Plaque PsoriasisPhase 2NCT01987843
Dose-finding Study of MT-1303 in Subjects With Moderate to Severe Chronic Plaque Psoriasis
A Phase 2 study testing MT-1303-Low, MT-1303-Middle and MT-1303-High in people with Plaque Psoriasis, run by Tanabe Pharma Corporation at 52 sites in 8 countries.
Trial summary
The primary objectives of the study are: To evaluate the safety and tolerability of three dose levels of MT-1303 in subjects with moderate to severe chronic plaque psoriasis. To evaluate the efficacy of three doses levels of MT-1303 in subjects with moderate to severe chronic plaque psoriasis compared to placebo after… 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?
- MT-1303-Low, MT-1303-Middle and MT-1303-High
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 142 participants
- Where
- 52 sitesin 8 countries
- Study dates
- Sep 2013to Nov 2014
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have been diagnosed with plaque psoriasis for at least 6 months prior to screening
- Have moderate to severe chronic plaque psoriasis as defined by PASI score ≥ 12 and BSA ≥ 10% at baseline
- In the investigator's opinion is a candidate for systemic therapy
Who cannot join
- Non-plaque forms of psoriasis (e.g., guttate, erythrodermic or pustular)
- Current drug-induced or aggravated psoriasis (e.g., a new onset of psoriasis or an exacerbation of psoriasis from beta-blockers, calcium-channel blockers, or lithium carbonate)
- History of any of a list of pre-defined cardiovascular diseases
- History or known presence of any significant infectious, metabolic, oncological, ophthalmological or respiratory system disease or illness likely to render the subject unsuitable for the study.
- Previous exposure to any other S1P receptor modulator
- Receipt of a live vaccine within 28 days prior to randomisation
- Need, or likely need for, treatment with Class I or III anti-arrhythmic drugs or with heart-rate-lowering beta-blockers or calcium-channel blockers, or with any other drugs which can reduce the heart rate
- Clinically significant findings electrocardiogram (ECG) findings.
Trial locations and contacts
52 sites in 8 countries.
52 sites in 8 countries
Germany11 sites
Research Site
Bavaria
Research Site
Cologne
Research Site
Düsseldorf
Research Site
Essen
Research Site
Gera
Research Site
Hamburg
Research Site
Hanau
Research Site
Hessen
Research Site
Kiel
Research Site
Lübeck
Research Site
Mainz
Poland11 sites
Research Site
Bialystok
Research Site
Bydgoszcz
Research Site
Gdansk
Research Site
Katowice
Research Site
Lodzkie
Research Site
Malopolska
Research Site
Olsztyn
Research Site
Środa Wielkopolska
Research Site
Warsaw
Research Site
Woj. Wielkopolskie
Research Site
Wroclaw
Ukraine11 sites
Research Site
Dniepropetrovsk
Research Site
Dnipro
Research Site
Donetskaya
Research Site
Kyiv
Research Site
Luhansk
Research Site
Lviv
Research Site
Odesa
Research Site
Simferopol
Research Site
Ternopil
Research Site
Uzhhorod
Research Site
Zaporizhzhya
Hungary5 sites
Research Site
Debrecen
Research Site
NyÃ-regyháza
Research Site
Orosháza
Research Site
Szeged
Research Site
Veszprém
Russia5 sites
Research Site
Chelyabinsk
Research Site
Moscow
Research Site
Saint Petersburg
Research Site
Saratovskaya
Research Site
Yaroslavl
Latvia4 sites
Research Site
Jelgava
Research Site
Madona
Research Site
Riga
Research Site
Ventspils
Bulgaria3 sites
Research Site
Dupnitsa
Research Site
Pleven
Research Site
Sofia
About this study
Official title: A Phase IIa, Multicentre, Randomised, Double-Blind, Parallel Group, Placebo-Controlled Study to Evaluate Safety, Tolerability and Clinical Efficacy of MT-1303 in Subjects With Moderate to Severe Chronic Plaque Psoriasis
The primary objectives of the study are:
- To evaluate the safety and tolerability of three dose levels of MT-1303 in subjects with moderate to severe chronic plaque psoriasis.
- To evaluate the efficacy of three doses levels of MT-1303 in subjects with moderate to severe chronic plaque psoriasis compared to placebo after 16 weeks of treatment on Psoriasis Area and Severity Index (PASI).
- Conditions
- Plaque Psoriasis
- Being tested
- MT-1303-Low, MT-1303-Middle, MT-1303-High, Placebo
- Keywords
- Psoriasis, Plaque Psoriasis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MT-1303-LowDrug
MT-1303-MiddleDrug
MT-1303-HighDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| MT-1303-Low | Experimental | MT-1303-Low Dose Receives: Drug: MT-1303-Low |
| MT-1303-Middle | Experimental | MT-1303-Middle Dose Receives: Drug: MT-1303-Middle |
| MT-1303-High | Experimental | MT-1303-High Dose Receives: Drug: MT-1303-High |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects who achieve PASI 75 (at least 75% reduction from baseline)
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2013 (estimated)
- Study startSep 2013
- Primary completionSep 2014
- Study completionNov 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanabe Pharma Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01987843
- Sponsor's protocol ID
- MT-1303-E06
- Status last verified
- Dec 2014
- First submitted
- 13 Nov 2013
- Last updated
- 18 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa, Multicentre, Randomised, Double-Blind, Parallel Group, Placebo-Controlled Study to Evaluate Safety, Tolerability and Clinical Efficacy of MT-1303 in Subjects With Moderate to Severe Chronic Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT01987843
- Acronym / sponsor ID
- MT-1303-E06
- Conditions
- Plaque Psoriasis
- Keywords
- Psoriasis, Plaque Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Tanabe Pharma CorporationIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 19 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.
The primary objectives of the study are:
- To evaluate the safety and tolerability of three dose levels of MT-1303 in subjects with moderate to severe chronic plaque psoriasis.
- To evaluate the efficacy of three doses levels of MT-1303 in subjects with moderate to severe chronic plaque psoriasis compared to placebo after 16 weeks of treatment on Psoriasis Area and Severity Index (PASI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MT-1303-Low | Experimental | Drug: MT-1303-LowMT-1303-Low Dose |
| MT-1303-Middle | Experimental | Drug: MT-1303-MiddleMT-1303-Middle Dose |
| MT-1303-High | Experimental | Drug: MT-1303-HighMT-1303-High Dose |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Have been diagnosed with plaque psoriasis for at least 6 months prior to screening
- Have moderate to severe chronic plaque psoriasis as defined by PASI score ≥ 12 and BSA ≥ 10% at baseline
- In the investigator's opinion is a candidate for systemic therapy
Key exclusion criteria (8 listed)
- Non-plaque forms of psoriasis (e.g., guttate, erythrodermic or pustular)
- Current drug-induced or aggravated psoriasis (e.g., a new onset of psoriasis or an exacerbation of psoriasis from beta-blockers, calcium-channel blockers, or lithium carbonate)
- History of any of a list of pre-defined cardiovascular diseases
- History or known presence of any significant infectious, metabolic, oncological, ophthalmological or respiratory system disease or illness likely to render the subject unsuitable for the study.
- Previous exposure to any other S1P receptor modulator
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 |
|---|---|---|
| MT-1303-Low | Drug | MT-1303-Low |
| MT-1303-Middle | Drug | MT-1303-Middle |
| MT-1303-High | Drug | MT-1303-High |
| Placebo | Drug | Placebo |
Primary outcome
Proportion of subjects who achieve PASI 75 (at least 75% reduction from baseline)
Time frame: 16 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 18 Dec 2014.
Related trials for Plaque Psoriasis
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1/2
A Study to Evaluate the Efficacy and Safety of CS32582 in Participants With Moderate to Severe Plaque Psoriasis
Plaque Psoriasis
Not yet recruitingPhase 3
A Study of Zasocitinib in Adults With Non-pustular Palmoplantar Psoriasis
Palmoplantar Psoriasis
RecruitingPhase 4
A Study to Investigate the Effectiveness of Tirzepatide (LY3298176) Following Initiation of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque PsO and Obesity or Overweight in Clinical Practice (TOGETHER AMPLIFY-PsO)
Psoriasis, Overweight or Obesity
Active, not recruitingPhase 3
A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
Plaque Psoriasis
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.
52 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MT-1303-Low, MT-1303-Middle and MT-1303-High in people with Plaque Psoriasis, run by Tanabe Pharma Corporation at 52 sites in 8 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 18 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 52 sites in Germany, Poland, Ukraine, Hungary, Russia and 3 more countries. 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?
Proportion of subjects who achieve PASI 75 (at least 75% reduction from baseline) (time frame: 16 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 18 Dec 2014.