ELOWEN Clinical Trial for Patients with Lupus Skin Manifestations

Clinical trials are carefully controlled scientific studies that evaluate how well investigational or modified medicines may treat or prevent diseases in people. Clinical trials are conducted to answer question such as:

• Is the investigational treatment safe enough to outweigh the risks?

• What is the best dose needed for the investigational treatment to work?

• How often should the investigational treatment be given?

• How effective is the investigational treatment at treating or preventing symptoms or the condition?

A clinical trial follows a protocol that has been approved by regulatory agencies to ensure patient’s and trial participant’s safety. The protocol outlines the types of the study participants to include, the schedule of visits and procedures, safety precautions, and what and how data will be analyzed.

Reference: FDA (24 July 2025). Clinical Trial Basics, A&A with FDA Podcast, https://www.fda.gov/drugs/news-events-human-drugs/clinical-trial-basics

You can check if you are potentially eligible for this trial by completing a set of screening questions. You can find these on this website by clicking the “Get Started” button.

The clinical trial doctor or sponsor also has the right to discontinue a participant at any time for that person’s safety or if the participant no longer meets the trial requirements.

Participation is voluntary. You have the right to end your participation in the clinical trial at any time for any reason, or no reason at all. The clinical trial doctor or sponsor also has the right to discontinue a participant at any time for that person’s safety or if the participant no longer meets the trial requirements.

Clinical research studies must undergo rigorous reviews and follow strict rules. These rules help to ensure that the rights, safety, and well-being of participants are at the forefront of any study.

Participating in a clinical research study comes with benefits as well as risks. Before joining a study, potential participants must understand the risks, such as unknown or potentially serious side effects. Potential study participants can take as much time as they need to decide whether to take part and get as much information as they can. Before joining a study, the potential study participant will be asked to sign an informed consent form, which will include a full explanation of the study, including its potential risks.

It is a personal decision to take part. Participation in the study is voluntary. Please also consider:

• If a decision is made to participate, you/the person taking part can withdraw at any time during the study.

• The study team will explain the possible benefits and risks of the study during the informed consent process.

• A person does not have to join any study if they don’t want to.

• A team of doctors and nurses will carefully monitor the health of people taking part during the study.

• The study medication will be provided without you being charged.

• Taking part in the study may be useful for other people with lupus.

• People taking part in the study will need to strictly follow all the instructions from the study doctor and nurses.