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

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Abcentra
Study ID
NCT04776629
Phase
PHASE2
Status
Completed

Conditions

  • Cardiometabolic Syndrome
  • Coronary Artery Disease
  • Inflammation
  • Psoriasis

Eligibility Criteria

Sex
ALL
Age
30 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Orticumab — DRUG
    A human recombinant monoclonal antibody against a specific oxidized low-density lipoprotein (oxLDL) epitope
  • Placebo — DRUG
    Placebo for orticumab, containing all components of formulation except the active ingredient

Study Details

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.

Key Dates

Start date
Jun 30, 2021
Status verified
Mar 2026
Primary completion
Nov 11, 2022
Completion
Nov 11, 2022

Study Design

Enrollment
77 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: 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.
  • Placebo Comparator: 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.

Primary Outcome Measure

Mean Percent Change From Baseline in Psoriasis Area Severity Index (PASI) [ Time Frame: 106 days (Week 15) ]

Locations (13)

FacilityCityStateZIPSite coordinators
CCT- Research at the center for Dermatology and Plastic SurgeryScottsdaleArizona85260-
Derm Institute & Skin Care Ctr., Inc.Santa MonicaCalifornia90404-
Orange County Research CenterTustinCalifornia92780-
Blue Coast Research CenterVistaCalifornia92083-
Jacksonville Center for Clinical ResearchJacksonvilleFlorida32216-
Dawes Fretzin Clinical Research Group, LLCIndianapolisIndiana46250-
Excel Clinical ResearchLas VegasNevada89109-
Las Vegas Clinical TrialsLas VegasNevada89030-
Vital Prospects Clinical Research Institute, PCTulsaOklahoma85260-
SMS Clinical ResearchMesquiteTexas75149-
Texas Dermatology and Laser SpecialistsSan AntonioTexas78218-
Center for Clinical Studies, LTD.LLPWebsterTexas77598-
CCT Research - Springville DermatologySpringvilleUtah84663-

Find similar trials in Scottsdale, AZ

By condition
Psoriasis
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
CCT- Research at the center for Dermatology and Plastic Surgery· Scottsdale, AZDerm Institute & Skin Care Ctr., Inc.· Santa Monica, CAOrange County Research Center· Tustin, CABlue Coast Research Center· Vista, CAJacksonville Center for Clinical Research· Jacksonville, FLDawes Fretzin Clinical Research Group, LLC· Indianapolis, IN

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