TerminatedPhase 2

Evaluation of Safety, Efficacy, Pharmacokinetic and Pharmacodynamic of Bertilimumab in Patients With Active Moderate to Severe Ulcerative Colitis

Stopped: Sponsor Decision.

Israel32 participantsStarted 2015-07-31

Plain-language summary

This is a randomized, double blind, placebo-controlled, parallel group multi-center study in adult participants with active moderate to severe UC.

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Males or females, 18 to 70 years of age inclusive.
✓. Diagnosed with active moderate to severe UC per standard diagnostic criteria for a minimum of 3 months:
✓. Levels of eotaxin-1 in biopsied colon tissue of ≥100 pg/mg protein.
✓. Adequate cardiac, renal and hepatic function as determined by the Investigator and demonstrated by screening laboratory evaluations and physical examination results; these findings must all be within normal limits or judged not clinically significant by the Investigator.

✕. History of colonic or rectal surgery other than hemorrhoidal surgery or appendectomy.
✕. Currently receiving total parenteral nutrition (TPN).
✕. Positive Clostridium difficile toxin stool assay.
✕. Tested positive for active/latent mycobacterium tuberculosis (TB) infection.
✕. Pregnant or breast-feeding, or plan to become pregnant during the study.
✕. Males who are young and childless or planning to have more children in the future.
✕. Known hypersensitivity to bertilimumab or any of the drug excipients.
✕. History of infection requiring administration of any IV antibiotic, antiviral or antifungal medication within 30 days of Screening or any oral anti-infective agent within 14 days of Screening.

Change From Baseline in Total Mayo Score at Day 56

Timeframe: Baseline, Day 56

NCT IDNCT01671956

SponsorAlexion Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-08-31

Results submitted2025-11-14

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Males or females, 18 to 70 years of age inclusive.
✓. Diagnosed with active moderate to severe UC per standard diagnostic criteria for a minimum of 3 months:
✓. Levels of eotaxin-1 in biopsied colon tissue of ≥100 pg/mg protein.
✓. Adequate cardiac, renal and hepatic function as determined by the Investigator and demonstrated by screening laboratory evaluations and physical examination results; these findings must all be within normal limits or judged not clinically significant by the Investigator.

✕. History of colonic or rectal surgery other than hemorrhoidal surgery or appendectomy.
✕. Currently receiving total parenteral nutrition (TPN).
✕. Positive Clostridium difficile toxin stool assay.
✕. Tested positive for active/latent mycobacterium tuberculosis (TB) infection.
✕. Pregnant or breast-feeding, or plan to become pregnant during the study.
✕. Males who are young and childless or planning to have more children in the future.
✕. Known hypersensitivity to bertilimumab or any of the drug excipients.
✕. History of infection requiring administration of any IV antibiotic, antiviral or antifungal medication within 30 days of Screening or any oral anti-infective agent within 14 days of Screening.