ZED1227 Capsules in Patients Suffering from Symptoms Despite a Gluten-Free Diet

Identifiant de l'essai ICTRP
EUCTR2020-004612-97 (ICTRP)

Titre officiel (approuvé par le comité d'éthique)
A phase IIb, double-blind, randomised, placebo-controlled, trial to evaluate the efficacy and tolerability of ZED1227 in celiac disease subjects experiencing symptoms despite gluten-free diet (BASEC)

Titre académique
A phase IIb, double-blind, randomised, placebo-controlled trial to evaluate the efficacy and tolerability of ZED1227 in celiac disease subjects experiencing symptoms despite gluten-free diet - ZED1227 for treatment of symptomatic celiac disease subjects (ICTRP)

Titre public
A clinical trial to evaluate ZED1227 in comparison with placebo in subjects with celiac disease experiencing symptoms despite gluten-free diet (ICTRP)

Maladie en cours d'investigation
Treatment of celiac disease
MedDRA version: 20.0Level: LLTClassification code 10007864Term: Celiac diseaseSystem Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] (ICTRP)

Intervention étudiée

Product Code: ZED1227 10 mg capsules
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: ZED1227
Current Sponsor code: ZED1227
Other descriptive name: Methyl (E,6S)-7-[[1-[2-(2-ethylbutylamino)-2-oxoethyl]-2-oxopyridin-3-yl]amino]-6-[(3-methylimidazole-4-carbonyl)amino]-7-oxohept-2-enoate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Product Code: ZED1227 25 mg capsules
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: ZED1227
Current Sponsor code: ZED1227
Other descriptive name: Methyl (E,6S)-7-[[1-[2-(2-ethylbutylamino)-2-oxoethyl]-2-oxopyridin-3-yl]amino]-6-[(3-methylimidazole-4-carbonyl)amino]-7-oxohept-2-enoate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Product Code: ZED1227 50 mg capsules
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: ZED1227
Current Sponsor code: ZED1227
Other descriptive name: Methyl (E,6S)-7-[[1-[2-(2-ethylbutylamino)-2-oxoethyl]-2-oxopyridin-3-yl]amino]-6-[(3-methylimidazole-4-carbonyl)amino]-7-oxohept-2-enoate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

(ICTRP)

Type d'essai
Interventional clinical trial of medicinal product (ICTRP)

Plan de l'étude
Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 4 (ICTRP)

Critères d'inclusion/exclusion
Gender:
Female: yes
Male: yes

Inclusion criteria:
?Documented initial biopsy proven diagnosis of celiac disease at least 12 months prior to V0
?Adherence to a gluten-free diet (GFD) for at least 12 months prior to V0
?Human leukocyte antigen DQ (HLA-DQ) typing compatible with celiac disease
?At least one moderate or severe gastrointestinal symptom (i.e., diarrhoea, abdominal pain, bloating or nausea) during the last 4 weeks prior to Baseline Visit
?Negative diagnosis of Helicobacter pylori infection

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 330
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70
(ICTRP)

Exclusion criteria:
?Selective immunoglobulin A deficiency
?Subjects diagnosed to have confirmed refractory celiac disease type I (RCDI) or II (RCDII), with the exception that patients with a diagnosis of RCDI can be considered for inclusion if they do not have clear signs of T cell monoclonality or atypical T cells and if they do not present with very severe symptoms and/or parameters of significant malabsorption and if they have not received prior treatment with immunosuppressants such as budesonide or azathioprine
?Severe complications of celiac disease
?Any concomitant diseases of the intestinal tract in addition to celiac disease that might, in the investigator's opinion, interfere with assessment of symptoms of abdominal pain, diarrhea, or other components of celiac disease
?Evidence of relevant systemic disease




Critères d'évaluation principaux et secondaires
Main Objective: To assess 3 different doses and 2 different dosing schedules of ZED1227 capsules for efficacy in:
- Improvement of the duodenal mucosal morphology as measured by morphometry (VH:CrD), and
- Improvement of celiac disease symptoms assessed by Celiac Disease Symptom Diary (CDSD) in celiac disease subjects experiencing symptoms and having mucosal damage despite gluten-free diet.;Secondary Objective: To assess efficacy of ZED1227 capsules for

? Improvement and changes of duodenal mucosal morphology as measured by morphometry (VH:CrD),
? Improvement and changes of celiac disease symptoms assessed by CDSD,
? Improvement in the Marsh-Oberhuber grouped classes
? Changes of inflammatory cell subsets in duodenal biopsies,
? Changes in serum markers of celiac inflammation,
? Safety and tolerability in terms of adverse events and laboratory parameters,
? Subjects? quality of life.;Primary end point(s): Multi-component endpoint:
-improvement of intestinal mucosal morphology
-improvement in Non-Stool GI Specific Symptom Score OR as an improvement in Diarrhoea Severity Score

;Timepoint(s) of evaluation of this end point: 12 weeks, from Baseline Visit B1 (week 5) to Visit 7 (week 17) (ICTRP)

Secondary end point(s): ? Improvement of intestinal mucosal morphology
? Changes in intestinal mucosal morphology
? Changes in Patient Reported Outcomes (PRO)
? Change in health-related quality of life (EQ-5D-5L)
? Change in serological markers;Timepoint(s) of evaluation of this end point: 12 weeks, from Baseline Visit B1 (week 5) to Visit 7 (week 17) (ICTRP)

Date d'enregistrement
06.04.2023 (ICTRP)

Inclusion du premier participant
23.02.2023 (ICTRP)

Sponsors secondaires
non disponible

Contacts supplémentaires
Dept. of Clinical Research & Develo, mohrbacher@drfalkpharma.de, +497611514156, Dr. Falk Pharma GmbH (ICTRP)

ID secondaires
CEC-4/CEL, 2020-004612-97-FI (ICTRP)

Résultats-Données individuelles des participants
non disponible

Informations complémentaires sur l'essai
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-004612-97 (ICTRP)