PsoriasisPhase 2NCT02970331
A Phase 2, Multicenter, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Pefcalcitol Ointment, 0.005%, Applied Topically Twice Daily (BID) for 8 Weeks in Adolescent Subjects 12 to < 17 Years of Age With Plaque Psoriasis
A Phase 2 study testing pefcalcitol ointment, 0.005% in people with Psoriasis, run by Maruho Co., Ltd..
Trial summary
A multi-center, open-label study that will evaluate the safety/tolerability and pharmacodynamics as well as the pharmacokinetic profile (sub-population analysis), in 50 evaluable adolescents 12 to < 17 years of age. Read more about this study
- Who is it for?
- Ages 12 to 16 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- pefcalcitol ointment, 0.005%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2019to Dec 2019
- 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 12 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- male or females 12 to < 17 years of age
- Have a confirmed diagnosis of plaque psoriasis
- Negative pregnancy test
- Group 1: Have plaque psoriasis with an IGA score of ≥ 2 (mild), with at least one lesion ) and up to 20% Body Surface Area (BSA) involvement not including psoriasis on the face and scalp
- Group 2: Have plaque psoriasis with a IGA score of ≥ 2 (mild), with plaque psoriasis involving at least 10% and up to 20% Body Surface Area (BSA) not including psoriasis on the face and scalp
Who cannot join
- known allergy or intolerance to the study drug or other vitamin D3 analogs or any of its components
- history of or active generalized guttate, pustular or erythrodermic exfoliative psoriasis
- history or presence of contact dermatitis induced by a topical medicine or other serious skin condition that is not well controlled
- Use topical treatments known to have beneficial effects on psoriasis
- Use phototherapy, oral corticosteroids, oral retinoid, oral immunosuppressive/immunomodulate drugs, cytostatics, cyclosporine or methotrexate within 30 days prior to the first dose of study drug
- Use any approved biologics for psoriasis within 30 days or 5 half-lives of the biologic before the first dose of study drug
Show all 16Show fewer
- Are treated with medications known to worsen psoriasis
- Are taking an oral vitamin D
- Are taking medications that affect calcium metabolism;
- Subjects who have an average of three (3) QTcF measurements of > 450 milliseconds as shown on the ECG (Group 2 only);
- Have clinically significant abnormal calcium homeostasis parameters at Visit 1;
- Have clinically significant liver or renal dysfunction
- Have any other clinically significant laboratory abnormalities, co-morbidities or psychiatric conditions which that would place the subject at increased risk or would confound the primary or secondary objectives of the study;
- Use of any investigational drugs or biologics and/or participated in any clinical trial within the last 60 days before the day of the first dose of study drug or are taking part in a non-medication study which, that would interfere with study compliance or outcome assessments;
- Are pregnant or lactating females;
- Have a known history of congenital or acquired immunodeficiency.
About this study
A multi-center, open-label study that will evaluate the safety/tolerability and pharmacodynamics as well as the pharmacokinetic profile (sub-population analysis), in 50 evaluable adolescents 12 to < 17 years of age.
- Conditions
- Psoriasis
- Being tested
- pefcalcitol ointment, 0.005%
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pefcalcitol ointment, 0.005%Drug
pefcalcitol ointment, 0.005%
| Study group | Role | What they receive |
|---|---|---|
| pefcalcitol | Experimental | pefcalcitol 0.005% BID for 8 weeks Receives: Drug: pefcalcitol ointment, 0.005% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in incidence and severity of application site adverse events
Measured: screening, weeks 0,2,4 and 8
Change in incidence and severity of all AEs and their relationship to study drug
Measured: screening, weeks 0,2,4 and 8
Changes from baseline (pre-dose, Day 1) in safety laboratory parameters
Measured: week 8
Changes from baseline (pre-dose, Day 1) in calcium homeostasis parameters (total serum calcium and albumin-corrected calcium levels, plasma parathyroid hormone (PTH), and serum alkaline phosphatase)
Measured: week 8
Determination of plasma concentrations of Pefcalcitol and its metabolites
Measured: Day 1 and Day 15
Secondary outcomes (4)
Proportion of subjects with an IGA score of absence (0) or very mild (1) with a minimum of a 2-grade improvement from baseline
Measured: week 8
Proportion of subjects who achieved an mPASI 75 from baseline (Week 0) to Week 8, or who achieved an mPASI 50 and a 5-point improvement in the CDLQI from baseline
Measured: week 8
Proportion of subjects who achieved success in each of the three individual components of the mPASI (scaling, thickness and erythema) from baseline
Measured: week 8
Proportion of subjects who achieved a 5-point improvement in the CDLQI from baseline
Measured: week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2016 (estimated)
- Study startJun 2019 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Why it stopped: FDA requested us to stop the study
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 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
- NCT02970331
- Sponsor's protocol ID
- CLS008-CO-PR-001
- Status last verified
- Jan 2019
- First submitted
- 16 Nov 2016
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Pefcalcitol Ointment, 0.005%, Applied Topically Twice Daily (BID) for 8 Weeks in Adolescent Subjects 12 to < 17 Years of Age With Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT02970331
- Acronym / sponsor ID
- CLS008-CO-PR-001
- Conditions
- Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: FDA requested us to stop the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Maruho Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2019 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 22 Nov 2016 (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.
A multi-center, open-label study that will evaluate the safety/tolerability and pharmacodynamics as well as the pharmacokinetic profile (sub-population analysis), in 50 evaluable adolescents 12 to < 17 years of age.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pefcalcitol | Experimental | Drug: pefcalcitol ointment, 0.005%pefcalcitol 0.005% BID for 8 weeks |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- male or females 12 to < 17 years of age
- Have a confirmed diagnosis of plaque psoriasis
- Negative pregnancy test
- Group 1: Have plaque psoriasis with an IGA score of ≥ 2 (mild), with at least one lesion ) and up to 20% Body Surface Area (BSA) involvement not including psoriasis on the face and scalp
- Group 2: Have plaque psoriasis with a IGA score of ≥ 2 (mild), with plaque psoriasis involving at least 10% and up to 20% Body Surface Area (BSA) not including psoriasis on the face and scalp
Key exclusion criteria (16 listed)
- known allergy or intolerance to the study drug or other vitamin D3 analogs or any of its components
- history of or active generalized guttate, pustular or erythrodermic exfoliative psoriasis
- history or presence of contact dermatitis induced by a topical medicine or other serious skin condition that is not well controlled
- Use topical treatments known to have beneficial effects on psoriasis
- Use phototherapy, oral corticosteroids, oral retinoid, oral immunosuppressive/immunomodulate drugs, cytostatics, cyclosporine or methotrexate within 30 days prior to the first dose of study drug
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 |
|---|---|---|
| pefcalcitol ointment, 0.005%pefcalcitol ointment, 0.005% | Drug | pefcalcitol |
Primary outcome
Change in incidence and severity of application site adverse events
Time frame: screening, weeks 0,2,4 and 8
Change in incidence and severity of all AEs and their relationship to study drug
Time frame: screening, weeks 0,2,4 and 8
Changes from baseline (pre-dose, Day 1) in safety laboratory parameters
Time frame: week 8
Changes from baseline (pre-dose, Day 1) in calcium homeostasis parameters (total serum calcium and albumin-corrected calcium levels, plasma parathyroid hormone (PTH), and serum alkaline phosphatase)
Time frame: week 8
Determination of plasma concentrations of Pefcalcitol and its metabolites
Time frame: Day 1 and Day 15
4 secondary outcomes
Proportion of subjects with an IGA score of absence (0) or very mild (1) with a minimum of a 2-grade improvement from baseline
Time frame: week 8
Proportion of subjects who achieved an mPASI 75 from baseline (Week 0) to Week 8, or who achieved an mPASI 50 and a 5-point improvement in the CDLQI from baseline
Time frame: week 8
Proportion of subjects who achieved success in each of the three individual components of the mPASI (scaling, thickness and erythema) from baseline
Time frame: week 8
Proportion of subjects who achieved a 5-point improvement in the CDLQI from baseline
Time frame: week 8
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing pefcalcitol ointment, 0.005% in people with Psoriasis, run by Maruho Co., Ltd..
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 5 inclusion and 16 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: withdrawn, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
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 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 was withdrawn before enrolling participants, so there are no results.
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?
Change in incidence and severity of application site adverse events (time frame: screening, weeks 0,2,4 and 8). The study lists 5 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 18 Apr 2023.