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

• Sponsor: Novartis Pharmaceuticals (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04074590
• Collaborator: (none)
• Enrollment: 45
• Locations: 23
• Arms: 2
• Anticipated Duration (Months): 33.6
• Patients Per Site: 2
• Patients Per Site Per Month: 0.1

Study Details

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.

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

Study Design

• Study Type: Interventional
• Anticipated 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 placeboThis 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: Feb 3, 2020
• Anticipated Primary Completion Date: Nov 23, 2022
• Anticipated Study Completion Date: Nov 23, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LYS006 Experimental drug	Drug: LYS006; capsule for oral use
Placebo Comparator: Placebo Placebo comparator	Drug: Placebo; capsule for oral use

Outcome Measures

Primary Outcome Measures

1. Clinical remission rate at the end of Week 8 [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

1. Number and severity of adverse events [Week 8]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigative Site	Downers Grove	Illinois	United States	60515
2	Novartis Investigative Site	Brooklyn	New York	United States	11221
3	Novartis Investigative Site	Sofia		Bulgaria	1612
4	Novartis Investigative Site	Praha 19	Czech Republic	Czechia	19000
5	Novartis Investigative Site	Zlin	Czech Republic	Czechia	762 75
6	Novartis Investigative Site	Havirov		Czechia	73601
7	Novartis Investigative Site	Kiel	Schleswig- Holstein	Germany	24105
8	Novartis Investigative Site	Berlin		Germany	10629
9	Novartis Investigative Site	Budapest		Hungary	1085
10	Novartis Investigative Site	Lorenskog	Oslo	Norway	1478
11	Novartis Investigative Site	Nowy Targ	Malopolskie	Poland	34-400
12	Novartis Investigative Site	Warszawa	Mazowieckie	Poland	00-728
13	Novartis Investigative Site	Piotrkow Trybunalski		Poland	97-300
14	Novartis Investigative Site	Poznan		Poland	60 529
15	Novartis Investigative Site	Novosibirsk		Russian Federation	630007
16	Novartis Investigative Site	St Petersburg		Russian Federation	191014
17	Novartis Investigative Site	Tomsk		Russian Federation	634063
18	Novartis Investigative Site	Velikiy Novgorod		Russian Federation	173008
19	Novartis Investigative Site	Yekaterinburg		Russian Federation	620109
20	Novartis Investigative Site	Bardejov		Slovakia	08501
21	Novartis Investigative Site	Kosice		Slovakia	04013
22	Novartis Investigative Site	Presov		Slovakia	08001
23	Novartis Investigative Site	Glasgow		United Kingdom	G51 4TF

Sponsors and Collaborators

• Novartis Pharmaceuticals

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT04074590
• Other Study ID Numbers: CLYS006X2202; 2019-003113-34
• First Posted: Aug 30, 2019
• Last Update Posted: Aug 24, 2022
• Last Verified: Aug 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Novartis Pharmaceuticals: ulcerative colitis, efficacy, safety
• Additional relevant MeSH terms: Colitis; Colitis, Ulcerative; Ulcer

Study Results

No Results Posted as of Aug 24, 2022