Leronlimab (PRO 140) in Patients With Nonalcoholic Steatohepatitis

Part of paid clinical trials in Coronado, California.

Sponsor
CytoDyn, Inc.
Study ID
NCT04521114
Phase
PHASE2
Status
Completed

Conditions

  • Nonalcoholic Steatohepatitis (NASH)

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Placebo — DRUG
    Placebo will be administered subcutaneously every week for 13 weeks.
  • leronlimab 700 mg — DRUG
    700 mg leronlimab will be administered subcutaneously every week for 13 weeks.
  • leronlimab 350 mg — DRUG
    350 mg leronlimab will be administered subcutaneously every week for 13 weeks.

Study Details

This is a phase II study of of Leronlimab (PRO 140)-Humanized monoclonal antibody to CCR5 in patients with Nonalcoholic Steatohepatitis (NASH).

Key Dates

Start date
Dec 1, 2020
Status verified
Jan 2023
Primary completion
Dec 29, 2021
Completion
Dec 29, 2021

Study Design

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

Arms

  • Experimental: Leronlimab 700 mg
    Leronlimab 700 mg SC weekly injection
  • Experimental: Leronlimab 350 mg
    Leronlimab 350 mg SC weekly injection
  • Placebo Comparator: Placebo
    Placebo SC weekly injection

Primary Outcome Measure

MRI-PDFF Change From Baseline to Week 14 [ Time Frame: Change from baseline (day one, first day of treatment) to EOT (day 92, 13 weeks of treatment) ]

Locations (7)

FacilityCityStateZIPSite coordinators
Southern California Research CenterCoronadoCalifornia92118-
Meridien ResearchMaitlandFlorida32751-
Floridian Clinical ResearchMiami LakesFlorida33016-
Sensible Healthcare, LLCOcoeeFlorida34761-
Center for Advanced Research & EducationGainesvilleGeorgia30501-
Care United Research LLCForneyTexas75126-
American Research CorporationSan AntonioTexas78215-

Find similar trials in Coronado, CA

By research site
Southern California Research Center· Coronado, CAMeridien Research· Maitland, FLFloridian Clinical Research· Miami Lakes, FLSensible Healthcare, LLC· Ocoee, FLCenter for Advanced Research & Education· Gainesville, GACare United Research LLC· Forney, TX

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