U.S. flag

An official website of the United States government

Skip to main page content
Completed

A Proof-of-Activity Study With Orticumab in Subjects With Psoriasis and Cardiometabolic Risk Factors

ClinicalTrials.gov ID NCT04776629
Sponsor Abcentra
Information provided by Abcentra (Responsible Party)
Last Update Posted 2024-02-02
Bookmark

Study Overview

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.

Show less
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
Conditions
Psoriasis
Inflammation
Coronary Artery Disease
Cardiometabolic Syndrome
Intervention / Treatment
  • Drug: Orticumab
  • Drug: Placebo
  • Drug: Orticumab
  • Drug: Placebo
Other Study ID Numbers
  • Ort-2020-01
Study Start (Actual)
2021-06-30
Primary Completion (Actual)
2022-11-11
Study Completion (Actual)
2022-11-11
Enrollment (Actual)
77
Study Type
Interventional
Phase
Phase 2

Contacts and Locations

This section provides contact details for people who can answer questions about joining this study, and information on where this study is taking place.

To learn more, please see the Contacts and Locations section in How to Read a Study Record(https://clinicaltrials.gov/study-basics/how-to-read-study-record#contacts-and-locations).

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies(https://clinicaltrials.gov/study-basics/learn-about-studies).
Eligibility Criteria
Description

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).
Show less
Ages Eligible for Study
30 Years and older (AdultOlder Adult )
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

/
Design Details
Primary Purpose : Treatment
Allocation : Randomized
Interventional Model : Parallel Assignment
Masking : Quadruple (ParticipantCare ProviderInvestigatorOutcomes Assessor)

Arms and Interventions

Participant Group/Arm Intervention/Treatment
Participant Group/Arm Active Comparator: 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.

Intervention/Treatment Drug: Orticumab
  • A human recombinant monoclonal antibody against a specific oxidized low-density lipoprotein (oxLDL) epitope

  • Other Names:
    • MLDL1278a; BI-204; Anti-oxLDL Antibody
Participant Group/Arm Placebo Comparator: 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.

Intervention/Treatment Drug: Placebo
  • Placebo for orticumab, containing all components of formulation except the active ingredient

Primary Outcome Measures
Outcome Measure 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) ScorePercentage 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 scale106 days (Week 15)
Incidence of Treatment Emergent Adverse Events (TEAEs) 106 days (Week 15)
Incidence of serious adverse events (SAEs) 106 days (Week 15)
Incidence of abnormal hemodynamic parametersheart rate (HR) and blood pressure (BP)Weeks 3, 7, 11 and 15
Incidence of abnormal laboratory tests results Weeks 3 and 15
Incidence of abnormal physical examination findingsPhysical 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.Weeks 3, 7, 11, 15
Secondary Outcome Measures
Outcome Measure 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 PASI50PASI75 is a 75 percent reduction in PASI score. PASI50 is a 50 percent reduction in PASI scoreWeeks 1, 3, 7, and 11
Mean percent change in Baseline in Body Surface Area (BSA) % involvementMinimum: 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) scoreDLQI 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) ScoreThe 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
Other Outcome Measures
Outcome Measure Measure Description Time Frame
Change in Coronary Artery Inflammation by CCTAChange in coronary artery perivascular fat attenuation index (FAI) measured by coronary computed tomographic angiography (CCTA)106 days (Week 15)
Change in coronary artery plaque burden by CCTAChange in total, noncalcified and low attenuation coronary artery plaque volume106 days (Week 15)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.
Sponsor
Abcentra
Investigators
  • Principal Investigator:Joel Neutel, MD,Orange County Research Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
2021-02-16
First Submitted that Met QC Criteria
2021-02-25
First Posted
2021-03-02
Study Record Updates
Last Update Submitted that met QC Criteria
2024-02-01
Last Update Posted
2024-02-02
Last Verified
2024-02

More Information

/

Additional Relevant MeSH Terms