Phase I/II Study on the Tolerance and Efficacy of Daratumumab in Patients with Active Toxic Epidermal Necrolysis

The primary objective of this study is to evaluate the **tolerance** and **efficacy** of **daratumumab**, an anti-CD38+ antibody, in patients with **Toxic Epidermal Necrolysis (TEN)** during the active phase of the disease. This is a Phase I/II study, which is crucial for determining the safety profile and potential therapeutic benefits of daratumumab in managing TEN, a severe and life-threatening condition characterized by extensive skin detachment and mucosal involvement. The study aims to provide insights into a novel therapeutic approach that could improve patient outcomes in this critical condition.

The clinical trial focuses on participants diagnosed with **Toxic Epidermal Necrolysis**. The study population includes both male and female subjects, encompassing an age range that includes both adults and adolescents. The trial involves a vulnerable population, although the specific number of participants has not been disclosed by the sponsor. Participants were selected based on criteria that are not specified in the available data. Lifestyle considerations such as diet, physical activity, or habits have not been detailed. The trial does not provide explicit information on key inclusion or exclusion criteria, and the main objective of the study is not specified in the provided data.

The clinical trial is designed to evaluate a new therapeutic approach for **Toxic Epidermal Necrolysis** using anti-CD38+ antibodies. This study is structured as a Phase I/II trial to assess the tolerance and efficacy of the investigational product, DARATUMUMAB. The trial is set to commence recruitment on April 1, 2025, and is expected to conclude by April 1, 2028. The study employs a randomized, double-blind, controlled design to ensure the reliability and validity of the results. Participants will be randomly assigned to either the treatment group receiving DARATUMUMAB or a control group, with neither the participants nor the investigators aware of the group assignments to minimize bias.

The sequence of study visits begins with an inclusion visit, where potential participants undergo a screening process to determine eligibility based on predefined criteria. Following successful screening, participants will be enrolled in the study and attend regular follow-up visits to monitor their response to the treatment and any adverse effects. These visits are crucial for collecting data on the primary and secondary endpoints of the trial. The end-of-study visit marks the conclusion of the participant's involvement, where final assessments are conducted to evaluate the overall outcomes of the treatment.

The expected length of participant involvement in the trial is approximately three years, aligning with the overall trial duration. Participants may be subject to early termination from the study if they experience significant adverse effects, fail to comply with the study protocol, or withdraw consent. The trial's design and procedures are meticulously planned to ensure the safety and well-being of participants while providing valuable insights into the potential benefits of DARATUMUMAB for treating Toxic Epidermal Necrolysis.

The clinical trial involves the administration of an **experimental medication**. However, specific details regarding the name, pharmaceutical form, dosage, route, and frequency of administration of the experimental medication are not provided in the available data. The trial documentation does not specify whether the medication is a **paediatric formulation** or if it is classified as an **orphan drug**. Additionally, there is no information on the maximum daily dose, total dose, or treatment period for the experimental medication.

In addition to the experimental medication, the trial may include the use of **non-experimental treatments** such as standard-of-care therapy, placebo, or comparator treatment. However, the data does not provide explicit details about these treatments. Information regarding the administration, dosing schedules, and participant compliance monitoring for these non-experimental treatments is also not available.

The clinical trial is scheduled to commence recruitment on April 1, 2025, with an estimated completion date of April 1, 2028. The trial is categorized under phase 9, indicating an advanced stage of clinical research. Efficacy assessments will be conducted throughout the trial period, although specific parameters or endpoints for evaluating efficacy are not detailed in the provided data. The trial will adhere to a structured timeline to ensure systematic data collection and analysis. The absence of explicit endpoints or measurement tools in the source material suggests that these details will be defined in the comprehensive trial protocol, which will guide the evaluation of the investigational product's efficacy. The trial's design will likely incorporate validated methodologies to ensure the reliability and validity of the efficacy assessments.