An Open-Label, Multi-Center Extension Study to Characterize the Long-Term Safety and Efficacy of BMS-986165 in Subjects with Moderate-to-Severe Plaque Psoriasis

The primary objective of this study is to characterize the **safety** and tolerability of long-term use of BMS-986165, also known as deucravacitinib, in subjects with moderate-to-severe plaque psoriasis. This is clinically relevant as it aims to ensure that the extended use of this therapeutic agent does not result in adverse effects, thereby supporting its potential as a viable long-term treatment option for this chronic dermatological condition.

Secondary objectives include characterizing the maintenance of response to BMS-986165 in the treatment of subjects with moderate to severe plaque psoriasis. This is important to determine the sustained efficacy of the treatment over time, which is crucial for managing a condition that often requires ongoing therapy.

The clinical trial involves a total of **995 participants** diagnosed with **moderate-to-severe plaque psoriasis**. The study population includes both male and female subjects, with an age range corresponding to categories 3 and 4, which typically represent adults and older adults. Participants were selected based on their completion of a protocol-required treatment period in a related study of BMS-986165. The trial includes individuals who are not pregnant, lactating, or planning pregnancy during the study period, as confirmed by a negative urine test prior to the start of the study drug. The trial population encompasses a vulnerable group, indicating that special considerations are in place to ensure their safety and well-being throughout the study. Lifestyle factors such as diet, physical activity, or other habits are not specified in the available data.

The clinical trial is designed to evaluate the long-term safety and efficacy of **deucravacitinib** in subjects with moderate-to-severe plaque psoriasis. This is an open-label, multi-center extension study, which follows a randomized, controlled trial design. The trial is expected to run from January 2, 2020, to August 7, 2026, with participants involved for a maximum treatment period of 240 weeks. The study involves the administration of deucravacitinib in the form of a film-coated tablet, with a maximum daily dose of 6 mg. A placebo to match the BMS 986165 tablet is also utilized in the study.

Participants are required to have completed the protocol-required treatment period in an applicable study of BMS-986165 in moderate-to-severe psoriasis to be eligible. The study begins with an inclusion visit, where eligibility is confirmed, and informed consent is obtained. Women of childbearing potential must have a negative urine pregnancy test 24 hours prior to the start of the study drug. The primary endpoint focuses on the occurrence of adverse events and serious adverse events, while secondary endpoints include the sPGA 0/1 response and PASI 75 response.

Study visits are scheduled at regular intervals to monitor the safety and efficacy of the treatment. Follow-up visits are conducted to assess the participants' response to the treatment and to record any adverse events. The end-of-study visit marks the conclusion of the participant's involvement, where final assessments are made. Participants may be terminated early from the study if they experience significant adverse events, withdraw consent, or fail to comply with the study protocol. The trial is not categorized as low intervention and is classified as a phase 3 trial.

The clinical trial involves the administration of **deucravacitinib**, a chemical entity developed by Bristol-Myers Squibb International Corporation. Deucravacitinib is provided in the form of a **film-coated tablet**. The active substance, deucravacitinib, is chemically synthesized and is also known by its sponsor product code, BMS-986165. The maximum daily dose of deucravacitinib is 6 mg, with a total maximum dose of 10080 mg over the course of the study. The medication is administered orally, and the treatment period can extend up to 240 days. Participant compliance with the dosing schedule is monitored throughout the trial to ensure adherence to the prescribed regimen.

In addition to the experimental medication, a **placebo** is used as a comparator in the study. The placebo is designed to match the BMS-986165 tablet in appearance but does not contain any active pharmaceutical ingredients. The placebo serves as a control to evaluate the efficacy and safety of deucravacitinib in subjects with moderate-to-severe plaque psoriasis. The administration route and frequency for the placebo are consistent with those of the experimental medication to maintain the study's integrity and ensure unbiased results.

The efficacy of the clinical trial involving **deucravacitinib** for moderate-to-severe plaque psoriasis will be assessed using specific secondary endpoints. These endpoints include the sPGA 0/1 response and PASI 75 response. The sPGA (static Physician's Global Assessment) 0/1 response measures the proportion of subjects achieving clear or almost clear skin, while the PASI 75 response evaluates the percentage of participants achieving at least a 75% improvement in the Psoriasis Area and Severity Index score from baseline. These efficacy parameters will be collected and analyzed throughout the trial to determine the long-term effectiveness of the treatment.