lcerative colitis

Phase 1

• Conditions: Mild to moderate ulcerative colitis; MedDRA version: 20.0Level: PTClassification code 10009900Term: Colitis ulcerativeSystem Organ Class: 10017947 - Gastrointestinal disorders; MedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2019-003113-34-NO
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-21
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

following criteria:
1. Written informed consent must be obtained before any assessment is
performed.
2. Male and female subjects aged 18-75 years at Screening.
3. Patients diagnosed with UC established at least 3 months prior to
screening.
4. Patients with mild to moderate UC which is defined by a total Mayo
Score between 5 and 10 (inclusive),comprised of the following
subscores;
- Endoscopic subscore: 2 or 3 (determined from central reading of
screening endoscopy)
- Stool frequency subscore: 1-3
- Rectal bleeding subscore: 1-3
- Physician's global assessment subscore: 1-2.
5. Disease must extend beyond 15 cm from the anal verge (assessed by
screening endoscopy).
6. Patients must have responded inadequately or have intolerance to
conventional therapy with oral 5-ASA prior to screening , and be willing
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to continue 5-ASA at a stable dose during the study treatment period.
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 33
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 12

Exclusion Criteria

The patients fulfilling any of the following criteria are not eligible for
inclusion in this study:
- Use of investigational drugs within 4 weeks or 5 half-lives of screening,
whichever is longer; or longer if required by local regulations.
- 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
- Are taking any of the prohibited medications listed in Table 6 2 and do
not fulfill the washout period.
- Patients receiving concomitant medication(s) that is/are known to
inhibit OAT3 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.
- Has severe UC-during the screening period.
- Has previous diagnosis with Crohn's disease, indeterminate colitis,
microscopic colitis or acute diverticulitis based on medical history.
- 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.
- Active systemic infections (other than common cold) during the 2
weeks prior to randomization. Evidence of Clostridium difficile infection within 8 weeks
or other intestinal pathogen infection within 4 weeks prior to the first dose of
study drug.
- History of toxic megacolon, abdominal abscess, symptomatic colonic
stricture, or stoma; history or is at risk of colectomy.
- 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.
- 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.
- Patients with clinically relevant primary sclerosing cholangitis
Other protocol-defined exclusion criteria may apply.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Secondary Objective: To assess safety and tolerability of LYS006 in patients with mild to moderate ulcerative colitis compared to placebo.;Primary end point(s): Clinical remission rate;Timepoint(s) of evaluation of this end point: Week 8 using the full Mayo score;Main Objective: To assess the induction of clinical remission by LYS006 in patients with mild to moderate ulcerative colitis compared to placebo

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Number and severity of adverse events / number of subjects with adverse events<br>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 87)