Plaque PsoriasisPhase 2NCT01483924
Study to Evaluate Apo805K1 in Subjects With Moderate to Severe Chronic Plaque Psoriasis
A Phase 2 study testing Apo805K1 in people with Plaque Psoriasis, run by ApoPharma at 7 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of 12 weeks of treatment with Apo805K1 in subjects with moderate to severe chronic plaque psoriasis. 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?
- Apo805K1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Nov 2011to Oct 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Main Inclusion Criteria:
- A clinical diagnosis of moderate to severe chronic plaque psoriasis for at least 6 months (before Baseline assessment) with current body surface area (BSA) involvement ≥10% and Psoriasis Area Severity Index (PASI) ≥10.
- Male and female subjects 18 to 65 years of age, inclusive.
- At least one psoriatic plaque ≥6 mm in diameter (in a location suitable for biopsy).
- Signed and witnessed written informed consent form obtained prior to the first study intervention, as well as the ability to adhere to study restrictions, appointments and evaluation schedule.
Main Exclusion Criteria:
- Treatment of psoriasis with biologic agents within 90 days prior to Baseline assessment and during the study.
- Treatment with methotrexate, cyclosporine, retinoids, hydroxyurea or other systemic agents within 30 days prior to Baseline assessment and during the study.
- Phototherapy within 30 days prior to Baseline assessment and during the study.
- Psoriasis topical therapy within 14 days prior to Baseline assessment and during the study (exception: non-medicated emollients and tar shampoo will be allowed).
- History of liver disease or abnormal liver enzymes
- Serum creatinine ≥1.5 times the upper limit of normal for age and sex-matched controls.
- Previous treatment with Apo805K1or Thymodepressin or other immunosuppressant drugs.
- Evidence of skin conditions other than psoriasis (e.g., eczema) that could interfere with psoriasis assessments.
- History of chronic infection or malignancy
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States6 sites
Menter Dermatology Research Institute
Dallas, Texas, 75246
Center for Clinical Studies
Houston, Texas, 77030
Center for Clinical Studies
Houston, Texas, 77598
Axis Clinical Trials
Los Angeles, California, 90017
Axis Clinical Trials
Los Angeles, California, 90036
The University of Utah
Salt Lake City, Utah, 84132
About this study
Official title: A 12-week Randomized, Double-blind, Placebo-controlled, Multicenter, Multiple Sequential Dose Escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Apo805K1 in Subjects With Moderate to Severe Chronic Plaque Psoriasis
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of 12 weeks of treatment with Apo805K1 in subjects with moderate to severe chronic plaque psoriasis.
Read the detailed description
- To evaluate the safety and tolerability of 12 weeks of treatment with Apo805K1
- To evaluate the pharmacokinetics of Apo805K1 following daily administration for 14 days
- To evaluate the efficacy and pharmacodynamics of Apo805K1
- Conditions
- Plaque Psoriasis
- Being tested
- Apo805K1
- Keywords
- Mild to Moderate Chronic Plaque Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apo805K1Drug
Sequential parallel dose escalation.
| Study group | Role | What they receive |
|---|---|---|
| 10 mg Apo805K1, or placebo | Experimental | Not described Receives: Drug: Apo805K1 |
| 30 mg Apo805K1, or placebo | Experimental | Not described Receives: Drug: Apo805K1 |
| 60 mg Apo805K1, or placebo | Experimental | Not described Receives: Drug: Apo805K1 |
| 100 mg Apo805K1, or placebo | Experimental | Not described Receives: Drug: Apo805K1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Adverse Events
The number of patients in each treatment group who reported at least 1 adverse event, including clinically significant changes from baseline in vital signs, 12-lead ECG, physical examinations and laboratory tests, from the time of the first dose until the last study visit.
Measured: 12 Weeks
Secondary outcomes (8)
Cmax of Apo805K1 Following Multiple Doses, Assessed at Day 14
Cmax for dosages of 10 mg, 30 mg, 60 mg, or 100 mg Apo805K1, determined on Day 14. Serial blood samples for PK analysis were collected pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose.
.
Measured: 12 hours
Tmax of Apo805K1 Following Multiple Doses, Assessed at Day 14
Tmax for dosages of 10 mg, 30 mg, 60 mg, or 100 mg Apo805K1, determined on Day 14. Serial blood samples for PK analysis were collected pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose.
Measured: 12 hours
AUC 0-infinity of Apo805K1 Following Multiple Doses, Assessed at Day 14
AUC 0-infinity for dosages of 10 mg, 30 mg, 60 mg, or 100 mg Apo805K1, determined on Day 14. Serial blood samples for PK analysis were collected pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose.
Measured: 12 hours
T 1/2 of Apo805K1 Following Multiple Doses, Assessed at Day 14
T 1/2 for dosages of 10 mg, 30 mg, 60 mg, or 100 mg Apo805K1, determined on Day 14. Serial blood samples for PK analysis were collected pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose.
Measured: 12 hours
Efficacy of Apo805K1 as Assessed by Change From Baseline in Psoriasis Area Severity Index (PASI) Scores
PASI is a quantitative measure of psoriasis that combines an assessment of the severity of lesions and a measurement of how much of the body surface area is affected into a single score ranging from 0 (no disease) to 72 (maximal disease). Thus, a decrease in PASI score indicates improvement. This outcome measure compared the difference in change in PASI score from baseline to Week 12 between the active treatment groups and the placebo group.
Measured: Baseline to 12 Weeks
Efficacy of APO805K1 as Assessed by Achievement of PASI-75
The proportion of patients in each treatment group who achieved at least a 75% improvement in PASI score from baseline at Week 12
Measured: 12 weeks
Efficacy of Apo805K1 as Assessed by Change From Baseline at Week 12 in Lattice System-Physician Global Assessment (LS-PGA) Scores
The LS-PGA is a standardized method for determining categories of psoriasis severity. The percentage of body surface area involved is assessed on a scale ranging from 1 (0%) to 7 (51-100%); measures of plaque severity (thickness, erythema, and scaling) are assessed using a 4-point scale ranging from "none" to "marked"; and an algorithm is used to combine the above scores to determine a final score on a scale ranging from 0 (clear) to 7 (very severe). Thus, a decrease in LS-PGA score indicates improvement. This outcome measure compared the difference in change in LS-PGA score from baseline to Week 12 between the active treatment groups and the placebo group.
Measured: Baseline to 12 weeks
Efficacy of Apo805K1 as Assessed by Change From Baseline to Week 12 in Physician Global Assessment (PGA) Score
In the PGA, the physician assigns a single estimate of a patient's overall severity of the disease using a scale ranging from 0 (Clear) to 7 (Severe). (Unlike the LS-PGA, the individual elements of psoriasis plaque morphology or degree of body surface area involvement are not quantified.) Thus, a decrease in PGA score indicates improvement. This outcome measure compared the difference in change in PGA score from baseline to Week 12 between the active treatment groups and the placebo group.
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2011 (estimated)
- Study startNov 2011
- Primary completionAug 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- ApoPharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01483924
- Sponsor's protocol ID
- AP03-0210
- Status last verified
- Feb 2015
- First submitted
- 30 Nov 2011
- Last updated
- 20 Feb 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-week Randomized, Double-blind, Placebo-controlled, Multicenter, Multiple Sequential Dose Escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Apo805K1 in Subjects With Moderate to Severe Chronic Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT01483924
- Acronym / sponsor ID
- AP03-0210
- Conditions
- Plaque Psoriasis
- Keywords
- Mild to Moderate Chronic Plaque Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- ApoPharmaIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Aug 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 2 Dec 2011 (estimated)
- Results
- Posted 20 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of 12 weeks of treatment with Apo805K1 in subjects with moderate to severe chronic plaque psoriasis.
Detailed description
- To evaluate the safety and tolerability of 12 weeks of treatment with Apo805K1
- To evaluate the pharmacokinetics of Apo805K1 following daily administration for 14 days
- To evaluate the efficacy and pharmacodynamics of Apo805K1
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 10 mg Apo805K1, or placebo | Experimental | Drug: Apo805K1 |
| 30 mg Apo805K1, or placebo | Experimental | Drug: Apo805K1 |
| 60 mg Apo805K1, or placebo | Experimental | Drug: Apo805K1 |
| 100 mg Apo805K1, or placebo | Experimental | Drug: Apo805K1 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Apo805K1Sequential parallel dose escalation. | Drug | 10 mg Apo805K1, or placebo, 100 mg Apo805K1, or placebo, 30 mg Apo805K1, or placebo, 60 mg Apo805K1, or placebo |
Primary outcome
Number of Patients With Adverse Events
Time frame: 12 Weeks
The number of patients in each treatment group who reported at least 1 adverse event, including clinically significant changes from baseline in vital signs, 12-lead ECG, physical examinations and laboratory tests, from the time of the first dose until the last study visit.
8 secondary outcomes
Cmax of Apo805K1 Following Multiple Doses, Assessed at Day 14
Time frame: 12 hours
Tmax of Apo805K1 Following Multiple Doses, Assessed at Day 14
Time frame: 12 hours
AUC 0-infinity of Apo805K1 Following Multiple Doses, Assessed at Day 14
Time frame: 12 hours
T 1/2 of Apo805K1 Following Multiple Doses, Assessed at Day 14
Time frame: 12 hours
Efficacy of Apo805K1 as Assessed by Change From Baseline in Psoriasis Area Severity Index (PASI) Scores
Time frame: Baseline to 12 Weeks
Efficacy of APO805K1 as Assessed by Achievement of PASI-75
Time frame: 12 weeks
Efficacy of Apo805K1 as Assessed by Change From Baseline at Week 12 in Lattice System-Physician Global Assessment (LS-PGA) Scores
Time frame: Baseline to 12 weeks
Efficacy of Apo805K1 as Assessed by Change From Baseline to Week 12 in Physician Global Assessment (PGA) Score
Time frame: Baseline to 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Apo805K1 in people with Plaque Psoriasis, run by ApoPharma at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 20 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, 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 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?
Yes. Results are posted in the registry (first posted 20 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Patients With Adverse Events (time frame: 12 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 20 Feb 2015.