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

NCT ID: NCT04776629

Last Updated: 2024-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 77 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-30
• Study Completion Date: 2022-11-11

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.

Conditions

Psoriasis; Inflammation; Coronary Artery Disease; Cardiometabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Orticumab

Intervention Type: DRUG

A human recombinant monoclonal antibody against a specific oxidized low-density lipoprotein (oxLDL) epitope

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo for orticumab, containing all components of formulation except the active ingredient

Interventions

Orticumab

A human recombinant monoclonal antibody against a specific oxidized low-density lipoprotein (oxLDL) epitope

Intervention Type: DRUG

Placebo

Placebo for orticumab, containing all components of formulation except the active ingredient

Intervention Type: DRUG

Other Intervention Names

MLDL1278a; BI-204; Anti-oxLDL Antibody

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).

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abcentra

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joel Neutel, MD

Role: PRINCIPAL_INVESTIGATOR

Orange County Research Center

Locations

CCT- Research at the center for Dermatology and Plastic Surgery

Scottsdale, Arizona, United States

Derm Institute & Skin Care Ctr., Inc.

Santa Monica, California, United States

Orange County Research Center

Tustin, California, United States

Blue Coast Research Center

Vista, California, United States

Jacksonville Center for Clinical Research

Jacksonville, Florida, United States

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, United States

Las Vegas Clinical Trials

Las Vegas, Nevada, United States

Excel Clinical Research

Las Vegas, Nevada, United States

Vital Prospects Clinical Research Institute, PC

Tulsa, Oklahoma, United States

SMS Clinical Research

Mesquite, Texas, United States

Texas Dermatology and Laser Specialists

San Antonio, Texas, United States

Center for Clinical Studies, LTD.LLP

Webster, Texas, United States

CCT Research - Springville Dermatology

Springville, Utah, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 38523341 (View on PubMed)

Other Identifiers

Ort-2020-01

Identifier Type: -

Identifier Source: org_study_id