Psoriasis Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

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).

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

77

Study ID:

NCT04776629

Recruitment Status:

Completed

Sponsor:

Abcentra

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There are 12 Locations for this study

See Locations Near You

CCT- Research at the center for Dermatology and Plastic Surgery
Scottsdale Arizona, 85260, United States
Derm Institute & Skin Care Ctr., Inc.
Santa Monica California, 90404, United States
Orange County Research Center
Tustin California, 92780, United States
Blue Coast Research Center
Vista California, 92083, United States
Jacksonville Center for Clinical Research
Jacksonville Florida, 32216, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis Indiana, 46250, United States
Las Vegas Clinical Trials
Las Vegas Nevada, 89030, United States
Excel Clinical Research
Las Vegas Nevada, 89109, United States
Vital Prospects Clinical Research Institute, PC
Tulsa Oklahoma, 85260, United States
SMS Clinical Research
Mesquite Texas, 75149, United States
Texas Dermatology and Laser Specialists
San Antonio Texas, 78218, United States
Center for Clinical Studies, LTD.LLP
Webster Texas, 77598, United States
CCT Research - Springville Dermatology
Springville Utah, 84663, United States

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

77

Study ID:

NCT04776629

Recruitment Status:

Completed

Sponsor:


Abcentra

How clear is this clinincal trial information?

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