Pfizer Inc ((PFE)) announced an update on their ongoing clinical study.
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Pfizer Inc. is conducting a clinical study titled ‘Open-Label Induction and Maintenance Study of Oral CP-690,550 (Tofacitinib) in Children with Moderately to Severely Active Ulcerative Colitis.’ The study aims to evaluate the efficacy, safety, and pharmacokinetics of tofacitinib in pediatric patients with moderate to severe ulcerative colitis (UC). This research is significant as it could provide a new treatment option for children who have not responded to existing therapies.
The intervention being tested is the drug tofacitinib, administered in an open-label format. It is designed to achieve systemic exposure equivalent to the adult dosage of 5 mg BID, with the possibility of increasing to 10 mg BID if necessary. The purpose is to induce and maintain remission in pediatric UC patients.
The study follows an open-label, Phase 3 design with a sequential intervention model. It includes a screening period, induction phase, maintenance phase, and an extension phase, with no masking involved. The primary goal is treatment-focused, aiming to achieve remission in participants.
Key dates for the study include its start on October 26, 2020, with the latest update submitted on October 22, 2025. These dates are crucial for tracking the study’s progress and ensuring timely updates for stakeholders.
This study update could positively impact Pfizer’s stock performance by enhancing investor confidence in the company’s pipeline for pediatric treatments. It also positions Pfizer competitively in the pharmaceutical industry, particularly in the pediatric UC treatment market.
The study is ongoing, with further details available on the ClinicalTrials portal.