Clinical Trial

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

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.

Primary Outcome Measures:

1. Mean percent change from Baseline in Psoriasis Area Severity Index (PASI) [ Time Frame: 106 days (Week 15) ]
   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)
2. Percentage of participants achieving treatment success by the 5-point static Investigator’s Global Assessment modified 2011 version (sIGA) Score [ Time Frame: 106 days (Week 15) ]
   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
3. Incidence of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: 106 days (Week 15) ]
4. Incidence of serious adverse events (SAEs) [ Time Frame: 106 days (Week 15) ]
5. Incidence of abnormal hemodynamic parameters [ Time Frame: Weeks 3, 7, 11 and 15 ]
   heart rate (HR) and blood pressure (BP)
6. Incidence of abnormal laboratory tests results [ Time Frame: Weeks 3 and 15 ]
7. Incidence of abnormal physical examination findings [ Time Frame: Weeks 3, 7, 11, 15 ]
   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.

Secondary Outcome Measures:

1. Mean percent change from Baseline in Psoriasis Area Severity Index (PASI) [ Time Frame: Weeks 1, 3, 7, and 11 ]
   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)
2. Percentage of Participants achieving PASI75 and PASI50 [ Time Frame: Weeks 1, 3, 7, and 11 ]
   PASI75 is a 75 percent reduction in PASI score. PASI50 is a 50 percent reduction in PASI score
3. Mean percent change in Baseline in Body Surface Area (BSA) % involvement [ Time Frame: Weeks 1, 3, 7, 11, 15 ]
   Minimum: 0 percent, Maximum: 100 percent. Higher percentage indicates more skin with psoriasis.
4. Mean change from Baseline in Dermatology Life Quality Index (DLQI) score [ Time Frame: Weeks 3, 7, 11, 15 ]
   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).
5. Mean change from Baseline in Itch Numerical Rating Scale (INRS) Score [ Time Frame: Weeks 3 and 15 ]
   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’.

Other Outcome Measures:

1. Change in Coronary Artery Inflammation by CCTA [ Time Frame: 106 days (Week 15) ]
   Change in coronary artery perivascular fat attenuation index (FAI) measured by coronary computed tomographic angiography (CCTA)
2. Change in coronary artery plaque burden by CCTA [ Time Frame: 106 days (Week 15) ]
   Change in total, noncalcified and low attenuation coronary artery plaque volume