Mild to moderate ulcerative colitis MedDRA version: 20.0 Level: PT Classification code 10009900 Term: Colitis ulcerative System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Product Name: LYS006
Product Code: LYS006
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: not yet defined
Current Sponsor code: LYS006
Other descriptive name: LYS006
Concentration unit: mg mil
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The patients eligible for inclusion in this study must fulfill all of the following criteria: 1. Written informed consent must be obtained before any assessment is performed. 2. Male and female subjects aged 18-65 years at Screening. 3. Patients diagnosed with UC established at least 3 months prior to screening and history including at least one relapse. 4. Patients with mild to moderate UC which is defined by a total Mayo Score between 5 and 9 (inclusive), with an endoscopic subscore of 2 or 3 and all other three subscores to a maximum 2 (stool frequency, rectal bleeding, physician's global assessment) determined within 14 days prior to baseline visit. 5. Disease must extend beyond 15 cm from the anal verge (assessed by colonoscopy within 14 days prior to Baseline). 6. Patients must have responded inadequately or have intolerance to conventional therapy with oral 5-ASA prior to screening. 7. Able to communicate well with the investigator, to understand and comply with the requirements of 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 35 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: The patients fulfilling any of the following criteria are not eligible for inclusion in this study: 1. Use of investigational drugs within 4 weeks or 5 half-lives of screening, whichever is longer; or longer if required by local regulations. 2. Confirmed laboratory findings at screening showing: • Total white blood cell count (WBC) outside the range of 3,000 – 12,000 /µL. o Subjects with mild leukocytosis (WBC not higher than 15,000 /µL) may be eligible, if the elevated WBC, according to the Investigator, is attributable to disease activity and/or to corticosteroid therapy and other causes such as hematological or infectious diseases can be excluded; • Platelets <100,000/µL; • Hemoglobin <9 g/dL and/or other signs of severe anemia 3. Are taking any of the prohibited medications listed in Table 6 2 and do not fulfill the washout period at the time of randomization. 4. Patients receiving concomitant medication(s) that is/are known to inhibit OAT3 or BCRP and that cannot be discontinued or replaced by safe alternative medication within 5 halflives or 1 week (whichever is longer) prior to baseline and for the duration of the study. 5. Has severe UC at Screening. 6. Has previous diagnosis with Crohn's disease, indeterminate colitis, microscopic colitis or acute diverticulitis based on medical history. 7. Any severe, progressive or uncontrolled medical or psychiatric condition, or other factors at randomization that in the judgment of the investigator prevents the patient from participating in the study. 8. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test at Screening. 9. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using basic methods of contraception during dosing of study Treatment. Other protocol-defined exclusion criteria may apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the induction of clinical remission by LYS006 in patients with mild to moderate ulcerative colitis compared to placebo;Secondary Objective: To assess safety and tolerability of LYS006 in patients with mild to moderate ulcerative colitis;Primary end point(s): Clinical remission rate;Timepoint(s) of evaluation of this end point: Week 12 of treatment (Day 85) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Number and severity of adverse events / number of subjects with adverse events Safety and tolerability based on general safety measurements (safety laboratory parameters, vital signs and ECG parameters);Timepoint(s) of evaluation of this end point: From Baseline visit till end of trial visit (Day 115) | — |
Countries
Bulgaria, Czech Republic, Germany, Hungary, Norway, Poland, Russian Federation, Slovakia, United States
Contacts
Public ContactPublic Information Desk
Novartis Hungary Kft.
Outcome results
None listed