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

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

Last update

Apr 22, 2020

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