NCT04776629

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

Completed Phase 2 Last updated 2 February 2024

What this trial tests

Phase 2 trial testing Orticumab in Psoriasis in 77 participants. Completed in 11 November 2022.

Timeline

30 June 2021

Primary endpoint
11 November 2022

11 November 2022

Quick facts

Lead sponsor	Abcentra
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	77
Start date	30 June 2021
Primary completion	11 November 2022
Estimated completion	11 November 2022
Sites	13 locations across United States

Drugs / interventions tested

• Orticumab — full drug profile →
• Placebo

Conditions studied

• Psoriasis — all drugs for Psoriasis →
• Inflammation — all drugs for Inflammation →
• Coronary Artery Disease — all drugs for Coronary Artery Disease →
• Cardiometabolic Syndrome — all drugs for Cardiometabolic Syndrome →

Sponsor

Abcentra

Who can join

30 and older, any sex, with Psoriasis or Inflammation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. The why and how of adaptive immune responses in ischemic cardiovascular disease.
   Mallat Z, Binder CJ. · · 2022 · cited 48× · PMID 36382200 · DOI 10.1038/s44161-022-00049-1
2. 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.
   Farina CJ, Davidson MH, Shah PK, Stark C, et al · · 2024 · cited 18× · PMID 38523341 · DOI 10.1093/cvr/cvae057
3. Therapeutic Avenues to Modulate B-Cell Function in Patients With Cardiovascular Disease.
   O'Brien JW, Case A, Kemper C, Zhao TX, et al · · 2024 · cited 7× · PMID 38813699 · DOI 10.1161/atvbaha.124.319844
4. Elevated soluble LOX-1 predicts risk of first-time myocardial infarction.
   Schiopu A, Björkbacka H, Narasimhan G, Loong BJ, et al · · 2023 · cited 4× · PMID 38134912 · DOI 10.1080/07853890.2023.2296552
5. Inflammation reprogramming and immunomodulation: Next-generation treatments for atherosclerosis.
   Choudhury RP, Hargreaves R, Chai J, Fisher EA. · · 2025 · PMID 40782797 · DOI 10.1016/j.xcrm.2025.102288