Plaque PsoriasisPhase 2NCT01301157
Study to Investigate the Efficacy and the Safety of M518101 in Plaque Psoriasis Patients
A Phase 2 study testing M518101 and Dovonex in people with Plaque Psoriasis, run by Maruho Co., Ltd. at 32 sites in United States.
Trial summary
This study is to evaluate the efficacy and safety of M518101 and the dose relationship among two doses of M518101 and placebo in male and female plaque psoriasis patients. 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 and Dovonex
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 294 participants
- Where
- 32 sitesUnited States
- Study dates
- Feb 2011to Jan 2012
- 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 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 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 are not deemed eligible as determined by medical history, physical examination or clinical laboratory safety tests.
Show all 12Show fewer
- 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
- Who have used any investigational medicinal product and/or participated in any clinical study within 60 days before the day of signing the ICF.
- Who have been treated with systemic therapy within 2 weeks before the day of signing the ICF and during the wash-out period.
- Who have been treated with biologics within 5 half-lives of the biologics before the day of randomization.
- Who have been treated with topical therapy during the wash-out period.
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
United States32 sites
Atlanta Dermatology, Vein & Research Ctr
Alpharetta, Georgia, 30022
Arlington Research Center, Inc
Arlington, Texas, 76011
Medical Development Centers, LLC
Baton Rouge, Louisiana, 70808
University of Alabama (UAB) Dermatology
Birmingham, Alabama, 35233
Visions Clinical Research
Boynton Beach, Florida, 33472
Radiant Research
Columbus, Ohio, 43212
Hamzavi Dermatology
Fort Gratiot, Michigan, 48059
Sierra Medical Research
Fresno, California, 93710
Palmetto Clinical Trial Services, LLC
Greenville, South Carolina, 29607
Dermatology Consulting Services
High Point, North Carolina, 27262
Center for Clinical Studies, Texas Medical Center
Houston, Texas, 77030
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46256
Ameriderm Research
Jacsonville, Florida, 32216
Baker Allergy, Asthma and Dermatology Research Center, LLC
Lake Oswego, Oregon, 97035
Dartmouth-Hitchcock Medical Center, Section of Dermatology
Lebanon, New Hampshire, 03756
Derm Research
Louisville, Kentucky, 40217
Coastal Carolina Research
Mobile, Alabama, 36608
Virginia Clinical Research Inc.
Norfolk, Virginia, 23507
OUHSC-Dermatology
Oklahoma City, Oklahoma, 73104
Medical Development Centers, LLC
Opelousas, Louisiana, 70570
Ameriderm Research
Ormond Beach, Florida, 32174
Skin Search of Rochester, Inc.
Rochester, New York, 14623
Dermatology Clinical Research Center
San Antonio, Texas, 78229
Therapeutics Clinical Research
San Diego, California, 92123
Clinical Science Institute
Santa Monica, California, 90404
Dermatology Associates
Seattle, Washington, 98101
NorthShore University HealthSystem
Skokie, Illinois, 60077
The Southbend Clinic, LLC
South Bend, Indiana, 46617
Central Dermatology
St Louis, Missouri, 63117
Washington University, Dermatology Clinical Trials Unit
St Louis, Missouri, 63141
DermResearchCenter of New York, Inc
Stony Brook, New York, 11790
Wilmington Dermatology Center
Wilmington, North Carolina, 28403
About this study
This study is to evaluate the efficacy and safety of M518101 and the dose relationship among two doses of M518101 and placebo in male and female plaque psoriasis patients.
Read the detailed description
This study is to evaluate the efficacy and safety of M518101 and the dose response relationship among two doses of M518101 and placebo in male and female plaque psoriasis patients and to confirm the persistence of the effect of M518101.
- Conditions
- Plaque Psoriasis
- Being tested
- M518101, placebo, Dovonex
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
DovonexDrug
Proper quantity twice a day
| Study group | Role | What they receive |
|---|---|---|
| 25ug M518101 | Experimental | Not described Receives: Drug: M518101 |
| Vehicle | Placebo comparator | Not described Receives: Drug: placebo |
| Dovonex | Active comparator | Not described Receives: Drug: Dovonex |
| 50ug M518101 | Experimental | Not described Receives: Drug: M518101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
severity of plaque psoriasis
Measured: 8 weeks after dosing
Secondary outcomes (1)
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 posted23 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionJan 2012
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 294 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maruho Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01301157
- Sponsor's protocol ID
- M518101-US01
- Status last verified
- Oct 2015
- First submitted
- 18 Feb 2011
- Last updated
- 5 Nov 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2015. 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 Plaque Psoriasis Patients
- ClinicalTrials.gov ID
- NCT01301157
- Acronym / sponsor ID
- M518101-US01
- Conditions
- Plaque Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 294 participants (actual)
- Lead sponsor
- Maruho Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Jan 2012 (actual)
- First posted
- 23 Feb 2011 (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 and the dose relationship among two doses of M518101 and placebo in male and female plaque psoriasis patients.
Detailed description
This study is to evaluate the efficacy and safety of M518101 and the dose response relationship among two doses of M518101 and placebo in male and female plaque psoriasis patients and to confirm the persistence of the effect of M518101.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 25ug M518101 | Experimental | Drug: M518101 |
| Vehicle | Placebo comparator | Drug: placebo |
| Dovonex | Active comparator | Drug: Dovonex |
| 50ug M518101 | Experimental | Drug: M518101 |
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 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 (12 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 | 25ug M518101, 50ug M518101 |
| placeboProper quantity twice a day | Drug | Vehicle |
| DovonexProper quantity twice a day | Drug | Dovonex |
Primary outcome
severity of plaque psoriasis
Time frame: 8 weeks after dosing
1 secondary 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 5 Nov 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.
32 sites 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 and Dovonex in people with Plaque Psoriasis, run by Maruho Co., Ltd. at 32 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 12 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 5 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 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 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 (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 5 Nov 2015.