Study of Efficacy, Safety, and Tolerability of LYS006, in Patients With Mild to Moderate Ulcerative Colitis

A Randomized, Multi-center, Subject and Investigator-blinded, Placebo-controlled, Parallel-group Study to Assess the Efficacy Safety and Tolerability of LYS006 in Patients With Mild to Moderate Ulcerative Colitis

ClinicalTrials.gov Identifier: NCT04074590

Novartis Reference Number: CLYS006X2202

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

The purpose of the study is to assess preliminary efficacy, safety, and tolerability of LYS006 in patients with mild to moderate ulcerative colitis and to determine if LYS006 has an adequate clinical profile for further development in this indication.

Condition 
Colitis, Ulcerative
Phase 
Phase 2
Overall status 
Recruiting
Enrollment count 
45 participants
Start date 
Feb 03, 2020
Completion date 
Dec 13, 2021
Gender 
All
Age(s)
18 Years - 65 Years (Adult, Older Adult)

Interventions

Drug
LYS006
capsule for oral use
Drug
Placebo
capsule for oral use

Eligibility Criteria

Key Inclusion Criteria:

Male and female subjects 18-65 years of age with an established diagnosis of ulcerative colitis at least 3 months prior to screening and history including at least one relapse are eligible for the study
Patients must have active disease with a full Mayo Score between 5 and 9 (inclusive) with an endoscopy score of 2 or 3 and rectal bleeding, stool frequency and physician's global assessment with a maximum of 2.
Patients must have responded inadequately to conventional therapy with oral 5-ASA prior to screening.

Key Exclusion Criteria:

Has severe UC at screening, as defined by an average bloody stool frequency of >6 per day and at least one of the following:
Resting heart rate >90 bpm or postural hypotension defined by a decrease in BP of greater than 20 mm Hg systolic or 10 mm Hg diastolic within 3 minutes of standing after being in supine or sitting position
Oral temperature of >38°C
Hemoglobin of <9 g/dL
Has previous diagnosis with Crohn's disease, indeterminate colitis, microscopic colitis or acute diverticulitis based on medical history
Previous treatment with biologics (such as anti-TNFα agents) within 3 months or 5 half-lives (whichever is longer) prior to randomization, or anti-IL12/23 blocking agents within 6 months prior to randomization
Any systemic immunosuppressant or immunomodulator, such as cyclosporine, methotrexate, azathioprine within 4 weeks and cyclophosphamide within 3 months, prior to randomization
A dose of > 10 mg/d prednisone or equivalent in the last 4 weeks prior to randomization

Study Locations

United States
Novartis Investigative Site
Recruiting
Downers Grove, 60515
Illinois
United States
Novartis Investigative Site
Recruiting
Brooklyn, 11221
New York
United States
Czechia
Novartis Investigative Site
Recruiting
Praha 19, 19000
Czech Republic
Czechia
Novartis Investigative Site
Recruiting
Zlin, 762 75
Czech Republic
Czechia
Hungary
Novartis Investigative Site
Recruiting
Budapest, 1085
-
Hungary

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
1-888-669-6682
Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111
Email: 

Have a question?

Call 1-999-669-6682 or email [email protected]