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

Primary Purpose

Colitis, Ulcerative

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
LYS006
Placebo
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colitis, Ulcerative focused on measuring ulcerative colitis, efficacy, safety

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

LYS006

Placebo

Arm Description

Experimental drug

Placebo comparator

Outcomes

Primary Outcome Measures

Clinical remission rate at the end of Week 8
proportion of the patients who who achieve clinical remission after 8-week treatment. Clinical remission is defined as a full Mayo score of 2 points or lower, with no individual subscore exceeding one point.

Secondary Outcome Measures

Number and severity of adverse events
To assess safety and tolerability of LYS006 in patients with mild to moderate ulcerative colitis compared to placebo

Full Information

First Posted
August 29, 2019
Last Updated
June 7, 2023
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT04074590
Brief Title
Study of Efficacy, Safety, and Tolerability of LYS006, in Patients With Mild to Moderate Ulcerative Colitis
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Terminated
Why Stopped
Sponsor decision due to strategic considerations
Study Start Date
February 3, 2020 (Actual)
Primary Completion Date
November 7, 2022 (Actual)
Study Completion Date
November 7, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colitis, Ulcerative
Keywords
ulcerative colitis, efficacy, safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
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
Masking
ParticipantInvestigator
Masking Description
Subject and investigator blinded via randomization
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LYS006
Arm Type
Experimental
Arm Description
Experimental drug
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo comparator
Intervention Type
Drug
Intervention Name(s)
LYS006
Intervention Description
capsule for oral use
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
capsule for oral use
Primary Outcome Measure Information:
Title
Clinical remission rate at the end of Week 8
Description
proportion of the patients who who achieve clinical remission after 8-week treatment. Clinical remission is defined as a full Mayo score of 2 points or lower, with no individual subscore exceeding one point.
Time Frame
Week 8
Secondary Outcome Measure Information:
Title
Number and severity of adverse events
Description
To assess safety and tolerability of LYS006 in patients with mild to moderate ulcerative colitis compared to placebo
Time Frame
Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Novartis Investigative Site
City
Sofia
ZIP/Postal Code
1612
Country
Bulgaria
Facility Name
Novartis Investigative Site
City
Praha 19
State/Province
Czech Republic
ZIP/Postal Code
19000
Country
Czechia
Facility Name
Novartis Investigative Site
City
Zlin
State/Province
Czech Republic
ZIP/Postal Code
762 75
Country
Czechia
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
10629
Country
Germany
Facility Name
Novartis Investigative Site
City
Nowy Targ
State/Province
Malopolskie
ZIP/Postal Code
34-400
Country
Poland
Facility Name
Novartis Investigative Site
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
00-728
Country
Poland
Facility Name
Novartis Investigative Site
City
Poznan
ZIP/Postal Code
60 529
Country
Poland
Facility Name
Novartis Investigative Site
City
Novosibirsk
ZIP/Postal Code
630007
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Kosice
ZIP/Postal Code
04013
Country
Slovakia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Learn more about this trial

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

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