Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary purpose of this proof-of-activity, phase 2 trial is to evaluate the safety and activity of orticumab in subjects with moderate to severe psoriasis and cardiometabolic risk factors.
This randomized, double-blind, study is designed to compare the effect of orticumab against placebo in subjects with moderate to severe psoriasis and cardiometabolic risk factors. A total of 75 subjects will be randomized in a double-blind fashion to receive intravenous (IV) infusions either of orticumab or placebo for up to 78 days.
Participants will be enrolled into one of the two groups: active treatment or placebo. Subjects will be randomized in a 2:1 ratio, orticumab to placebo and receive up to 11 weeks of treatment.
Planned treatments are weekly x 4 , then monthly x 2 . The Internal Safety Review Committee (ISRC) will review the blinded safety data after the first subject completes the first dose (Day 1), the first five subjects complete the first dose (Day 1), and the first ten subjects complete the first dose (Day 1). The IRSC will review all adverse reactions to all administered doses at these times.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Treatment | Active Comparator | Dosage: Repeating intravenous dose. Administered by infusion over 30 minutes. Frequency and duration: once weekly x 4 weeks, then once monthly x 2 months. |
|
| Placebo | Placebo Comparator | Dosage: Repeating intravenous dose. Administered by infusion over 30 minutes. Frequency and duration: once weekly x 4 weeks, then once monthly x 2 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Orticumab | Drug | A human recombinant monoclonal antibody against a specific oxidized low-density lipoprotein (oxLDL) epitope |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Percent Change From Baseline in Psoriasis Area Severity Index (PASI) | PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease) | 106 days (Week 15) |
| Percentage of Participants Achieving Treatment Success by the 5-point Static Investigator's Global Assessment Modified 2011 Version (sIGA) Score | Percentage of participants achieving treatment success (clear =0 or almost clear =1) and greater than or equal to (>=) 2 Point Improvement at Week 15 on the sIGA scale | 106 days (Week 15) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Percent Change From Baseline in Psoriasis Area Severity Index (PASI) | PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease) | Weeks 1, 3, 7, and 11 |
| Percentage of Participants Achieving PASI75 and PASI50 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Coronary Artery Inflammation by CCTA | Change in coronary artery perivascular fat attenuation index (FAI) measured by coronary computed tomographic angiography (CCTA) as report in FAI-Score. - Fat Attenuation Index score is a standardized measurement of coronary inflammation for each coronary artery (adjusted for age, sex as well as technical, biological, and anatomical characteristics) to allow individualized interpretation of the degree of coronary inflammation. FAI-Score range from 0-100. Higher FAI-Score means more inflammation. - CaRi-Heart® Risk Score provides an individualized absolute risk of a fatal cardiac event within the next 8 years, incorporating:
We reported the change in FAI Score and CaRi-Heart Risk Score from baseline here. |
Inclusion criteria:
Exclusion Criteria:
Subjects are excluded from the study if any of the following criteria are met:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Joel Neutel, MD | Orange County Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CCT- Research at the center for Dermatology and Plastic Surgery | Scottsdale | Arizona | 85260 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38523341 | Derived | Farina CJ, Davidson MH, Shah PK, Stark C, Lu W, Shirodaria C, Wright T, Antoniades CA, Nilsson J, Mehta NN. Inhibition of oxidized low-density lipoprotein with orticumab inhibits coronary inflammation and reduces residual inflammatory risk in psoriasis: a pilot randomized, double-blind placebo-controlled trial. Cardiovasc Res. 2024 May 29;120(7):678-680. doi: 10.1093/cvr/cvae057. No abstract available. |
Not provided
Not provided
Participants were randomized 2:1 to receive orticumab or placebo.
The trial was conducted at 21 clinical sites in the United States.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Active Treatment | Dosage: Repeating intravenous dose. Administered by infusion over 30 minutes. Frequency and duration: once weekly x 4 weeks, then once monthly x 2 months. |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 5, 2021 | Feb 12, 2026 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Placebo for orticumab, containing all components of formulation except the active ingredient |
|
PASI75 is a 75 percent reduction in PASI score. PASI50 is a 50 percent reduction in PASI score |
| Weeks 1, 3, 7, and 11 |
| Mean Percent Change in Baseline in Body Surface Area (BSA) % Involvement | Minimum: 0 percent, Maximum: 100 percent. Higher percentage indicates more skin with psoriasis. | Weeks 1, 3, 7, 11, 15 |
| Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Score | DLQI is a ten-question questionnaire used to measure the impact of skin disease on the quality of life of an affected person. Each question is scored from 0 to 3, giving a possible score range from 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life). | Weeks 3, 7, 11, 15 |
| Mean Change From Baseline in Itch Numerical Rating Scale (INRS) Score | The Itch NRS is a self-administered subject reported outcome questionnaire that is completed during protocol specified clinic visits. Participants indicate itch severity by circling the integer that best describes the worst level of itching due to psoriasis in the past 24 h on an 11-point scale anchored at 0, representing 'no itching' and 10, representing 'worst itch imaginable'. | Weeks 3 and 15 |
| 106 days (Week 15) |
| Change in Coronary Artery Plaque Burden by CCTA | Change in total, noncalcified and low attenuation coronary artery plaque volume some measurements have inter-quartile of 0 and median of 0 because most of the participants have a baseline value of 0 (no plaque at baseline) and remain no changes during the trial. | 106 days (Week 15) |
| Derm Institute & Skin Care Ctr., Inc. |
| Santa Monica |
| California |
| 90404 |
| United States |
| Orange County Research Center | Tustin | California | 92780 | United States |
| Blue Coast Research Center | Vista | California | 92083 | United States |
| Jacksonville Center for Clinical Research | Jacksonville | Florida | 32216 | United States |
| Dawes Fretzin Clinical Research Group, LLC | Indianapolis | Indiana | 46250 | United States |
| Las Vegas Clinical Trials | Las Vegas | Nevada | 89030 | United States |
| Excel Clinical Research | Las Vegas | Nevada | 89109 | United States |
| Vital Prospects Clinical Research Institute, PC | Tulsa | Oklahoma | 85260 | United States |
| SMS Clinical Research | Mesquite | Texas | 75149 | United States |
| Texas Dermatology and Laser Specialists | San Antonio | Texas | 78218 | United States |
| Center for Clinical Studies, LTD.LLP | Webster | Texas | 77598 | United States |
| CCT Research - Springville Dermatology | Springville | Utah | 84663 | United States |
Dosage: Repeating intravenous dose. Administered by infusion over 30 minutes.
Frequency and duration: once weekly x 4 weeks, then once monthly x 2 months.
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent-to-treat (ITT) analysis population included all randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Active Treatment | Dosage: Repeating intravenous dose. Administered by infusion over 30 minutes. Frequency and duration: once weekly x 4 weeks, then once monthly x 2 months. |
| BG001 | Placebo | Dosage: Repeating intravenous dose. Administered by infusion over 30 minutes. Frequency and duration: once weekly x 4 weeks, then once monthly x 2 months. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Intent-to-treat (ITT) analysis population included all randomized participants. | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex: Female, Male | Intent-to-treat (ITT) analysis population included all randomized participants. | Count of Participants | Participants |
| |||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | 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 | Mean Percent Change From Baseline in Psoriasis Area Severity Index (PASI) | PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease) | ITT analysis population included all randomized participants. 'Overall Number of Participants Analyzed' = participants with available data. | Posted | Mean | Standard Deviation | Percentage change of score | 106 days (Week 15) |
|
|
| ||||||||||||||||||||||||||||
| Primary | Percentage of Participants Achieving Treatment Success by the 5-point Static Investigator's Global Assessment Modified 2011 Version (sIGA) Score | Percentage of participants achieving treatment success (clear =0 or almost clear =1) and greater than or equal to (>=) 2 Point Improvement at Week 15 on the sIGA scale | ITT analysis population included all randomized participants. 'Overall Number of Participants Analyzed' = participants with available data. | Posted | Count of Participants | Participants | 106 days (Week 15) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Mean Percent Change From Baseline in Psoriasis Area Severity Index (PASI) | PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease) | numbers of participants are different in some visits due to participants discontinued from the trial | Posted | Mean | Standard Deviation | PASI score % change | Weeks 1, 3, 7, and 11 |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving PASI75 and PASI50 | PASI75 is a 75 percent reduction in PASI score. PASI50 is a 50 percent reduction in PASI score | numbers of participants are different in some visits due to participants discontinued from the trial | Posted | Count of Participants | Participants | Weeks 1, 3, 7, and 11 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Mean Percent Change in Baseline in Body Surface Area (BSA) % Involvement | Minimum: 0 percent, Maximum: 100 percent. Higher percentage indicates more skin with psoriasis. | numbers of participants are different in some visits due to participants discontinued from the trial | Posted | Mean | Standard Deviation | percentage change of body surface | Weeks 1, 3, 7, 11, 15 |
|
| |||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Score | DLQI is a ten-question questionnaire used to measure the impact of skin disease on the quality of life of an affected person. Each question is scored from 0 to 3, giving a possible score range from 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life). | numbers of participants are different in some visits due to participants discontinued from the trial | Posted | Mean | Standard Deviation | score | Weeks 3, 7, 11, 15 |
|
| |||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in Itch Numerical Rating Scale (INRS) Score | The Itch NRS is a self-administered subject reported outcome questionnaire that is completed during protocol specified clinic visits. Participants indicate itch severity by circling the integer that best describes the worst level of itching due to psoriasis in the past 24 h on an 11-point scale anchored at 0, representing 'no itching' and 10, representing 'worst itch imaginable'. | numbers of participants are different in some visits due to participants discontinued from the trial | Posted | Mean | Standard Deviation | scores on a scale | Weeks 3 and 15 |
|
| |||||||||||||||||||||||||||||
| Other Pre-specified | Change in Coronary Artery Inflammation by CCTA | Change in coronary artery perivascular fat attenuation index (FAI) measured by coronary computed tomographic angiography (CCTA) as report in FAI-Score. - Fat Attenuation Index score is a standardized measurement of coronary inflammation for each coronary artery (adjusted for age, sex as well as technical, biological, and anatomical characteristics) to allow individualized interpretation of the degree of coronary inflammation. FAI-Score range from 0-100. Higher FAI-Score means more inflammation. - CaRi-Heart® Risk Score provides an individualized absolute risk of a fatal cardiac event within the next 8 years, incorporating:
We reported the change in FAI Score and CaRi-Heart Risk Score from baseline here. | The difference between the number of participants analyzed and the participant flow is because the endpoint is analyzed based on participants with paired CCTA scans. Not all participants have analyzable paired CCTA scans from baseline and follow-up visit due to CCTA scan quality. | Posted | Mean | Standard Deviation | scores on a scale | 106 days (Week 15) |
| ||||||||||||||||||||||||||||||
| Other Pre-specified | Change in Coronary Artery Plaque Burden by CCTA | Change in total, noncalcified and low attenuation coronary artery plaque volume some measurements have inter-quartile of 0 and median of 0 because most of the participants have a baseline value of 0 (no plaque at baseline) and remain no changes during the trial. | Posted | Median | Inter-Quartile Range | cubic millimeter | 106 days (Week 15) |
|
|
From enrollment until end of follow-up, up to 15 weeks
[Not Specific]
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Treatment | Dosage: Repeating intravenous dose. Administered by infusion over 30 minutes. Frequency and duration: once weekly x 4 weeks, then once monthly x 2 months. | 0 | 52 | 2 | 52 | 4 | 52 |
| EG001 | Placebo | Dosage: Repeating intravenous dose. Administered by infusion over 30 minutes. Frequency and duration: once weekly x 4 weeks, then once monthly x 2 months. | 0 | 25 | 0 | 25 | 5 | 25 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Bone abscess | Infections and infestations | Non-systematic Assessment | The event was determined to be not related to receiving the intervention |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Covid-19 infection | Infections and infestations | Non-systematic Assessment |
| ||
| Headache | Nervous system disorders | Non-systematic Assessment |
|
The study was randomized at a 2:1 ratio (orticumab: placebo). This resulted in lower overall statistical power to detect a difference <7% improvement between groups.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Scientist | Abcentra | 4243694401 | info@abcentra.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 11, 2022 | Feb 12, 2026 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| D007249 | Inflammation |
| D003324 | Coronary Artery Disease |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000604072 | MLDL1278A |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Black |
|
| Asian |
|
| American Native |
|
|
|
|
|
|
|
| Placebo |
Dosage: Repeating intravenous dose. Administered by infusion over 30 minutes. Frequency and duration: once weekly x 4 weeks, then once monthly x 2 months. |
|
|
|
| Not achieved |
|
| Not achieved |
|
| Not achieved |
|
| Not achieved |
|
| Not achieved |
|
| Not achieved |
|
| Not achieved |
|