Evaluation of Long-Term Safety and Tolerability of Cenerimod in Adults with Moderate-to-Severe Systemic Lupus Erythematosus on Background Therapy

The primary objective of this Phase 3, multicenter, open-label, single-arm extension study is to evaluate the **long-term safety** and **tolerability** of cenerimod 4 mg, administered as a film-coated tablet, in adult subjects with moderate-to-severe **systemic lupus erythematosus** (SLE) who are receiving background therapy. This assessment is clinically relevant as it aims to ensure the sustained safety profile of cenerimod, a chemical-origin medication, over an extended treatment period, thereby providing critical data on its long-term use in managing SLE.

The clinical trial involves a total of **663 participants** diagnosed with **systemic lupus erythematosus** (SLE). The study population comprises both male and female subjects aged between 18 and 75 years. Participants were selected based on their completion of a 12-month double-blind treatment period in one of the parent studies (ID-064A301, ID-064A302) and their ability to meet specific criteria, such as not having met any study treatment stopping criteria during the parent study. The trial includes individuals who completed the last scheduled visit of the parent study, with exceptions made for those unable to do so for reasons beyond their control, pending sponsor approval. The study population is characterized by a diverse age range and includes both genders, with considerations for women of child-bearing potential, who are required to adhere to specific contraceptive measures and pregnancy testing protocols. The trial does not specify particular lifestyle considerations such as diet or physical activity. Participants are considered a vulnerable population, reflecting the careful selection and monitoring required for this study.

The clinical trial is a Phase 3, multicenter, open-label, single-arm extension study designed to evaluate the long-term safety and tolerability of **cenerimod** in adult subjects with moderate-to-severe **systemic lupus erythematosus** (SLE) who are on background therapy. The primary objective is to assess the long-term safety and tolerability of cenerimod 4 mg. The trial is expected to commence recruitment on August 15, 2024, and conclude by May 1, 2028. Participants will be involved in the study for a maximum treatment period of 36 months, with the study drug administered orally in the form of a film-coated tablet.

Study visits are structured to ensure comprehensive monitoring and data collection. The inclusion visit, or screening, will confirm eligibility based on criteria such as age (18-75 years), completion of a prior 12-month double-blind treatment period in parent studies, and absence of treatment stopping criteria. Women of child-bearing potential must have a negative pregnancy test at Visit 1 and agree to monthly urine pregnancy tests and effective contraception use during and after the study. Follow-up visits will occur regularly to monitor the occurrence of treatment-emergent adverse events, serious adverse events, and adverse events of special interest. The end-of-study visit will finalize data collection and assess the overall safety profile of cenerimod.

Participants may be terminated early from the study if they experience significant adverse events or fail to comply with study protocols. The study's design does not include a control group, and it is not blinded, as it is an open-label study. The trial will focus on the occurrence of adverse events as primary endpoints, with no secondary endpoints specified. The study is not classified as a low-intervention trial, and it is not intended for pediatric populations. The trial is sponsored by Idorsia Pharmaceuticals Ltd, and the investigational product is of chemical origin.

The clinical trial involves the administration of **cenerimod**, an experimental medication, to evaluate its long-term safety and tolerability in adult subjects with moderate-to-severe **systemic lupus erythematosus** (SLE). Cenerimod is provided in the form of a **film-coated tablet** and is manufactured by Idorsia Pharmaceuticals Ltd. The active substance, cenerimod, is of chemical origin. The dosage for this trial is set at 4 mg per day, administered orally. The maximum treatment period for participants is 36 months. The trial is designed as an open-label, single-arm extension study, where cenerimod is administered on top of background therapy.

In addition to the experimental treatment, participants will continue to receive their standard-of-care therapy for SLE, which may include a variety of medications as determined by their healthcare provider. This background therapy is not specified in the trial documentation but is considered essential for the management of SLE symptoms. The trial does not include a placebo or comparator treatment group, as it is focused on assessing the long-term effects of cenerimod in conjunction with existing therapies.

Participant compliance with the dosing schedule will be monitored throughout the study to ensure adherence to the prescribed regimen. This monitoring is crucial for evaluating the safety and efficacy of cenerimod over the extended treatment period. The trial's primary objective is to gather data on the long-term safety profile of cenerimod when used alongside standard SLE treatments.

The efficacy of the clinical trial will be assessed through the evaluation of primary endpoints related to the safety and tolerability of **cenerimod** in adult subjects with moderate-to-severe systemic lupus erythematosus (SLE). The primary endpoints include the occurrence of treatment-emergent adverse events, serious adverse events, and adverse events of special interest, which encompass anticipated risks of treatment with **cenerimod**, known class effects, and events potentially related to SLE comorbidities. These endpoints will be monitored up to the final study visit. The trial is designed as a Phase 3, multicenter, open-label, single-arm extension study, focusing on the long-term safety and tolerability of **cenerimod** 4 mg administered orally in conjunction with background therapy. The study will include participants who have completed a 12-month double-blind treatment period in parent studies and meet specific inclusion criteria. The trial is estimated to conclude by May 2028, with recruitment starting in August 2024.