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

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abcentra

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).