Amgen’s Long-Term Pediatric Psoriasis Study on Apremilast: Why the Latest Update Matters for Investors

Amgen Inc (AMGN) announced an update on their ongoing clinical study.

Amgen Extends Pediatric Psoriasis Study: What Investors Should Know

Study Overview: This Phase 3b study, officially titled “A Phase 3b, Multi Center, Open-label, Long-term Extension Study of Apremilast (CC-10004) in Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis,” follows children and teens who finished an earlier apremilast trial. The goal is to track long-term safety and benefits of ongoing treatment in a real-world style setting. For investors, the study matters because it supports the case for broader and longer use of apremilast in a younger population, a key growth area in immunology.

Intervention/Treatment: The trial tests apremilast, an oral drug for inflammatory skin disease. Children weighing 20 kg to under 50 kg receive 20 mg twice a day, while those at or above 50 kg receive 30 mg twice a day, with dose increases as they grow. The purpose is to see how well long‑term dosing works and how safe it remains in everyday use for pediatric plaque psoriasis.

Study Design: This is an interventional study using a single treatment group, so every enrolled child receives apremilast and there is no placebo or comparison drug. There is no masking or blinding; doctors, patients, and the sponsor know what is given. The primary purpose is treatment, focused on seeing how patients respond over several years, rather than comparing against another therapy.

Study Timeline: The study was first submitted on November 21, 2019, marking the formal launch and regulatory filing. It was designed as a long‑term extension with up to 208 weeks of treatment plus eight weeks of follow‑up, building on a prior core trial. The study’s overall status is now listed as completed, but the record received a fresh update on December 19, 2025, suggesting data cleaning and reporting are ongoing. No results have yet been posted, so investors are still waiting for public outcome data.

Market Implications: A positive long‑term safety and benefit profile in children could support label expansion efforts and strengthen the franchise value of apremilast within Amgen’s inflammation portfolio. Durable pediatric data may help defend share against competitors in systemic psoriasis treatments and biologics from peers such as Novartis and Eli Lilly, especially in markets that value oral options and long‑term safety. The recent update confirms that Amgen continues to invest in clinical support for apremilast, which may bolster investor confidence in the asset’s staying power, though the absence of posted results means any share price reaction should remain muted until data appear. Overall, this update signals ongoing progress rather than a clear catalyst, but it keeps apremilast in focus within the competitive psoriasis landscape.

The study is completed but recently updated, and further details will be available on the ClinicalTrials portal as data are released.

To learn more about AMGN’s potential, visit the Amgen Inc drug pipeline page.