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Foralumab

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

Ensayo de Tiziana Life Sciences Ltd en NASH - Nonalcoholic Steatohepatitis · NAFLD · T2DM (Type 2 Diabetes Mellitus) (del registro, en inglés).

Más ensayos de: Esteatohepatitis no alcohólica.

Fase

Fase 2

Estado

Retirado antes de empezar

Fin del objetivo primario

dic 2018

estimado por el promotor

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, triple ciego. Comenzó en dic 2017.

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Due to MOH request.».

Qué mide

severity and duration for all adverse events (30 days after last dose) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis 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.

Más ensayos de TLSA

Todos los de TLSA, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT03291249), actualizada en sep 2019.