Status:
COMPLETED
A Proof-of-Activity Study With Orticumab in Subjects With Psoriasis and Cardiometabolic Risk Factors
Lead Sponsor:
Abcentra
Conditions:
Psoriasis
Inflammation
Eligibility:
All Genders
30+ years
Phase:
PHASE2
Brief 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 subjec...
Eligibility Criteria
Inclusion
- 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).
Exclusion
Key Trial Info
Start Date :
June 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 11 2022
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT04776629
Start Date
June 30 2021
End Date
November 11 2022
Last Update
February 2 2024
Active Locations (13)
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1
CCT- Research at the center for Dermatology and Plastic Surgery
Scottsdale, Arizona, United States, 85260
2
Derm Institute & Skin Care Ctr., Inc.
Santa Monica, California, United States, 90404
3
Orange County Research Center
Tustin, California, United States, 92780
4
Blue Coast Research Center
Vista, California, United States, 92083