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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-000518-31 | EudraCT Number |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LYC-30937-EC 25 mg PO QD | Experimental | LYC-30937-EC 25 mg by mouth once daily for 8 weeks |
|
| Placebo PO QD | Placebo Comparator | Matching placebo by mouth once daily for 8 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LYC-30937-EC | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Type of Adverse Events (AEs) Serious Adverse Events (SAEs) and AEs That Led to Discontinuation of Treatment. | 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. |
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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Participants were 18 to 75 years of age with active ulcerative colitis for at least 6 months prior to screening, had a total Mayo score (TMS) ≥ 4 to ≤ 11, with endoscopic subscore ≥ 2, and rectal bleeding subscore ≥ 1 at screening.
Participants were enrolled at 42 study centers within 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 for 8 weeks |
| FG001 | Placebo | Matching placebo by mouth once daily for 8 weeks |
| 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 | Yes | No | No | Study Protocol | Jun 5, 2017 | Jan 29, 2019 |
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| 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. | 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. | 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. | 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. | Baseline to Week 8 |
| 10 weeks |
| Long Beach |
| California |
| 90822 |
| United States |
| Lycera Investigational Site | Mission Hills | California | 91345 | United States |
| Lycera Investigational Site | Rialto | California | 92377 | United States |
| Lycera Investigational Site | Hollywood | Florida | 33021 | United States |
| Lycera Investigational Site | Miami | Florida | 33176 | United States |
| Lycera Investigational Site | Decatur | Georgia | 30033 | United States |
| Lycera Investigational Site | Marietta | Georgia | 30060 | United States |
| Lycera Investigational Site | Chicago | Illinois | 60637 | United States |
| Lycera Investigational Site | Louisville | Kentucky | 40202 | United States |
| Lycera Investigational Site | Baton Rouge | Louisiana | 70809 | United States |
| Lycera Investigational Site | Ann Arbor | Michigan | 48109 | United States |
| Lycera Investigational Site | Brooklyn | New York | 11230 | United States |
| Lycera Investigational Site | New York | New York | 10024 | United States |
| Lycera Investigational Site | The Bronx | New York | 10461 | United States |
| Lycera Investigational Site | Greenville | North Carolina | 27834 | United States |
| Lycera Investigational Site | Flourtown | Pennsylvania | 19031 | United States |
| Lycera Investigational Site | Philadelphia | Pennsylvania | 19104 | United States |
| Lycera Investigational Site | Sayre | Pennsylvania | 18840 | United States |
| Lycera Investigational Site | Nashville | Tennessee | 37212 | United States |
| Lycera Investigational Site | Union City | Tennessee | 38261 | United States |
| Lycera Investigational Site. | Houston | Texas | 76092 | United States |
| Lycera Investigational Sites | Houston | Texas | 77004 | United States |
| Lycera Investigational Site | Houston | Texas | 77004 | United States |
| Lycera Investigational Site | Houston | Texas | 77030 | United States |
| Lycera Investigational Site | San Antonio | Texas | 78229 | United States |
| Lycera Investigational Site | Victoria | British Columbia | V8V 3M9 | Canada |
| Lycera Investigational Site | Toronto | Ontario | M5G 1X5 | Canada |
| Lycera Investigational Site | Ostrava | 722 00 | Czechia |
| Lycera Investigational Site | Prague | 130 00 | Czechia |
| Lycera Investigational Site | Slaný | 274 01 | 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 | Debrecen | 4031 | Hungary |
| Lycera Investigational Site | Debrecen | 4032 | Hungary |
| Lycera Investigational Site | Hatvan | 3000 | Hungary |
| Lycera Investigational Site | Amsterdam | 1081 HZ | Netherlands |
| 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 | 25 364 | Poland |
| Lycera Investigational Site | Krakow | 30-415 | Poland |
| Lycera Investigational Site | Krakow | 31-009 | Poland |
| Lycera Investigational Site | Ksawerów | 95-054 | Poland |
| Lycera Investigational Site | Lodz | 93-034 | Poland |
| Lycera Investigational Site | Lublin | 20-008 | Poland |
| Lycera Investigational Site | Lublin | 20-362 | Poland |
| Lycera Investigational Site | Nowa Sól | 67-100 | 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 | 50-053 | Poland |
| Lycera Investigational Site | Wroclaw | 50-449 | Poland |
| Lycera Investigational Site | Wroclaw | 53-333 | Poland |
| Lycera Investigational Site | Wroclaw | 54-144 | Poland |
| Lycera Investigational Site | Włocławek | 87-800 | Poland |
| Lycera Investigational Site | Belgrade | 11000 | Serbia |
| Lycera Investigational Site | Belgrade | 11080 | 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 |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | LYC-30937-EC | LYC-30937-EC 25 mg by mouth once daily for 8 weeks |
| BG001 | Placebo | Matching placebo by mouth once daily for 8 weeks |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Baseline Total Mayo Score (TMS) and Modified Mayo Score (MMS) | TMS range: 0 (normal/no disease) to 12 (severe disease). TMS comprised of 4 subscores: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, physician's global assessment subscore. MMS range: 0 (normal/no disease) to 9 (severe disease). MMS comprised of 3 subscores: stool frequency subscore, rectal bleeding subscore, endoscopy subscore. | One subject in the placebo treatment arm did not have a complete Mayo score at baseline and therefore they were not included in this analysis population. | Mean | Standard Deviation | units on a scale |
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| 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 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. | The analysis population consisted of all randomized subjects (Full Analysis Set). | Posted | Count of Participants | Participants | 8 weeks |
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| Secondary | 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. | The analysis population consisted of all randomized subjects (Full Analysis Set). | Posted | Count of Participants | Participants | 8 weeks |
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| Secondary | 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. | The analysis population consisted of all randomized subjects (Full Analysis Set). | Posted | Count of Participants | Participants | 8 weeks |
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| Secondary | 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. | The analysis population consisted of all randomized subjects (Full Analysis Set). | Posted | Count of Participants | Participants | 8 weeks |
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| Secondary | 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. | All randomized subjects who had an elevated baseline fecal calprotectin level of ≥ 250 µg/g and who had both a baseline and Week 8 value. | Posted | Least Squares Mean | Standard Error | percent change from baseline | Baseline to Week 8 |
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| Secondary | 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. | All randomized subjects randomized who had TMS scores at baseline and Week 8. | Posted | Least Squares Mean | Standard Error | Percent Change from baseline | Baseline to Week 8 |
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| Other Pre-specified | Number of Subjects With Type of Adverse Events (AEs) Serious Adverse Events (SAEs) and AEs That Led to Discontinuation of Treatment. | 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. | Safety Set, consisting of all randomized subjects who took at least one dose of study drug. | Posted | Count of Participants | Participants | 10 weeks |
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Adverse events were collected from the time a subject signed informed consent through the Week 10 follow-up visit. SAEs occurring after the last study visit that were determined by the investigator to be related to study drug were to be reported.
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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 25 mg PO QD | LYC-30937-EC 25 mg by mouth once daily for 8 weeks LYC-30937-EC | 0 | 62 | 1 | 62 | 10 | 62 |
| EG001 | Placebo PO QD | Matching placebo by mouth once daily for 8 weeks Placebo | 0 | 62 | 3 | 62 | 11 | 62 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
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| Clostridium difficile infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
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| Renal colic | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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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 |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 15, 2018 | Jan 29, 2019 | SAP_001.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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| Serbia |
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| Baseline MMS Mean (Standard Deviation) |
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