Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2009
- Study completion
- Dec 2009
- First posted
- 20 Apr 2009 (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.
This study is to investigate the efficacy and safety of M518101 in male and female plaque psoriasis patients with refractory plaques.
Study design
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Who are able and willing to give signed informed consent
- Who are male or females aged between 18 and 65 years with plaque psoriasis confirmed by the Investigator.
- Who have less than 20% of body surface area (BSA) afflicted with plaques
- Who are neither pregnant nor breast-feeding, nor plan to become pregnant during the study.
Key exclusion criteria (11 listed)
- Who have a history of allergy to vitamin D3 derivative preparations.
- Who have a history of relevant drug hypersensitivity.
- Who have a history of contact dermatitis induced by a topical medicine.
- Who are pregnant or lactating.
- Who have any renal or hepatic insufficiency, or clinically significant cardiac, renal or hepatic disease.
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 |
|---|---|---|
| M518101Proper quantity twice a day | Drug | – |
| placeboProper quantity twice a day | Drug | – |
Primary outcome
Severity of plaque psoriasis
1 secondary outcome
Investigator and Patient overall assessment
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 3 Nov 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing M518101 in people with Plaque Psoriasis, run by Maruho Co., Ltd. at 1 site in United Kingdom.
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 11 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 3 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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.
What does the primary outcome measure?
Severity of plaque psoriasis. 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 3 Nov 2010.