A Phase 1b, Multicenter, Randomized, Blinded, Placebo-controlled Study to Evaluate the Efficacy of Guselkumab in Subjects with Familial Adenomatous Polyposis

Overview

About this study

This is a proof-of-concept study to evaluate the preliminary clinical activity of guselkumab in subjects with Familial Adenomatous Polyposis. The study is designed to determine if guselkumab has clinical activity in the colorectum and duodenum, by reducing the number of polyps over a period of 24 weeks.

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. Please contact the study team to discuss whether or not you are eligible to participate in a study.

Inclusion Criteria:

  • Phenotypic familial adenomatous polyposis (FAP) with disease involvement of the colorectum by either genetic or clinical diagnosis: Adenomatous polyposis coli (APC) germline mutation with or without family history, or with greater than (>)100 adenomas in large intestine and a family history of FAP, attenuated FAP is allowed. FAP phenotype post colectomy for polyposis with a family history of FAP may be allowed.
  • Post-colectomy or subtotal colectomy.
  • Polyps with a sum of diameters greater than or equal to (≥)10 millimeter (mm) in the rectum or pouch on biopsy at screening.
  • A woman of childbearing potential must agree not to get pregnant during the study and at least 12 weeks after the last dose of study administration.
  • A woman must agree not to breast feed or donate eggs (ova, oocytes) during the study and for a period of 12 weeks after the last administration of study drug.

Exclusion Criteria:

  • Prior use of any biologic therapy targeting interleukin (IL)-12/23, IL-17, or IL-23 receptor.
  • Use of non-steroidal anti-inflammatory drugs other than aspirin during the study. The use 81 milligram (mg) of aspirin a day or 650 mg of aspirin per week is allowed.
  • Treatment with other FAP-directed drug therapy (including NSAID [Nonsteroidal anti-inflammatory drug] drugs), unless completes a 4-week washout period prior to randomization.
  • High grade dysplasia or cancer on biopsy at screening in GI tract (including stomach, duodenum, and colon/rectum/pouch).
  • Duodenal, colorectal, or pouch polyp >1 centimeter (cm) not excised at the screening evaluation.

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

Niloy Jewel Samadder, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Douglas Riegert-Johnson, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Rochester, Minn.

Mayo Clinic principal investigator

Niloy Jewel Samadder, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20469366

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