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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.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Colitis, Ulcerative
Interventions Drug: LYC-30937-EC
Drug: Placebo
Enrollment 124
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title LYC-30937-EC Placebo
Hide Arm/Group Description LYC-30937-EC 25 mg by mouth once daily for 8 weeks Matching placebo by mouth once daily for 8 weeks
Period Title: Overall Study
Started 62 62
Completed 60 59
Not Completed 2 3
Reason Not Completed
Lack of Efficacy             1             0
Withdrawal by Subject             1             1
Adverse Event             0             2
Arm/Group Title LYC-30937-EC Placebo Total
Hide Arm/Group Description LYC-30937-EC 25 mg by mouth once daily for 8 weeks Matching placebo by mouth once daily for 8 weeks Total of all reporting groups
Overall Number of Baseline Participants 62 62 124
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 62 participants 62 participants 124 participants
43.8  (11.94) 39.3  (13.26) 41.5  (12.77)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 62 participants 62 participants 124 participants
Female
27
  43.5%
25
  40.3%
52
  41.9%
Male
35
  56.5%
37
  59.7%
72
  58.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 62 participants 62 participants 124 participants
Hispanic or Latino
3
   4.8%
4
   6.5%
7
   5.6%
Not Hispanic or Latino
59
  95.2%
58
  93.5%
117
  94.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 62 participants 62 participants 124 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   1.6%
0
   0.0%
1
   0.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   1.6%
1
   0.8%
Black or African American
1
   1.6%
2
   3.2%
3
   2.4%
White
60
  96.8%
59
  95.2%
119
  96.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Netherlands Number Analyzed 62 participants 62 participants 124 participants
2 1 3
Hungary Number Analyzed 62 participants 62 participants 124 participants
1 1 2
United States Number Analyzed 62 participants 62 participants 124 participants
11 17 28
Czechia Number Analyzed 62 participants 62 participants 124 participants
3 2 5
Poland Number Analyzed 62 participants 62 participants 124 participants
43 38 81
Serbia Number Analyzed 62 participants 62 participants 124 participants
2 3 5
Baseline Total Mayo Score (TMS) and Modified Mayo Score (MMS)   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Baseline TMS Mean (Standard Deviation) Number Analyzed 62 participants 61 participants 123 participants
7.9  (1.46) 7.8  (1.77) 7.9  (1.62)
Baseline MMS Mean (Standard Deviation) Number Analyzed 62 participants 62 participants 124 participants
6.0  (1.38) 5.7  (1.55) 5.8  (1.47)
[1]
Measure Description:

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.

[2]
Measure Analysis Population Description: 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.
1.Primary Outcome
Title Number of Subjects Who Achieve Clinical Remission at Week 8 Using Modified Mayo Score.
Hide Description

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.

Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population consisted of all randomized subjects (Full Analysis Set).
Arm/Group Title LYC-30937-EC 25 mg PO QD Placebo PO QD
Hide Arm/Group Description:

LYC-30937-EC 25 mg by mouth once daily for 8 weeks

LYC-30937-EC

Matching placebo by mouth once daily for 8 weeks

Placebo

Overall Number of Participants Analyzed 62 62
Measure Type: Count of Participants
Unit of Measure: Participants
7
  11.3%
12
  19.4%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LYC-30937-EC 25 mg PO QD, Placebo PO QD
Comments The response rate difference is the mean difference in response rates between the treatment and placebo responders. The p-value is based on one-sided Pearson chi-square test.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.106
Comments one-sided p-value
Method Chi-squared
Comments Statistical test was a one-sided performed at the 5% level of significance. Pearson chi-square test was used to test the null hypothesis.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -8.1
Confidence Interval (2-Sided) 90%
-18.6 to 2.5
Estimation Comments 90% CI obtained based on normal approximation.
2.Secondary Outcome
Title Number of Subjects Who Achieve Clinical Remission at Week 8 Using the Total Mayo Score.
Hide Description

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.

Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population consisted of all randomized subjects (Full Analysis Set).
Arm/Group Title LYC-30937-EC 25 mg PO QD Placebo PO QD
Hide Arm/Group Description:

LYC-30937-EC 25 mg by mouth once daily for 8 weeks

LYC-30937-EC

Matching placebo by mouth once daily for 8 weeks

Placebo

Overall Number of Participants Analyzed 62 62
Measure Type: Count of Participants
Unit of Measure: Participants
7
  11.3%
12
  19.4%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LYC-30937-EC 25 mg PO QD, Placebo PO QD
Comments The response rate difference is the mean difference in response rates between the treatment and placebo responders. The p-value is based on one-sided Pearson chi-square test.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.106
Comments one-sided p-value
Method Chi-squared
Comments Statistical test was a one-sided performed at the 5% level of significance. Pearson chi-square test was used to test the null hypothesis.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -8.1
Confidence Interval (2-Sided) 90%
-18.6 to 2.5
Estimation Comments 90% CI obtained based on normal approximation.
3.Secondary Outcome
Title Number of Subjects With a Clinical Response on the Modified Mayo Score at Week 8.
Hide Description

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.

Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population consisted of all randomized subjects (Full Analysis Set).
Arm/Group Title LYC-30937-EC 25 mg PO QD Placebo PO QD
Hide Arm/Group Description:

LYC-30937-EC 25 mg by mouth once daily for 8 weeks

LYC-30937-EC

Matching placebo by mouth once daily for 8 weeks

Placebo

Overall Number of Participants Analyzed 62 62
Measure Type: Count of Participants
Unit of Measure: Participants
32
  51.6%
36
  58.1%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LYC-30937-EC 25 mg PO QD, Placebo PO QD
Comments The response rate difference is the mean difference in response rates between the treatment and placebo responders. The p-value is based on one-sided Pearson chi-square test.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.235
Comments one-sided p-value
Method Chi-squared
Comments Statistical test was a one-sided performed at the 5% level of significance. Pearson chi-square test was used to test the null hypothesis.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -6.5
Confidence Interval (2-Sided) 90%
-21.1 to 8.2
Estimation Comments 90% CI obtained based on normal approximation.
4.Secondary Outcome
Title Number of Subjects With a Clinical Response on the Total Mayo Score at Week 8.
Hide Description

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.

Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population consisted of all randomized subjects (Full Analysis Set).
Arm/Group Title LYC-30937-EC 25 mg PO QD Placebo PO QD
Hide Arm/Group Description:

LYC-30937-EC 25 mg by mouth once daily for 8 weeks

LYC-30937-EC

Matching placebo by mouth once daily for 8 weeks

Placebo

Overall Number of Participants Analyzed 62 62
Measure Type: Count of Participants
Unit of Measure: Participants
26
  41.9%
32
  51.6%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LYC-30937-EC 25 mg PO QD, Placebo PO QD
Comments The response rate difference is the mean difference in response rates between the treatment and placebo responders. The p-value is based on one-sided Pearson chi-square test.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.140
Comments one-sided p-value
Method Chi-squared
Comments Statistical test was a one-sided performed at the 5% level of significance. Pearson chi-square test was used to test the null hypothesis.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -9.7
Confidence Interval (2-Sided) 90%
-24.3 to 5.0
Estimation Comments 90% CI obtained based on normal approximation.
5.Secondary Outcome
Title Percent Change From Baseline to Week 8 in Fecal Calprotectin in Subjects With Baseline Fecal Calprotectin ≥ 250 µg/g
Hide Description Fecal calprotectin is an indicator of inflammation in the colon with higher levels indicative of higher levels of inflammation.
Time Frame Baseline to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title LYC-30937-EC 25 mg PO QD Placebo PO QD
Hide Arm/Group Description:

LYC-30937-EC 25 mg by mouth once daily for 8 weeks

LYC-30937-EC

Matching placebo by mouth once daily for 8 weeks

Placebo

Overall Number of Participants Analyzed 51 44
Least Squares Mean (Standard Error)
Unit of Measure: percent change from baseline
-35.22  (13.81) 9.37  (15.07)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LYC-30937-EC 25 mg PO QD, Placebo PO QD
Comments Subjects included in this analysis were those with a baseline fecal calprotectin value ≥ 250 µg/g.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.032
Comments [Not Specified]
Method ANCOVA
Comments The mean change from baseline at Week 8 was analyzed using ANCOVA with a factor for treatment and a covariate for baseline scores.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -44.59
Confidence Interval (2-Sided) 90%
-78.66 to -10.53
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Percent Change From Baseline in Total Mayo Score at Week 8.
Hide Description

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.

Time Frame Baseline to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized subjects randomized who had TMS scores at baseline and Week 8.
Arm/Group Title LYC-30937-EC 25 mg PO QD Placebo PO QD
Hide Arm/Group Description:

LYC-30937-EC 25 mg by mouth once daily for 8 weeks

LYC-30937-EC

Matching placebo by mouth once daily for 8 weeks

Placebo

Overall Number of Participants Analyzed 59 58
Least Squares Mean (Standard Error)
Unit of Measure: Percent Change from baseline
-2.49  (0.33) -2.67  (0.33)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LYC-30937-EC 25 mg PO QD, Placebo PO QD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.708
Comments [Not Specified]
Method ANCOVA
Comments The mean change from baseline at Week 8 was analyzed using ANCOVA with a factor for treatment and a covariate for baseline scores.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.18
Confidence Interval (2-Sided) 90%
-0.60 to 0.95
Estimation Comments [Not Specified]
7.Other Pre-specified Outcome
Title Number of Subjects With Type of Adverse Events (AEs) Serious Adverse Events (SAEs) and AEs That Led to Discontinuation of Treatment.
Hide Description 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.
Time Frame 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set, consisting of all randomized subjects who took at least one dose of study drug.
Arm/Group Title LYC-30937-EC 25 mg PO QD Placebo PO QD
Hide Arm/Group Description:

LYC-30937-EC 25 mg by mouth once daily for 8 weeks

LYC-30937-EC

Matching placebo by mouth once daily for 8 weeks

Placebo

Overall Number of Participants Analyzed 62 62
Measure Type: Count of Participants
Unit of Measure: Participants
Subjects with ≥ 1 TEAE
22
  35.5%
27
  43.5%
Subjects with ≥ 1 TESAE
1
   1.6%
3
   4.8%
Subjects with TEAE leading to discontinuation
0
   0.0%
2
   3.2%
Time Frame 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.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title LYC-30937-EC 25 mg PO QD Placebo PO QD
Hide Arm/Group Description

LYC-30937-EC 25 mg by mouth once daily for 8 weeks

LYC-30937-EC

Matching placebo by mouth once daily for 8 weeks

Placebo

All-Cause Mortality
LYC-30937-EC 25 mg PO QD Placebo PO QD
Affected / at Risk (%) Affected / at Risk (%)
Total   0/62 (0.00%)      0/62 (0.00%)    
Hide Serious Adverse Events
LYC-30937-EC 25 mg PO QD Placebo PO QD
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/62 (1.61%)      3/62 (4.84%)    
Infections and infestations     
Clostridium difficile infection  1  0/62 (0.00%)  0 1/62 (1.61%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenocarcinoma  1  1/62 (1.61%)  1 0/62 (0.00%)  0
Renal and urinary disorders     
Renal colic  1  0/62 (0.00%)  0 1/62 (1.61%)  1
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolism  1  0/62 (0.00%)  0 1/62 (1.61%)  1
1
Term from vocabulary, MedDRA (19.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
LYC-30937-EC 25 mg PO QD Placebo PO QD
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/62 (16.13%)      11/62 (17.74%)    
Gastrointestinal disorders     
Abdominal pain  1  4/62 (6.45%)  4 6/62 (9.68%)  8
Nervous system disorders     
Headache  1  6/62 (9.68%)  6 5/62 (8.06%)  6
1
Term from vocabulary, MedDRA (19.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: H. Jeffrey Wilkins, MD, Chief Medical Officer
Organization: Lycera Corp.
Phone: 484-243-6222
EMail: wilkins@lycera.com
Layout table for additonal information
Responsible Party: Lycera Corp.
ClinicalTrials.gov Identifier: NCT02762500    
Other Study ID Numbers: LYC-30937-2001
2016-000518-31 ( EudraCT Number )
First Submitted: May 3, 2016
First Posted: May 5, 2016
Results First Submitted: January 29, 2019
Results First Posted: April 2, 2019
Last Update Posted: April 2, 2019