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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-003633-26 | EudraCT Number |
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Lack of efficacy of test drug
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The purpose of this study is to allow subjects completing study LYC-30937-2001 the opportunity to receive LYC-30937-EC 25 mg.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LYC-30937-EC | Experimental | LYC-30937-EC 25 mg by mouth once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LYC-30937-EC | Drug | LYC-30937-EC 25 mg by mouth once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 46 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| H. Jeffrey Wilkins, MD | Lycera Corp. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lycera Investigational Site | Little Rock | Arkansas | 72212 | United States | ||
| Lycera Investigational Site |
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Eligible subjects were those completing the preceding double-blind study LYC-30937-2001 Week 8 visit.
Participants were enrolled at 40 study centers with the United States, Poland, Hungary, Czech Republic, Serbia and Netherlands. Study centers included academic medical centers and non-academic medical clinics.
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| ID | Title | Description |
|---|---|---|
| FG000 | LYC-30937-EC | LYC-30937-EC 25 mg by mouth once daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 22, 2016 |
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| Mission Hills |
| California |
| 91345 |
| United States |
| Lycera Investigational Site | Miami | Florida | 33176 | United States |
| Lycera Investigational Site | Chicago | Illinois | 60637 | United States |
| Lycera Investigational Site | Ann Arbor | Michigan | 48109 | United States |
| Lycera investigational site | Greenville | North Carolina | 27834 | United States |
| Lycera Investigational Site | Nashville | Tennessee | 37212 | United States |
| Lycera Investigational Site | Houston | Texas | 77030 | United States |
| Lycera investigational site | San Antonio | Texas | 78229 | United States |
| Lycera Investigational Site | Ostrava | 722 00 | Czechia |
| Lycera Investigational Site | Prague | 130 00 | Czechia |
| Lycera Investigational Site | Ústí nad Labem | 401 13 | Czechia |
| Lycera Investigational Site | Budapest | 1088 | Hungary |
| Lycera Investigational Site | Budapest | 1125 | Hungary |
| Lycera Investigational Site | Rotterdam | 3015 CE | Netherlands |
| Lycera Investigational Site | Bydgoszcz | 85-168 | Poland |
| Lycera Investigational Site | Bydgoszcz | 85-681 | Poland |
| Lycera Investigational Site | Katowice | 40-211 | Poland |
| Lycera Investigational Site | Katowice | 40-659 | Poland |
| Lycera Investigational Site | Katowice | 40-752 | Poland |
| Lycera Investigational Site | Kielce | 25-355 | Poland |
| Lycera Investigational Site | Krakow | 31-009 | Poland |
| Lycera Investigational Site | Lublin | 20-362 | Poland |
| Lycera Investigational Site | Piaseczno | 05-500 | Poland |
| Lycera Investigational Site | Poznan | 61-113 | Poland |
| Lycera Investigational Site | Skierniewice | 96-100 | Poland |
| Lycera Investigational Site | Sopot | 81-756 | Poland |
| Lycera Investigational Site | Staszów | 28-200 | Poland |
| Lycera Investigational Site | Szczecin | 71-270 | Poland |
| Lycera Investigational Site | Warsaw | 02-507 | Poland |
| Lycera Investigational Site | Warsaw | 04-749 | Poland |
| Lycera Investigational Site | Wroclaw | 50-449 | Poland |
| Lycera Investigational Site | Wroclaw | 53-333 | Poland |
| Lycera Investigational Site | Wroclaw | Poland |
| Lycera Investigational Site | Włocławek | 87-800 | Poland |
| Lycera Investigational Site | Belgrade | 11000 | Serbia |
| Lycera Investigational Site | Kragujevac | 34000 | Serbia |
| Lycera Investigational Site | Niš | 18000 | Serbia |
| Lycera Investigational Site | Subotica | 24000 | Serbia |
| Lycera Investigational Site | Zrenjanin | 23000 | Serbia |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | LYC-30937-EC | LYC-30937-EC 25 mg by mouth once daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Enrolled subjects were from Netherlands, Hungary, United States, Czechia, Poland, Serbia. | Number | subjects |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Safety Set, consisting of all subjects who took at least 1 dose of study drug. 112 subjects signed consent to participate in the study and 111 of these were confirmed to have taken at least 1 dose of study drug. (One subject was lost to follow-up after enrolling and it was not confirmed that they took study drug.) | Posted | Count of Participants | Participants | 46 weeks |
|
|
|
Adverse events were collected from the time the subject signed informed consent through their last study visit, up to 46 weeks.
Adverse events occurring after the first dose of study drug (treatment-emergent adverse events) are reported in this section.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LYC-30937-EC | LYC-30937-EC 25 mg by mouth once daily | 0 | 111 | 6 | 111 | 18 | 111 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ulcerative colitis | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment | exacerbation of existing ulcerative colitis |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Chronic obstructuve pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment | exacerbation of existing COPD |
|
| Pneumonia | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colitis ulcerative | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment | exacerbation of existing ulcerative colitis |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
|
Center results cannot be submitted for publication before results of multicenter study are published unless it is more than 1 year since study completion. Then Investigator can publish if manuscript is submitted to Lycera ≥ 60 days prior to submission (or per Investigator contract). If Lycera decides publication would hinder development, Investigator must delay submission. Investigator must delete confidential information before submission and defer publication to allow patent applications.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| H. Jeffrey Wilkins MD, Chief Medical Officer | Lycera Corp. | 484-243-6222 | wilkins@lycera.com |
| Mar 5, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| United States |
|
| Czechia |
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| Poland |
|
| Serbia |
|
| Title | Measurements |
|---|---|
|