Back to resultsA Proof-of-Activity Study With Orticumab in Subjects With Psoriasis and Cardiometabolic Risk Factors
Primary Purpose
Psoriasis, Inflammation, Coronary Artery Disease
Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Orticumab
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis
Eligibility Criteria
Inclusion criteria:
- Stable/chronic plaque psoriasis with PASI score of ≥ 12 AND involving ≥ 10% of the subject's BSA.- ≥ 30 years of age at time of consent.
- BMI ≥ 30 kg/m2
- LDL ≥ 100 mg/dL at Screening.
- All females must have a negative serum pregnancy test result at Screening and a negative urine pregnancy test prior to dosing.
Exclusion Criteria:
Subjects are excluded from the study if any of the following criteria are met:
- Past use of orticumab.
- Any of the nonplaque forms of psoriasis: erythrodermic, guttate, or pustular.
- Scalp, palmar or plantar psoriasis only, at Screening or Baseline.
- Have evidence of skin conditions (e.g., eczema) at the time of Screening or Baseline visit that would interfere with theevaluation of psoriasis.
- Newly discovered Type 2 diabetes mellitus (T2DM)
- Moderate or high-intensity statin use or new use of a low-intensity statin therapy.
- No use of anti-coagulating or anti-thrombotic agents.
- Poorly controlled hypertension
- Use of an IL-23 blocker in the past 180 days, an IL-17 blocker in the past 16 weeks, or a TNF blocker in the past 12 weeks.
- Use of methotrexate, cyclosporine, or apremilast in the past 4 weeks.
- History of hypersensitivity or allergies to any contents in the orticumab formulation.
- A history of any clinically important abnormalities in cardiac rhythm or conduction.
- A history of prolonged QT intervals or a family history of long QT-syndrome at Screening.
- A history of first, second or third-degree atrioventricular (AV) block, or AV dissociation.
- A history of complete bundle branch block.
- Unstable angina pectoris, myocardial infarction, transient ischemic attack, or stroke within 3 months prior to Screening, or participants who have undergone percutaneous coronary intervention or a coronary artery bypass graft within 6 months prior to Screening or who are due to undergo these procedures at the time of Screening.
- Severe congestive heart failure (NYHA III or IV).
Sites / Locations
- CCT- Research at the center for Dermatology and Plastic Surgery
- Derm Institute & Skin Care Ctr., Inc.
- Orange County Research Center
- Blue Coast Research Center
- Jacksonville Center for Clinical Research
- Dawes Fretzin Clinical Research Group, LLC
- Las Vegas Clinical Trials
- Excel Clinical Research
- Vital Prospects Clinical Research Institute, PC
- SMS Clinical Research
- Texas Dermatology and Laser Specialists
- Center for Clinical Studies, LTD.LLP
- CCT Research - Springville Dermatology
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Active Treatment
Placebo
Arm Description
Dosage: Repeating intravenous dose. Administered by infusion over 30 minutes. Frequency and duration: once weekly x 4 weeks, then once monthly x 2 months.
Dosage: Repeating intravenous dose. Administered by infusion over 30 minutes. Frequency and duration: once weekly x 4 weeks, then once monthly x 2 months.
Outcomes
Primary Outcome Measures
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)
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
Incidence of Treatment Emergent Adverse Events (TEAEs)
Incidence of serious adverse events (SAEs)
Incidence of abnormal hemodynamic parameters
heart rate (HR) and blood pressure (BP)
Incidence of abnormal laboratory tests results
Incidence of abnormal physical examination findings
Physical examination will include the following organ or body system assessments: general appearance; eyes; ears, nose, and throat; head and neck; chest and lungs; cardiovascular; abdomen; musculoskeletal; lymphatic; dermatological; neurological; and extremities.
Secondary Outcome Measures
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)
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
Mean percent change in Baseline in Body Surface Area (BSA) % involvement
Minimum: 0 percent, Maximum: 100 percent. Higher percentage indicates more skin with psoriasis.
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).
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'.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04776629
Brief Title
A Proof-of-Activity Study With Orticumab in Subjects With Psoriasis and Cardiometabolic Risk Factors
Official Title
A Multi-Center, Randomized, Double-Blind, Placebo-controlled Proof-of-Activity Study With Orticumab in Subjects With Moderate-to-Severe Psoriasis and Cardiometabolic Risk Factors
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 30, 2021 (Actual)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
February 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abcentra
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis, Inflammation, Coronary Artery Disease, Cardiometabolic Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
77 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active Treatment
Arm Type
Active Comparator
Arm Description
Dosage: Repeating intravenous dose. Administered by infusion over 30 minutes.
Frequency and duration: once weekly x 4 weeks, then once monthly x 2 months.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Dosage: Repeating intravenous dose. Administered by infusion over 30 minutes.
Frequency and duration: once weekly x 4 weeks, then once monthly x 2 months.
Intervention Type
Drug
Intervention Name(s)
Orticumab
Other Intervention Name(s)
MLDL1278a; BI-204; Anti-oxLDL Antibody
Intervention Description
A human recombinant monoclonal antibody against a specific oxidized low-density lipoprotein (oxLDL) epitope
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo for orticumab, containing all components of formulation except the active ingredient
Primary Outcome Measure Information:
Title
Mean percent change from Baseline in Psoriasis Area Severity Index (PASI)
Description
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)
Time Frame
106 days (Week 15)
Title
Percentage of participants achieving treatment success by the 5-point static Investigator's Global Assessment modified 2011 version (sIGA) Score
Description
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
Time Frame
106 days (Week 15)
Title
Incidence of Treatment Emergent Adverse Events (TEAEs)
Time Frame
106 days (Week 15)
Title
Incidence of serious adverse events (SAEs)
Time Frame
106 days (Week 15)
Title
Incidence of abnormal hemodynamic parameters
Description
heart rate (HR) and blood pressure (BP)
Time Frame
Weeks 3, 7, 11 and 15
Title
Incidence of abnormal laboratory tests results
Time Frame
Weeks 3 and 15
Title
Incidence of abnormal physical examination findings
Description
Physical examination will include the following organ or body system assessments: general appearance; eyes; ears, nose, and throat; head and neck; chest and lungs; cardiovascular; abdomen; musculoskeletal; lymphatic; dermatological; neurological; and extremities.
Time Frame
Weeks 3, 7, 11, 15
Secondary Outcome Measure Information:
Title
Mean percent change from Baseline in Psoriasis Area Severity Index (PASI)
Description
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)
Time Frame
Weeks 1, 3, 7, and 11
Title
Percentage of Participants achieving PASI75 and PASI50
Description
PASI75 is a 75 percent reduction in PASI score. PASI50 is a 50 percent reduction in PASI score
Time Frame
Weeks 1, 3, 7, and 11
Title
Mean percent change in Baseline in Body Surface Area (BSA) % involvement
Description
Minimum: 0 percent, Maximum: 100 percent. Higher percentage indicates more skin with psoriasis.
Time Frame
Weeks 1, 3, 7, 11, 15
Title
Mean change from Baseline in Dermatology Life Quality Index (DLQI) score
Description
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).
Time Frame
Weeks 3, 7, 11, 15
Title
Mean change from Baseline in Itch Numerical Rating Scale (INRS) Score
Description
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'.
Time Frame
Weeks 3 and 15
Other Pre-specified Outcome Measures:
Title
Change in Coronary Artery Inflammation by CCTA
Description
Change in coronary artery perivascular fat attenuation index (FAI) measured by coronary computed tomographic angiography (CCTA)
Time Frame
106 days (Week 15)
Title
Change in coronary artery plaque burden by CCTA
Description
Change in total, noncalcified and low attenuation coronary artery plaque volume
Time Frame
106 days (Week 15)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Stable/chronic plaque psoriasis with PASI score of ≥ 12 AND involving ≥ 10% of the subject's BSA.- ≥ 30 years of age at time of consent.
BMI ≥ 30 kg/m2
LDL ≥ 100 mg/dL at Screening.
All females must have a negative serum pregnancy test result at Screening and a negative urine pregnancy test prior to dosing.
Exclusion Criteria:
Subjects are excluded from the study if any of the following criteria are met:
Past use of orticumab.
Any of the nonplaque forms of psoriasis: erythrodermic, guttate, or pustular.
Scalp, palmar or plantar psoriasis only, at Screening or Baseline.
Have evidence of skin conditions (e.g., eczema) at the time of Screening or Baseline visit that would interfere with theevaluation of psoriasis.
Newly discovered Type 2 diabetes mellitus (T2DM)
Moderate or high-intensity statin use or new use of a low-intensity statin therapy.
No use of anti-coagulating or anti-thrombotic agents.
Poorly controlled hypertension
Use of an IL-23 blocker in the past 180 days, an IL-17 blocker in the past 16 weeks, or a TNF blocker in the past 12 weeks.
Use of methotrexate, cyclosporine, or apremilast in the past 4 weeks.
History of hypersensitivity or allergies to any contents in the orticumab formulation.
A history of any clinically important abnormalities in cardiac rhythm or conduction.
A history of prolonged QT intervals or a family history of long QT-syndrome at Screening.
A history of first, second or third-degree atrioventricular (AV) block, or AV dissociation.
A history of complete bundle branch block.
Unstable angina pectoris, myocardial infarction, transient ischemic attack, or stroke within 3 months prior to Screening, or participants who have undergone percutaneous coronary intervention or a coronary artery bypass graft within 6 months prior to Screening or who are due to undergo these procedures at the time of Screening.
Severe congestive heart failure (NYHA III or IV).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joel Neutel, MD
Organizational Affiliation
Orange County Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
CCT- Research at the center for Dermatology and Plastic Surgery
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85260
Country
United States
Facility Name
Derm Institute & Skin Care Ctr., Inc.
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Orange County Research Center
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
Blue Coast Research Center
City
Vista
State/Province
California
ZIP/Postal Code
92083
Country
United States
Facility Name
Jacksonville Center for Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Dawes Fretzin Clinical Research Group, LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Facility Name
Las Vegas Clinical Trials
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89030
Country
United States
Facility Name
Excel Clinical Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Vital Prospects Clinical Research Institute, PC
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
85260
Country
United States
Facility Name
SMS Clinical Research
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75149
Country
United States
Facility Name
Texas Dermatology and Laser Specialists
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78218
Country
United States
Facility Name
Center for Clinical Studies, LTD.LLP
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
CCT Research - Springville Dermatology
City
Springville
State/Province
Utah
ZIP/Postal Code
84663
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Proof-of-Activity Study With Orticumab in Subjects With Psoriasis and Cardiometabolic Risk Factors
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