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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-03

Study Completion Date

2022-11-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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 clinical profile for further development in this indication.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

LIV001 in Patients with Mild-to-Moderate Active Ulcerative Colitis (UC)

NCT06749795

Ulcerative Colitis (UC)

NOT_YET_RECRUITING PHASE1

Open-label Extension Study to Assess Safety and Tolerability of LYC-30937-EC in Subjects With Active Ulcerative Colitis

NCT02764229

Colitis, Ulcerative

TERMINATED PHASE2

An Efficacy and Safety Study of LYC-30937-EC in Subjects With Active Ulcerative Colitis

NCT02762500

Colitis, Ulcerative

COMPLETED PHASE2

Efficacy and Safety of GLPG1205 in Subjects With Active Ulcerative Colitis

NCT02337608

Ulcerative Colitis

COMPLETED PHASE2

Efficacy and Safety of LC51-0255 in Subjects With Ulcerative Colitis

NCT04096573

Ulcerative Colitis

WITHDRAWN PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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. This study consisted of a screening period of up to 4 weeks, and a 8 week treatment period followed by a 30 day post treatment period safety follow up. The maximum study duration for each participant including the 4 week screening period was 16 weeks.

At the beginning of the treatment period, subjects were randomized to one of the two following treatment groups in 2:1 ratio

* LYS006
* matching placebo

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colitis, Ulcerative

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is 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. This study consists of a screening period of up to 4 weeks, and a 8 week treatment period followed by a 30 day post treatment period safety follow up. The maximum study duration for each such including the 4 week screening period is 16 weeks.

At the beginning of the treatment period, subjects will be randomized to one of the two following treatment groups in 2:1 ratio:

* LYS006
* matching placebo

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Subject and investigator blinded via randomization

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

LYS006

Experimental drug

Group Type EXPERIMENTAL

LYS006

Intervention Type DRUG

capsule for oral use

Placebo

Placebo comparator

Group Type PLACEBO_COMPARATOR

Placebo

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No