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An Efficacy and Safety Study of LYC-30937-EC in Subjects With Active 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02762500
Recruitment Status : Completed
First Posted : May 5, 2016
Results First Posted : April 2, 2019
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
Lycera Corp.

Tracking Information
First Submitted Date  ICMJE May 3, 2016
First Posted Date  ICMJE May 5, 2016
Results First Submitted Date  ICMJE January 29, 2019
Results First Posted Date  ICMJE April 2, 2019
Last Update Posted Date April 2, 2019
Study Start Date  ICMJE July 2016
Actual Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 11, 2019)
Number of Subjects Who Achieve Clinical Remission at Week 8 Using Modified Mayo Score. [ Time Frame: 8 weeks ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 3, 2016)
Proportion of subjects who achieve clinical remission at Week 8 using modified Mayo score (MMS). Clinical remission is defined as Mayo stool frequency score of ≤1, a Mayo rectal bleeding score of 0 and Mayo endoscopy score of ≤ 1. [ Time Frame: 8 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 11, 2019)
  • Number of Subjects Who Achieve Clinical Remission at Week 8 Using the Total Mayo Score. [ Time Frame: 8 weeks ]
    The total Mayo score is a tool designed to measure disease activity for ulcerative colitis. Scoring ranges from 0 to 12 points and consists of 4 subscores (stool frequency, rectal bleeding, endoscopy, physicians global assessment), each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopy scoring was performed centrally. Clinical remission on the total Mayo Score is defined as a total Mayo score of ≤ 2, with no individual subscore > 1.
  • Number of Subjects With a Clinical Response on the Modified Mayo Score at Week 8. [ Time Frame: 8 weeks ]
    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 response on the modified Mayo score at Week 8 was defined as a reduction from the baseline modified Mayo score of ≥ 2 points and ≥ 25%, and a decrease from baseline in rectal bleeding score of ≥ 1 point or absolute rectal bleeding score of ≤ 1 point.
  • Number of Subjects With a Clinical Response on the Total Mayo Score at Week 8. [ Time Frame: 8 weeks ]
    The total Mayo score is a tool designed to measure disease activity for ulcerative colitis. Scoring ranges from 0 to 12 points and consists of 4 subscores (stool frequency, rectal bleeding, endoscopy, physicians global assessment), each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopy scoring was performed centrally. Clinical response on the total Mayo score at Week 8 was defined as a reduction from baseline total Mayo score of ≥ 3 points and ≥ 30%, and a decrease from baseline in rectal bleeding score of ≥ 1 point or absolute rectal bleeding score of ≤ 1 point.
  • Percent Change From Baseline to Week 8 in Fecal Calprotectin in Subjects With Baseline Fecal Calprotectin ≥ 250 µg/g [ Time Frame: Baseline to Week 8 ]
    Fecal calprotectin is an indicator of inflammation in the colon with higher levels indicative of higher levels of inflammation.
  • Percent Change From Baseline in Total Mayo Score at Week 8. [ Time Frame: Baseline to Week 8 ]
    Analyzes the change in total Mayo score score between baseline and Week 8 for all randomized subjects who had total Mayo score scores at both baseline and Week 8. The total Mayo score is a tool designed to measure disease activity for ulcerative colitis. Scoring ranges from 0 to 12 points and consists of 4 subscores (stool frequency, rectal bleeding, endoscopy, physicians global assessment), each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopy scoring was performed centrally.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 3, 2016)
  • Proportion of subjects who achieve clinical remission at Week 8 using TMS. Clinical remission is defined as Mayo score of ≤ 2, with no individual score >1. [ Time Frame: 8 weeks ]
  • Proportion of subjects with a clinical response at Week 8, defined as a reduction from baseline MMS of ≥ 2 points and ≥ 25%, and a decrease from baseline in rectal bleeding score of ≥ 1 point or absolute rectal bleeding score of ≤ 1 point. [ Time Frame: 8 weeks ]
  • Proportion of subjects with a clinical response at Week 8, defined as a reduction from baseline TMS of ≥ 3 points and ≥ 30%, and a decrease from baseline in rectal bleeding score of ≥ 1 point or absolute rectal bleeding score of ≤ 1 point. [ Time Frame: 8 weeks ]
  • Change from baseline to Week 8 in fecal calprotectin [ Time Frame: 8 weeks ]
Current Other Pre-specified Outcome Measures
 (submitted: March 11, 2019)
Number of Subjects With Type of Adverse Events (AEs) Serious Adverse Events (SAEs) and AEs That Led to Discontinuation of Treatment. [ Time Frame: 10 weeks ]
Adverse events (AEs) were collected from the time a subject signed the informed consent. Treatment-emergent adverse events (TEAEs) are AEs occurring or worsening after the first dose of study drug (LYC-30937-EC 25 mg or placebo). Adverse event severity was assessed by the Investigator using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v 4.03, with grading as follows: Grade 1 = mild (asymptomatic or mild symptoms), Grade 2 = moderate (minimal, local intervention, or noninvasive intervention indicated); Grade 3 = severe (or medically significant but not life-threatening); Grade 4 = life-threatening; Grade 5 = death.
Original Other Pre-specified Outcome Measures
 (submitted: May 3, 2016)
Incidence and type of adverse events (AEs) serious adverse events (SAEs) and AEs that led to discontinuation of treatment. [ Time Frame: 10 weeks ]
 
Descriptive Information
Brief Title  ICMJE An Efficacy and Safety Study of LYC-30937-EC in Subjects With Active Ulcerative Colitis
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled Parallel Group Study to Assess the Efficacy and Safety of Induction Therapy With LYC-30937-EC in Subjects With Active Ulcerative Colitis
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.
Detailed Description

Approximately 120 subjects will be randomized to receive either enteric-coated (EC) LYC-30937-EC 25 mg PO once daily (QD) or matching placebo PO QD for the duration of 8 weeks. Randomization will be stratified based on previous exposure to anti-tumor necrosis factor (TNF) agents such that at least 50% of the randomized subjects will be anti-TNF naïve .

The study will consist of 3 phases:

  • screening phase: up to 4 weeks
  • double-blind placebo-controlled phase treatment: 8 weeks
  • post-treatment follow-up: 2 weeks

Eligible subjects will be randomized at Week 0 (Study Day 1) to either LYC-30937-EC 25 mg or placebo. Screening will occur from Study Days -28 to -1. Randomization and first dosing will occur at Week 0/Study Day 1. Double-blind study visits will occur at Weeks 2, 4, and 8, with the last dose at Week 8/Study Day 57. Subjects will return at Week 10 for a post-treatment safety follow-up visit.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Colitis, Ulcerative
Intervention  ICMJE
  • Drug: LYC-30937-EC
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: LYC-30937-EC 25 mg PO QD
    LYC-30937-EC 25 mg by mouth once daily for 8 weeks
    Intervention: Drug: LYC-30937-EC
  • Placebo Comparator: Placebo PO QD
    Matching placebo by mouth once daily for 8 weeks
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 14, 2018)
124
Original Estimated Enrollment  ICMJE
 (submitted: May 3, 2016)
120
Actual Study Completion Date  ICMJE May 2018
Actual Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • Previous exposure to ≥ 2 approved or investigational biologic agents to treat UC.
  • History of UC treatment with a biologic agent within 12 weeks of screening.
  • Treatment with rectal steroids within 2 weeks of screening.
  • Treatment with an investigational agent within 30 days of screening.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Czechia,   Hungary,   Netherlands,   Poland,   Serbia,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT02762500
Other Study ID Numbers  ICMJE LYC-30937-2001
2016-000518-31 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Lycera Corp.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Lycera Corp.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: H. Jeffrey Wilkins, MD Lycera Corp.
PRS Account Lycera Corp.
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP