A single arm, open-label study to evaluate the efficacy and safety of ABBV-668 in subjects with moderate to severe ulcerative colitis.

The primary objective of this study is to characterize the **safety** and **efficacy** of ABBV-668 as a treatment in adult subjects with moderately to severely active **ulcerative colitis**. This is clinically relevant as it aims to provide insights into the therapeutic potential and safety profile of ABBV-668, which could inform treatment strategies for patients suffering from this chronic inflammatory bowel disease. No secondary objectives are specified for this study.

The clinical trial involves a total of **24 participants** diagnosed with **Ulcerative Colitis**. The study population comprises adult males and females, all of whom are at least 18 years old. Participants were selected based on their diagnosis of moderately to severely active Ulcerative Colitis, confirmed by appropriate biopsy documentation. The trial includes individuals who have demonstrated an inadequate response, loss of response, or intolerance to treatments such as oral aminosalicylates, corticosteroids, immunosuppressants, and/or biologics or targeted immunomodulators. The participants are not part of a vulnerable population, and the trial does not specify any particular lifestyle considerations such as diet or physical activity. The selection criteria ensure that the study focuses on individuals with an Adapted Mayo score of 5 to 9 points and an endoscopic subscore of 2 to 3, as confirmed by central review.

The clinical trial is designed as a **single-arm, open-label** study to evaluate the efficacy and safety of **ABBV-668** in adult subjects with moderate to severe **ulcerative colitis**. The primary objective is to characterize the safety and efficacy of the investigational product, ABBV-668, administered orally in capsule form. The trial is expected to last until April 2025, with recruitment having commenced in August 2023. Participants will be involved in the study for a maximum treatment period of 16 weeks.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to confirm eligibility based on criteria such as age, diagnosis of ulcerative colitis, and disease activity. The primary endpoint is the achievement of endoscopic improvement at Week 8, with secondary endpoints including clinical remission and response per the Adapted Mayo score. Follow-up visits will be scheduled to monitor the participants' response to treatment and any adverse events. The end-of-study visit will conclude the trial for each participant, assessing the overall outcomes and safety of the treatment.

Inclusion criteria require participants to be at least 18 years old with a confirmed diagnosis of ulcerative colitis for at least 90 days prior to the baseline visit. Participants must demonstrate an inadequate response or intolerance to previous treatments such as oral aminosalicylates, corticosteroids, immunosuppressants, or biologics. Conditions for early termination from the study include the initiation or dose escalation of UC-related corticosteroids, which would classify participants as non-responders. The trial does not include a control group, and all participants will receive the investigational product, ABBV-668.

The clinical trial involves the administration of **ABBV-668**, an experimental medication developed by **ABBVIE, INC.**. **ABBV-668** is presented in a **capsule** form and is intended for **oral use**. The active substance, also named **ABBV-668**, is of chemical origin. The trial is designed to evaluate the efficacy and safety of this compound in subjects with moderate to severe **ulcerative colitis**. The maximum treatment period for participants is set at 16 weeks. The dosage and frequency of administration are determined by the study protocol, although specific dosing details are not provided in the available data. The trial does not include a pediatric formulation, and **ABBV-668** is not classified as an orphan drug.

In this study, no non-experimental treatments such as standard-of-care therapy, placebo, or comparator treatments are mentioned. The focus is solely on the administration of **ABBV-668**. Participant compliance with the dosing schedule is monitored throughout the trial to ensure adherence to the protocol. The study is conducted as a single-arm, open-label trial, meaning all participants receive the experimental treatment, and both the researchers and participants are aware of the treatment being administered.

The efficacy of ABBV-668 in the treatment of moderate to severe **ulcerative colitis** will be assessed through a single-arm, open-label clinical trial. The primary endpoint for evaluating efficacy is the achievement of endoscopic improvement, defined as a Mayo Endoscopic Subscore (ESS) of 0 or 1, at Week 8. Secondary endpoints include the achievement of clinical remission, clinical response per Adapted Mayo score, clinical response per Partial Adapted Mayo score, and endoscopic remission, all assessed at Week 8. The Adapted Mayo score is a validated scale used to measure disease activity in ulcerative colitis, and it will be utilized to determine clinical remission and response. The trial will compare the proportion of subjects achieving these endpoints in the ABBV-668 treatment group against historical placebo data, with subjects counted as non-responders after the initiation or dose escalation of UC-related corticosteroids. Efficacy assessments will be conducted at specified timepoints, with the primary and secondary endpoints evaluated at Week 8 of the treatment period.