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

Completed · Phase 2 · Has a placebo group

Conditions studied: Psoriasis, Inflammation, Coronary Artery Disease, Cardiometabolic Syndrome

In brief

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.

Key facts

Study ID

NCT04776629

Run by

Abcentra

People needed

77

Starts

2021-06-30

Expected to finish

2022-11-11

Last updated by the study team

2026-05-11

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• 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

Full record on ClinicalTrials.gov

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