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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.
A) To evaluate the safety and tolerability of 12 weeks of treatment with Apo805K1
B) To evaluate the pharmacokinetics of Apo805K1 following daily administration for 14 days
C) To evaluate the efficacy and pharmacodynamics of Apo805K1
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 10 mg Apo805K1, or placebo | Experimental |
| |
| 30 mg Apo805K1, or placebo | Experimental |
| |
| 60 mg Apo805K1, or placebo | Experimental |
| |
| 100 mg Apo805K1, or placebo | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apo805K1 | Drug | Sequential parallel dose escalation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. . | 12 hours |
| Tmax of Apo805K1 Following Multiple Doses, Assessed at Day 14 |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Axis Clinical Trials | Los Angeles | California | 90017 | United States | ||
| Axis Clinical Trials |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Three patients in each of the 4 dose-escalating cohorts were randomized to receive placebo tablets that matched the active product in size and number (one 10 mg tablet, three 10 mg tablets, one 50 mg plus one 10 mg tablet, or two 50 mg tablets, respectively), daily for 12 weeks. The data of all placebo recipients were pooled for analyses. |
| FG001 | Apo805K1 10 mg | Patients in this treatment group received a single 10 mg tablet of Apo805K1 daily for 12 weeks |
| FG002 | Apo805K1 30 mg | Patients in this treatment group received three 10 mg tablets of Apo805K1 daily for 12 weeks |
| FG003 | Apo805K1 60 mg | Patients in this treatment group received one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks |
| FG004 | Apo805K1 100 mg | Patients in this treatment group received two 50 mg tablets of Apo805K1 daily for 12 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
A total of 60 patients were enrolled. No formal sample size calculation for this study was done, as this study was an exploratory study with main objective to assess the safety and tolerability of Apo805K1.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Three patients in each of the 4 dose-escalating cohorts were randomized to receive placebo tablets that matched the active product in size and number (one 10 mg tablet, three 10 mg tablets, one 50 mg plus one 10 mg tablet, or two 50 mg tablets, respectively), daily for 12 weeks. The data of all placebo recipients were pooled for analyses. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The Safety Population consisted of all patients who received at least 1 dose of study medication. | Posted | Number | participants | 12 Weeks |
|
Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug
Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Three patients in each of the 4 dose-escalating cohorts were randomized to take placebo tablets that matched the active product in size and number (one 10 mg tablet, three 10 mg tablets, one 50 mg plus one 10 mg tablet, or two 50 mg tablets, respectively), daily for 12 weeks. The data of all placebo recipients were pooled for analyses. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pustular psoriasis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bundle branch block right | Cardiac disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Fernando Tricta, MD | ApoPharma Inc. | Phone: 416-401-7332 | ftricta@apopharma.com |
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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. |
| 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. | 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. | 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. | 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 | 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. | 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. | Baseline to 12 weeks |
| Los Angeles |
| California |
| 90036 |
| United States |
| Menter Dermatology Research Institute | Dallas | Texas | 75246 | United States |
| Center for Clinical Studies | Houston | Texas | 77030 | United States |
| Center for Clinical Studies | Houston | Texas | 77598 | United States |
| The University of Utah | Salt Lake City | Utah | 84132 | United States |
| Innovaderm Research Inc. | Montreal | Quebec | H2K4L5 | Canada |
| Adverse Event |
|
| Non-compliance |
|
| Sponsor concern over ECG result |
|
| BG001 |
| Apo805K1 10 mg |
Patients in this treatment group received a single 10 mg tablet of Apo805K1 daily for 12 weeks |
| BG002 | Apo805K1 30 mg | Patients in this treatment group received three 10 mg tablets of Apo805K1 daily for 12 weeks |
| BG003 | Apo805K1 60 mg | Patients in this treatment group received one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks |
| BG004 | Apo805K1 100 mg | Patients in this treatment group received two 50 mg tablets of Apo805K1 daily for 12 weeks |
| BG005 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| Apo805K1 10 mg |
Patients in this treatment group received a single 10 mg tablet of Apo805K1 daily for 12 weeks |
| OG002 | Apo805K1 30 mg | Patients in this treatment group received three 10 mg tablets of Apo805K1 daily for 12 weeks |
| OG003 | Apo805K1 60 mg | Patients in this treatment group received one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks |
| OG004 | Apo805K1 100 mg | Patients in this treatment group received two 50 mg tablets of Apo805K1 daily for 12 weeks |
|
|
| Secondary | 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. . | The Pharmacokinetics Population consisted of all patients who received Apo805K1 and provided evaluable PK data on at least one visit (Day 1 or Day 14) | Posted | Mean | Standard Deviation | ng/mL | 12 hours |
|
|
|
| Secondary | 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. | Posted | Median | Full Range | hour | 12 hours |
|
|
|
| Secondary | 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. | The Pharmacokinetics Population consisted of all patients who received Apo805K1 and provided evaluable PK data on at least one visit (Day 1 or Day 14) | Posted | Mean | Standard Deviation | ng *hr/mL | 12 hours |
|
|
|
| Secondary | 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. | The Pharmacokinetics Population consisted of all patients who received Apo805K1 and provided evaluable PK data on at least one visit (Day 1 or Day 14) | Posted | Mean | Standard Deviation | hour | 12 hours |
|
|
|
| Secondary | 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. | The Efficacy Population was defined as all patients who received at least 1 dose of study medication and completed at least 1 post-baseline efficacy assessment. | Posted | Mean | Standard Deviation | units on a scale | Baseline to 12 Weeks |
|
|
|
|
| Secondary | 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 | The Efficacy Population was defined as all patients who received at least 1 dose of study medication and completed at least 1 post-baseline efficacy assessment. | Posted | Number | percentage of patients | 12 weeks |
|
|
|
|
| Secondary | 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. | The Efficacy Population was defined as all patients who received at least 1 dose of study medication and completed at least 1 post-baseline efficacy assessment. | Posted | Mean | Standard Deviation | units on a scale | Baseline to 12 weeks |
|
|
|
|
| Secondary | 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. | The Efficacy Population was defined as all patients who received at least 1 dose of study medication and completed at least 1 post-baseline efficacy assessment. | Posted | Mean | Standard Deviation | units on a scale | Baseline to 12 weeks |
|
|
|
|
| 0 |
| 12 |
| 4 |
| 12 |
| EG001 | Apo805K1 10 mg | Patients in this treatment group took a single 10 mg tablet of Apo805K1 daily for 12 weeks | 0 | 12 | 5 | 12 |
| EG002 | Apo805K1 30 mg | Patients in this treatment group took three 10 mg tablets of Apo805K1 daily for 12 weeks | 1 | 12 | 7 | 12 |
| EG003 | Apo805K1 60 mg | Patients in this treatment group took one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks | 0 | 12 | 6 | 12 |
| EG004 | Apo805K1 100 mg | Patients in this treatment group took two 50 mg tablets of Apo805K1 daily for 12 weeks | 0 | 12 | 5 | 12 |
| Blepharitis | Eye disorders | MedDRA | Systematic Assessment |
|
| Blepharospasm | Eye disorders | MedDRA | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA | Systematic Assessment |
|
| Optic nerve cupping | Eye disorders | MedDRA | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA | Systematic Assessment |
|
| Pain | General disorders | MedDRA | Systematic Assessment |
|
| Vessel puncture site pain | General disorders | MedDRA | Systematic Assessment |
|
| Bronchitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Panic attack | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Breast cyst | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Pustular psoriasis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Skin haemorrhage | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
Not provided