NCT01171807

Erythrocytes-Mediated Delivery Of Dexamethasone 21-Phosphate In Steroid-Dependent Ulcerative Colitis

Dexamethasone Intra-Erythrocyte Therapy in Patients With Chron's Disease or Ulcerative Colitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Quince Therapeutics S.p.A. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Objectives: The primary objective of this trial was to evaluate the patients response rate at the end of the study. Patients were considered responder if one of the following conditions occurs: * Disease remission (Powell Tuck ≤ 3 or CDAI \< 150) and withdrawal of oral steroids therapy from at least the second treatment procedure; * Disease marked improvement versus basal conditions (at least 5 point decrease in Powell Tuck index or 150 point decrease in CDAI score) and withdrawal of oral steroids therapy from at least the second treatment procedure. Secondary objectives: * to evaluate the endogenous cortisole production after receiving the study treatment * to evaluate the inflammatory indexes (ESR and CPR) after receiving the study treatment * to evaluate the endoscopic remission in patients suffering from mesalazine refractory Ulcerative Colitis * to evaluate the safety of dexamethasone intra-erythrocyte therapy with particular attention to steroid-related adverse events.

Detailed description

This was a single-center, placebo-controlled, randomised, phase II explorative study with the aim to investigate the ability of the new steroid delivery system to induce or maintain remission in steroid-dependent or mesalazine refractory patients suffering from Chron's disease (CD) or Ulcerative Colitis (UC) . Once the patient was deemed eligible for the study, the treatment plan was selected as follows In the Dexamethasone arm (DEX 21-P): * steroid-dependant patients: one treatment procedure every 30 days up to a total of 6 procedures * mesalazine refractory active UC patients: one treatment procedure every 15 days up to a total of 3 procedures. In the placebo arm: Patients assigned to placebo arm performed the same procedure as the patients assigned to the DEX 21-P group without loading in the Red Blood Cells the Dex 21-P. The planned duration of individual patient participation in the study was a maximum of 6 or 28 weeks, depending from the assigned treatment scheme.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	Dex 21-P	At each procedure 50 ml of patient whole blood was washed with saline solution and centrifugated. The isolated erythrocytes were suspended into 2 hypotonic solutions to make their membrane permeable and incubated with Dex 21-P sodium salt up to obtain a final concentration of 10 mM. The drug loaded erythrocytes were immediately re-infused by using a suitable filter.
DRUG	Placebo	Patients assigned to placebo arm performed the same procedure as the patients assigned to the DEX 21-P group without loading in the Red Blood Cells the Dex 21-P

Timeline

• Start date: 2003-07-22
• Primary completion: 2007-05-15
• Completion: 2007-05-15
• First posted: 2010-07-29
• Last updated: 2024-09-24
• Results posted: 2024-09-24

Locations

1 site across 1 country: Italy