Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 2:41 PM
Ignite Modification Date:
2025-12-24 @ 2:41 PM
NCT ID:
NCT05678959
Brief Summary:
This was an extension study to evaluate the long-term safety and efficacy of ligelizumab in participants who completed a ligelizumab Phase III study in food allergy.
Detailed Description:
This was a 3-year extension study with a 16-week follow-up period. The study enabled participants from planned multiple Phase III "core" studies to roll over to this extension study once the participants had completed predefined minimal requirements of a "core" study and agreed to consent to participate in this study.
Participants received ligelizumab treatment allocated in the core study, except for maximum responder (MR) participants performing conditional discontinuation of study treatment. Any participant considered a MR, as defined by an oral food challenge (OFC), performed conditional discontinuation of study treatment. This was to assess whether further treatment was still required because of disease modification by ligelizumab and/or a change in the underlying phenotype following the natural history of the disease (outgrowth of allergy) demonstrated by sustained unresponsiveness.
A subset of participants was offered administration of study treatment at home either by the participant him/herself (self-administration) or by parent/caregiver following training at three visits at the clinic.
Study:
NCT05678959
Study Brief:
Protocol Section:
NCT05678959