Back to resultsAn Efficacy and Safety Study of LYC-30937-EC in Subjects With Moderate Chronic Plaque-type Psoriasis
Primary Purpose
Psoriasis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Drug: LYC-30937-EC
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis
Eligibility Criteria
Inclusion Criteria:
- Have a diagnosis of plaque-type psoriasis for at least 6 months prior to screening.
- Must have chronic moderate plaque-type psoriasis confirmed at both screening and baseline visits. Moderate plaque-type psoriasis is defined as a PASI > 7, with body surface area (BSA) involvement 5-15% inclusive and overall lesion severity of "moderate" or "marked, " where "moderate" = plaque elevation (0.75mm), moderate red coloration, coarse scale predominates; "marked" = moderate plaque elevation (1.0mm), bright red coloration, and thick, non-tenacious scale predominates.
- Female subjects of childbearing potential must agree to use two highly effective forms of contraception during study participation and for 30 days after their last dose of treatment of study drug treatment.
- Male subjects with partners of childbearing potential must take appropriate precautions to avoid fathering a child while participating in the study and use appropriate barrier contraception or abstinence during the study and for 30 days after their last dose of study drug.
- Agree to avoid prolonged sun exposure and avoid tanning booths or ultraviolet (UV) light sources during the study.
- Ability to provide written informed consent and to be compliant with the schedule of events.
Exclusion Criteria:
- Non-plaque-type psoriasis (eg, pustular, erythrodermic, and guttate psoriasis).
- Drug-induced psoriasis (ie, new onset or current exacerbation from beta-blockers, calcium channel blockers, or lithium).
- Spontaneously improving or rapidly deteriorating plaque psoriasis.
- Comorbid psoriatic arthritis that is not amenable to treatment with NSAIDs.
- Treatment with a biologic agent for psoriasis.
- Failed 2 or more systemic treatments for plaque psoriasis.
- Received phototherapy or prolonged sun exposure or use of tanning booth or other ultraviolet light source within 4 weeks of initiating screening procedures.
- Received systemic drug therapy (non-biologic) for plaque psoriasis or any systemic medication that could affect psoriasis or its evaluation (PASI or IGA), including but not limited to oral or injectable corticosteroids, retinoids, sulfasalazine, within 4 weeks of initiating screening procedures.
- Received topical medication that could affect psoriasis or its evaluation (PASI or IGA), including but not limited to corticosteroids, retinoids, topical vitamin D derivatives, pimecrolimus, tacrolimus, calcipotriene, within 2 weeks of initiating screening procedures.
- Received immunosuppressant agents (eg, cyclosporine, azathioprine, methotrexate) within 8 weeks of initiating screening procedures.
Any of the following laboratory abnormalities:
- liver function tests > 1.5 x the upper limit of normal (ULN) or direct bilirubin > 1.5 x ULN
- hemoglobin < 8.5 g/dl (international system units [SI]: < 85 g/L)
- neutrophils < 1500/mm3 (SI: < 1.5 x 109/L)
- white blood cell (WBC) count < 3,000/mm3 (SI: < 3.0 x 109/L)
- platelets < 80,000 mm3 (SI: 80 x 109/L)
- international normalized ratio (INR) > 1.5
- serum creatinine > 1.4 mg/dL for women or > 1.6 mg/dL for men
- Clinically relevant hepatic, neurological, pulmonary, dermatological, ophthalmological, gastrointestinal, endocrine, psychiatric, or other major systemic disease making implementation of the protocol or interpretation of the study difficult or that would put the subject at risk by participating in the study.
- History of or currently active primary or secondary immunodeficiency.
- Treatment with an investigational agent within 30 days prior to initiating screening procedures.
Sites / Locations
- Lycera Investigational Site
- Lycera Investigational Site
- Lycera Investigational Site
- Lycera Investigational Site
- Lycera Investigational Site
- Lycera Investigational Site
- Lycera Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
LYC-30937-EC 25 mg PO once daily (QD)
Matching Placebo PO QD
Arm Description
LYC-30937-EC 25 mg by mouth once daily for 12 weeks
Placebo enteric coated (EC) by mouth once daily for 12 weeks
Outcomes
Primary Outcome Measures
The Mean Percent Change From Baseline to Week 12 in Psoriasis Area and Severity Index (PASI).
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).
Secondary Outcome Measures
The Number of Subjects Who Achieve a ≥ 75% Reduction From Baseline in PASI at Week 12.
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).
The Mean Percent Change From Baseline to Week 12 in Percent Body Surface Area (BSA).
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.
The Number of Subjects Who Achieve "Cleared" (Score = 0) or "Minimal" (Score = 1) on the Static Investigators Global Assessment at Week 12.
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].
The Number of Subjects Who Achieve a 2 Step Reduction on the Static Investigators Global Assessment (IGA) at Week 12.
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].
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02872285
Brief Title
An Efficacy and Safety Study of LYC-30937-EC in Subjects With Moderate Chronic Plaque-type Psoriasis
Official Title
A Randomized, Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of LYC-30937-EC in Subjects With Moderate Chronic Plaque-Type Psoriasis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
December 5, 2016 (Actual)
Primary Completion Date
June 22, 2017 (Actual)
Study Completion Date
June 22, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lycera Corp.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The objective of this Phase 2 trial is to determine the efficacy and safety of LYC-30937-EC in patients with moderate plaque-type psoriasis.
Detailed Description
Approximately 30 subjects will be enrolled in this double-blind, placebo-controlled study. The randomization will be stratified 2:1 into the LYC-30937-EC cohort (2) or the placebo cohort (1). The active cohort will receive LYC-30937-EC 25 mg once daily, which demonstrated safety and tolerability in Phase I trials.
The study is designed for patients with previously diagnosed moderate chronic plaque-type psoriasis and consists of the following:
Screening period (initials assessment and eligibility scoring)
Day 1: confirm eligibility, baseline efficacy assessments (PASI, IGA), randomize and initiate dosing
Week 2: safety assessments including vital signs, body temperature, physical exam, clinical labs will be performed
Week 4: efficacy (PASI, IGA) and safety assessments including vital signs, body temperature, physical exam, and clinical labs will be performed
Week 8: efficacy (PASI, IGA) and safety assessments including vital signs, body temperature, physical exam, and clinical labs will be performed
Week 12: final efficacy assessments (PASI, IGA), safety assessments including vital signs, body temperature, physical exam, ECG, and clinical labs will be performed
Week 14: final safety assessments including vital signs, body temperature, and clinical labs
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LYC-30937-EC 25 mg PO once daily (QD)
Arm Type
Experimental
Arm Description
LYC-30937-EC 25 mg by mouth once daily for 12 weeks
Arm Title
Matching Placebo PO QD
Arm Type
Placebo Comparator
Arm Description
Placebo enteric coated (EC) by mouth once daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Drug: LYC-30937-EC
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
The Mean Percent Change From Baseline to Week 12 in Psoriasis Area and Severity Index (PASI).
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
Secondary Outcome Measure Information:
Title
The Number of Subjects Who Achieve a ≥ 75% Reduction From Baseline in PASI at Week 12.
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
Title
The Mean Percent Change From Baseline to Week 12 in Percent Body Surface Area (BSA).
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
Title
The Number of Subjects Who Achieve "Cleared" (Score = 0) or "Minimal" (Score = 1) on the Static Investigators Global Assessment at Week 12.
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
Title
The Number of Subjects Who Achieve a 2 Step Reduction on the Static Investigators Global Assessment (IGA) at Week 12.
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have a diagnosis of plaque-type psoriasis for at least 6 months prior to screening.
Must have chronic moderate plaque-type psoriasis confirmed at both screening and baseline visits. Moderate plaque-type psoriasis is defined as a PASI > 7, with body surface area (BSA) involvement 5-15% inclusive and overall lesion severity of "moderate" or "marked, " where "moderate" = plaque elevation (0.75mm), moderate red coloration, coarse scale predominates; "marked" = moderate plaque elevation (1.0mm), bright red coloration, and thick, non-tenacious scale predominates.
Female subjects of childbearing potential must agree to use two highly effective forms of contraception during study participation and for 30 days after their last dose of treatment of study drug treatment.
Male subjects with partners of childbearing potential must take appropriate precautions to avoid fathering a child while participating in the study and use appropriate barrier contraception or abstinence during the study and for 30 days after their last dose of study drug.
Agree to avoid prolonged sun exposure and avoid tanning booths or ultraviolet (UV) light sources during the study.
Ability to provide written informed consent and to be compliant with the schedule of events.
Exclusion Criteria:
Non-plaque-type psoriasis (eg, pustular, erythrodermic, and guttate psoriasis).
Drug-induced psoriasis (ie, new onset or current exacerbation from beta-blockers, calcium channel blockers, or lithium).
Spontaneously improving or rapidly deteriorating plaque psoriasis.
Comorbid psoriatic arthritis that is not amenable to treatment with NSAIDs.
Treatment with a biologic agent for psoriasis.
Failed 2 or more systemic treatments for plaque psoriasis.
Received phototherapy or prolonged sun exposure or use of tanning booth or other ultraviolet light source within 4 weeks of initiating screening procedures.
Received systemic drug therapy (non-biologic) for plaque psoriasis or any systemic medication that could affect psoriasis or its evaluation (PASI or IGA), including but not limited to oral or injectable corticosteroids, retinoids, sulfasalazine, within 4 weeks of initiating screening procedures.
Received topical medication that could affect psoriasis or its evaluation (PASI or IGA), including but not limited to corticosteroids, retinoids, topical vitamin D derivatives, pimecrolimus, tacrolimus, calcipotriene, within 2 weeks of initiating screening procedures.
Received immunosuppressant agents (eg, cyclosporine, azathioprine, methotrexate) within 8 weeks of initiating screening procedures.
Any of the following laboratory abnormalities:
liver function tests > 1.5 x the upper limit of normal (ULN) or direct bilirubin > 1.5 x ULN
hemoglobin < 8.5 g/dl (international system units [SI]: < 85 g/L)
neutrophils < 1500/mm3 (SI: < 1.5 x 109/L)
white blood cell (WBC) count < 3,000/mm3 (SI: < 3.0 x 109/L)
platelets < 80,000 mm3 (SI: 80 x 109/L)
international normalized ratio (INR) > 1.5
serum creatinine > 1.4 mg/dL for women or > 1.6 mg/dL for men
Clinically relevant hepatic, neurological, pulmonary, dermatological, ophthalmological, gastrointestinal, endocrine, psychiatric, or other major systemic disease making implementation of the protocol or interpretation of the study difficult or that would put the subject at risk by participating in the study.
History of or currently active primary or secondary immunodeficiency.
Treatment with an investigational agent within 30 days prior to initiating screening procedures.
Facility Information:
Facility Name
Lycera Investigational Site
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46032
Country
United States
Facility Name
Lycera Investigational Site
City
Andover
State/Province
Massachusetts
ZIP/Postal Code
01810
Country
United States
Facility Name
Lycera Investigational Site
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
Lycera Investigational Site
City
East Windsor
State/Province
New Jersey
ZIP/Postal Code
08520
Country
United States
Facility Name
Lycera Investigational Site
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Lycera Investigational Site
City
Broomall
State/Province
Pennsylvania
ZIP/Postal Code
19008
Country
United States
Facility Name
Lycera Investigational Site
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
An Efficacy and Safety Study of LYC-30937-EC in Subjects With Moderate Chronic Plaque-type Psoriasis
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