Clinically inactive Ulcerative Colitis at risk of relapse MedDRA version: 19.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856
Conditions
Interventions
Trade Name: Clipper
Product Name: Beclometasone dipropionate
Pharmaceutical Form: Tablet
INN or Proposed INN: BECLOMETASONE DIPROPIONATE
CAS Number: 5534-09-8
Concentration unit: mg milligram(s)
Conce
Sponsors
CHIESI ESPAÑA S.A.U.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients 18 years of age or older. 2. Patients with a diagnosis of left-sided or extended ulcerative colitis at least one year before the screening visit. 3. Patients in clinical remission (Partial Mayo Score Index =2 with no single item >1 and rectal bleeding score = 0) at the screening visit. 4. Patients who had at least one relapse of the disease in the 2 years prior to the screening visit. 5. Patients who, according to the medical history, have FC levels above 250 µg/g of faeces in the 30 days preceding the screening visit confirmed between screening and baseline visit by a central laboratory. 6. Receiving treatment at stable doses of oral 5-aminosalicylate for at least 4 weeks prior to the screening visit. 7. Patients who have signed the informed consent form for participating in the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 4
Exclusion criteria
Exclusion criteria: 1. Presence of stoma or prior colon resection. 2. Patients with ulcerative colitis confined to the rectum (15 cm or less from the anal border) 3. Receiving treatment with oral or rectal treatment with systemic corticosteroids, immunomodulating agents [thiopurines (azathioprine and 6-mercaptopurine), methotrexate, calcineurin inhibitors (cyclosporine and tacrolimus)] or biologic treatment in the 12 weeks prior to the screening visit 4. Previous intolerance or toxicity associated with systemic corticosteroids. 5. Pregnant or lactating women and all women physiologically capable of becoming pregnant (i.e. women of childbearing potential) unless are using one or more of the highly effective contraceptive measures* at the screening visit. 6. Presence of any disease for which corticosteroid treatment is contraindicated. 7. Any serious disease or comorbidity. 8. Treatment with nonsteroidal anti-inflammatory drugs during more than 7 consecutive days within the 3 months prior to the screening visit. 9. Patients with 8 years or more after the onset of colitic symptoms without a colonoscopy in the 3 years prior to the screening visit. 10. Patients who received any investigational new drug, or participated in a clinical study within the last 8 weeks. 11. Any other condition that, in the judgment of the Investigator, may prevent a patient from completing all the procedures required or patients who refuse to, or lack the capacity to, provide consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the superiority of oral beclometasone dipropionate (BDP) over placebo on lowering levels of faecal calprotectin (FC) below 100 µg/g after 4 weeks of treatment in patients with clinical remission and at risk of relapse who are receiving treatment with 5-aminosalicylate (5-ASA);Secondary Objective: • To assess the effect of oral BDP on lowering FC levels below 100 µg/g after 8 weeks of treatment. • To assess the effect of oral BDP on lowering FC levels below 150 µg/g after 4 and 8 weeks of treatment. • To assess the effect of oral BDP on lowering FC levels below 50 µg/g after 4 and 8 weeks of treatment. • To assess the effect of oral BDP on intra-patient change of FC levels after 4 and 8 weeks of treatment. • To assess the effect of oral BDP on disease activity after 4 and 8 weeks of treatment. • To evaluate the safety of oral BDP treatment.;Primary end point(s): Percentage of patients with FC levels below 100 µg/g after 4 weeks of treatment.;Timepoint(s) of evaluation of this end point: Evaluation after 4 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Percentage of patients with FC levels below 100 µg/g after 8 weeks of treatment. • Percentage of patients with FC levels below 150 µg/g after 4 and 8 weeks of treatment. • Percentage of patients with FC levels below 50 µg/g after 4 and 8 weeks of treatment. • Mean intra-patient change in FC levels after 4 and 8 weeks of treatment. • Percentage of patients with disease worsening – after 4 and 8 weeks of treatment: increase of the Partial Mayo Score Index, hospitalization, treatment with classic corticosteroids or changes in maintenance treatment.;Timepoint(s) of evaluation of this end point: Evaluation after 4 and 8 weeks of treatment | — |
Countries
Spain
Contacts
Public ContactDepartamento de Ensayos Clínicos
Dynamic Science S.L
Outcome results
None listed