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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04074590
Recruitment Status : Recruiting
First Posted : August 30, 2019
Last Update Posted : October 23, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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.

Condition or disease Intervention/treatment Phase
Colitis, Ulcerative Drug: LYS006 Drug: Placebo Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Double (Participant, Investigator)
Masking Description: Subject and investigator blinded via randomization
Primary Purpose: Treatment
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
Actual Study Start Date : February 3, 2020
Estimated Primary Completion Date : January 7, 2022
Estimated Study Completion Date : January 7, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LYS006
Experimental drug
Drug: LYS006
capsule for oral use

Placebo Comparator: Placebo
Placebo comparator
Drug: Placebo
capsule for oral use




Primary Outcome Measures :
  1. Clinical remission rate at the end of Week 8 [ Time Frame: Week 8 ]
    proportion of the patients who reach the status of clinical remission after 8-week treatment. Clinical remission is defined as the full Mayo score of 2 points or lower, with no individual subscore exceeding one point.


Secondary Outcome Measures :
  1. Number and severity of adverse events [ Time Frame: Week 8 ]
    To assess safety and tolerability of LYS006 in patients with mild to moderate ulcerative colitis compared to placebo



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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 physician's global assessment with a maximum of 1or 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 bloody stools per day and at least one of the following:
  • Oral temperature of >37.8°C
  • Hemoglobin of <10.5 g/dL
  • CRP > 30 mg/L
  • Erythrocyte sedimentation rate (ESR) > 33 mm/h
  • 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 screening endoscopy, or anti-IL12/23 blocking agents within 6 months prior to screening endoscopy
  • Any systemic immunosuppressant or immunomodulator, such as cyclosporine, methotrexate, azathioprine within 4 weeks and cyclophosphamide within 3 months, prior to screening endoscopy
  • A dose of > 10 mg/d prednisone or equivalent in the last 4 weeks prior to screening endoscopy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04074590


Contacts
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Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111

Locations
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United States, Illinois
Novartis Investigative Site Withdrawn
Downers Grove, Illinois, United States, 60515
United States, New York
Novartis Investigative Site Withdrawn
Brooklyn, New York, United States, 11221
Bulgaria
Novartis Investigative Site Recruiting
Sofia, Bulgaria, 1612
Czechia
Novartis Investigative Site Recruiting
Praha 19, Czech Republic, Czechia, 19000
Novartis Investigative Site Recruiting
Zlin, Czech Republic, Czechia, 762 75
Germany
Novartis Investigative Site Recruiting
Kiel, Schleswig- Holstein, Germany, 24105
Novartis Investigative Site Recruiting
Berlin, Germany, 10629
Hungary
Novartis Investigative Site Recruiting
Budapest, Hungary, 1085
Norway
Novartis Investigative Site Recruiting
Lorenskog, Oslo, Norway, 1478
Poland
Novartis Investigative Site Recruiting
Piotrkow Trybunalski, Poland, 97-300
Novartis Investigative Site Recruiting
Poznan, Poland, 60 529
Sponsors and Collaborators
Novartis Pharmaceuticals
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04074590    
Other Study ID Numbers: CLYS006X2202
First Posted: August 30, 2019    Key Record Dates
Last Update Posted: October 23, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
ulcerative colitis, efficacy, safety
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases