Efficacy of AlbenDazole to inDuce mUcosal healing in Patients with Crohn's disease on anti-TNF monotherapy

Phase 1

• Conditions: Crohn's disease; MedDRA version: 20.0Level: LLTClassification code 10013099Term: Disease CrohnsSystem Organ Class: 100000004856; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2017-001737-85-NL
• Lead Sponsor: academic medical centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-04-03
• Last Update Posted: 6 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

1.Patients =18 years and =65 years
2.Diagnosis of CD, based on endoscopy and histopathologic examination of mucosal biopsies
3.Written informed consent
4.Active mucosal disease as defined by a repeated faecal calprotectine = 250 µg/g at 2 consecutive occasions (=2 weeks and =3 months interval) AND presence of mucosal lesions as defined by a SES-CD > 6 (= 4 for L1 (ileal) disease) on screening ileocolonoscopy
5.On anti-TNF therapy (ADM at a dose of 40mg Subcutaneous (SC) every week (QW) or every other week (Q2W) and IFX at a dose of 5-10 mg/kg every 4-8 weeks) for a period of at least 4 months at stable dose.
6.Therapeutic trough serum concentrations of anti-TNF at screening (for IFX = 3 µg/ml and for adalimumab (ADM) = 5 µg/ml and undetectable levels of anti-drug antibodies (ADA’s) at baseline.

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 110
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Ulcerative colitis or indeterminate colitis
2.Current malignancy
3.Women: current pregnancy wish, pregnancy or lactation. Men: active child wish
4.Ongoing use of an immunomodulator (including azathioprine, methotrexate, 6-thioguanine, 6 mercaptopurine or mycophenolic acid).
5.Prior failure on anti-TNF and immunomodulator combination therapy due to refractory disease per treating physicians opinion.
6.Elevated liver enzymes (ALAT, ASAT, LDH, ?-GT, AF) >1.5 times the upper limit of normal (ULN)
7.Current use of any CYP3A4 inducing or inhibiting agents
8.Patients on prednisone >10mg/day or budesonide >6mg/day
9.Patients who require rescue therapy with corticosteroids during the screening phase
10.Leukopenia (neutrophil count < 1.8x10^9/L) and/or thrombopenia <50 x 10^9/L
11.Other conditions which in the opinion of the investigator may interfere with the subject’s ability to comply with the study procedure

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: In the current project the main objective is to evaluate the efficacy and safety of the addition of albendazole to anti-TNF monotherapy (=4 months) in adult patients with Crohn’s disease with incomplete mucosal healing.;Secondary Objective: Secondary objective is to conduct a cost-effectiveness and cost-utility analysis and a budget impact analysis of anti-TNF and albendazol combination therapy.;Primary end point(s): 1. Proportion of patients with absence of ulcers on centrally read endoscopies after 12 weeks of albendazole and anti-TNF combination treatment compared to placebo;Timepoint(s) of evaluation of this end point: At week 12