OptIMMize-2: A Phase 3 Multicenter, Single-arm, Open-label Extension Study to Assess the Safety, Tolerability, and Efficacy of Risankizumab in Subjects With Moderate to Severe Plaque Psoriasis Who Have Completed Participation in Study M19-977 (OptIMMize-1).

The primary objective of this study is to evaluate the long-term **safety**, tolerability, and efficacy of **risankizumab** in subjects with moderate to severe **plaque psoriasis** who have completed participation in the preceding study, Study M19-977. This is clinically relevant as it aims to provide comprehensive data on the sustained effects and potential adverse events associated with prolonged use of risankizumab, thereby informing treatment decisions and optimizing patient management in this population.

The clinical trial involves a total of **89 participants** who have been diagnosed with **plaque psoriasis**. The study population includes both male and female subjects, with an age range that encompasses adults. Participants were selected based on their completion of a preceding study, specifically Study M19-977, and their eligibility for the current study, M19-973. The trial population includes individuals from a vulnerable population, indicating a need for careful consideration of their health status and any potential risks associated with participation. The study does not specify particular lifestyle considerations such as diet or physical activity, focusing instead on the long-term safety, tolerability, and efficacy of risankizumab in treating moderate to severe plaque psoriasis.

The clinical trial is designed as a **Phase 3**, single-arm, open-label extension study to evaluate the long-term safety, tolerability, and efficacy of **risankizumab** in subjects with moderate to severe **plaque psoriasis**. Participants eligible for this study are those who have completed participation in the preceding study, M19-977. The trial will involve the administration of **risankizumab** via subcutaneous injection, with a maximum treatment period of 204 weeks. The study is not categorized as low intervention and is conducted under the sponsorship of AbbVie Deutschland GmbH & Co. KG.

The trial will commence with an inclusion (screening) visit to confirm eligibility based on the completion of study M19-977 and adherence to all inclusion criteria. Participants will then proceed to receive the investigational product, **risankizumab**, in a solution for injection in a pre-filled syringe. The primary endpoint of the study is the number of participants experiencing adverse events, which will be monitored throughout the trial duration.

Study visits will be scheduled at regular intervals to assess the safety and efficacy of the treatment. These visits will include clinical evaluations, laboratory tests, and assessments of disease activity. The end-of-study visit will mark the conclusion of the participant's involvement, where final evaluations will be conducted to gather comprehensive data on the long-term effects of the treatment.

The expected length of participant involvement is up to 204 weeks, contingent upon the absence of any adverse events or conditions that may necessitate early termination from the study. Such conditions include significant adverse reactions or non-compliance with study protocols. The trial is estimated to conclude by November 20, 2029, with recruitment having started on October 1, 2022.

The clinical trial involves the administration of **Risankizumab**, a biologic agent formulated as a **solution for injection in pre-filled syringe**. This experimental medication is designed for subcutaneous administration. The dosing regimen for Risankizumab involves a maximum total dose of 935 mg over a treatment period of 204 weeks. The active substance, Risankizumab, is a protein-based therapeutic agent developed by AbbVie Deutschland GmbH & Co. KG. The medication is not formulated for pediatric use and is not classified as an orphan drug.

Another formulation of the experimental medication, referred to as **ABBV-066**, is also utilized in the study. Like Risankizumab, ABBV-066 is provided as a **solution for injection in pre-filled syringe** and is administered subcutaneously. The maximum daily dose for ABBV-066 is 150 mg, with a cumulative dose not exceeding 2550 mg over the same 204-week treatment period. The active substance in ABBV-066 is identical to that in Risankizumab, ensuring consistency in the therapeutic approach. Both formulations are developed by AbbVie Deutschland GmbH & Co. KG and share the same protein-based origin.

No non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatments, are specified for this study. The trial is designed to assess the long-term safety, tolerability, and efficacy of Risankizumab in subjects with moderate to severe plaque psoriasis who have completed participation in a preceding study. Participant compliance with the dosing schedule is monitored throughout the trial to ensure adherence to the treatment protocol.

The efficacy of **risankizumab** in the clinical trial will be assessed as part of a Phase 3 multicenter, single-arm, open-label extension study. This study is designed to evaluate the long-term safety, tolerability, and efficacy of **risankizumab** in subjects with moderate to severe plaque psoriasis who have completed participation in the preceding study, M19-977. The primary endpoint for efficacy assessment is the number of participants with adverse events, which will be monitored throughout the study duration. The trial does not specify additional secondary efficacy endpoints. The study will utilize a solution for injection in a pre-filled syringe, administered subcutaneously, with a maximum treatment period of 204 weeks. The data collected will be analyzed to determine the efficacy of **risankizumab** in maintaining or improving the condition of participants with moderate to severe plaque psoriasis over the long term.