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

Last Update: Nov 13, 2020

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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 
Jan 07, 2022
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
Patients must have active disease with a full Mayo Score between 5 and 10 (inclusive) with an endoscopy score of 2 or 3, rectal bleeding and stool frequency scores 1 to 3, and physician's global assessment with a maximum of 1or 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 bloody stools per day and at least one of the following:
Oral temperature of >37.8°C
Hemoglobin of <10.5 g/dL
CRP > 30 mg/L
Erythrocyte sedimentation rate (ESR) > 33 mm/h
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 screening endoscopy, or anti-IL12/23 blocking agents within 6 months prior to screening endoscopy
Any systemic immunosuppressant or immunomodulator, such as cyclosporine, methotrexate, azathioprine within 4 weeks and cyclophosphamide within 3 months, prior to screening endoscopy
A dose of > 10 mg/d prednisone or equivalent in the last 4 weeks prior to screening endoscopy

Study Locations

United States
Novartis Investigative Site
Withdrawn
Downers Grove, 60515
Illinois
United States
Novartis Investigative Site
Withdrawn
Brooklyn, 11221
New York
United States
Bulgaria
Novartis Investigative Site
Recruiting
Sofia, 1612
-
Bulgaria
Czechia
Novartis Investigative Site
Recruiting
Praha 19, 19000
Czech Republic
Czechia
Novartis Investigative Site
Recruiting
Zlin, 762 75
Czech Republic
Czechia
Germany
Novartis Investigative Site
Recruiting
Kiel, 24105
Schleswig- Holstein
Germany
Novartis Investigative Site
Recruiting
Berlin, 10629
-
Germany
Hungary
Novartis Investigative Site
Recruiting
Budapest, 1085
-
Hungary
Norway
Novartis Investigative Site
Recruiting
Lorenskog, 1478
Oslo
Norway
Poland
Novartis Investigative Site
Recruiting
Piotrkow Trybunalski, 97-300
-
Poland
Novartis Investigative Site
Recruiting
Poznan, 60 529
-
Poland
Russian Federation
Novartis Investigative Site
Recruiting
St Petersburg, 191014
-
Russian Federation

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]