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Riley Children’s Health First in World to Enroll Pediatric Patient in Ulcerative Colitis Trial

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Learn About Ulcerative Colitis

08/04/2026

Riley Children’s Health became the first site in the world to enroll a pediatric patient in the QUASAR Jr. trial, the first approved clinical trial evaluating Tremfya (guselkumab) for children with ulcerative colitis. This reinforces Riley Children’s pediatric gastroenterology leadership through the advancement of treatment options for children with complex inflammatory bowel disease. The medication is already approved for several adult inflammatory conditions, including ulcerative colitis along with plaque psoriasis, psoriatic arthritis, and Crohn’s disease, but remains under investigation for pediatric use.

Ulcerative colitis is a chronic inflammatory bowel disease that can range from mild symptoms to severe disease, causing bloody diarrhea, weight loss, and impaired growth. Therapeutic options for children with severe, treatment-resistant ulcerative colitis remain limited, and some patients ultimately require colon removal surgery when standard therapies fail. Overall, the ongoing trial is evaluating whether Tremfya, which targets the inflammatory protein IL-23, can help control disease activity and offer a new treatment pathway for pediatric patients. More specifically, the trial measures outcomes including sustained clinical remission, endoscopic improvement, corticosteroid-free remission and safety. Early results have been encouraging, with the first enrolled Riley patient responding to therapy and avoiding colectomy to date.

The study is led by Marian Pfefferkorn, MD, pediatric gastroenterologist at Riley Children’s and director of endoscopy for the Division of Pediatric Gastroenterology, Hepatology and Nutrition at IU School of Medicine. As principal investigator, Dr. Pfefferkorn oversees patient selection, treatment monitoring and evaluation of the therapy’s potential role in pediatric care.

“A coordinated team effort supported by strong research infrastructure and an experienced research coordinator allowed us to quickly identify this patient as a candidate and move efficiently into enrollment,” said Pfefferkorn. “For children with limited remaining options, participation in a trial like this can offer a meaningful opportunity to potentially avoid colectomy.”

Riley Children’s selection as the first enrolling site reflects the strength of its pediatric gastroenterology research program, including extensive experience conducting multicenter clinical trials and industry-sponsored studies. As a tertiary referral center serving Indiana and surrounding states, Riley Children’s continues to provide patients access to advanced medical care and emerging therapies.

As a Phase 3 multicenter trial, this study represents an important step toward expanding treatment options for children with severe ulcerative colitis and advancing research designed specifically for pediatric patients. The effort highlights Riley Children’s commitment to translating promising scientific discoveries into new clinical opportunities for children with complex chronic diseases.

Learn more about Riley Children’s Health pediatric gastroenterology program, research and clinical breakthroughs in the annual report.

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Preventing Flare Ups in Children with Ulcerative Colitis

Ulcerative colitis (UC) is a chronic inflammatory bowel disease that...

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Learn About Ulcerative Colitis
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Designated as Best Children's Hospitals by U.S. News & World Report, Ranked in 10 Specialties in 2023-24

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