A Phase 1b Open-Label Study to Evaluate the Safety and Efficacy of CLN-978 in Patients with Moderate to Severe Systemic Lupus Erythematosus

The primary objective of this phase 1b open-label pilot study is to evaluate the clinical application of CLN-978 in patients diagnosed with systemic lupus erythematosus. This investigation aims to assess the therapeutic potential of the compound in managing moderate to severe manifestations of the disease.

This study involves a total of 28 patients diagnosed with systemic lupus erythematosus. The study population includes both male and female participants. The age range of the subjects corresponds to the 3 to 4 year category. The sponsor did not provide information regarding lifestyle considerations or specific selection processes.

This Phase 1b, open-label, pilot study evaluates the efficacy and safety of CLN-978 in individuals diagnosed with systemic lupus erythematosus. The research methodology involves an assessment of participants through a structured sequence of clinical encounters. The process commences with a screening visit to determine eligibility based on the defined inclusion and exclusion criteria. Following enrollment, participants undergo scheduled follow-up visits to monitor clinical responses and safety parameters. The study concludes with an end-of-study visit. The overall duration of the trial is estimated to extend through December 2029. Participation may be discontinued prior to the scheduled completion if specific clinical criteria for early termination are met.

The assessment of efficacy in this Phase 3 clinical trial for Systemic Lupus Erythematosus will be conducted according to the established protocol parameters. The specific methods for evaluating therapeutic impact and the designated measurement timepoints are not defined in the provided data.