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An Efficacy and Safety Study of LYC-30937-EC in Subjects With Moderate Chronic Plaque-type Psoriasis

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: NCT02872285
Recruitment Status : Completed
First Posted : August 19, 2016
Results First Posted : April 2, 2019
Last Update Posted : April 10, 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 Psoriasis
Interventions Drug: Drug: LYC-30937-EC
Drug: Placebo
Enrollment 33
Recruitment Details Participants were enrolled at 7 study centers within the United States. Study centers were dermatology medical clinics experienced in conducting clinical trials.
Pre-assignment Details Participants were 18 to 75 years of age with chronic plaque-type psoriasis for ≥ 6 months prior to screening. Eligible patients had a baseline Psoriasis Area and Severity Index (PASI) score > 7 with body surface area (BSA) involvement of 5-15% and overall lesion severity rated as moderate or marked.
Arm/Group Title LYC-30937-EC 25 mg PO QD Matching Placebo PO QD
Hide Arm/Group Description

LYC-30937-EC 25 mg by mouth once daily for 12 weeks

Drug: LYC-30937-EC

Placebo enteric coated (EC) by mouth once daily for 12 weeks

Placebo

Period Title: Overall Study
Started 22 11
Completed 17 9
Not Completed 5 2
Reason Not Completed
Withdrawal by Subject             2             0
Lost to Follow-up             2             2
Discontinued due to back surgery             1             0
Arm/Group Title LYC-30937-EC 25 mg PO QD Matching Placebo PO QD Total
Hide Arm/Group Description

LYC-30937-EC 25 mg by mouth once daily for 12 weeks

Drug: LYC-30937-EC

Placebo enteric coated (EC) by mouth once daily for 12 weeks

Placebo

Total of all reporting groups
Overall Number of Baseline Participants 22 11 33
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 11 participants 33 participants
51.6  (13.91) 48.5  (12.96) 50.6  (13.48)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 11 participants 33 participants
Female
9
  40.9%
5
  45.5%
14
  42.4%
Male
13
  59.1%
6
  54.5%
19
  57.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 11 participants 33 participants
Hispanic or Latino
1
   4.5%
1
   9.1%
2
   6.1%
Not Hispanic or Latino
21
  95.5%
10
  90.9%
31
  93.9%
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 22 participants 11 participants 33 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
   9.1%
0
   0.0%
2
   6.1%
White
20
  90.9%
11
 100.0%
31
  93.9%
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%
Baseline Psoriasis Area and Severity Index (PASI) score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 22 participants 11 participants 33 participants
9.72  (2.12) 9.38  (2.66) 9.61  (2.28)
[1]
Measure Description: The PASI is a measure of chronic plaque-type psoriasis disease. It combines lesion severity (erythema, thickness, scaling) and skin surface area involvement in 4 defined anatomical body regions (head, upper extremities, trunk, lower extremities). PASI scores range from 0 to 72 with higher scores indicative of greater disease severity. Lesion severity (erythema, thickness, scaling) is scored on a scale of 0 (none) to 4 (very severe) on each of the 4 body regions. Degree of skin area involvement in each body region is scored on a scale of 0 (no involvement) to 6 (90-100% involvement).
1.Primary Outcome
Title The Mean Percent Change From Baseline to Week 12 in Psoriasis Area and Severity Index (PASI).
Hide Description This endpoint was calculated in each treatment group by taking the Week 12 PASI score and subtracting the baseline PASI and dividing by the baseline PASI, then multiplying by 100 to get the percent change from baseline. The PASI is a measure of chronic plaque-type psoriasis disease. It combines lesion severity (erythema, thickness, scaling) and skin surface area involvement in 4 defined anatomical body regions (head, upper extremities, trunk, lower extremities). PASI score ranges from 0 to 72 with higher scores indicative of greater disease severity. Lesion severity (erythema, thickness, scaling) is scored on a scale of 0 (none) to 4 (very severe) on each of the 4 body regions. Degree of skin area involvement in each body region is scored on a scale of 0 (no involvement) to 6 (90-100% involvement).
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all randomized subjects. Randomized subjects included in this analysis had to have both a baseline and a Week 12 PASI score.
Arm/Group Title LYC-30937-EC 25 mg PO QD Matching Placebo PO QD
Hide Arm/Group Description:

LYC-30937-EC 25 mg by mouth once daily for 12 weeks

Drug: LYC-30937-EC

Placebo enteric coated (EC) by mouth once daily for 12 weeks

Placebo

Overall Number of Participants Analyzed 18 9
Mean (Standard Deviation)
Unit of Measure: percent change
-25.08  (26.43) -12.63  (19.67)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LYC-30937-EC 25 mg PO QD, Matching Placebo PO QD
Comments Subjects included in this analysis had to have both a baseline and Week 12 PASI scores.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2205
Comments ANCOVA was used to compare mean percent change in PASI score between baseline and Week 12 between LYC-30937 and placebo treatment groups with treatment as a factor and baseline as a covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -12.80
Confidence Interval (2-Sided) 95%
-33.793 to 8.199
Estimation Comments [Not Specified]
2.Secondary Outcome
Title The Number of Subjects Who Achieve a ≥ 75% Reduction From Baseline in PASI at Week 12.
Hide Description

This endpoint calculated the number of subjects achieving a ≥ 75% reduction in their Week 12 PASI score compared to their baseline PASI.

The PASI is a measure of chronic plaque-type psoriasis disease. It combines lesion severity (erythema, thickness, scaling) and skin surface area involvement in 4 defined anatomical body regions (head, upper extremities, trunk, lower extremities). PASI score ranges from 0 to 72 with higher scores indicative of greater disease severity. Lesion severity (erythema, thickness, scaling) is scored on a scale of 0 (none) to 4 (very severe) on each of the 4 body regions. Degree of skin area involvement in each body region is scored on a scale of 0 (no involvement) to 6 (90-100% involvement).

Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all randomized subjects. Randomized subjects included in this analysis were those with PASI scores at baseline and at Week 12.
Arm/Group Title LYC-30937-EC 25 mg PO QD Matching Placebo PO QD
Hide Arm/Group Description:

LYC-30937-EC 25 mg by mouth once daily for 12 weeks

Drug: LYC-30937-EC

Placebo enteric coated (EC) by mouth once daily for 12 weeks

Placebo

Overall Number of Participants Analyzed 18 9
Measure Type: Count of Participants
Unit of Measure: Participants
1
   5.6%
0
   0.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LYC-30937-EC 25 mg PO QD, Matching Placebo PO QD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4712
Comments [Not Specified]
Method Chi-squared
Comments 2-sided p-value.
3.Secondary Outcome
Title The Mean Percent Change From Baseline to Week 12 in Percent Body Surface Area (BSA).
Hide Description Mean percent change from baseline to Week 12 in %BSA was calculated by taking the Week 12 %BSA and subtracting the baseline %BSA then dividing by the baseline %BSA and multiplying by 100. The mean percent change from baseline to Week 12 in each treatment group were compared using analysis of covariance with treatment as a factor and baseline as a covariate.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all randomized subjects. Randomized subjects included in this analysis had to have both a baseline and a Week 12 %BSA score.
Arm/Group Title LYC-30937-EC 25 mg PO QD Matching Placebo PO QD
Hide Arm/Group Description:

LYC-30937-EC 25 mg by mouth once daily for 12 weeks

Drug: LYC-30937-EC

Placebo enteric coated (EC) by mouth once daily for 12 weeks

Placebo

Overall Number of Participants Analyzed 18 9
Mean (Standard Deviation)
Unit of Measure: percent change
-12.69  (26.18) -7.68  (35.75)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LYC-30937-EC 25 mg PO QD, Matching Placebo PO QD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6695
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -5.34
Confidence Interval (2-Sided) 95%
-30.87 to 20.18
Estimation Comments [Not Specified]
4.Secondary Outcome
Title The Number of Subjects Who Achieve "Cleared" (Score = 0) or "Minimal" (Score = 1) on the Static Investigators Global Assessment at Week 12.
Hide Description This endpoint is number of subjects who achieved a score of 0 or 1 on the static IGA at week 12. The static IGA is used to measure psoriasis severity. The static IGA used in this study was a 6-point scale: 0 = Cleared [no plaque elevation, erythema or scaling, hyperpigmentation may be present]; 1 = Minimal [minimal plaque elevation (=0.25mm), faint erythema, minimal scaling with occasional fine scale over < 5% of lesion]; 2 = Mild [mild plaque elevation (=0.5mm), light red coloration, fine scale predominates]; 3 = Moderate [moderate plaque elevation (=0.75mm), moderate red coloration, coarse scale predominates]; 4 = Marked (marked plaque elevation (=1mm), bright red coloration, thick non-tenacious scale predominates]; 5 = Severe (severe plaque elevation (≥1.25mm), dusky to deep red coloration, very thick tenacious scale predominates].
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all randomized subjects. Randomized subjects included in this analysis had to have both a baseline and a Week 12 static IGA score.
Arm/Group Title LYC-30937-EC 25 mg PO QD Matching Placebo PO QD
Hide Arm/Group Description:

LYC-30937-EC 25 mg by mouth once daily for 12 weeks

Drug: LYC-30937-EC

Placebo enteric coated (EC) by mouth once daily for 12 weeks

Placebo

Overall Number of Participants Analyzed 18 9
Measure Type: Count of Participants
Unit of Measure: Participants
1
   5.6%
0
   0.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LYC-30937-EC 25 mg PO QD, Matching Placebo PO QD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4712
Comments 2-sided p-value
Method Chi-squared
Comments [Not Specified]
5.Secondary Outcome
Title The Number of Subjects Who Achieve a 2 Step Reduction on the Static Investigators Global Assessment (IGA) at Week 12.
Hide Description This endpoint is based on number of subjects who achieved a 2 step reduction in the static IGA at week 12 (ie, a score of 5 at baseline to a score of 3 or less at Week 12). The static IGA is used to measure psoriasis severity. The static IGA used in this study was a 6-point scale: 0 = Cleared [no plaque elevation, erythema or scaling, hyperpigmentation may be present]; 1 = Minimal [minimal plaque elevation (=0.25mm), faint erythema, minimal scaling with occasional fine scale over < 5% of lesion]; 2 = Mild [mild plaque elevation (=0.5mm), light red coloration, fine scale predominates]; 3 = Moderate [moderate plaque elevation (=0.75mm), moderate red coloration, coarse scale predominates]; 4 = Marked (marked plaque elevation (=1mm), bright red coloration, thick non-tenacious scale predominates]; 5 = Severe (severe plaque elevation (≥1.25mm), dusky to deep red coloration, very thick tenacious scale predominates].
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all randomized subjects. Randomized subjects included in this analysis had to have both a baseline and a Week 12 static IGA score.
Arm/Group Title LYC-30937-EC 25 mg PO QD Matching Placebo PO QD
Hide Arm/Group Description:

LYC-30937-EC 25 mg by mouth once daily for 12 weeks

Drug: LYC-30937-EC

Placebo enteric coated (EC) by mouth once daily for 12 weeks

Placebo

Overall Number of Participants Analyzed 18 9
Measure Type: Count of Participants
Unit of Measure: Participants
1
   5.6%
0
   0.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LYC-30937-EC 25 mg PO QD, Matching Placebo PO QD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4712
Comments 2-sided p-value
Method Chi-squared
Comments [Not Specified]
Time Frame Adverse events were collected from the time subjects signed the study informed consent until the Week 14 follow-up visit. Treatment-emergent adverse events were those adverse events occurring or worsening after the first dose of study drug (LYC-30937-EC or placebo) up to the Week 14 follow-up visit.
Adverse Event Reporting Description AE 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.
 
Arm/Group Title LYC-30937-EC 25 mg PO QD Matching Placebo PO QD
Hide Arm/Group Description

LYC-30937-EC 25 mg by mouth once daily for 12 weeks

Drug: LYC-30937-EC

Placebo enteric coated (EC) by mouth once daily for 12 weeks

Placebo

All-Cause Mortality
LYC-30937-EC 25 mg PO QD Matching Placebo PO QD
Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)      0/11 (0.00%)    
Hide Serious Adverse Events
LYC-30937-EC 25 mg PO QD Matching Placebo PO QD
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/22 (0.00%)      0/11 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
LYC-30937-EC 25 mg PO QD Matching Placebo PO QD
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/22 (50.00%)      4/11 (36.36%)    
Blood and lymphatic system disorders     
Lymphadenopathy  1  0/22 (0.00%)  0 1/11 (9.09%)  1
Gastrointestinal disorders     
Diarrhoea  1  1/22 (4.55%)  2 1/11 (9.09%)  2
Flatulence  1  0/22 (0.00%)  0 2/11 (18.18%)  2
General disorders     
Fatigue  1  0/22 (0.00%)  0 1/11 (9.09%)  1
Infections and infestations     
Gastroenteritis viral  1  2/22 (9.09%)  2 0/11 (0.00%)  0
Nasopharyngitis  1  2/22 (9.09%)  2 0/11 (0.00%)  0
Upper respiratory tract infection  1  2/22 (9.09%)  2 0/11 (0.00%)  0
Injury, poisoning and procedural complications     
Fractured coccyx  1  0/22 (0.00%)  0 1/11 (9.09%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia  1  0/22 (0.00%)  0 1/11 (9.09%)  2
Nervous system disorders     
Headache  1  2/22 (9.09%)  6 0/11 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Cough  1  2/22 (9.09%)  2 0/11 (0.00%)  0
Oropharyngeal pain  1  0/22 (0.00%)  0 1/11 (9.09%)  1
Skin and subcutaneous tissue disorders     
Pruritis  1  2/22 (9.09%)  2 0/11 (0.00%)  0
Psoriasis  1  0/22 (0.00%)  0 1/11 (9.09%)  1
Seborroea  1  0/22 (0.00%)  0 1/11 (9.09%)  1
Vascular disorders     
Varicose vein  1  0/22 (0.00%)  0 1/11 (9.09%)  1
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 ≥18 months 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: NCT02872285    
Other Study ID Numbers: LYC-30937-2003
First Submitted: August 16, 2016
First Posted: August 19, 2016
Results First Submitted: January 29, 2019
Results First Posted: April 2, 2019
Last Update Posted: April 10, 2019