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

• Register: ClinicalTrials.gov
• Last refreshed on: 20 June 2023
• Main ID: NCT04074590
• Date of registration: 29/08/2019
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharmaceuticals
• Public title: Study of Efficacy, Safety, and Tolerability of LYS006, in Patients With Mild to Moderate Ulcerative Colitis
• Scientific title: 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
• Date of first enrolment: February 3, 2020
• Target sample size: 23
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT04074590
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Bulgaria, Czechia, Germany, Hungary, Norway, Poland, Russian Federation, Slovakia, United Kingdom, United States

Key inclusion & exclusion criteria

Key Inclusion Criteria:

- 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 Criteria:

- 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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Colitis, Ulcerative

Intervention(s)

Drug: Placebo

Drug: LYS006

Primary Outcome(s)

Clinical remission rate at the end of Week 8 [Time Frame: Week 8]

Secondary Outcome(s)

Number and severity of adverse events [Time Frame: Week 8]

Secondary ID(s)

2019-003113-34

CLYS006X2202

Source(s) of Monetary Support

Please refer to primary and secondary sponsors