PsoriasisPhase 3NCT01908595
Long Term Study to Evaluate Safety and Efficacy of M518101 in Subjects With Plaque Psoriasis
A Phase 3 study testing M518101 in people with Psoriasis, run by Maruho North America Inc. at 31 sites in United States.
Trial summary
This study is to evaluate the efficacy and safety for long term use of M518101 in subjects with plaque psoriasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- M518101
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 31 sitesUnited States
- Study dates
- Aug 2013to May 2015
- 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
- Who are able and willing to give signed informed consent
- Who are male or females aged 18 years or older with plaque psoriasis confirmed by the Investigator.
- Who have up to 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 or a history of relevant drug hypersensitivity.
- Who are pregnant or lactating.
- Who have any renal or hepatic insufficiency, or clinically significant cardiac, renal or hepatic disease.
- Who are not deemed eligible as determined by medical history, physical examination or clinical laboratory safety tests.
- 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.
- Whose serum calcium levels exceed the upper limit of reference range
Show all 10Show fewer
- Who have used any investigational medicinal product and/or participated in any clinical study within 60 days of treatment.
- Who have been treated with systemic therapy within 30days of treatment.
- Who have treated with biologics within 5 half-lives of the biologics before the day of treatment
- Who have been treated with topical therapy within 14days before the day of treatment.
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
United States31 sites
Peachtree Dermatology Associates Research Center
Atlanta, Georgia, 30327
Bakersfield Dermatology and Skin Cancer Medical Group
Bakersfield, California, 93309
Dermatology and Aesthetic Center Skin Care
Boca Raton, Florida, 33486
PMG research of raleigh
Cary, North Carolina, 27518
Radiant Research
Cincinnati, Ohio, 45249
Horizons Clinical Research Center
Denver, Colorado, 80220
Minnesota Clinical Study Center
Fridley, Minnesota, 55432
J Woodson Dermatology and Associates
Henderson, Nevada, 89074
Suzanne Bruce & Associates
Houston, Texas, 77056
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
PMG Research of Bristol
Kingsport, Tennessee, 37660
Dermatology Associates of Knoxville
Knoxville, Tennessee, 37917
The skin wellness center
Knoxville, Tennessee, 37922
Bager Allergy, Asthma and Dermatology Research Center
Lake Oswego, Oregon, 97035
Dermatology Research Associates
Los Angeles, California, 90045
Madison Skin & Research
Madison, Wisconsin, 53719
Agave Clinical Research
Mesa, Arizona, 85202
FXM Research Miramar
Miramar, Florida, 33027
New York University
New York, New York, 10016
Renstar Medical Research
Ocala, Florida, 34471
Kansas City Dermatology
Overland Park, Kansas, 66215
Research Across America
Plano, Texas, 75093
Dermatology Research Center
Salt Lake City, Utah, 84117
Progressive Clinical Research
San Antonio, Texas, 78229
Stephen Miller
San Antonio, Texas, 78249
Medical Center for Clinical Research
San Diego, California, 92108
ATS Clinical Research
Santa Monica, California, 90404
Northshore University Health System
Skokie, Illinois, 60077
South bend clinic
South Bend, Indiana, 46617
USF Health Morsani Center for Advanced Healthcare
Tampa, Florida, 33612
PMG Research of Wilmington
Wilmington, North Carolina, 28401
About this study
Official title: An Open-label, Multi-center, Long-term Study to Evaluate the Safety and Efficacy of M518101 in Subjects With Plaque Psoriasis
This study is to evaluate the efficacy and safety for long term use of M518101 in subjects with plaque psoriasis.
- Conditions
- Psoriasis
- Being tested
- M518101
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
M518101Drug
| Study group | Role | What they receive |
|---|---|---|
| M518101 | Experimental | Proper quantity twice daily Receives: Drug: M518101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time course change of Investigator Global Assessment
Measured: 4 weeks interval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2013 (estimated)
- Study startAug 2013
- Primary completionMay 2015
- Study completionMay 2015
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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 480 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maruho North America Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01908595
- Sponsor's protocol ID
- M518101-US04
- Status last verified
- Aug 2015
- First submitted
- 23 Jul 2013
- Last updated
- 2 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multi-center, Long-term Study to Evaluate the Safety and Efficacy of M518101 in Subjects With Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT01908595
- Acronym / sponsor ID
- M518101-US04
- Conditions
- Psoriasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- Maruho North America Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 25 Jul 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.
This study is to evaluate the efficacy and safety for long term use of M518101 in subjects with plaque psoriasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| M518101 | Experimental | Drug: M518101Proper quantity twice daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- 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 18 years or older with plaque psoriasis confirmed by the Investigator.
- Who have up to 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 (10 listed)
- Who have a history of allergy to vitamin D3 derivative preparations or a history of relevant drug hypersensitivity.
- Who are pregnant or lactating.
- Who have any renal or hepatic insufficiency, or clinically significant cardiac, renal or hepatic disease.
- Who are not deemed eligible as determined by medical history, physical examination or clinical laboratory safety tests.
- 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.
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 |
|---|---|---|
| M518101 | Drug | M518101 |
Primary outcome
Time course change of Investigator Global Assessment
Time frame: 4 weeks interval
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 2 Sep 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.
The record lists no contact. Use the official record to reach the sponsor.
31 sites in 1 country: 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 Psoriasis, run by Maruho North America Inc. at 31 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?
The sponsor lists 4 inclusion and 10 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 2 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 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 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?
Time course change of Investigator Global Assessment (time frame: 4 weeks interval). 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 Sep 2015.