Status:
TERMINATED
Study of Efficacy, Safety, and Tolerability of LYS006, in Patients With Mild to Moderate Ulcerative Colitis
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Colitis, Ulcerative
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The purpose of the study was to assess preliminary efficacy, safety, and tolerability of LYS006 in adult patients with mild to moderate ulcerative colitis and to determine if LYS006 has an adequate cl...
Detailed Description
This was a randomized, placebo-controlled, subject and investigator blinded, multicenter, non-confirmatory, parallel group, proof of concept study in patients with mild to moderate ulcerative colitis....
Eligibility Criteria
Inclusion
- Key
- Male and female subjects 18-75 years of age with an established diagnosis of ulcerative colitis at least 3 months prior to screening are eligible for the study.
- 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 a physician's global assessment of 1 or 2.
- Patients must have responded inadequately to conventional therapy with oral 5-ASA prior to screening.
- Key
Exclusion
- Has previous diagnosis with Crohn's disease, indeterminate colitis, microscopic colitis or acute diverticulitis based on medical history.
- History of toxic megacolon, abdominal abscess, symptomatic colonic stricture, or stoma; history or is at risk of colectomy.
- Treatment with biologics within 3 months or 5 half-lives (whichever is longer) prior to screening endoscopy, non-biologics advanced therapies within 4 weeks prior to screening endoscopy, systemic immunosuppressant or immunomodulator within 6 week, topical treatment with 5-ASA or steroids within 2 weeks prior to screening endoscopy
Key Trial Info
Start Date :
February 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 7 2022
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT04074590
Start Date
February 3 2020
End Date
November 7 2022
Last Update
June 20 2024
Active Locations (9)
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1
Novartis Investigative Site
Sofia, Bulgaria, 1612
2
Novartis Investigative Site
Prague, Czech Republic, Czechia, 19000
3
Novartis Investigative Site
Zlín, Czech Republic, Czechia, 762 75
4
Novartis Investigative Site
Berlin, Germany, 10629