NCT04776629

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: Abcentra · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Orticumab	A human recombinant monoclonal antibody against a specific oxidized low-density lipoprotein (oxLDL) epitope
DRUG	Placebo	Placebo for orticumab, containing all components of formulation except the active ingredient

Timeline

• Start date: 2021-06-30
• Primary completion: 2022-11-11
• Completion: 2022-11-11
• First posted: 2021-03-02
• Last updated: 2024-02-02

Locations

13 sites across 1 country: United States

Regulatory

• FDA-regulated drug study