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

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ClinicalTrials.gov Identifier: NCT04776629
Recruitment Status : Recruiting
First Posted : March 2, 2021
Last Update Posted : August 2, 2021
Sponsor:
Information provided by (Responsible Party):
Abcentra

Tracking Information
First Submitted Date  ICMJE February 16, 2021
First Posted Date  ICMJE March 2, 2021
Last Update Posted Date August 2, 2021
Actual Study Start Date  ICMJE June 30, 2021
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 25, 2021)
  • Mean percent change from Baseline in Psoriasis Area Severity Index (PASI) [ Time Frame: 106 days (Week 15) ]
    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 [ Time Frame: 106 days (Week 15) ]
    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) [ Time Frame: 106 days (Week 15) ]
  • Incidence of serious adverse events (SAEs) [ Time Frame: 106 days (Week 15) ]
  • Incidence of abnormal hemodynamic parameters [ Time Frame: Weeks 3, 7, 11 and 15 ]
    heart rate (HR) and blood pressure (BP)
  • Incidence of abnormal laboratory tests results [ Time Frame: Weeks 3 and 15 ]
  • Incidence of abnormal physical examination findings [ Time Frame: Weeks 3, 7, 11, 15 ]
    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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 25, 2021)
  • Mean percent change from Baseline in Psoriasis Area Severity Index (PASI) [ Time Frame: Weeks 1, 3, 7, and 11 ]
    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 [ Time Frame: Weeks 1, 3, 7, and 11 ]
    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 [ Time Frame: Weeks 1, 3, 7, 11, 15 ]
    Minimum: 0 percent, Maximum: 100 percent. Higher percentage indicates more skin with psoriasis.
  • Mean change from Baseline in Dermatology Life Quality Index (DLQI) score [ Time Frame: Weeks 3, 7, 11, 15 ]
    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 [ Time Frame: Weeks 3 and 15 ]
    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'.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 25, 2021)
  • Change in Coronary Artery Inflammation by CCTA [ Time Frame: 106 days (Week 15) ]
    Change in coronary artery perivascular fat attenuation index (FAI) measured by coronary computed tomographic angiography (CCTA)
  • Change in coronary artery plaque burden by CCTA [ Time Frame: 106 days (Week 15) ]
    Change in total, noncalcified and low attenuation coronary artery plaque volume
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Proof-of-Activity Study With Orticumab in Subjects With Psoriasis and Cardiometabolic Risk Factors
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Psoriasis
  • Inflammation
  • Coronary Artery Disease
  • Cardiometabolic Syndrome
Intervention  ICMJE
  • Drug: Orticumab
    A human recombinant monoclonal antibody against a specific oxidized low-density lipoprotein (oxLDL) epitope
    Other Name: MLDL1278a; BI-204; Anti-oxLDL Antibody
  • Drug: Placebo
    Placebo for orticumab, containing all components of formulation except the active ingredient
Study Arms  ICMJE
  • 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: Drug: Orticumab
  • 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: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 25, 2021)
75
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Christopher Farina, MS, RAC 424-263-6364 info@abcentra.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04776629
Other Study ID Numbers  ICMJE Ort-2020-01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Abcentra
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Abcentra
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Joel Neutel, MD Orange County Research Center
PRS Account Abcentra
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP