Colitis, UlcerativePhase 2NCT02764229
Open-label Extension Study to Assess Safety and Tolerability 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 40 sites in 6 countries.
Trial summary
The purpose of this study is to allow subjects completing study LYC-30937-2001 the opportunity to receive LYC-30937-EC 25 mg. 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?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 40 sitesin 6 countries
- Study dates
- 1 Nov 2016to 18 Jul 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
- Completed the 8-week double-blind treatment period of study LYC-30937-2001
- Male and females of childbearing potential must agree to use adequate birth control during the study and for 30 days after discontinuing study drug
- Non-pregnant, non-lactating females who are not planning to become pregnant while enrolled in this study
- Investigator considers it safe and potentially beneficial to participate
- Ability to provide written informed consent and to be compliant with study schedule
Who cannot join
- Subjects who completed study LYC-30937-2001, but who experienced a serious adverse event that was considered related to investigational product, has an unstable medical condition, or for any other reason in the opinion of the investigator should not participate in this study
Trial locations and contacts
40 sites in 6 countries.
40 sites in 6 countries
Poland20 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, 25-355
Lycera Investigational Site
Krakow, 31-009
Lycera Investigational Site
Lublin, 20-362
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, 50-449
Lycera Investigational Site
Wroclaw, 53-333
Lycera Investigational Site
Wroclaw
United States9 sites
Lycera Investigational Site
Ann Arbor, Michigan, 48109
Lycera Investigational Site
Chicago, Illinois, 60637
Lycera investigational site
Greenville, North Carolina, 27834
Lycera Investigational Site
Houston, Texas, 77030
Lycera Investigational Site
Little Rock, Arkansas, 72212
Lycera Investigational Site
Miami, Florida, 33176
Lycera Investigational Site
Mission Hills, California, 91345
Lycera Investigational Site
Nashville, Tennessee, 37212
Lycera investigational site
San Antonio, Texas, 78229
Serbia5 sites
Lycera Investigational Site
Belgrade, 11000
Lycera Investigational Site
Kragujevac, 34000
Lycera Investigational Site
Niš, 18000
Lycera Investigational Site
Subotica, 24000
Lycera Investigational Site
Zrenjanin, 23000
Czechia3 sites
Lycera Investigational Site
Ostrava, 722 00
Lycera Investigational Site
Prague, 130 00
Lycera Investigational Site
Ústí nad Labem, 401 13
Hungary2 sites
Lycera Investigational Site
Budapest, 1088
Lycera Investigational Site
Budapest, 1125
About this study
Official title: A Multicenter Open-label Extension Study to Assess the Safety and Tolerability of LYC-30937-EC in Subjects With Active Ulcerative Colitis
The purpose of this study is to allow subjects completing study LYC-30937-2001 the opportunity to receive LYC-30937-EC 25 mg.
Read the detailed description
Subjects who complete the 8 week treatment period of the double-blind, placebo-controlled study LYC-30937-2001 will have the option of receiving LYC-30397-EC 25 mg PO QD in this open-label extension study (LYC-30937-2002). Subjects meeting eligibility criteria will enter this open-label extension trial upon completion of the LYC-30937-2001 Week 8 study procedures. This open-label extension study will consist of 44 weeks of treatment followed by a 2 weeks post-treatment follow-up.
- Conditions
- Colitis, Ulcerative
- Being tested
- LYC-30937-EC
- 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
LYC-30937-EC 25 mg by mouth once daily
| Study group | Role | What they receive |
|---|---|---|
| LYC-30937-EC | Experimental | LYC-30937-EC 25 mg by mouth once daily Receives: Drug: LYC-30937-EC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Types of Adverse Events (AEs), Serious Adverse Events and AEs That Led to Discontinuation of Treatment
Adverse events (AEs) were collected from the time a subject signed the informed consent and completed participation in the preceding double-blind trial LYC-30937-2001. Treatment-emergent adverse events (TEAEs) are AEs occurring or worsening after the first dose of study drug (LYC-30937-EC 25 mg). 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.
Measured: 46 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2016 (estimated)
- Study start1 Nov 2016
- Primary completion18 Jul 2018
- Study completion18 Jul 2018
Why it stopped: Lack of efficacy of test drug
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 112 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
- NCT02764229
- Sponsor's protocol ID
- LYC-30937-2002
- Other IDs
- 2016-003633-26, 2016
- Status last verified
- Mar 2019
- First submitted
- 4 May 2016
- Last updated
- 27 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Open-label Extension Study to Assess the Safety and Tolerability of LYC-30937-EC in Subjects With Active Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT02764229
- Acronym / sponsor ID
- LYC-30937-2002
- Conditions
- Colitis, Ulcerative
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of efficacy of test drug
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Lycera Corp.Industry (pharma, biotech, devices)
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 18 Jul 2018 (actual)
- Study completion
- 18 Jul 2018 (actual)
- First posted
- 6 May 2016 (estimated)
- Results
- Posted 27 Mar 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 this study is to allow subjects completing study LYC-30937-2001 the opportunity to receive LYC-30937-EC 25 mg.
Detailed description
Subjects who complete the 8 week treatment period of the double-blind, placebo-controlled study LYC-30937-2001 will have the option of receiving LYC-30397-EC 25 mg PO QD in this open-label extension study (LYC-30937-2002). Subjects meeting eligibility criteria will enter this open-label extension trial upon completion of the LYC-30937-2001 Week 8 study procedures. This open-label extension study will consist of 44 weeks of treatment followed by a 2 weeks post-treatment follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LYC-30937-EC | Experimental | Drug: LYC-30937-ECLYC-30937-EC 25 mg by mouth once daily |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Completed the 8-week double-blind treatment period of study LYC-30937-2001
- Male and females of childbearing potential must agree to use adequate birth control during the study and for 30 days after discontinuing study drug
- Non-pregnant, non-lactating females who are not planning to become pregnant while enrolled in this study
- Investigator considers it safe and potentially beneficial to participate
- Ability to provide written informed consent and to be compliant with study schedule
Key exclusion criteria (1 listed)
- Subjects who completed study LYC-30937-2001, but who experienced a serious adverse event that was considered related to investigational product, has an unstable medical condition, or for any other reason in the opinion of the investigator should not participate in this study
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-ECLYC-30937-EC 25 mg by mouth once daily | Drug | LYC-30937-EC |
Primary outcome
Number of Subjects With Types of Adverse Events (AEs), Serious Adverse Events and AEs That Led to Discontinuation of Treatment
Time frame: 46 weeks
Adverse events (AEs) were collected from the time a subject signed the informed consent and completed participation in the preceding double-blind trial LYC-30937-2001. Treatment-emergent adverse events (TEAEs) are AEs occurring or worsening after the first dose of study drug (LYC-30937-EC 25 mg). 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 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.
40 sites in 6 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 40 sites in 6 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 1 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: stopped early, as of the sponsor's last update on 27 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in Poland, United States, Serbia, Czechia, Hungary and 1 more country. 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. 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 27 Mar 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 With Types of Adverse Events (AEs), Serious Adverse Events and AEs That Led to Discontinuation of Treatment (time frame: 46 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 27 Mar 2019.