Abbvie ((ABBV)), Abbvie (($CC:ABBV.CUR)) announced an update on their ongoing clinical study.
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AbbVie is conducting a Phase 3 multicenter study titled ‘A Phase 3 Multicenter Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Upadacitinib With Open-Label Induction, Randomized, Double-Blind Maintenance and Open-Label Long-Term Extension in Pediatric Subjects With Moderately to Severely Active Crohn’s Disease and Inadequate Response, Intolerance, or Medical Contraindications to Corticosteroids, Immunosuppressants, and/or Biologic Therapy.’ The study aims to assess the safety and effectiveness of Upadacitinib in treating pediatric patients with moderate to severe Crohn’s Disease who have not responded well to other treatments.
The intervention being tested is Upadacitinib, an oral medication already approved for adults with moderate to severe Crohn’s Disease. It is being evaluated for use in children aged 2 to 18 years to determine its safety and efficacy in this younger population.
This interventional study is randomized and follows a sequential intervention model. It employs quadruple masking, meaning that the participant, care provider, investigator, and outcomes assessor are all blinded to the treatment allocation. The primary purpose of the study is treatment-focused.
The study began on July 26, 2024, with primary completion expected in the future. The last update was submitted on August 11, 2025. These dates are crucial as they mark the progression and current status of the study.
The market implications of this study are significant for AbbVie, as successful results could strengthen its position in the pediatric Crohn’s Disease market, potentially boosting its stock performance and investor confidence. The study’s progress is also relevant in the context of competition within the pharmaceutical industry, where advancements in treatment options can shift market dynamics.
The study is ongoing, with further details available on the ClinicalTrials portal.