Plaque PsoriasisPhase 1NCT03018509
Study to Evaluate Safety,Tolerability,Pharmacodynamics & Pharmacokinetics of JTE-451 in Active Plaque Psoriasis Subjects
A Phase 1 study testing JTE-451 in people with Plaque Psoriasis and Psoriasis, run by Shionogi Inc. at 5 sites in Canada.
Trial summary
Study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic effect of JTE-451 administered for 4 weeks in subjects with active plaque psoriasis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Plaque Psoriasis, Psoriasis, Skin Diseases
- What is being tested?
- JTE-451
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 5 sitesCanada
- Study dates
- Dec 2016to 20 Jun 2017
- Phase
- Phase 1
- 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
- Minimum of two psoriatic plaques (i.e., one clinical target lesion and one biopsy target lesion).
- Each of the two target lesions must have a psoriatic lesion severity sum (PLSS) of ≥6
- Body mass index (BMI) of 18 to 38 kg/m2 (inclusive)
Who cannot join
- Prior exposure to >2 systemic biologic agents and/or small molecules including investigational therapies for the treatment of psoriasis or have not discontinued systemic biologic agents and/or small molecules anti-psoriasis therapy including investigational therapies due to lack of efficacy;
- Subjects with significant health problems, other than having plaque psoriasis (as determined by medical history, physical examination, chest X-ray, vital signs and 12-lead ECG) that could either interfere with study evaluations or place subject at undue risk;
- Presence of erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis at Visit 1;
- Conditions (e.g., clinically-significant eczema or severe acne in the target lesion area) that would interfere with study evaluations;
- Positive quantiFERON®-TB Gold test, negative chest X-ray findings for tubercle bacillus (TB) or lack any other evidence of active or latent TB;
- History of a clinically-significant infection (e.g., required oral antimicrobial therapy) within 4 weeks prior to Visit 2;
- Subjects who do not have clinical laboratory test results within the normal reference ranges (i.e., are deemed not to be clinically significant) or clinically not acceptable to the Investigator;
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
Study site
Markham, Ontario
Study site
Peterborough, Ontario
Study site
Richmond Hill, Ontario
Study site
Surrey, British Columbia
Study site
Waterloo, Ontario
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of JTE-451 Administered for 4 Weeks in Subjects With Active Plaque Psoriasis
Study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic effect of JTE-451 administered for 4 weeks in subjects with active plaque psoriasis.
- Conditions
- Plaque Psoriasis, Psoriasis, Skin Diseases
- Being tested
- JTE-451, Placebo
- Keywords
- JTE-451, psoriasis
- Medical subject headings
- Psoriasis, Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JTE-451Drug
Active drug tablets containing JTE-451
PlaceboDrug
Placebo tablets identical in appearance to the active drug tablets
| Study group | Role | What they receive |
|---|---|---|
| JTE-451 Dose 1 | Experimental | JTE-451 dose 1 for 28 days Receives: Drug: JTE-451 |
| JTE-451 Dose 2 | Experimental | JTE-451 dose 2 for 28 days Receives: Drug: JTE-451 |
| JTE-451 Dose 3 | Experimental | JTE-451 dose 3 for 28 days Receives: Drug: JTE-451 |
| JTE-451 Dose 4 | Experimental | JTE-451 dose 4 for 28 days Receives: Drug: JTE-451 |
| Placebo | Experimental | Placebo for 28 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events
Measured: 4 weeks
Percent change from baseline in the clinical target PLSS
Measured: Weeks 1, 2, 3 and 4
Percent change from baseline in the clinical target lesion erythema
Measured: Weeks 1, 2, 3 and 4
Percent change from baseline in the clinical target lesion induration
Measured: Weeks 1, 2, 3 and 4
Percent change from baseline in the clinical target lesion scaling
Measured: Weeks 1, 2, 3 and 4
Change from baseline in the clinical target lesion sPGA score
Measured: Weeks 1, 2, 3 and 4
Number of subjects with clinical target lesion sPGA scores of 0 or 1
Measured: Week 1
Number of subjects with clinical target lesion sPGA scores of 0 or 1
Measured: Week 2
Number of subjects with clinical target lesion sPGA scores of 0 or 1
Measured: Week 3
Number of subjects with clinical target lesion sPGA scores of 0 or 1
Measured: Week 4
Number of subjects with at least a 2-point improvement in sPGA score
Measured: Baseline to Week 4
Trough concentration during multiple dosing prior to next dose (Ctrough)
Measured: Weeks 1, 2, 3 and 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2017 (estimated)
- Study startDec 2016
- Primary completion20 Jun 2017
- Study completion20 Jun 2017
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shionogi Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03018509
- Sponsor's protocol ID
- AE451-X-16-003
- Status last verified
- Jun 2017
- First submitted
- 6 Jan 2017
- Last updated
- 2 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of JTE-451 Administered for 4 Weeks in Subjects With Active Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT03018509
- Acronym / sponsor ID
- AE451-X-16-003
- Conditions
- Plaque Psoriasis, Psoriasis, Skin Diseases
- Keywords
- JTE-451, psoriasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Shionogi Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2016
- Primary completion
- 20 Jun 2017 (actual)
- Study completion
- 20 Jun 2017 (actual)
- First posted
- 12 Jan 2017 (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.
Study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic effect of JTE-451 administered for 4 weeks in subjects with active plaque psoriasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| JTE-451 Dose 1 | Experimental | Drug: JTE-451JTE-451 dose 1 for 28 days |
| JTE-451 Dose 2 | Experimental | Drug: JTE-451JTE-451 dose 2 for 28 days |
| JTE-451 Dose 3 | Experimental | Drug: JTE-451JTE-451 dose 3 for 28 days |
| JTE-451 Dose 4 | Experimental | Drug: JTE-451JTE-451 dose 4 for 28 days |
| Placebo | Experimental | Drug: PlaceboPlacebo for 28 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Minimum of two psoriatic plaques (i.e., one clinical target lesion and one biopsy target lesion).
- Each of the two target lesions must have a psoriatic lesion severity sum (PLSS) of ≥6
- Body mass index (BMI) of 18 to 38 kg/m2 (inclusive)
Key exclusion criteria (7 listed)
- Prior exposure to >2 systemic biologic agents and/or small molecules including investigational therapies for the treatment of psoriasis or have not discontinued systemic biologic agents and/or small molecules anti-psoriasis therapy including investigational therapies due to lack of efficacy;
- Subjects with significant health problems, other than having plaque psoriasis (as determined by medical history, physical examination, chest X-ray, vital signs and 12-lead ECG) that could either interfere with study evaluations or place subject at undue risk;
- Presence of erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis at Visit 1;
- Conditions (e.g., clinically-significant eczema or severe acne in the target lesion area) that would interfere with study evaluations;
- Positive quantiFERON®-TB Gold test, negative chest X-ray findings for tubercle bacillus (TB) or lack any other evidence of active or latent TB;
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 |
|---|---|---|
| JTE-451Active drug tablets containing JTE-451 | Drug | JTE-451 Dose 1, JTE-451 Dose 2, JTE-451 Dose 3, JTE-451 Dose 4 |
| PlaceboPlacebo tablets identical in appearance to the active drug tablets | Drug | Placebo |
Primary outcome
Number of adverse events
Time frame: 4 weeks
Percent change from baseline in the clinical target PLSS
Time frame: Weeks 1, 2, 3 and 4
Percent change from baseline in the clinical target lesion erythema
Time frame: Weeks 1, 2, 3 and 4
Percent change from baseline in the clinical target lesion induration
Time frame: Weeks 1, 2, 3 and 4
Percent change from baseline in the clinical target lesion scaling
Time frame: Weeks 1, 2, 3 and 4
Change from baseline in the clinical target lesion sPGA score
Time frame: Weeks 1, 2, 3 and 4
Number of subjects with clinical target lesion sPGA scores of 0 or 1
Time frame: Week 1
Number of subjects with clinical target lesion sPGA scores of 0 or 1
Time frame: Week 2
Number of subjects with clinical target lesion sPGA scores of 0 or 1
Time frame: Week 3
Number of subjects with clinical target lesion sPGA scores of 0 or 1
Time frame: Week 4
Number of subjects with at least a 2-point improvement in sPGA score
Time frame: Baseline to Week 4
Trough concentration during multiple dosing prior to next dose (Ctrough)
Time frame: Weeks 1, 2, 3 and 4
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 Jul 2017.
- Individual participant dataSharing planned: No
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JTE-451 in people with Plaque Psoriasis and Psoriasis, run by Shionogi Inc. at 5 sites in Canada.
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 7 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 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Number of adverse events (time frame: 4 weeks). The study lists 12 primary outcomes in all. 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 Jul 2017.