Plaque PsoriasisPhase 3NCT01989429
Efficacy Study Comparing Topical M518101 and Vitamin D3 in Adult Psoriasis Patients
A Phase 3 study testing M518101 in people with Plaque Psoriasis, run by Maruho Europe Limited at 6 sites in 6 countries.
Trial summary
M5181 - a novel vitamin D3 analogue - is currently under development for the treatment of plaque psoriasis and is being developed as a topical ointment formulation (M518101) Clinical and non-clinical studies indicate that M5181 is an effective treatment for plaque psoriasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- 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
- 788 participants
- Where
- 6 sitesin 6 countries
- Study dates
- Oct 2013to Dec 2014
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients aged 18 years or older on the day of signing the informed consent form (ICF)
- Psoriasis patients with up to 20% affected body surface area ( BSA) (not including face or scalp)
- Investigator Global Assessment(IGA) of moderate to severe and who are suitable for topical therapy
Who cannot join
- Pregnant or lactating females;
- Patients with known allergic reactions, irritations or sensitivity to vitamin D3 derivatives drug hypersensitivity to other components of the investigational products;
- Patients who have been treated with topical steroids, topical immunosuppressive/ immunomodulative drugs, topical vitamin D3 derivative, topical retinoids, anthralin, coal tar (except when used as shampoo) salicylic acid within 14 days of randomization
- Patients, who in the opinion of the investigator, have clinically relevant history or presence of any disease, any other skin disorder, any chronic medical condition which is not well controlled or surgical history which may interfere with the conduct of the trial
- Patients whose calcium test at screening exceed the upper limit of reference range (including serum calcium, albumin, phosphate, parathyroid hormone);
- Patients who have used any study drug (including experimental biologics) and/or participated in any clinical trial within the last 60 days before the day of randomization
- Patients who have been treated with any biologics for their psoriasis within 30 days or 5 half-lives (whichever is longer) of the biologic before the day of randomization the longest documented half-life of the biologic should be used to calculate the 5 half-lives;
- Patients who have been treated with phototherapy (laser, oral steroids, oral retinoid, oral immunosuppressive/immunomodulative drugs, cytostatics, cyclosporine or methotrexate within 30 days of randomization
Trial locations and contacts
6 sites in 6 countries.
6 sites in 6 countries
Lithuania1 site
PI Hospital of Lithuanian University of Health Sciences
Kaunas
About this study
Official title: A Randomized, Double-blind, Parallel Group Phase III Multi-center Trial to Compare Twice Daily Topical Application of M518101, Daivonex® and Vehicle in Patients With Plaque Psoriasis III
M5181 - a novel vitamin D3 analogue - is currently under development for the treatment of plaque psoriasis and is being developed as a topical ointment formulation (M518101)
Clinical and non-clinical studies indicate that M5181 is an effective treatment for plaque psoriasis.
Based on the results of previous phase II trials the phase III trial has been designed to evaluate efficacy and safety of an 8-week treatment period with 50 μg/g M518101 in a larger population of patients with stable plaque psoriasis.
- Conditions
- Plaque Psoriasis
- Being tested
- M518101
- Keywords
- psoriasis, Vitamin D3, topical, ointments
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
M518101Drug
Also called vitamin D3, psoriasis treatment
8-week comparative treatment period ( twice daily application) followed by a maximum 8-week period to evaluate time to relapse
| Study group | Role | What they receive |
|---|---|---|
| Daivonex | Active comparator | topical application Receives: Drug: M518101 |
| vehicle | Placebo comparator | topical application Receives: Drug: M518101 |
| M518101 | Experimental | topical application Receives: Drug: M518101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of psoriasis
% reduction in mPASI(modified psoriasis area and severity index) will be measured
Measured: 8 weeks
Secondary outcomes (1)
Duration of response following 8 week treatment
if mPASI is reduced by 50% or more at V7 , patients will be followed up for a further 8 weeks to evaluate time to relapse
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2014
- Study completionDec 2014
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 788 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maruho Europe Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Maruho Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- D Thaci, Prof.Dr, Principal investigator, University of Lubeck, Dermatology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01989429
- Sponsor's protocol ID
- M518101-EU04
- Other IDs
- 2013-001632-21
- Status last verified
- Dec 2015
- First submitted
- 28 Oct 2013
- Last updated
- 31 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Parallel Group Phase III Multi-center Trial to Compare Twice Daily Topical Application of M518101, Daivonex® and Vehicle in Patients With Plaque Psoriasis III
- ClinicalTrials.gov ID
- NCT01989429
- Acronym / sponsor ID
- M518101-EU04
- Conditions
- Plaque Psoriasis
- Keywords
- psoriasis, Vitamin D3, topical, ointments
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 788 participants (actual)
- Lead sponsor
- Maruho Europe LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Maruho Co., Ltd.
- Study start
- Oct 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 21 Nov 2013 (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.
M5181 - a novel vitamin D3 analogue - is currently under development for the treatment of plaque psoriasis and is being developed as a topical ointment formulation (M518101)
Clinical and non-clinical studies indicate that M5181 is an effective treatment for plaque psoriasis.
Based on the results of previous phase II trials the phase III trial has been designed to evaluate efficacy and safety of an 8-week treatment period with 50 μg/g M518101 in a larger population of patients with stable plaque psoriasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Daivonex | Active comparator | Drug: M518101topical application |
| vehicle | Placebo comparator | Drug: M518101topical application |
| M518101 | Experimental | Drug: M518101topical application |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female patients aged 18 years or older on the day of signing the informed consent form (ICF)
- Psoriasis patients with up to 20% affected body surface area ( BSA) (not including face or scalp)
- Investigator Global Assessment(IGA) of moderate to severe and who are suitable for topical therapy
Key exclusion criteria (8 listed)
- Pregnant or lactating females;
- Patients with known allergic reactions, irritations or sensitivity to vitamin D3 derivatives drug hypersensitivity to other components of the investigational products;
- Patients who have been treated with topical steroids, topical immunosuppressive/ immunomodulative drugs, topical vitamin D3 derivative, topical retinoids, anthralin, coal tar (except when used as shampoo) salicylic acid within 14 days of randomization
- Patients, who in the opinion of the investigator, have clinically relevant history or presence of any disease, any other skin disorder, any chronic medical condition which is not well controlled or surgical history which may interfere with the conduct of the trial
- Patients whose calcium test at screening exceed the upper limit of reference range (including serum calcium, albumin, phosphate, parathyroid hormone);
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 |
|---|---|---|
| M518101Also: vitamin D3, psoriasis treatment8-week comparative treatment period ( twice daily application) followed by a maximum 8-week period to evaluate time to relapse | Drug | Daivonex, M518101, vehicle |
Primary outcome
Severity of psoriasis
Time frame: 8 weeks
% reduction in mPASI(modified psoriasis area and severity index) will be measured
1 secondary outcome
Duration of response following 8 week treatment
Time frame: 8 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 31 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.
D Thaci, Prof.Dr principal investigator
University of Lubeck, Dermatology Department
6 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing M518101 in people with Plaque Psoriasis, run by Maruho Europe Limited at 6 sites in 6 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 3 inclusion and 8 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 31 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 6 sites in Austria, Bulgaria, Germany, Hungary, Lithuania and 1 more country. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 psoriasis (time frame: 8 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 31 Dec 2015.