A Multi-Center, Randomized, Double-Blind, Placebo-controlled Proof-of-Activity Study With Orticumab in Subjects With Moderate-to-Severe Psoriasis and Cardiometabolic Risk Factors
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Abcentra
- Enrollment
- 77
- Locations
- 13
- Primary Endpoint
- Mean Percent Change From Baseline in Psoriasis Area Severity Index (PASI)
Study Overview
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 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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 30 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
Arms & Interventions
Placebo
Dosage: Repeating intravenous dose. Administered by infusion over 30 minutes.
Frequency and duration: once weekly x 4 weeks, then once monthly x 2 months.
Intervention: Placebo (Drug)
Active Treatment
Dosage: Repeating intravenous dose. Administered by infusion over 30 minutes.
Frequency and duration: once weekly x 4 weeks, then once monthly x 2 months.
Intervention: Orticumab (Drug)
Outcomes
Primary Outcomes
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)
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
Secondary Outcomes
- Mean Percent Change From Baseline in Psoriasis Area Severity Index (PASI)(Weeks 1, 3, 7, and 11)
- Percentage of Participants Achieving PASI75 and PASI50(Weeks 1, 3, 7, and 11)
- Mean Percent Change in Baseline in Body Surface Area (BSA) % Involvement(Weeks 1, 3, 7, 11, 15)
- Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Score(Weeks 3, 7, 11, 15)
- Mean Change From Baseline in Itch Numerical Rating Scale (INRS) Score(Weeks 3 and 15)