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Assessment of the Safety of Foralumab, an Oral Anti-CD3 Antibody, in Patients With NASH and T2DM

NCT03291249 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2019-09-12

No results posted yet for this study

Summary

This is a randomized, placebo-controlled, four-arm, double-blind study. Subjects will be randomized (1:1:1:1) to receive either a daily oral placebo solution or a daily oral dose of 0.5 mg, 2.5 mg or 5.0 mg Foralumab Solution for 30 consecutive days. Subjects will record adverse events and daily administration of study medication in a subject diary. This will serve as a measure of compliance and record of safety and tolerability. Subjects will be followed up for 30 days following completion of treatment.

Study visits performed on Days 14, 30 and 60 of the study, will monitor metabolic parameters (body mass index \[BMI\] and waist circumference), serum lipid profiles, immunological markers (c-reactive protein \[CRP\] and an array of cytokines), hepatic enzymes and functions (13C-methacetin breath test \[MBT\]) and liver steatosis/fibrosis, which will be compared to baseline levels (Day 1).

The safety and tolerability of the treatment regimen will be determined by monitoring vital signs, laboratory values, adverse events and physical findings throughout the study. In addition, its efficacy will be established upon either reduced Day 30 serum alanine aminotransferase (ALT) levels, reduced hemoglobin A1c (HbA1c) or improved homeostasis model assessment (HOMA) or HOMA of insulin resistance (HOMA-IR) scores as compared to baseline (Day 1). In addition, to assess the efficacy of the tested Foralumab Solution regimen in improving overall subject status, a battery of exploratory metabolic, immunologic and hepatic markers will be evaluated on Days 30 and 60.

Conditions

  • NASH - Nonalcoholic Steatohepatitis
  • NAFLD
  • T2DM (Type 2 Diabetes Mellitus)

Interventions

DRUG

Foralumab

Anti CD3 mAb

OTHER

placebo

Placebo oral solution

DRUG

Omeprazole 20mg

Omeprazole is a proton pump inhibitor used to neutralize stomach PH

Sponsors & Collaborators

  • Tiziana Life Sciences LTD

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-01
Primary Completion
2018-12-01
Completion
2019-06-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03291249 on ClinicalTrials.gov