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

NCT02762500 | Completed Phase 2 Results DMC

• 2 other identifiers: LYC-30937-20012016-000518-31
• Study Type: interventional
• Target: 124
• Locations: 7 countries
• Sites: 71

Brief Summary

The purpose of the study is to evaluate the efficacy and safety of LYC-30937-EC given orally once daily in subjects with active ulcerative colitis (UC) defined as a total Mayo score (TMS) of 4-11 inclusive, with an endoscopic score of ≥ 2 and a rectal bleeding score of ≥ 1 at screening.

Conditions

Colitis, Ulcerative

Outcome Measures

Primary Outcomes (1)

• Number of Subjects Who Achieve Clinical Remission at Week 8 Using Modified Mayo Score.

  The modified Mayo score is a tool designed to measure disease activity for ulcerative colitis. Scoring ranges from 0 to 9 points and consists of 3 subscores (stool frequency, rectal bleeding, endoscopy), each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopy scoring was performed centrally. Clinical remission on the modified Mayo score was defined as a Mayo stool frequency subscore of ≤ 1, Mayo rectal bleeding subscore of 0 and a Mayo endoscopy subscore of ≤ 1.

  8 weeks

Secondary Outcomes (5)

• Number of Subjects Who Achieve Clinical Remission at Week 8 Using the Total Mayo Score.

  8 weeks

• Number of Subjects With a Clinical Response on the Modified Mayo Score at Week 8.

  8 weeks

• Number of Subjects With a Clinical Response on the Total Mayo Score at Week 8.

  8 weeks

• Percent Change From Baseline to Week 8 in Fecal Calprotectin in Subjects With Baseline Fecal Calprotectin ≥ 250 µg/g

  Baseline to Week 8

• Percent Change From Baseline in Total Mayo Score at Week 8.

  Baseline to Week 8

Other Outcomes (1)

• Number of Subjects With Type of Adverse Events (AEs) Serious Adverse Events (SAEs) and AEs That Led to Discontinuation of Treatment.

  10 weeks

Study Arms (2)

LYC-30937-EC 25 mg PO QD

EXPERIMENTAL

LYC-30937-EC 25 mg by mouth once daily for 8 weeks

Drug: LYC-30937-EC

Placebo PO QD

PLACEBO COMPARATOR

Matching placebo by mouth once daily for 8 weeks

Drug: Placebo

Interventions

LYC-30937-EC DRUG

LYC-30937-EC 25 mg PO QD

Placebo DRUG

Placebo PO QD

Eligibility Criteria

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

You may qualify if:

• Clinical UC diagnosis ≥ 6 months prior to screening with minimum disease extent of ≥ 15cm from anal verge.
• Active UC defined as a TMS of 4-11 (inclusive) with endoscopic subscore of ≥ 2 and rectal bleeding subscore of ≥ 1 at screening.
• Females of childbearing potential must have a negative pregnancy test at screening and baseline visits and must agree to use acceptable methods of birth control while in the trial and for 30 days after taking the last dose of study drug.
• May be currently receiving treatment with oral aminosalicylates (ASA) for ≥ 6 weeks at a stable dose for ≥ 3 weeks prior to the screening screening endoscopy and/or thiopurine at a stable dose ≥ 8 weeks prior to the screening endoscopy and/or prednisone (dose 20 mg daily) or equivalent for ≥ 4 weeks and receiving stable dose for ≥ 2 weeks prior to screening endoscopy
• able to provide written informed consent and be compliant with study procedures.

You may not qualify if:

• History of Crohn's disease (CD) or indeterminate colitis or the presence or history of fistula consistent with CD.
• Presence of colon polyps.
• Severe extensive disease that in the investigators discretion is likely to require colonic surgery during the 8 week double-blind portion of the trial (eg, fulminant colitis, toxic megacolon, bowel perforation, evidence of acute abdomen).
• History of alcohol or drug abuse within 1 year of randomization.
• History of cancer including solid tumors and hematological malignancies (except basal cell and in situ squamous cell carcinomas of the skin that have been adequately treated with no recurrence for ≥ 1 year prior to screening.
• History or currently active primary or secondary immunodeficiency.
• Clinically relevant hepatic, neurologic, pulmonary, ophthalmological, gastrointestinal, endocrine, psychiatric, or other major systemic disease making implementation of the study difficult or that would put the subject at risk by participating in the study
• Positive test for Clostridium difficile or positive stool culture for enteric pathogens or presence of ova or parasites at screening.
• Liver function tests \> 1.5 x upper limit of normal (ULN) or direct bilirubin \> 1.5 x ULN
• Hemoglobin \< 8.5 g/dl
• Neutrophils \< 1500/mm3
• White blood cell (WBC) count \< 3000/mm3
• Platelets \< 80000 mm3
• International normalized ratio (INR) \> 1.5
• Treatment with an immunosuppressant agent within 8 weeks of screening.

Sponsors & Collaborators

• Lycera Corp.: lead

Study Sites (71)

Lycera Investigational Site

Little Rock, Arkansas, 72212, United States

Location

Lycera Investigational Site

Long Beach, California, 90822, United States

Location

Lycera Investigational Site

Mission Hills, California, 91345, United States

Location

Lycera Investigational Site

Rialto, California, 92377, United States

Location

Lycera Investigational Site

Hollywood, Florida, 33021, United States

Location

Lycera Investigational Site

Miami, Florida, 33176, United States

Location

Lycera Investigational Site

Decatur, Georgia, 30033, United States

Location

Lycera Investigational Site

Marietta, Georgia, 30060, United States

Location

Lycera Investigational Site

Chicago, Illinois, 60637, United States

Location

Lycera Investigational Site

Louisville, Kentucky, 40202, United States

Location

Lycera Investigational Site

Baton Rouge, Louisiana, 70809, United States

Location

Lycera Investigational Site

Ann Arbor, Michigan, 48109, United States

Location

Lycera Investigational Site

Brooklyn, New York, 11230, United States

Location

Lycera Investigational Site

New York, New York, 10024, United States

Location

Lycera Investigational Site

The Bronx, New York, 10461, United States

Location

Lycera Investigational Site

Greenville, North Carolina, 27834, United States

Location

Lycera Investigational Site

Flourtown, Pennsylvania, 19031, United States

Location

Lycera Investigational Site

Philadelphia, Pennsylvania, 19104, United States

Location

Lycera Investigational Site

Sayre, Pennsylvania, 18840, United States

Location

Lycera Investigational Site

Nashville, Tennessee, 37212, United States

Location

Lycera Investigational Site

Union City, Tennessee, 38261, United States

Location

Lycera Investigational Site.

Houston, Texas, 76092, United States

Location

Lycera Investigational Sites

Houston, Texas, 77004, United States

Location

Lycera Investigational Site

Houston, Texas, 77004, United States

Location

Lycera Investigational Site

Houston, Texas, 77030, United States

Location

Lycera Investigational Site

San Antonio, Texas, 78229, United States

Location

Lycera Investigational Site

Victoria, British Columbia, V8V 3M9, Canada

Location

Lycera Investigational Site

Toronto, Ontario, M5G 1X5, Canada

Location

Lycera Investigational Site

Ostrava, 722 00, Czechia

Location

Lycera Investigational Site

Prague, 130 00, Czechia

Location

Lycera Investigational Site

Slaný, 274 01, Czechia

Location

Lycera Investigational Site

Ústí nad Labem, 401 13, Czechia

Location

Lycera Investigational Site

Budapest, 1088, Hungary

Location

Lycera Investigational Site

Budapest, 1125, Hungary

Location

Lycera Investigational Site

Debrecen, 4031, Hungary

Location

Lycera Investigational Site

Debrecen, 4032, Hungary

Location

Lycera Investigational Site

Hatvan, 3000, Hungary

Location

Lycera Investigational Site

Amsterdam, 1081 HZ, Netherlands

Location

Lycera Investigational Site

Rotterdam, 3015 CE, Netherlands

Location

Lycera Investigational Site

Bydgoszcz, 85-168, Poland

Location

Lycera Investigational Site

Bydgoszcz, 85-681, Poland

Location

Lycera Investigational Site

Katowice, 40-211, Poland

Location

Lycera Investigational Site

Katowice, 40-659, Poland

Location

Lycera Investigational Site

Katowice, 40-752, Poland

Location

Lycera Investigational Site

Kielce, 25 364, Poland

Location

Lycera Investigational Site

Krakow, 30-415, Poland

Location

Lycera Investigational Site

Krakow, 31-009, Poland

Location

Lycera Investigational Site

Ksawerów, 95-054, Poland

Location

Lycera Investigational Site

Lodz, 93-034, Poland

Location

Lycera Investigational Site

Lublin, 20-008, Poland

Location

Lycera Investigational Site

Lublin, 20-362, Poland

Location

Lycera Investigational Site

Nowa Sól, 67-100, Poland

Location

Lycera Investigational Site

Piaseczno, 05-500, Poland

Location

Lycera Investigational Site

Poznan, 61-113, Poland

Location

Lycera Investigational Site

Skierniewice, 96-100, Poland

Location

Lycera Investigational Site

Sopot, 81-756, Poland

Location

Lycera Investigational Site

Staszów, 28-200, Poland

Location

Lycera Investigational Site

Szczecin, 71-270, Poland

Location

Lycera Investigational Site

Warsaw, 02-507, Poland

Location

Lycera Investigational Site

Warsaw, 04-749, Poland

Location

Lycera Investigational Site

Wroclaw, 50-053, Poland

Location

Lycera Investigational Site

Wroclaw, 50-449, Poland

Location

Lycera Investigational Site

Wroclaw, 53-333, Poland

Location

Lycera Investigational Site

Wroclaw, 54-144, Poland

Location

Lycera Investigational Site

Włocławek, 87-800, Poland

Location

Lycera Investigational Site

Belgrade, 11000, Serbia

Location

Lycera Investigational Site

Belgrade, 11080, Serbia

Location

Lycera Investigational Site

Kragujevac, 34000, Serbia

Location

Lycera Investigational Site

Niš, 18000, Serbia

Location

Lycera Investigational Site

Subotica, 24000, Serbia

Location

Lycera Investigational Site

Zrenjanin, 23000, Serbia

Location

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: H. Jeffrey Wilkins, MD, Chief Medical Officer
• Organization: Lycera Corp.

wilkins@lycera.com

484-243-6222

Study Officials

• H. Jeffrey Wilkins, MD

  Lycera Corp.

  STUDY DIRECTOR

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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2016
• First Posted: May 5, 2016
• Study Start: July 1, 2016
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: April 2, 2019
• Results First Posted: April 2, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (6); CZ (4); CA (2); HU (5); PL (26); US (26); NL (2)