CClinicalTrials.gg
Sign In
CompletedNCT02872285Updated Apr 10, 2019Results posted

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

A Phase 2 interventional study of Drug: LYC-30937-EC and Placebo in Psoriasis, sponsored by Lycera Corp.. Completed at 7 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-04-10.

Sponsored by Lycera Corp. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
33
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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
02

Conditions studied

  • Psoriasis

Browse trials for

03

In context

Psoriasis

1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.

This study's enrollment of 33 is below the median of 70 across 1,447 interventional studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

Lycera Corp. is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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:

    1. liver function tests > 1.5 x the upper limit of normal (ULN) or direct bilirubin > 1.5 x ULN
    2. hemoglobin \< 8.5 g/dl (international system units [SI]: \< 85 g/L)
    3. neutrophils \< 1500/mm3 (SI: \< 1.5 x 109/L)
    4. white blood cell (WBC) count \< 3,000/mm3 (SI: \< 3.0 x 109/L)
    5. platelets \< 80,000 mm3 (SI: 80 x 109/L)
    6. international normalized ratio (INR) > 1.5
    7. 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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
33 participants (actual)

Study arms

  • Experimental
    LYC-30937-EC 25 mg PO once daily (QD)

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

    Drug: Drug: LYC-30937-EC

  • Placebo comparator
    Matching Placebo PO QD

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

    Drug: Placebo

Interventions

  • DrugDrug: LYC-30937-EC
  • DrugPlacebo
06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: Baseline to Week 12

Secondary outcomes

  1. 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).

    Time frame: Baseline to Week 12

  2. 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.

    Time frame: Baseline to Week 12

  3. 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\].

    Time frame: 12 weeks

  4. 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\].

    Time frame: 12 weeks

07

Results

Posted Apr 2, 2019

Participant flow

Participants were enrolled at 7 study centers within the United States. Study centers were dermatology medical clinics experienced in conducting clinical trials.

Participant flow — Overall Study
MilestoneLYC-30937-EC 25 mg PO QDMatching Placebo PO QD
Started2211
Completed179
Not completed52
Withdrew: Withdrawal by subject20
Withdrew: Lost to follow-up22
Withdrew: Discontinued due to back surgery10

Outcome measures

PrimaryThe 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).

Time frame:
Baseline to Week 12
Reported as:
Mean · percent change
The Mean Percent Change From Baseline to Week 12 in Psoriasis Area and Severity Index (PASI).
percent changeLYC-30937-EC 25 mg PO QDMatching Placebo PO QD
The Mean Percent Change From Baseline to Week 12 in Psoriasis Area and Severity Index (PASI).-25.08 ± 26.43-12.63 ± 19.67
Statistical analysis
  • LYC-30937-EC 25 mg PO QD vs Matching Placebo PO QD · ANCOVA · p = 0.2205 (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.) · Mean difference (final values): -12.80 · 95% CI -33.793 to 8.199
SecondaryThe 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).

Time frame:
Baseline to Week 12
Reported as:
Count of participants · Participants
The Number of Subjects Who Achieve a ≥ 75% Reduction From Baseline in PASI at Week 12.
ParticipantsLYC-30937-EC 25 mg PO QDMatching Placebo PO QD
The Number of Subjects Who Achieve a ≥ 75% Reduction From Baseline in PASI at Week 12.10
Statistical analysis
  • LYC-30937-EC 25 mg PO QD vs Matching Placebo PO QD · Chi-squared · p = 0.47122-sided p-value.
SecondaryThe 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.

Time frame:
Baseline to Week 12
Reported as:
Mean · percent change
The Mean Percent Change From Baseline to Week 12 in Percent Body Surface Area (BSA).
percent changeLYC-30937-EC 25 mg PO QDMatching Placebo PO QD
The Mean Percent Change From Baseline to Week 12 in Percent Body Surface Area (BSA).-12.69 ± 26.18-7.68 ± 35.75
Statistical analysis
  • LYC-30937-EC 25 mg PO QD vs Matching Placebo PO QD · ANCOVA · p = 0.6695 · Mean difference (final values): -5.34 · 95% CI -30.87 to 20.18
SecondaryThe 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\].

Time frame:
12 weeks
Reported as:
Count of participants · Participants
The Number of Subjects Who Achieve "Cleared" (Score = 0) or "Minimal" (Score = 1) on the Static Investigators Global Assessment at Week 12.
ParticipantsLYC-30937-EC 25 mg PO QDMatching Placebo PO QD
The Number of Subjects Who Achieve "Cleared" (Score = 0) or "Minimal" (Score = 1) on the Static Investigators Global Assessment at Week 12.10
Statistical analysis
  • LYC-30937-EC 25 mg PO QD vs Matching Placebo PO QD · Chi-squared · p = 0.4712 (2-sided p-value)
SecondaryThe 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\].

Time frame:
12 weeks
Reported as:
Count of participants · Participants
The Number of Subjects Who Achieve a 2 Step Reduction on the Static Investigators Global Assessment (IGA) at Week 12.
ParticipantsLYC-30937-EC 25 mg PO QDMatching Placebo PO QD
The Number of Subjects Who Achieve a 2 Step Reduction on the Static Investigators Global Assessment (IGA) at Week 12.10
Statistical analysis
  • LYC-30937-EC 25 mg PO QD vs Matching Placebo PO QD · Chi-squared · p = 0.4712 (2-sided p-value)

Adverse events

Collected over 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.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
LYC-30937-EC 25 mg PO QD0/22 (0%)0/22 (0%)11/22 (50%)
Matching Placebo PO QD0/11 (0%)0/11 (0%)4/11 (36.4%)
Most frequent other events
Showing 10 of 16
Most frequent other events
EventLYC-30937-EC 25 mg PO QDMatching Placebo PO QD
FlatulenceGastrointestinal disorders0/222/11
CoughRespiratory, thoracic and mediastinal disorders2/220/11
Gastroenteritis viralInfections and infestations2/220/11
HeadacheNervous system disorders2/220/11
NasopharyngitisInfections and infestations2/220/11
PruritisSkin and subcutaneous tissue disorders2/220/11
Upper respiratory tract infectionInfections and infestations2/220/11
DiarrhoeaGastrointestinal disorders1/221/11
ArthralgiaMusculoskeletal and connective tissue disorders0/221/11
FatigueGeneral disorders0/221/11

Baseline characteristics

Age, Continuous
Age, Continuous(years)LYC-30937-EC 25 mg PO QDMatching Placebo PO QDTotal
Mean51.6 ± 13.9148.5 ± 12.9650.6 ± 13.48
Sex: Female, Male
Sex: Female, Male(Participants)LYC-30937-EC 25 mg PO QDMatching Placebo PO QDTotal
Female9514
Male13619
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)LYC-30937-EC 25 mg PO QDMatching Placebo PO QDTotal
Hispanic or Latino112
Not Hispanic or Latino211031
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)LYC-30937-EC 25 mg PO QDMatching Placebo PO QDTotal
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American202
White201131
More than one race000
Unknown or Not Reported000
Baseline Psoriasis Area and Severity Index (PASI) score
Baseline Psoriasis Area and Severity Index (PASI) score(units on a scale)LYC-30937-EC 25 mg PO QDMatching Placebo PO QDTotal
Mean9.72 ± 2.129.38 ± 2.669.61 ± 2.28
08

Study locations

7 sites
  • Lycera Investigational Site
    Carmel, Indiana 46032, United States
  • Lycera Investigational Site
    Andover, Massachusetts 01810, United States
  • Lycera Investigational Site
    Fridley, Minnesota 55432, United States
  • Lycera Investigational Site
    East Windsor, New Jersey 08520, United States
  • Lycera Investigational Site
    High Point, North Carolina 27262, United States
  • Lycera Investigational Site
    Broomall, Pennsylvania 19008, United States
  • Lycera Investigational Site
    Norfolk, Virginia 23502, United States
09

References and documents

Study documents

  • Study protocol · Aug 30, 2016
  • Statistical analysis plan · Jul 14, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 10, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02872285
Lead sponsor
Lycera Corp.
Responsible party
Sponsor
First posted
Aug 19, 2016
Start date
Dec 5, 2016
Primary completion
Jun 22, 2017
Completion
Jun 22, 2017
Results posted
Apr 2, 2019
Last update
Apr 10, 2019

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Psoriasis→

Other studies from this sponsor

Lycera Corp.

Start the discussion