A Protocol of Icotrokinra Therapy in Adult and Adolescent Participants With Moderately to Severely Active Ulcerative Colitis

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age12+
SponsorJanssen Research & Development, LLC

About this trial

The purpose of this protocol is to evaluate the efficacy (how well it works), safety and tolerability of oral icotrokinra as therapy in adult and adolescent participants with moderately to severely active ulcerative colitis (UC, a chronic disease of the large intestine in which the lining of the colon becomes inflamed and develops tiny open ulcers).

Eligibility criteria

Qualifiers

Diagnosis of ulcerative colitis (UC) established at least 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of UC

Moderately to severely active UC, defined as a baseline (Week I-0) modified Mayo score of 5 to 9, inclusive, using the endoscopy subscore obtained during the central review of the screening video endoscopy

An endoscopy subscore greater than or equal to (>=) 2 as obtained during central review of the screening video endoscopy

Adolescent Participants: body weight must be >= 40 kilograms (kg) at baseline (Week I-0)

Disqualifiers

Participants with current known complications of UC such as fulminant colitis, toxic megacolon, or any other manifestation that might require colonic surgery while enrolled in the study

Presence of a stoma

Presence or history of a fistula

Colonic resection within 24 weeks before baseline or any other intra-abdominal or other major surgery performed within 12 weeks before baseline

Trial design

Treatments tested in this trial

  • Icotrokinra
  • Placebo

Treatment groups

882 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.