PsoriasisPhase 3NCT01873677
Study to Evaluate the Efficacy and Safety 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 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?
- Yes, some participants may receive a placebo
- How many people
- 537 participants
- Where
- 31 sitesUnited States
- Study dates
- Jun 2013to Apr 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 randomization.
- Who have been treated with systemic therapy within 30days of randomization.
- Who have treated with biologics within 5 half-lives of the biologics before the day of randomization
- Who have been treated with topical therapy within 14days before the day of randomization.
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
United States31 sites
Visions Clinical Research
Boynton Beach, Florida, 33472
PMG research of Raleigh
Cary, North Carolina, 27518
Radiant Research
Edina, Minnesota, 55435
Philadelphia Institute of Dermatology
Fort Washington, Pennsylvania, 19034
Minnesota Clinical Study Center
Fridley, Minnesota, 55432
Radiant Research
Greer, South Carolina, 29650
Derm Dox Center for Dermatology
Hazleton, Pennsylvania, 18201
The Center for Skin Research
Houston, Texas, 77056
Dawes Fretzin Clinical Research Group
Indianapolis, Indiana, 46256
North Florida Dermatology Associates
Jacksonville, Florida, 32204
Clinical Partners
Johnston, Rhode Island, 02919
Suzanne Bruce and Associates The Center for Skin Research
Katy, Texas, 77494
Shondra Smith Dermatology & Advanced Aesthetics
Lake Charles, Louisiana, 70605
International Dermatology Research Inc
Miami, Florida, 33144
FXM Research Miramar
Miramar, Florida, 33027
Coastal Clinical Research
Mobile, Alabama, 36608
The Savin Center
New Haven, Connecticut, 06511
Renstar Medical Research
Ocala, Florida, 34471
Oklahoma University Health Science Center
Oklahoma City, Oklahoma, 73104
Omni Dermatology
Phoenix, Arizona, 85018
Belleair Research Center
Pinellas Park, Florida, 33781
The Indiana Clinical Trials Center
Plainfield, Indiana, 46168
Rhode Island Hospital Dermatology
Providence, Rhode Island, 02903
Dermatology Clinical Res.
San Antonio, Texas, 78229
Skin Surgery Medical Group
San Diego, California, 92117
University Clinical Trials
San Diego, California, 92123
Dermatology Associates
Seattle, Washington, 98101
Olympian Clinical Research
Tampa, Florida, 33609
Center for Clinical Studies
Webster, Texas, 77598
Atlantic Dermatology Associates
Wilmington, North Carolina, 28401
Wake Forest University
Winston-Salem, North Carolina, 27104
About this study
Official title: A Randomized, Vehicle Controlled, Double Blind, Parallel Group, Multi Center Phase III Study to Evaluate the Safety and Efficacy of M518101 in Subjects With Plaque Psoriasis
This study is to evaluate the efficacy and safety of M518101 in subjects with plaque psoriasis.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
M518101Drug
VehicleDrug
| Study group | Role | What they receive |
|---|---|---|
| Vehicle | Placebo comparator | Proper quantity twice a day Receives: Drug: Vehicle |
| M518101 | Experimental | Proper quantity twice a day Receives: Drug: M518101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator Global Assessment
Measured: 8 weeks after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionApr 2015
- Study completionApr 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 537 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
- NCT01873677
- Sponsor's protocol ID
- M518101-US02
- Status last verified
- Aug 2015
- First submitted
- 6 Jun 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
- A Randomized, Vehicle Controlled, Double Blind, Parallel Group, Multi Center Phase III Study to Evaluate the Safety and Efficacy of M518101 in Subjects With Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT01873677
- Acronym / sponsor ID
- M518101-US02
- Conditions
- Psoriasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 537 participants (actual)
- Lead sponsor
- Maruho North America Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 10 Jun 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 of M518101 in subjects with plaque psoriasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vehicle | Placebo comparator | Drug: VehicleProper quantity twice a day |
| M518101 | Experimental | Drug: M518101Proper quantity twice a day |
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 |
| Vehicle | Drug | Vehicle |
Primary outcome
Investigator Global Assessment
Time frame: 8 weeks after dosing
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. 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?
Investigator Global Assessment (time frame: 8 weeks after dosing). 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.