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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
77
CCT- Research at the center for Dermatology and Plastic Surgery
Scottsdale, Arizona, United States
Derm Institute & Skin Care Ctr., Inc.
Santa Monica, California, United States
Orange County Research Center
Mean percent change from Baseline in Psoriasis Area Severity Index (PASI)
PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease)
Time frame: 106 days (Week 15)
Percentage of participants achieving treatment success by the 5-point static Investigator's Global Assessment modified 2011 version (sIGA) Score
Percentage of participants achieving treatment success (clear =0 or almost clear =1) and greater than or equal to (\>=) 2 Point Improvement at Week 15 on the sIGA scale
Time frame: 106 days (Week 15)
Incidence of Treatment Emergent Adverse Events (TEAEs)
Time frame: 106 days (Week 15)
Incidence of serious adverse events (SAEs)
Time frame: 106 days (Week 15)
Incidence of abnormal hemodynamic parameters
heart rate (HR) and blood pressure (BP)
Time frame: Weeks 3, 7, 11 and 15
Incidence of abnormal laboratory tests results
Time frame: Weeks 3 and 15
Incidence of abnormal physical examination findings
Physical examination will include the following organ or body system assessments: general appearance; eyes; ears, nose, and throat; head and neck; chest and lungs; cardiovascular; abdomen; musculoskeletal; lymphatic; dermatological; neurological; and extremities.
Time frame: Weeks 3, 7, 11, 15
Mean percent change from Baseline in Psoriasis Area Severity Index (PASI)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Tustin, California, United States
Blue Coast Research Center
Vista, California, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States
Las Vegas Clinical Trials
Las Vegas, Nevada, United States
Excel Clinical Research
Las Vegas, Nevada, United States
Vital Prospects Clinical Research Institute, PC
Tulsa, Oklahoma, United States
SMS Clinical Research
Mesquite, Texas, United States
...and 3 more locations
PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease)
Time frame: Weeks 1, 3, 7, and 11
Percentage of Participants achieving PASI75 and PASI50
PASI75 is a 75 percent reduction in PASI score. PASI50 is a 50 percent reduction in PASI score
Time frame: Weeks 1, 3, 7, and 11
Mean percent change in Baseline in Body Surface Area (BSA) % involvement
Minimum: 0 percent, Maximum: 100 percent. Higher percentage indicates more skin with psoriasis.
Time frame: Weeks 1, 3, 7, 11, 15
Mean change from Baseline in Dermatology Life Quality Index (DLQI) score
DLQI is a ten-question questionnaire used to measure the impact of skin disease on the quality of life of an affected person. Each question is scored from 0 to 3, giving a possible score range from 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life).
Time frame: Weeks 3, 7, 11, 15
Mean change from Baseline in Itch Numerical Rating Scale (INRS) Score
The Itch NRS is a self-administered subject reported outcome questionnaire that is completed during protocol specified clinic visits. Participants indicate itch severity by circling the integer that best describes the worst level of itching due to psoriasis in the past 24 h on an 11-point scale anchored at 0, representing 'no itching' and 10, representing 'worst itch imaginable'.
Time frame: Weeks 3 and 15