Effect of RO7049665 on Patients with Autoimmune Hepatitis no longer taking steroids
Research type
Research Study
Full title
A DOUBLE-BLIND, RANDOMIZED,PARALLEL-GROUP, PHASE 2 STUDY TO INVESTIGATE THE EFFECT OF RO7049665 ON THE TIME TO RELAPSE FOLLOWING STEROID TAPERING IN PATIENTS WITH AUTOIMMUNE HEPATITIS
IRAS ID
293594
Contact name
Head, EU/International Pharmaceuticals Division, PDR
Contact email
Sponsor organisation
F. Hoffmann-La Roche Ltd
Eudract number
2020-003990-23
Clinicaltrials.gov Identifier
NIHR, HEPA 46613
Duration of Study in the UK
5 years, months, days
Research summary
Autoimmune hepatitis (AIH) is a rare chronic liver disease that occurs when the immune system attacks the liver cells that ultimately, can lead to liver failure. The disease has a prevalence of 16-18 affected people / 100 000 inhabitants in Europe. It can affect people of all ages and sexes, though the female to male ratio is approximately 4:1. AIH is characterized by a large heterogeneity of clinical, laboratory, and histological manifestations and therefore difficult to diagnose. There is currently no approved treatment. AIH patients usually respond rapidly to immunosuppressive treatment but relapse quickly after its tapering. Most patients are on treatment for extended periods and often for life. Side effects of long-term treatment can be quite severe. Therefore, there is an unmet medical need in patients with AIH to replace the current standard of care (SoC) with a less burdening maintenance.
Study BP42698 is the first study where RO7049665 is administered to patients with AIH. RO7049665 is injected subcutaneously into the abdomen. It is a 3-parallel arm (2 dose levels of RO7049665 versus placebo), randomized, placebo-controlled, double-blind, event-driven phase 2 study to assess efficacy of RO7049665 over placebo in patients with AIH in stable 2 year remission. Event-driven, means that participants stay in the study and on treatment until they experience an event. When a total of 45 events is reached, the participant stops or for other reasons or withdraws consent, or the study ends.
The study is anticipated to run for approximately 25 months, until the necessary number of events is observed. It is not possible to estimate the duration for an individual patient as the occurrence of an event cannot be reliably estimated for an individual.
The proposed study is planned to be conducted worldwide. A total of 84 male and female participants will be enrolled.
REC name
London - Chelsea Research Ethics Committee
REC reference
21/LO/0146
Date of REC Opinion
23 Mar 2021
REC opinion
Further Information Favourable Opinion