NCT04521114

Leronlimab (PRO 140) in Patients With Nonalcoholic Steatohepatitis

A Phase II, Multi-center, Two-Part, Three-Arm, Dose-Ranging Study of the Safety and Efficacy of Leronlimab (PRO 140) in Adult Patients With Nonalcoholic Steatohepatitis (NASH)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: CytoDyn, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This is an exploratory phase II, multi-center, two-part study (Part 1: randomized, placebo-controlled, two-arm with 60 patients; Part 2: non-randomized, single-arm, open-label with 30 patients) designed to evaluate the safety and efficacy of leronlimab after subcutaneous (SC) administration in patients with NASH for 13 weeks. A Follow Up visit was conducted 28 (± 3) days after receiving the last study treatment (i.e., after last dose of Leronlimab (PRO 140) or placebo.

Conditions

• Nonalcoholic Steatohepatitis (NASH)

Interventions

Type	Name	Description
DRUG	Placebo	Placebo will be administered subcutaneously every week for 13 weeks.
DRUG	leronlimab 700 mg	700 mg leronlimab will be administered subcutaneously every week for 13 weeks.
DRUG	leronlimab 350 mg	350 mg leronlimab will be administered subcutaneously every week for 13 weeks.

Timeline

• Start date: 2020-12-01
• Primary completion: 2021-12-29
• Completion: 2021-12-29
• First posted: 2020-08-20
• Last updated: 2023-03-01
• Results posted: 2023-03-01

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study