Colitis, UlcerativePhase 2NCT02762500
An Efficacy and Safety Study of LYC-30937-EC in Subjects With Active Ulcerative Colitis
A Phase 2 study testing LYC-30937-EC in people with Colitis, Ulcerative, run by Lycera Corp. at 71 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colitis, Ulcerative
- What is being tested?
- LYC-30937-EC
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 71 sitesin 7 countries
- Study dates
- Jul 2016to May 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 19Show fewer
- 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.
Trial locations and contacts
71 sites in 7 countries.
71 sites in 7 countries
United States26 sites
Lycera Investigational Site
Ann Arbor, Michigan, 48109
Lycera Investigational Site
Baton Rouge, Louisiana, 70809
Lycera Investigational Site
Brooklyn, New York, 11230
Lycera Investigational Site
Chicago, Illinois, 60637
Lycera Investigational Site
Decatur, Georgia, 30033
Lycera Investigational Site
Flourtown, Pennsylvania, 19031
Lycera Investigational Site
Greenville, North Carolina, 27834
Lycera Investigational Site
Hollywood, Florida, 33021
Lycera Investigational Site.
Houston, Texas, 76092
Lycera Investigational Sites
Houston, Texas, 77004
Lycera Investigational Site
Houston, Texas, 77004
Lycera Investigational Site
Houston, Texas, 77030
Lycera Investigational Site
Little Rock, Arkansas, 72212
Lycera Investigational Site
Long Beach, California, 90822
Lycera Investigational Site
Louisville, Kentucky, 40202
Lycera Investigational Site
Marietta, Georgia, 30060
Lycera Investigational Site
Miami, Florida, 33176
Lycera Investigational Site
Mission Hills, California, 91345
Lycera Investigational Site
Nashville, Tennessee, 37212
Lycera Investigational Site
New York, New York, 10024
Lycera Investigational Site
Philadelphia, Pennsylvania, 19104
Lycera Investigational Site
Rialto, California, 92377
Lycera Investigational Site
San Antonio, Texas, 78229
Lycera Investigational Site
Sayre, Pennsylvania, 18840
Lycera Investigational Site
The Bronx, New York, 10461
Lycera Investigational Site
Union City, Tennessee, 38261
Poland26 sites
Lycera Investigational Site
Bydgoszcz, 85-168
Lycera Investigational Site
Bydgoszcz, 85-681
Lycera Investigational Site
Katowice, 40-211
Lycera Investigational Site
Katowice, 40-659
Lycera Investigational Site
Katowice, 40-752
Lycera Investigational Site
Kielce, 25 364
Lycera Investigational Site
Krakow, 30-415
Lycera Investigational Site
Krakow, 31-009
Lycera Investigational Site
Ksawerów, 95-054
Lycera Investigational Site
Lodz, 93-034
Lycera Investigational Site
Lublin, 20-008
Lycera Investigational Site
Lublin, 20-362
Lycera Investigational Site
Nowa Sól, 67-100
Lycera Investigational Site
Piaseczno, 05-500
Lycera Investigational Site
Poznan, 61-113
Lycera Investigational Site
Skierniewice, 96-100
Lycera Investigational Site
Sopot, 81-756
Lycera Investigational Site
Staszów, 28-200
Lycera Investigational Site
Szczecin, 71-270
Lycera Investigational Site
Warsaw, 02-507
Lycera Investigational Site
Warsaw, 04-749
Lycera Investigational Site
Włocławek, 87-800
Lycera Investigational Site
Wroclaw, 50-053
Lycera Investigational Site
Wroclaw, 50-449
Lycera Investigational Site
Wroclaw, 53-333
Lycera Investigational Site
Wroclaw, 54-144
Serbia6 sites
Lycera Investigational Site
Belgrade, 11000
Lycera Investigational Site
Belgrade, 11080
Lycera Investigational Site
Kragujevac, 34000
Lycera Investigational Site
Niš, 18000
Lycera Investigational Site
Subotica, 24000
Lycera Investigational Site
Zrenjanin, 23000
Hungary5 sites
Lycera Investigational Site
Budapest, 1088
Lycera Investigational Site
Budapest, 1125
Lycera Investigational Site
Debrecen, 4031
Lycera Investigational Site
Debrecen, 4032
Lycera Investigational Site
Hatvan, 3000
Czechia4 sites
Lycera Investigational Site
Ostrava, 722 00
Lycera Investigational Site
Prague, 130 00
Lycera Investigational Site
Slaný, 274 01
Lycera Investigational Site
Ústí nad Labem, 401 13
Canada2 sites
Lycera Investigational Site
Toronto, Ontario, M5G 1X5
Lycera Investigational Site
Victoria, British Columbia, V8V 3M9
Netherlands2 sites
Lycera Investigational Site
Amsterdam, 1081 HZ
Lycera Investigational Site
Rotterdam, 3015 CE
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Colitis, Ulcerative
- Being tested
- LYC-30937-EC, Placebo
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LYC-30937-ECDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| LYC-30937-EC 25 mg PO QD | Experimental | LYC-30937-EC 25 mg by mouth once daily for 8 weeks Receives: Drug: LYC-30937-EC |
| Placebo PO QD | Placebo comparator | Matching placebo by mouth once daily for 8 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (5)
Number of Subjects Who Achieve Clinical Remission at Week 8 Using the Total Mayo Score.
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.
Measured: 8 weeks
Number of Subjects With a Clinical Response on the Modified Mayo Score at Week 8.
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.
Measured: 8 weeks
Number of Subjects With a Clinical Response on the Total Mayo Score at 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.
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.
Measured: 8 weeks
Percent Change From Baseline to Week 8 in Fecal Calprotectin in Subjects With Baseline Fecal Calprotectin ≥ 250 µg/g
Fecal calprotectin is an indicator of inflammation in the colon with higher levels indicative of higher levels of inflammation.
Measured: Baseline to Week 8
Percent Change From Baseline in Total Mayo Score at 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.
Measured: Baseline to Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2016 (estimated)
- Study startJul 2016
- Primary completionMay 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Colitis, UlcerativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lycera Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- H. Jeffrey Wilkins, MD, Study director, Lycera Corp.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02762500
- Sponsor's protocol ID
- LYC-30937-2001
- Other IDs
- 2016-000518-31, 2016
- Status last verified
- Mar 2019
- First submitted
- 3 May 2016
- Last updated
- 2 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02762500
- Acronym / sponsor ID
- LYC-30937-2001
- Conditions
- Colitis, Ulcerative
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Lycera Corp.Industry (pharma, biotech, devices)
- Study start
- Jul 2016
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 5 May 2016 (estimated)
- Results
- Posted 2 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LYC-30937-EC 25 mg PO QD | Experimental | Drug: LYC-30937-ECLYC-30937-EC 25 mg by mouth once daily for 8 weeks |
| Placebo PO QD | Placebo comparator | Drug: PlaceboMatching placebo by mouth once daily for 8 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LYC-30937-EC | Drug | LYC-30937-EC 25 mg PO QD |
| Placebo | Drug | Placebo PO QD |
Primary outcome
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.
5 secondary outcomes
Number of Subjects Who Achieve Clinical Remission at Week 8 Using the Total Mayo Score.
Time frame: 8 weeks
Number of Subjects With a Clinical Response on the Modified Mayo Score at Week 8.
Time frame: 8 weeks
Number of Subjects With a Clinical Response on the Total Mayo Score at Week 8.
Time frame: 8 weeks
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
Percent Change From Baseline in Total Mayo Score at Week 8.
Time frame: Baseline to Week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
H. Jeffrey Wilkins, MD study director
Lycera Corp.
71 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LYC-30937-EC in people with Colitis, Ulcerative, run by Lycera Corp. at 71 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 71 sites in United States, Poland, Serbia, Hungary, Czechia and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects Who Achieve Clinical Remission at Week 8 Using Modified Mayo Score. (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2019.