Intra-erythrocyte Dexamethasone Versus Placebo in Patients With Steroid-dependent Crohn's Disease

NCT01277289 | Terminated Phase 3 Results

• 2 other identifiers: Crodex012008-007329-38
• Study Type: interventional
• Target: 51
• Locations: 3 countries
• Sites: 8

Brief Summary

Primary objective: Assessment of the efficacy of EryDex vs PLACEBO in maintaining patients with steroid-dependent Crohn's disease in clinical remission throughout 12 months without oral steroids. Secondary objectives:

1. 1.safety of EryDex
2. 2.emergence of new adverse effects from steroids or disappearance of those possibly pre-existing in the various subgroups of patients;
3. 3.duration of the period of remission;
4. 4.evaluation of the hypophysis-adrenal function;
5. 5.study of plasma concentrations of dexamethasone;
6. 6.effect of therapy on the metabolism of calcium and on indexes of inflammation;
7. 7.assessing the quality of life;
8. 8.rate of surgical resection
9. 9.evaluation of the indirect costs of care.

Conditions

Crohn's Disease

Keywords

dexamethasone; ery-dex; Chron's disease; CD

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients Maintaining Steroids-free Clinical Remission (CDAI<150) Without Surgery for 12 Months

  Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) \< 150. A therapy failure was considered to have occurred in patients with a CDAI score over 150 for \> 2 weeks and/or the need for systemic steroids (with / without surgery). Hence, the higher the index, the worse the outcome.

  after 12 months

Secondary Outcomes (4)

• Number of Participants With Treatment Emergent Adverse Events (TEAEs)

  after 12 months

• Percentage of Patients Interrupting the Study Because of Adverse Events

  after 12 months

• Duration of the Period of Steroid-free Clinical Remission

  From end of the steroid therapy to relapse, up to 545 days

• Dosing of Serum Cortisol

  At Baseline and at the end of the study (18 months)

Study Arms (2)

Ery-dex

EXPERIMENTAL

Ery-dex (dexamethasone sodium phosphate)is administered as intra-erythrocyte drug at monthly interval

Drug: Dexamethasone

Placebo

PLACEBO COMPARATOR

placebo comparator (sodium chloride instead of dexamethasone sodium phosphate) is administered in infusion at monthly interval.

Drug: Dexamethasone

Interventions

Dexamethasone DRUG

500 mg/20 ml encapsulated in erythrocytes, every month for 12 months

Also known as: Ery-dex

Ery-dex; Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects;
• Age \> 18 years;
• Patients with steroid-dependent Crohn's disease, documented in the medical history, having suffered from at least one episode of relapse (CDAI \> 150) in the last 12 months. Patients should have been in clinical remission (CDAI \< 150) for at least four weeks, on stable therapy with at least 10 mg of methylprednisolone (or equivalent), or been on steroidal tapering after a recent relapse. Patients with intolerance or resistance to AZT/6-MP/MTX were eligible;
• Patients willing and able to give written informed consent.

You may not qualify if:

• Patients with Crohn's disease with intestinal sub-occlusion, or suspect of abdominal abscess, or with active perianal disease, or with clinically active disease at randomization (CDAI ≥150);
• Patients already on therapy with immunosuppressant agents (AZT, 6-MP, MTX) for less than 4 months;
• Patients having received therapy with infliximab (or other anti-TNF) in the previous 3 months;
• Investigational treatments in the previous 3 months prior to randomization;
• Pregnant women, or women who were not using valid birth-control measures, except those in surgical menopause; breast feeding;
• Non collaborating subjects or those unable to be compliant with the treatment and the study schedules;
• Severe concomitant diseases such as :
• patients with inadequate "bone marrow reserve": WBC \< 3000 /mm3; PLTs \< 75000 /mm3; Hb \< 8 g/dl
• liver disease with total bilirubin ≥ 3 times the upper limit of normal (ULN), AST (GOT) ≥ 3x ULN, alkaline phosphatase ≥ 3x ULN
• renal disease with serum creatinine ≥ 3 mg/dl
• serious cardiac, allergic, lung, neurological diseases, neoplastic or pre-neoplastic disease
• diseases (other than Crohn's) requiring chronic steroid treatment;
• Elective surgery already scheduled at the start of the study (NB: patients having undergone previous surgery for Crohn's disease could be enrolled, if the patient had fully recovered and had been in remission for at least 4 weeks);
• Chronic use of alcohol; drug addiction;
• Subjects with contra-indication to the use of steroids (i.e. systemic fungal infections);

Sponsors & Collaborators

• Quince Therapeutics S.p.A.: lead

Study Sites (8)

Policlinico Sant'Orsola

Bologna, 40138, Italy

Location

Ospedale Careggi

Florence, 50100, Italy

Location

Ospedale Cervello

Palermo, 90100, Italy

Location

Complesso Integrato Columbus

Rome, 00100, Italy

Location

Ospedale San Camillo

Rome, 00152, Italy

Location

A.O. San Donato

San Donato Milanese, 20097, Italy

Location

Spitalul Clinic Judetean De Urgenta

Cluj-Napoca, 400006, Romania

Location

Clinic CIBER EHD

Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

Crohn Disease

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Angelo Andriulli, MD
• Organization: Erydel

aandriulli@operapadrepio.it

+39 882 410784

Study Officials

• Angelo Andriulli, MD

  Unafilliated

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2011
• First Posted: January 14, 2011
• Study Start: June 3, 2009
• Primary Completion: December 30, 2011
• Study Completion: June 1, 2012
• Last Updated: June 3, 2024
• Results First Posted: June 3, 2024

Record last verified: 2023-12

Locations

ES (1); IT (6); RO (1)