A Study Of Icotrokinra In Participants With Moderately To Severely Active Crohn's Disease

Overview

About this study

The purpose of this study is to evaluate how-well icotrokinra works (clinical efficacy) and how safe it is (safety) in participants with moderately to severely active Crohn's disease (CD; a long-term condition causing severe inflammation of the intestinal tract).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Diagnosis of CD established at least 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of CD

  • Moderately to severely active CD based on CDAI criteria, defined as baseline (Week I-0) CDAI score >=220 but <=450 and either mean daily SF count >=4, or mean daily AP score >=2

  • Moderately to severely active CD based on SES-CD criteria assessed by baseline (Week I-0) endoscopic evidence of active ileal and/or colonic CD as assessed during central review of the screening video ileocolonoscopy defined as a SES-CD >= 6 for participants with colonic or ileocolonic disease, and SES-CD >= 4 for participants with isolated ileal disease, based on the presence of ulceration in any 1 of the 5 ileocolonic segments

  • A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test (beta-hCG) at screening and a negative urine pregnancy test at Week I-0 prior to administration of study intervention and agree to further pregnancy tests

  • Demonstrated an inadequate response, loss of response, or failure to tolerate previous conventional therapy (advanced drug therapy [ADT]-naïve) or advanced therapy defined as biologics and/or advanced oral agents for the treatment of CD (ADT-inadequate responder [IR]) as defined in the protocol

Exclusion Criteria:

  • Has complications of CD, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation, that may require surgery while enrolled in the study and/or could impair the use of instruments (such as CDAI) to assess response to study intervention

  • Presence of a stoma or ostomy

  • Participants with presence of active fistulas may be included if there is no surgery needed

  • Colonic resection within 24 weeks before baseline or any other major surgery performed within 12 weeks before baseline

  • Presence on screening colonoscopy of adenomatous colon polyps outside of an area of known colitis not removed before randomization

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 11/26/2025. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Manreet Kaur

Contact us for the latest status

Contact information:

Griffith Stratford

(480) 301-4251

Stratford.Griffith@mayo.edu

Rochester, Minn.

Mayo Clinic principal investigator

Edward Loftus

Contact us for the latest status

Contact information:

Troy Ofstie

(507) 266-4728

IBDRESEARCH@mayo.edu

More information

Publications

Publications are currently not available