Study of efficacy, safety and tolerability of LYS006 in patients with mild to moderate ulcerative 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-SK
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-04-27
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

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

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 18-75 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 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
- Patients who previously received more than one class of biologic therapy for UC (i.e. anti- TNF blockers).
- History or current evidence of colonic dysplasia or adenomatous colonic polyps.

Other protocol-defined exclusion criteria may apply.

Study & Design

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