Trial Outcomes & Findings for An Efficacy and Safety Study of LYC-30937-EC in Subjects With Moderate Chronic Plaque-type Psoriasis (NCT NCT02872285)

Last Updated: 2019-04-10

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

33 participants

Primary outcome timeframe

Baseline to Week 12

Results posted on

2019-04-10

Participant Flow

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

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.

Participant milestones

Participant milestones
Measure	LYC-30937-EC 25 mg PO QD LYC-30937-EC 25 mg by mouth once daily for 12 weeks Drug: LYC-30937-EC	Matching Placebo PO QD Placebo enteric coated (EC) by mouth once daily for 12 weeks Placebo
Overall Study STARTED	22	11
Overall Study COMPLETED	17	9
Overall Study NOT COMPLETED	5	2

Reasons for withdrawal

Reasons for withdrawal
Measure	LYC-30937-EC 25 mg PO QD LYC-30937-EC 25 mg by mouth once daily for 12 weeks Drug: LYC-30937-EC	Matching Placebo PO QD Placebo enteric coated (EC) by mouth once daily for 12 weeks Placebo
Overall Study Withdrawal by Subject	2	0
Overall Study Lost to Follow-up	2	2
Overall Study Discontinued due to back surgery	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LYC-30937-EC 25 mg PO QD n=22 Participants LYC-30937-EC 25 mg by mouth once daily for 12 weeks Drug: LYC-30937-EC	Matching Placebo PO QD n=11 Participants Placebo enteric coated (EC) by mouth once daily for 12 weeks Placebo	Total n=33 Participants Total of all reporting groups
Age, Continuous	51.6 years STANDARD_DEVIATION 13.91 • n=5 Participants	48.5 years STANDARD_DEVIATION 12.96 • n=7 Participants	50.6 years STANDARD_DEVIATION 13.48 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	5 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	6 Participants n=7 Participants	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=5 Participants	10 Participants n=7 Participants	31 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants	11 Participants n=7 Participants	31 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Baseline Psoriasis Area and Severity Index (PASI) score	9.72 units on a scale STANDARD_DEVIATION 2.12 • n=5 Participants	9.38 units on a scale STANDARD_DEVIATION 2.66 • n=7 Participants	9.61 units on a scale STANDARD_DEVIATION 2.28 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline to Week 12

Population: 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.

Outcome measures

Outcome measures
Measure	LYC-30937-EC 25 mg PO QD n=18 Participants LYC-30937-EC 25 mg by mouth once daily for 12 weeks Drug: LYC-30937-EC	Matching Placebo PO QD n=9 Participants Placebo enteric coated (EC) by mouth once daily for 12 weeks Placebo
The Mean Percent Change From Baseline to Week 12 in Psoriasis Area and Severity Index (PASI).	-25.08 percent change Standard Deviation 26.43	-12.63 percent change Standard Deviation 19.67

SECONDARY outcome

Timeframe: Baseline to Week 12

Population: 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.

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).

Outcome measures

Outcome measures
Measure	LYC-30937-EC 25 mg PO QD n=18 Participants LYC-30937-EC 25 mg by mouth once daily for 12 weeks Drug: LYC-30937-EC	Matching Placebo PO QD n=9 Participants Placebo enteric coated (EC) by mouth once daily for 12 weeks Placebo
The Number of Subjects Who Achieve a ≥ 75% Reduction From Baseline in PASI at Week 12.	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline to Week 12

Population: 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.

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.

Outcome measures

Outcome measures
Measure	LYC-30937-EC 25 mg PO QD n=18 Participants LYC-30937-EC 25 mg by mouth once daily for 12 weeks Drug: LYC-30937-EC	Matching Placebo PO QD n=9 Participants Placebo enteric coated (EC) by mouth once daily for 12 weeks Placebo
The Mean Percent Change From Baseline to Week 12 in Percent Body Surface Area (BSA).	-12.69 percent change Standard Deviation 26.18	-7.68 percent change Standard Deviation 35.75

SECONDARY outcome

Timeframe: 12 weeks

Population: 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.

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\].

Outcome measures

Outcome measures
Measure	LYC-30937-EC 25 mg PO QD n=18 Participants LYC-30937-EC 25 mg by mouth once daily for 12 weeks Drug: LYC-30937-EC	Matching Placebo PO QD n=9 Participants Placebo enteric coated (EC) by mouth once daily for 12 weeks Placebo
The Number of Subjects Who Achieve "Cleared" (Score = 0) or "Minimal" (Score = 1) on the Static Investigators Global Assessment at Week 12.	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 12 weeks

Population: 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.

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\].

Outcome measures

Outcome measures
Measure	LYC-30937-EC 25 mg PO QD n=18 Participants LYC-30937-EC 25 mg by mouth once daily for 12 weeks Drug: LYC-30937-EC	Matching Placebo PO QD n=9 Participants Placebo enteric coated (EC) by mouth once daily for 12 weeks Placebo
The Number of Subjects Who Achieve a 2 Step Reduction on the Static Investigators Global Assessment (IGA) at Week 12.	1 Participants	0 Participants

Adverse Events

LYC-30937-EC 25 mg PO QD

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Matching Placebo PO QD

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

H. Jeffrey Wilkins MD, Chief Medical Officer

Lycera Corp.

Phone: 484-243-6222

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER

Other adverse events
Measure	LYC-30937-EC 25 mg PO QD n=22 participants at risk LYC-30937-EC 25 mg by mouth once daily for 12 weeks Drug: LYC-30937-EC	Matching Placebo PO QD n=11 participants at risk Placebo enteric coated (EC) by mouth once daily for 12 weeks Placebo
Respiratory, thoracic and mediastinal disorders Cough	9.1% 2/22 • Number of events 2 • 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. 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.	0.00% 0/11 • 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. 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.
Infections and infestations Gastroenteritis viral	9.1% 2/22 • Number of events 2 • 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. 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.	0.00% 0/11 • 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. 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.
Nervous system disorders Headache	9.1% 2/22 • Number of events 6 • 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. 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.	0.00% 0/11 • 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. 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.
Infections and infestations Nasopharyngitis	9.1% 2/22 • Number of events 2 • 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. 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.	0.00% 0/11 • 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. 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.
Skin and subcutaneous tissue disorders Pruritis	9.1% 2/22 • Number of events 2 • 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. 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.	0.00% 0/11 • 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. 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.
Infections and infestations Upper respiratory tract infection	9.1% 2/22 • Number of events 2 • 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. 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.	0.00% 0/11 • 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. 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.
Gastrointestinal disorders Diarrhoea	4.5% 1/22 • Number of events 2 • 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. 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.	9.1% 1/11 • Number of events 2 • 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. 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.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/22 • 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. 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.	9.1% 1/11 • Number of events 2 • 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. 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.
General disorders Fatigue	0.00% 0/22 • 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. 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.	9.1% 1/11 • Number of events 1 • 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. 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.
Gastrointestinal disorders Flatulence	0.00% 0/22 • 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. 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.	18.2% 2/11 • Number of events 2 • 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. 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.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/22 • 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. 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.	9.1% 1/11 • Number of events 1 • 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. 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.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/22 • 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. 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.	9.1% 1/11 • Number of events 1 • 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. 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.
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/22 • 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. 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.	9.1% 1/11 • Number of events 1 • 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. 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.
Skin and subcutaneous tissue disorders Seborroea	0.00% 0/22 • 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. 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.	9.1% 1/11 • Number of events 1 • 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. 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.
Vascular disorders Varicose vein	0.00% 0/22 • 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. 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.	9.1% 1/11 • Number of events 1 • 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. 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.
Injury, poisoning and procedural complications Fractured coccyx	0.00% 0/22 • 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. 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.	9.1% 1/11 • Number of events 1 • 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. 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.