Effects of Amiselimod in patients with mild to moderate Ulcerative Colitis.

• Register: EUCTR
• Last refreshed on: 16 December 2024
• Main ID: EUCTR2020-005232-30-DE
• Date of registration: 29/04/2021
• Prospective Registration: Yes
• Primary sponsor: Salix Pharmaceuticals, Inc.
• Public title: Effects of Amiselimod in patients with mild to moderate Ulcerative Colitis.
• Scientific title: A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Parallel Group Study Evaluating the Efficacy and Safety of Amiselimod (MT-1303) in Subjects with Mild to Moderate Ulcerative Colitis (UC)
• Date of first enrolment: 05/08/2021
• Target sample size: 336
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-005232-30
• 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: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 3
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Australia, Belarus, Bulgaria, Czech Republic, Czechia, Estonia, France, Georgia, Germany, Hungary, Italy, Japan, Korea, Republic of, Moldova, Republic of, New Zealand, Poland, Russian Federation, Serbia, Slovakia, Taiwan, Ukraine, United States

Contacts

• Name: Clinical Trial Manager
• Affiliation: Salix Pharmaceuticals, Inc.

• Name: Clinical Trial Manager
• Affiliation: Salix Pharmaceuticals, Inc.

Key inclusion & exclusion criteria

Inclusion criteria:
Subjects will be eligible if they are male or female aged between 18 to 75 years at time of consent (inclusive) with stable vital signs and a diagnosis of active mild UC (modified Mayo Score of 3 or 4) or moderate UC (modified Mayo Score of 5 to 8) confirmed at least 12 weeks prior to randomization by clinical and endoscopic evidence and corroborated by a histopathology report.
Subjects must have an endoscopic subscore of =2 from and evidence of active UC extending =15 cm from the anal verge confirmed by a screening colonoscopy.
If subjects are receiving oral or rectal 5-aminosalicylates (5-ASAs) or oral corticosteroids (=20 mg prednisolone equivalent per day) for treatment of their UC, they must be on a stable dose for at least 28 days prior to randomization.
Subjects who complete the Double-Blind Period of the study who, in the opinion of the Investigator, would benefit from continued treatment may participate in the OLE Period.
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 320
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 16

Exclusion criteria:
Subjects will be excluded from the study if they have:
• Any of the following: a diagnosis of Crohn’s disease, indeterminate colitis, colitis (pseudomembranous, microscopic, or ischemic) or coeliac disease, current or recent (within 12 weeks prior to randomization) evidence of fulminant colitis, proctitis (defined as a rectal inflammation within 15 cm from the anal verge), abdominal abscess, toxic megacolon, bowel obstruction, or bowel perforation; a history or evidence of any colonic resection or subtotal or total colectomy, ileostomy, colostomy, known fixed symptomatic stenosis of the intestine,
unresected adenomatous colonic polyps, or colonic mucosal dysplasia.
Clinically significant infections (e.g., pneumonia, pyelonephritis, or septicemia) within 4 weeks prior to randomization or previous clinically significant infections
requiring hospitalization within 6 months prior to randomization, active or latent tuberculosis, infections of hepatitis B, hepatitis C, human immunodeficiency virus (HIV), or history of disseminated herpes zoster.
• Active SARS-CoV-2 infection or complications related to COVID-19.
• A history of, or currently active, primary or secondary immunodeficiency, presence of progressive multifocal leukoencephalopathy (PML), or presence of demyelinating diseases.
• A history or evidence of two or more failures with biologic treatment for UC.
• Currently taking any medication for treatment of UC other than oral or rectal 5-ASAs or oral corticosteroids (=20 mg prednisolone equivalent per day)
• Been taking enemas or suppositories (other than stable dose of 5-ASA) for treatment of UC within 2 weeks prior to the Screening Visit.
• Been taking an unstable dose of probiotics or antidiarrheals 2 weeks prior to the Screening Visit.
• Had recent myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure with hospitalization, Class III/IV heart failure, Mobitz Type II 2nd degree or 3rd degree atrioventricular (AV) block, sick
sinus syndrome, prolonged QT interval, Wolff Parkinson White or other conduction abnormalities, low heart rate, ongoing treatment with Class I or Class III anti-arrhythmic drugs, heart-rate-lowering calcium-channel blockers, ß-blockers or with any other drugs which can reduce the heart rate, have known high risk for QT/QTc prolongation, or have clinically significant abnormal findings in 12-lead ECG that the Investigator considers may jeopardize the subject’s health.
• Forced expiratory volume in one second (FEV1) or forced expiratory vital capacity (FVC) <70% of predicted values at screening. For sites where DLCO will be assessed, the value (mL/min/mmHg) is < 80% of the predicted normal value for age, height, and gender.
• Macular oedema as assessed by OCT.
• History of non-response or treatment failure with amiselimod or other sphingosine 1-phosphate (S1P) receptor modulators.
• Fecal microbiota transplantation (FMT) within 12 months prior to the Screening Visit.
• Any of the following laboratory abnormalities:
o Hemoglobin (Hb) <9.0 g/dL.
o White blood cell (WBC) count <3.50 × 10^9/L (<3,500/µL).
o Absolute Neutrophil count <1.50 × 10^9/L (<1,500/µL).
o Absolute Lymphocyte count <0.80 × 10^9/L (<800/µL).
o Aspartate aminotransferase (AST) or alaninevaminotransferase (ALT) >2 × the upper limit of normal (ULN).
o Bilirubin >1.5 x the ULN; subjects with Gilbert’s syndrome may be enrolled with total bilirubin up to 5.0 mg/dl.
• Positive stool tests for enteric path

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

Health Condition(s) or Problem(s) studied

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

Ulcerative Colitis (UC)
MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856

Intervention(s)

Product Name: Amiselimod
Product Code: MT-1303
Pharmaceutical Form: Capsule
INN or Proposed INN: amiselimod
Other descriptive name: MT-1303
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.2-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use

Product Name: Amiselimod
Product Code: MT-1303
Pharmaceutical Form: Capsule
INN or Proposed INN: amiselimod
Other descriptive name: MT-1303
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.4-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use

Primary Outcome(s)

Main Objective: Assess the efficacy and safety of oral amiselimod (MT-1303) compared to placebo at 12 weeks as the induction treatment in subjects with active mild to moderate ulcerative colitis (UC).

Timepoint(s) of evaluation of this end point: at Day 85.

Secondary Objective: Assess the efficacy and safety of maintenance treatment with open-label amiselimod for up to 36 weeks (OLE Period) following completion of the Double-Blind Period.

Primary end point(s): Change from Baseline in the modified Mayo Score at Day 85. The modified Mayo Score is the sum of:
• Endoscopy subscore (excludes friability); plus
• Rectal bleeding subscore; plus
• Stool frequency subscore.

Secondary Outcome(s)

Secondary end point(s): • The proportion of subjects with endoscopic improvement at
Day 85. Endoscopic improvement is a Mayo endoscopic
subscore of =1.
• The change from Baseline in the 2-component Mayo Score (rectal bleeding plus endoscopic subscores) at Day 85.
• The proportion of subjects with clinical remission at Day 85 based on the modified Mayo Score defined as follows:
o Endoscopy subscore of =1 (excludes friability);
and
o Rectal bleeding subscore of 0; and
o At least one-point decrease in stool frequency subscore from Baseline to achieve a stool frequency subscore of =1.

Timepoint(s) of evaluation of this end point: at Day 85.

Secondary ID(s)

AMUC-2023

2020-005232-30-HU

Source(s) of Monetary Support

Salix Pharmaceuticals, Inc.

Ethics review

Status: Approved
Approval date: 26/07/2021
Contact: