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

Sponsor
Tiziana Life Sciences LTD
Study ID
NCT03291249
Phase
PHASE2
Status
Withdrawn

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • Foralumab — DRUG
    Anti CD3 mAb
  • placebo — OTHER
    Placebo oral solution
  • Omeprazole 20mg — DRUG
    Omeprazole is a proton pump inhibitor used to neutralize stomach PH

Study Details

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.

Key Dates

Start date
Dec 1, 2017
Status verified
Aug 2017
Primary completion
Dec 1, 2018
Completion
Jun 1, 2019

Study Design

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

Arms

  • Placebo Comparator: Group A
    Group A will receive placebo solution for 30 consecutive days
  • Experimental: Group B
    Group B will receive 0.5 mg Foralumab Solution daily for 30 consecutive days
  • Experimental: Group C
    Group B will receive 2.5 mg Foralumab Solution daily for 30 consecutive days
  • Experimental: Group D
    Group B will receive 5.0 mg Foralumab Solution daily for 30 consecutive days

Primary Outcome Measure

severity and duration for all adverse events [ Time Frame: 30 days after last dose ]

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