Phase 1b Open-Label Evaluation of CLN-978 in Patients with Active Moderate to Severe Sjogren's Disease

The primary objective of this study is to evaluate the safety and tolerability of **CLN-978** in patients with active, moderate to severe **Sjogren's Disease**. This is clinically relevant as it aims to determine the potential of CLN-978 as a therapeutic option for managing symptoms and improving the quality of life in individuals affected by this autoimmune condition. The study is designed as a Phase 1b, open-label trial, focusing on the initial assessment of the drug's safety profile in the target population.

The clinical trial involves a total of **26 participants** diagnosed with **Sjogren's Disease**. The study population includes both male and female subjects, with an age range spanning from 18 to 64 years. Participants were selected to ensure a diverse representation of the general adult population, including those considered vulnerable. The trial does not specify any particular lifestyle considerations such as diet or physical activity. The sponsor has not provided detailed information regarding the main objective of the trial or specific inclusion criteria.

The clinical trial is designed to evaluate the efficacy and safety of a new investigational product for the treatment of **Sjogren's Disease**. This study is a Phase 3, open-label trial, which means that both the researchers and participants will be aware of the treatment being administered. The trial is expected to commence recruitment on July 31, 2025, and is projected to conclude by December 31, 2028. Participants will be involved in the study for a duration that aligns with the trial's timeline, subject to their continued eligibility and adherence to the study protocol.

The trial will include several key visits, starting with an inclusion (screening) visit to assess eligibility based on predefined criteria. This visit will involve a comprehensive evaluation to ensure participants meet the necessary conditions for inclusion. Following successful screening, participants will undergo a series of follow-up visits at regular intervals to monitor their response to the treatment and to collect data on safety and efficacy. These visits are crucial for assessing the primary and secondary endpoints of the study. The end-of-study visit will mark the conclusion of a participant's involvement, during which final assessments will be conducted to gather comprehensive data on the treatment's impact.

Participants may be withdrawn from the study prior to its completion if they experience adverse effects that compromise their safety, if they fail to adhere to the study protocol, or if they choose to withdraw consent. The study's design and procedures are structured to ensure the collection of robust data while prioritizing participant safety and well-being throughout the trial duration.

No specific information regarding the experimental medication, including its name, pharmaceutical form, dosage, route, and frequency of administration, is provided in the available data. Consequently, a detailed description of the experimental treatment cannot be formulated based on the current dataset.

Similarly, there is no information available about any non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatment, used in the study. Therefore, a description of these elements is not possible with the given data.

Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also absent from the provided data. As such, no further details can be included in this description.

The clinical trial is designed to assess efficacy through a structured evaluation process. The trial is categorized as a Phase 3 study, indicating a focus on confirming the effectiveness of the intervention in a larger patient population. The trial is scheduled to commence recruitment on July 31, 2025, with an estimated completion date of December 31, 2028. Although specific efficacy parameters such as primary and secondary endpoints are not detailed, Phase 3 trials typically involve comprehensive assessments to determine the intervention's impact on the disease. These assessments may include symptom improvement scores, biomarker levels, or disease remission rates, measured at various timepoints throughout the study. The data collected will be analyzed to provide robust evidence of the intervention's efficacy, contributing to the overall understanding of its therapeutic potential.