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

NCT04074590 | Terminated Phase 2 Results FDA Drug

• 2 other identifiers: CLYS006X22022019-003113-34
• Study Type: interventional
• Target: 23
• Locations: 6 countries
• Sites: 9

Brief Summary

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.

Conditions

Colitis, Ulcerative

Keywords

ulcerative colitis, efficacy, safety

Outcome Measures

Primary Outcomes (1)

• Clinical Remission Rate at the End of the Study Treatment

  The Mayo score is an instrument designed to measure activity of ulcerative colitis. The Mayo score comprises of four sub scores: stool frequency, rectal bleeding, endoscopic findings and the Physician's Global Assessment (PhGA). Each sub score is graded from 0 to 3 with higher scores indicating more severe disease. The full Mayo score is the sum of four sub scores, ranging from 0 to 12. Clinical remission is defined as a full Mayo score of 2 points or lower, with no individual subscore exceeding one point. The clinical remission rate is expressed as percentage of participants. The binary endpoint of clinical remission rate (Yes/No) at the EoT visit was modelled with binomial distribution and analyzed via the Bayesian approach with baseline total Mayo score and treatment group as explanatory variables, to compare the remission rates between the LYS006 and placebo groups.

  Week 8

Secondary Outcomes (1)

• Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 86 days.

Study Arms (2)

LYS006

EXPERIMENTAL

Experimental drug

Drug: LYS006

Placebo

PLACEBO COMPARATOR

Placebo comparator

Drug: Placebo

Interventions

LYS006 DRUG

capsule for oral use

LYS006

Placebo DRUG

capsule for oral use

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (9)

Novartis Investigative Site

Sofia, 1612, Bulgaria

Location

Novartis Investigative Site

Prague, Czech Republic, 19000, Czechia

Location

Novartis Investigative Site

Zlín, Czech Republic, 762 75, Czechia

Location

Novartis Investigative Site

Berlin, 10629, Germany

Location

Novartis Investigative Site

Nowy Targ, Lesser Poland Voivodeship, 34-400, Poland

Location

Novartis Investigative Site

Warsaw, Masovian Voivodeship, 00-728, Poland

Location

Novartis Investigative Site

Poznan, 60 529, Poland

Location

Novartis Investigative Site

Novosibirsk, 630007, Russia

Location

Novartis Investigative Site

Košice, 04013, Slovakia

Location

Related Links

• Patient Lay Trial Summary

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

novartis.email@novartis.com

+ 1 862 778 8300

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Subject and investigator blinded via randomization
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: August 29, 2019
• First Posted: August 30, 2019
• Study Start: February 3, 2020
• Primary Completion: November 7, 2022
• Study Completion: November 7, 2022
• Last Updated: June 20, 2024
• Results First Posted: November 9, 2023

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share

Locations

BU (1); PL (3); RU (1); SL (1); CZ (2); DE (1)