Effect of Beclometasone dipropionate (BDP) on faecal Calprotectin levels in patients with clinically inactive Ulcerative Colitis at risk of relapse. BeCalCU study

• Register: EUCTR
• Last refreshed on: 3 July 2017
• Main ID: EUCTR2017-000330-61-ES
• Date of registration: 07/04/2017
• Prospective Registration: Yes
• Primary sponsor: CHIESI ESPAÑA S.A.U.
• Public title: Effect of Beclometasone dipropionate (BDP) on faecal Calprotectin levels in patients with clinically inactive Ulcerative Colitis at risk of relapse. BeCalCU study
• Scientific title: Effect of Beclometasone dipropionate (BDP) on faecal Calprotectin levels in patients with clinically inactive Ulcerative Colitis at risk of relapse. BeCalCU study - BeCalCU
• Date of first enrolment: 16/05/2017
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-000330-61
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: yes Other trial design description: Second part is Open-label, non-randomized and single arm design with BDP. If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Spain

Contacts

• Name: Departamento de Ensayos Clínicos
• Affiliation: Dynamic Science S.L

• Name: Departamento de Ensayos Clínicos
• Affiliation: Dynamic Science S.L

Key inclusion & exclusion 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:
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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Clinically inactive Ulcerative Colitis at risk of relapse
MedDRA version: 19.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856

Intervention(s)

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)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

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)

Primary end point(s): Percentage of patients with FC levels below 100 µg/g after 4 weeks of treatment.

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.

Timepoint(s) of evaluation of this end point: Evaluation after 4 weeks of treatment

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Evaluation after 4 and 8 weeks of treatment

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.

Secondary ID(s)

CHI-DIP-2016-01

Source(s) of Monetary Support

CHIESI ESPAÑA S.A.U.