Phase 2
N=77
A Proof-of-Activity Study With Orticumab in Subjects With Psoriasis and Cardiometabolic Risk Factors
Psoriasis · Inflammation · Coronary Artery Disease · Cardiometabolic Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT04776629 ↗Enrolled (actual)
77
Serious AEs
2.6%
Results posted
May 2026
Primary outcome: Primary: Mean Percent Change From Baseline in Psoriasis Area Severity Index (PASI) — -25.45; -18.95 Percentage change of score
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Orticumab (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Abcentra
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Percent Change From Baseline in Psoriasis Area Severity Index (PASI) |
-3.46; -1.24; -12.94; -8.28; -20.14; -5.47 | — |
| PRIMARY Percentage of Participants Achieving Treatment Success by the 5-point Static Investigator's Global Assessment Modified 2011 Version (sIGA) Score |
1; 1 | — |
| SECONDARY Mean Percent Change From Baseline in Psoriasis Area Severity Index (PASI) |
-3.46; -1.24; -12.94; -8.28; -20.14; -5.47 | — |
| SECONDARY Percentage of Participants Achieving PASI75 and PASI50 |
0; 0; 51; 24; 0; 0 | — |
| SECONDARY Mean Percent Change in Baseline in Body Surface Area (BSA) % Involvement |
-1.02; -1.93; -6.85; -6.88; -13.51; -0.66 | — |
| SECONDARY Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Score |
-3.6; -2.0; -3.5; -2.2; -3.8; -2.8 | — |
| SECONDARY Mean Change From Baseline in Itch Numerical Rating Scale (INRS) Score |
6.2; 6.7; 6.1; 7.1 | — |
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.
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).
Data sourced from ClinicalTrials.gov (NCT04776629). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.