Trial Outcomes & Findings for Mode of Action Study of Omalizumab in Patients With Chronic Idiopathic Urticaria (CIU) Who Fail to Respond to Antihistamine Treatment (NCT NCT01599637)

Last Updated: 2015-03-31

Results Overview

Observed values and absolute change in FcεRI positive skin cells: dermis non-lesional and lesional. The primary variable for this study was the relative change from baseline in the high affinity IgE receptor (FcεRI) positive skin cells, based on skin biopsies collected from patients with CIU after 12 weeks of treatment.The values are average of cell numbers derived from counting 5 consecutive microscopic fields. Area counted is 5x 0.196 mm2

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

40 participants

Primary outcome timeframe

Baseline through Day 85 post-treatment

Results posted on

2015-03-31

Participant Flow

Participant milestones

Participant milestones
Measure	IGE025 IGE025 administered subcutaneously every 4 weeks at the study center	Placebo to IGE025 Placebo administered subcutaneously every 4 weeks at the study center.	Healthy Volunteers Healthy volunteer data was collected at baseline only. These healthy volunteers did not receive any test treatment. The data collected from these individuals was used to provide a reference to help characterize the levels of skin biopsy markers and were used in the descriptive analyses but not formally compared with the corresponding levels in the treated subjects
Overall Study STARTED	20	10	10
Overall Study COMPLETED	19	8	10
Overall Study NOT COMPLETED	1	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	IGE025 IGE025 administered subcutaneously every 4 weeks at the study center	Placebo to IGE025 Placebo administered subcutaneously every 4 weeks at the study center.	Healthy Volunteers Healthy volunteer data was collected at baseline only. These healthy volunteers did not receive any test treatment. The data collected from these individuals was used to provide a reference to help characterize the levels of skin biopsy markers and were used in the descriptive analyses but not formally compared with the corresponding levels in the treated subjects
Overall Study administrative problems	0	2	0
Overall Study Adverse Event	1	0	0

Baseline Characteristics

Mode of Action Study of Omalizumab in Patients With Chronic Idiopathic Urticaria (CIU) Who Fail to Respond to Antihistamine Treatment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IGE025 n=20 Participants IGE025 administered subcutaneously every 4 weeks at the study center	Placebo to IGE025 n=10 Participants Placebo administered subcutaneously every 4 weeks at the study center.	Healthy Volunteers n=10 Participants Healthy volunteer data was collected at baseline only. These healthy volunteers did not receive any test treatment. The data collected from these individuals was used to provide a reference to help characterize the levels of skin biopsy markers and were used in the descriptive analyses but not formally compared with the corresponding levels in the treated subjects	Total n=40 Participants Total of all reporting groups
Age, Continuous	37.5 years STANDARD_DEVIATION 11.02 • n=5 Participants	41.1 years STANDARD_DEVIATION 7.96 • n=7 Participants	36.4 years STANDARD_DEVIATION 9.74 • n=5 Participants	38.7 years STANDARD_DEVIATION 10.11 • n=4 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	8 Participants n=7 Participants	10 Participants n=5 Participants	36 Participants n=4 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=5 Participants	10 Participants n=7 Participants	10 Participants n=5 Participants	40 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline through Day 85 post-treatment

Population: All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis. Patients with both baseline and week 12 data were included in this analysis

Outcome measures

Outcome measures
Measure	IGE025 n=20 Participants IGE025 administered subcutaneously every 4 weeks at the study center	Placebo IGE025 n=10 Participants Placebo IGE025 administered subcutaneously every 4 weeks at the study center
Observed Values and Absolute Change From Baseline in FceRI Positive Skin Cells: Dermis, Lesional and Non Lesional Skin FcεRI +ve skin cells: dermis lesional d85 (n=10,7)	13.40 FcεRI positive skin cells Standard Deviation 5.88	20.19 FcεRI positive skin cells Standard Deviation 8.76
Observed Values and Absolute Change From Baseline in FceRI Positive Skin Cells: Dermis, Lesional and Non Lesional Skin FcεRI +ve skin cells: dermis lesional D1 (n=19,8)	18.14 FcεRI positive skin cells Standard Deviation 7.08	15.17 FcεRI positive skin cells Standard Deviation 3.11
Observed Values and Absolute Change From Baseline in FceRI Positive Skin Cells: Dermis, Lesional and Non Lesional Skin FcεRI +ve skin cells:dermis lesional Chge(n=10,6)	-5.42 FcεRI positive skin cells Standard Deviation 7.42	3.69 FcεRI positive skin cells Standard Deviation 10.58
Observed Values and Absolute Change From Baseline in FceRI Positive Skin Cells: Dermis, Lesional and Non Lesional Skin FcεRI +ve skincells:dermis nonlesional D1(n=19,10)	18.91 FcεRI positive skin cells Standard Deviation 9.42	20.48 FcεRI positive skin cells Standard Deviation 5.54
Observed Values and Absolute Change From Baseline in FceRI Positive Skin Cells: Dermis, Lesional and Non Lesional Skin FcεRI +ve skincells:dermis nonlesional D85(n=18,8)	14.72 FcεRI positive skin cells Standard Deviation 7.56	20.81 FcεRI positive skin cells Standard Deviation 7.30
Observed Values and Absolute Change From Baseline in FceRI Positive Skin Cells: Dermis, Lesional and Non Lesional Skin FcεRI +ve skincells:dermis nonlesional Chg(n=17,8)	-5.40 FcεRI positive skin cells Standard Deviation 9.06	-0.07 FcεRI positive skin cells Standard Deviation 9.33

PRIMARY outcome

Timeframe: Baseline through Day 85 post-treatment

Observed values and absolute change in IgE positive skin cells: dermis non-lesional and lesional The primary variable for this study was the relative change from baseline in IgE positive skin cells, based on skin biopsies collected from patients with CIU after 12 weeks of treatment. The values are average of cell numbers derived from counting 5 consecutive microscopic fields. Area counted is 5x 0.196 mm2

Outcome measures

Outcome measures
Measure	IGE025 n=20 Participants IGE025 administered subcutaneously every 4 weeks at the study center	Placebo IGE025 n=10 Participants Placebo IGE025 administered subcutaneously every 4 weeks at the study center
Observed Values and Absolute Change From Baseline in IgE Positive Skin Cells: Dermis, Lesional and Non Lesional Skin IgE positive cells, lesional D1 (n=19,8)	12.93 IgE positive skin cells Standard Deviation 8.61	15.23 IgE positive skin cells Standard Deviation 15.71
Observed Values and Absolute Change From Baseline in IgE Positive Skin Cells: Dermis, Lesional and Non Lesional Skin IgE positive cells, lesional D85 (n=10,7)	6.73 IgE positive skin cells Standard Deviation 7.90	12.47 IgE positive skin cells Standard Deviation 6.54
Observed Values and Absolute Change From Baseline in IgE Positive Skin Cells: Dermis, Lesional and Non Lesional Skin IgE positive cells, lesional chg(n=10.6)	-5.69 IgE positive skin cells Standard Deviation 10.96	-3.95 IgE positive skin cells Standard Deviation 20.76
Observed Values and Absolute Change From Baseline in IgE Positive Skin Cells: Dermis, Lesional and Non Lesional Skin IgE positive cells,non-lesional D1 (n=19,10)	13.82 IgE positive skin cells Standard Deviation 10.21	16.59 IgE positive skin cells Standard Deviation 9.35
Observed Values and Absolute Change From Baseline in IgE Positive Skin Cells: Dermis, Lesional and Non Lesional Skin IgE positive cells,non-lesional D85 (n=18,8)	9.80 IgE positive skin cells Standard Deviation 11.66	18.30 IgE positive skin cells Standard Deviation 7.51
Observed Values and Absolute Change From Baseline in IgE Positive Skin Cells: Dermis, Lesional and Non Lesional Skin IgE positive cells,non-lesional Chng (n=17,8)	-4.87 IgE positive skin cells Standard Deviation 9.83	-0.84 IgE positive skin cells Standard Deviation 6.18

SECONDARY outcome

Timeframe: Baseline through Day 85

Population: Efficacy analysis set: Includes all randomized patients who received at least one dose of study drug and have post-randomization efficacy data.

Correlation of primary endpoint with The UAS7 which is a composite eDiary-recorded score with numeric severity intensity ratings on a scale of 0-3 (0 = none to 3 = intense/severe) for 1) the number of wheals (hives); and 2) the intensity of the itch. The daily UAS is the average of the morning and evening scores and the UAS7 is the sum of the daily UAS scores over 7 days.UAS7 score: The sum of the daily UAS scores over 7 days. Range: 0-42. If fewer than 7 but at least 4 daily values were non-missing, the remaining values were imputed to be the average. This is equivalent to multiplying the average of the non missing values by 7. UAS7 score: The sum of the daily UAS scores over 7 days. Range: 0-42. A higher score indicates worse disease.

Outcome measures

Outcome measures
Measure	IGE025 n=20 Participants IGE025 administered subcutaneously every 4 weeks at the study center	Placebo IGE025 n=10 Participants Placebo IGE025 administered subcutaneously every 4 weeks at the study center
Correlation of Change From Baseline in IgE Receptor FceRI With Change From Baseline in UAS7 at Week 12 by Treatment, Skin Layer and Lesion Status Dermis, lesional	0.3305 correlation coefficient	-0.1889 correlation coefficient
Correlation of Change From Baseline in IgE Receptor FceRI With Change From Baseline in UAS7 at Week 12 by Treatment, Skin Layer and Lesion Status Dermis, non-lesional	0.2785 correlation coefficient	0.5057 correlation coefficient
Correlation of Change From Baseline in IgE Receptor FceRI With Change From Baseline in UAS7 at Week 12 by Treatment, Skin Layer and Lesion Status Epidermis, lesional	0.0021 correlation coefficient	0.0101 correlation coefficient
Correlation of Change From Baseline in IgE Receptor FceRI With Change From Baseline in UAS7 at Week 12 by Treatment, Skin Layer and Lesion Status Epidermis, non-lesional	0.0644 correlation coefficient	0.1563 correlation coefficient

SECONDARY outcome

Timeframe: Baseline through Day 85

Population: Efficacy analysis set: Includes all randomized patients who received at least one dose of study drug and have post-randomization efficacy data.

Outcome measures

Outcome measures
Measure	IGE025 n=20 Participants IGE025 administered subcutaneously every 4 weeks at the study center	Placebo IGE025 n=10 Participants Placebo IGE025 administered subcutaneously every 4 weeks at the study center
Correlation of Change From Baseline in IgE on Positive Skin Cells With Change From Baseline in UAS7 at Week 12 by Treatment, Skin Layer and Lesion Status Dermis, lesional	0.4841 correlation coefficient	-0.0952 correlation coefficient
Correlation of Change From Baseline in IgE on Positive Skin Cells With Change From Baseline in UAS7 at Week 12 by Treatment, Skin Layer and Lesion Status Dermis, non-lesional	0.2759 correlation coefficient	0.4947 correlation coefficient
Correlation of Change From Baseline in IgE on Positive Skin Cells With Change From Baseline in UAS7 at Week 12 by Treatment, Skin Layer and Lesion Status Epidermis, lesional	0.2190 correlation coefficient	-0.1142 correlation coefficient
Correlation of Change From Baseline in IgE on Positive Skin Cells With Change From Baseline in UAS7 at Week 12 by Treatment, Skin Layer and Lesion Status Epidermis, non-lesional	0.1574 correlation coefficient	-0.2310 correlation coefficient

SECONDARY outcome

Timeframe: Baseline to Day 85

Population: All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis. Day 29 was an optional sampling time point in this paramter. The values are average of cell numbers derived from counting 5 consecutive microscopic fields. Area counted is 5x 0.196 mm2

The average number of cells derived from counting 5 consecutive microscopic fields. Area counted is 5x 0.196 mm2

Outcome measures

Outcome measures
Measure	IGE025 n=20 Participants IGE025 administered subcutaneously every 4 weeks at the study center	Placebo IGE025 n=10 Participants Placebo IGE025 administered subcutaneously every 4 weeks at the study center
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit Tryptase Epidermis non lesional Day 29 (n=4,0) Chg	0.00 # positive cells Standard Deviation 0.000	NA # positive cells Standard Deviation NA no observation made
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit Tryptase Epidermis non lesional Day 85 (n=18,8)	0.03 # positive cells Standard Deviation 0.103	0.00 # positive cells Standard Deviation 0.000
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit Tryptase Epidermis non lesional Day 85(n=17,8) Chg	0.04 # positive cells Standard Deviation 0.100	0.00 # positive cells Standard Deviation 0.000
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit Tryptase Epidermis non lesional Day140(n=16,7) Chg	0.03 # positive cells Standard Deviation 0.100	0.00 # positive cells Standard Deviation 0.000
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit Tryptase Epidermis lesional Baseline (n=19,8)	0.01 # positive cells Standard Deviation 0.046	0.08 # positive cells Standard Deviation 0.149
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit Tryptase Epidermis lesional day 8 (n=11,10)	0.33 # positive cells Standard Deviation 1.085	0.10 # positive cells Standard Deviation 0.316
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit Tryptase Epidermis lesional Day 8 (n=11,8) Chg	0.31 # positive cells Standard Deviation 1.093	0.05 # positive cells Standard Deviation 0.334
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit Tryptase Epidermis lesional Day 29 (n=5,0)	0.12 # positive cells Standard Deviation 0.268	NA # positive cells Standard Deviation NA no observation made
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit Tryptase Epidermis lesional Day 29 (n=5,0) Chg	0.08 # positive cells Standard Deviation 0.179	NA # positive cells Standard Deviation NA no observation made
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit Tryptase Epidermis lesional Day 85(n=10,7)	0.00 # positive cells Standard Deviation 0.000	0.00 # positive cells Standard Deviation 0.000
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit Tryptase Epidermis lesional Day 85(n=10,6) Chg	-0.02 # positive cells Standard Deviation 0.063	-0.10 # positive cells Standard Deviation 0.167
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit Tryptase Epidermis lesional Day 140 (n=7,5)	0.00 # positive cells Standard Deviation 0.000	0.00 # positive cells Standard Deviation 0.000
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit Tryptase Epidermis lesional Day 140 (n=7,4) Chg	-0.03 # positive cells Standard Deviation 0.076	-0.10 # positive cells Standard Deviation 0.200
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit Tryptase Dermis non lesional Baseline (n=19,10)	6.55 # positive cells Standard Deviation 3.988	7.20 # positive cells Standard Deviation 3.045
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit Tryptase Dermis non lesional Day 8 (n=19,10)	7.14 # positive cells Standard Deviation 4.479	8.37 # positive cells Standard Deviation 2.305
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit Tryptase Dermis non lesional Day 8 (n=18,10) Chg	1.14 # positive cells Standard Deviation 2.989	1.17 # positive cells Standard Deviation 3.030
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit Tryptase Dermis non lesional Day 29 (n=4,0)	8.22 # positive cells Standard Deviation 4.981	NA # positive cells Standard Deviation NA no observation made
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit Tryptase Dermis non lesional Day 29 (n=4,0) Chg	0.67 # positive cells Standard Deviation 4.816	NA # positive cells Standard Deviation NA no observation made
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit Tryptase Dermis non lesional Day 85 (n=18,8)	7.66 # positive cells Standard Deviation 4.076	8.33 # positive cells Standard Deviation 3.547
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit Tryptase Dermis non lesional Day 85 (n=17,8) Chg	0.54 # positive cells Standard Deviation 3.753	1.35 # positive cells Standard Deviation 3.839
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit Tryptase Dermis non lesional Day 140 (n=17,7)	7.77 # positive cells Standard Deviation 4.296	6.95 # positive cells Standard Deviation 1.812
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit Tryptase Dermis lesional Baseline (n=19,8)	6.08 # positive cells Standard Deviation 3.764	6.41 # positive cells Standard Deviation 2.658
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit Tryptase Dermis lesional Day 8 (n=11,10)	7.19 # positive cells Standard Deviation 3.618	6.99 # positive cells Standard Deviation 3.451
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit Tryptase Dermis lesional Day 8 (n=11,8) Chg	0.71 # positive cells Standard Deviation 2.809	0.88 # positive cells Standard Deviation 2.998
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit Tryptase Dermis lesional Day 29(n=5,0)	10.20 # positive cells Standard Deviation 4.658	NA # positive cells Standard Deviation NA no observation made
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit Tryptase Dermis lesional Day 29(n=5,0) Chg	3.80 # positive cells Standard Deviation 3.023	NA # positive cells Standard Deviation NA no observation made
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit Tryptase Dermis lesional Day 85(n=10,7)	6.76 # positive cells Standard Deviation 3.082	6.93 # positive cells Standard Deviation 3.135
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit Tryptase Dermis lesional Day 85(n=10,6) Chg	0.39 # positive cells Standard Deviation 4.141	1.67 # positive cells Standard Deviation 2.047
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit Tryptase Dermis lesional Day 140(n=7,5)	6.59 # positive cells Standard Deviation 6.335	6.79 # positive cells Standard Deviation 1.635
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit Tryptase Dermis lesional Day 140(n=7,4) Chg	2.68 # positive cells Standard Deviation 6.641	1.97 # positive cells Standard Deviation 2.049
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD8 Dermis non lesional Day 29(n=4,0) Change	1.80 # positive cells Standard Deviation 1.849	NA # positive cells Standard Deviation NA no observation made
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD11c Dermis lesional D8(n=11,10)	28.85 # positive cells Standard Deviation 22.240	22.12 # positive cells Standard Deviation 8.669
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD11c Dermis lesional D85 (n=10,7)	24.82 # positive cells Standard Deviation 13.724	22.59 # positive cells Standard Deviation 16.719
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD3 Epidermis non lesional Day 8 (n=19,10)	0.49 # positive cells Standard Deviation 0.754	0.34 # positive cells Standard Deviation 0.422
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD3 Epidermis non lesional Day 8 (n=18,10) Change	0.14 # positive cells Standard Deviation 0.636	-0.34 # positive cells Standard Deviation 1.091
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD3 Epidermis non lesional Day 29 (n=4,0)	0.32 # positive cells Standard Deviation 0.367	NA # positive cells Standard Deviation NA no observation made
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD3 Epidermis lesional Day 8(n=11,10) Change	0.14 # positive cells Standard Deviation 0.604	0.11 # positive cells Standard Deviation 1.058
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD3 Epidermis lesional Day 29(n=5,0) Change	-0.33 # positive cells Standard Deviation 0.574	NA # positive cells Standard Deviation NA no observations made
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD3 Dermis lesional Day 85 (n=10,7)	11.01 # positive cells Standard Deviation 3.615	14.44 # positive cells Standard Deviation 13.122
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD3 Dermis lesional Day 140 (n=7,5)	12.42 # positive cells Standard Deviation 7.600	14.58 # positive cells Standard Deviation 19.403
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD4 Dermis non lesional Day 29(n=4,0)	15.58 # positive cells Standard Deviation 5.070	NA # positive cells Standard Deviation NA no observation made
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD4 Dermis lesional Day 29(n=5,0)	17.12 # positive cells Standard Deviation 8.146	NA # positive cells Standard Deviation NA no observation made
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD4 Dermis lesional Day 29(n=5,0) Change	3.20 # positive cells Standard Deviation 4.250	NA # positive cells Standard Deviation NA no ondervation made
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD8 Epidermis non lesional Baseline(n=19,10)	0.20 # positive cells Standard Deviation 0.306	0.24 # positive cells Standard Deviation 0.420
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD8 Epidermis non lesional Day 29(n=4,0)	0.39 # positive cells Standard Deviation 0.347	NA # positive cells Standard Deviation NA no observation made
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD8 Epidermis non lesional Day 29(n=4,0) Change	-0.21 # positive cells Standard Deviation 0.448	NA # positive cells Standard Deviation NA no observation made
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD8 Dermis non lesional Day 140(n=17,7) Change	4.30 # positive cells Standard Deviation 2.357	5.09 # positive cells Standard Deviation 3.523
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD8 Dermis non lesional Day 29(n=5,0)	10.14 # positive cells Standard Deviation 6.133	NA # positive cells Standard Deviation NA no observation made
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD8 Dermis non lesional Day 29(n=5,0) Change	2.48 # positive cells Standard Deviation 5.639	NA # positive cells Standard Deviation NA no observation made
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD117 Dermis non lesional Day 85 (n=18,8)	10.93 # positive cells Standard Deviation 6.046	11.18 # positive cells Standard Deviation 4.568
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit Giemsa Epidermis non lesional Baseline (n=19,10)	0.00 # positive cells Standard Deviation 0.000	0.00 # positive cells Standard Deviation 0.000
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit Giemsa Epidermis non lesional Day 8 (n=19,10)	0.00 # positive cells Standard Deviation 0.000	0.00 # positive cells Standard Deviation 0.000
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit Giemsa Epidermis non lesional Day 140(n=17,8) Chge	0.00 # positive cells Standard Deviation 0.000	0.00 # positive cells Standard Deviation 0.000
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit Giemsa Dermis non lesional Day 140 (n=18,10 ) Chge	-1.35 # positive cells Standard Deviation 5.078	-4.86 # positive cells Standard Deviation 7.348
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit Giemsa Dermis lesional Day 140(n=6,5 )	7.57 # positive cells Standard Deviation 2.589	9.44 # positive cells Standard Deviation 10.468
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit H&E Dermis non lesional Day 29(n=4,0 ) Chge	0.00 # positive cells Standard Deviation 0.000	NA # positive cells Standard Deviation NA no observation made
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit H&E Dermis non lesional Day 85(n=16,8 ) Chge	0.00 # positive cells Standard Deviation 0.000	0.00 # positive cells Standard Deviation 0.000
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit H&E Dermis non lesional Day 140(n=17,7 )	0.00 # positive cells Standard Deviation 0.000	0.03 # positive cells Standard Deviation 0.076
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit H&E Dermis lesional Baseline(n=19,8 )	0.02 # positive cells Standard Deviation 0.071	0.03 # positive cells Standard Deviation 0.071
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit H&E Dermis lesional Day 29(n=5,0 )	0.00 # positive cells Standard Deviation 0.000	NA # positive cells Standard Deviation NA no observation made
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit H&E Dermis lesional Day 29(n=5,0 ) Chge	0.00 # positive cells Standard Deviation 0.000	NA # positive cells Standard Deviation NA no observation made
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit H&E Dermis lesional Day 85(n=10,6 )	0.00 # positive cells Standard Deviation 0.000	0.03 # positive cells Standard Deviation 0.082
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit Tryptase Epidermis non lesional Day 140 (n=17,7)	0.02 # positive cells Standard Deviation 0.097	0.00 # positive cells Standard Deviation 0.000
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit Tryptase Dermis non lesional Day 140 (n=16,7) Chg	1.27 # positive cells Standard Deviation 3.599	-0.62 # positive cells Standard Deviation 3.002
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD11c Epidermis Non lesional Baseline (n= 19,10)	1.06 # positive cells Standard Deviation 1.077	1.25 # positive cells Standard Deviation 0.584
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD11c Epidermis Non lesional Day 8 (n=19,10)	1.41 # positive cells Standard Deviation 1.313	0.95 # positive cells Standard Deviation 0.920
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD11c Epidermis Non lesional D 8(n=18,10) Chge	0.39 # positive cells Standard Deviation 1.351	-0.30 # positive cells Standard Deviation 1.255
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD11c Epidermis Non lesional D 29(n=4,0)	1.00 # positive cells Standard Deviation 0.000	NA # positive cells Standard Deviation NA no observations made
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD11c Epidermis Non lesional D 29(n=4,0) Chg	0.70 # positive cells Standard Deviation 0.383	NA # positive cells Standard Deviation NA no observations made
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD11c Epidermis Non lesional D 85(n=18,8)	1.19 # positive cells Standard Deviation 0.806	0.53 # positive cells Standard Deviation 0.544
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD11c Epidermis Non lesional D 85(n=17,8) Chge	0.04 # positive cells Standard Deviation 1.216	-0.84 # positive cells Standard Deviation 0.524
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD11c Epidermis Non lesional D 140(n=17,7)	1.25 # positive cells Standard Deviation 1.630	0.58 # positive cells Standard Deviation 0.942
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD11c Epidermis Non lesional D 140(n=17,7) Chge	0.04 # positive cells Standard Deviation 1.216	-0.75 # positive cells Standard Deviation 0.939
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD11c Epidermis lesional baseline (n=19,8)	1.17 # positive cells Standard Deviation 1.363	3.79 # positive cells Standard Deviation 8.028
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD11c Epidermis lesional D8 (n=11,10)	1.63 # positive cells Standard Deviation 1.425	1.19 # positive cells Standard Deviation 1.329
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD11c Epidermis lesional D8 (n=11,8) Change	0.39 # positive cells Standard Deviation 1.153	-2.74 # positive cells Standard Deviation 8.466
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD11c Epidermis lesional D29 (n=5,0)	1.56 # positive cells Standard Deviation 1.609	NA # positive cells Standard Deviation NA no observations made
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD11c Epidermis lesional D29 (n=5,0) Change	0.88 # positive cells Standard Deviation 1.677	NA # positive cells Standard Deviation NA no observations made
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD11c Epidermis lesional D85 (n=10,7)	1.18 # positive cells Standard Deviation 0.577	0.46 # positive cells Standard Deviation 0.378
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD11c Epidermis lesional D85 (n=10,6) Change	-0.06 # positive cells Standard Deviation 1.234	-4.06 # positive cells Standard Deviation 9.384
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD11c Epidermis lesional D140 (n=6,5)	0.53 # positive cells Standard Deviation 0.555	0.18 # positive cells Standard Deviation 0.171
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD11c Epidermis lesional D140 (n=6,5) Change	0.12 # positive cells Standard Deviation 0.599	-6.37 # positive cells Standard Deviation 11.503
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD11c Dermis non lesional baseline (n=19,10)	17.86 # positive cells Standard Deviation 7.322	22.97 # positive cells Standard Deviation 12.248
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD11c Dermis non lesional D8 (n=19,10)	18.33 # positive cells Standard Deviation 8.971	20.22 # positive cells Standard Deviation 10.861
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD11c Dermis non lesional D8 (n=19,10) Change	0.42 # positive cells Standard Deviation 7.613	-2.75 # positive cells Standard Deviation 6.149
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD11c Dermis non lesional D29 (n=4,0)	15.63 # positive cells Standard Deviation 10.636	NA # positive cells Standard Deviation NA no observations made
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD11c Dermis non lesional D29 (n=4,0) Change	0.93 # positive cells Standard Deviation 15.472	NA # positive cells Standard Deviation NA no observations made
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD11c Dermis non lesional D85 (n=18,8)	17.05 # positive cells Standard Deviation 5.656	23.73 # positive cells Standard Deviation 19.031
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD11c Dermis non lesional D85 (n=17,8) Change	-1.52 # positive cells Standard Deviation 7.562	-1.23 # positive cells Standard Deviation 15.514
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD11c Dermis non lesional D140 (n=17,7)	22.85 # positive cells Standard Deviation 11.189	15.58 # positive cells Standard Deviation 9.691
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD11c Dermis non lesional D140 (n=16,7) Change	3.51 # positive cells Standard Deviation 11.162	-11.51 # positive cells Standard Deviation 15.849
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD11c Dermis lesional baseline(n=19,8)	27.14 # positive cells Standard Deviation 12.552	22.46 # positive cells Standard Deviation 9.700
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD11c Dermis lesional D8(n=11,8) Change	3.56 # positive cells Standard Deviation 16.705	0.99 # positive cells Standard Deviation 8.677
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD11c Dermis lesional D29 (n=5,0)	27.04 # positive cells Standard Deviation 11.509	NA # positive cells Standard Deviation NA no observations made
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD11c Dermis lesional D29 (n=5,0) Change	-0.28 # positive cells Standard Deviation 5.403	NA # positive cells Standard Deviation NA no observations made
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD11c Dermis lesional D85 (n=10,6) Change	-0.09 # positive cells Standard Deviation 15.000	4.07 # positive cells Standard Deviation 22.288
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD11c Dermis lesional D140 (n=6,5)	37.33 # positive cells Standard Deviation 21.229	22.59 # positive cells Standard Deviation 16.719
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD11c Dermis lesional D140 (n=6,4) Change	11.30 # positive cells Standard Deviation 23.485	12.43 # positive cells Standard Deviation 9.210
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD3 Epidermis non lesional Baseline (n=19,10)	0.37 # positive cells Standard Deviation 0.593	0.68 # positive cells Standard Deviation 1.151
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD3 Epidermis non lesional Day 29 (n=4,0) Change	0.07 # positive cells Standard Deviation 0.094	NA # positive cells Standard Deviation NA no observation made
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD3 Epidermis non lesional Day 85 (n=18,8)	0.47 # positive cells Standard Deviation 0.660	0.30 # positive cells Standard Deviation 0.283
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD3 Epidermis non lesional Day 85 (n=17,8) Change	0.14 # positive cells Standard Deviation 0.438	-0.46 # positive cells Standard Deviation 1.249
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD3 Epidermis non lesional Day 140 (n=17,7)	0.36 # positive cells Standard Deviation 0.470	0.75 # positive cells Standard Deviation 1.245
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD3 Epidermis non lesional Day 140 (n=16,7) Change	-0.08 # positive cells Standard Deviation 0.554	-0.09 # positive cells Standard Deviation 2.092
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD3 Epidermis lesional Baseline (n=19,8)	0.42 # positive cells Standard Deviation 0.459	0.49 # positive cells Standard Deviation 0.892
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD3 Epidermis lesional Day 8(n=11,10)	0.55 # positive cells Standard Deviation 0.561	0.84 # positive cells Standard Deviation 0.913
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD3 Epidermis lesional Day 29(n=5,0)	0.28 # positive cells Standard Deviation 0.438	NA # positive cells Standard Deviation NA no observations made
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD3 Epidermis lesional Day 85(n=10,7)	0.46 # positive cells Standard Deviation 0.558	0.47 # positive cells Standard Deviation 0.499
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD3 Epidermis lesional Day 85(n=10,6) Change	0.07 # positive cells Standard Deviation 0.672	-0.09 # positive cells Standard Deviation 0.873
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD3 Epidermis lesional Day 140(n=7,5)	0.84 # positive cells Standard Deviation 0.983	0.94 # positive cells Standard Deviation 0.969
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD3 Epidermis lesional Day 140(n=7,4) Change	0.27 # positive cells Standard Deviation 0.843	0.98 # positive cells Standard Deviation 0.642
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD3 Dermis non lesional Baseline(n=19,10)	9.97 # positive cells Standard Deviation 4.924	12.46 # positive cells Standard Deviation 7.954
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD3 Dermis non lesional Day 8(n=19,10)	10.81 # positive cells Standard Deviation 5.359	8.66 # positive cells Standard Deviation 4.495
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD3 Dermis non lesional Day 8(n=18,10) Change	0.72 # positive cells Standard Deviation 6.503	-3.80 # positive cells Standard Deviation 5.984
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD3 Dermis non lesional Day 29(n=4,0)	6.87 # positive cells Standard Deviation 1.427	NA # positive cells Standard Deviation NA no observation made
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD3 Dermis non lesional Day 29(n=4,0) Change	-1.78 # positive cells Standard Deviation 3.096	NA # positive cells Standard Deviation NA no observaions made
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD3 Dermis non lesional Day 85(n=18,8)	12.71 # positive cells Standard Deviation 9.845	11.46 # positive cells Standard Deviation 7.900
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD3 Dermis non lesional Day 85(n=18,8) Change	2.61 # positive cells Standard Deviation 8.287	-2.09 # positive cells Standard Deviation 5.865
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD3 Dermis non lesional Day 140(n=17,7)	11.80 # positive cells Standard Deviation 6.960	7.22 # positive cells Standard Deviation 5.823
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD3 Dermis non lesional Day 140(n=16,7) Change	1.03 # positive cells Standard Deviation 5.717	-6.15 # positive cells Standard Deviation 10.618
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD3 Dermis lesional Baseline(n=19,8)	12.75 # positive cells Standard Deviation 6.934	11.94 # positive cells Standard Deviation 6.245
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD3 Dermis lesional Day 8 (n=11,10)	14.93 # positive cells Standard Deviation 8.543	12.56 # positive cells Standard Deviation 8.894
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD3 Dermis lesional Day 8 (n=11,10) Change	2.07 # positive cells Standard Deviation 6.576	1.58 # positive cells Standard Deviation 7.177
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD3 Dermis lesional Day 29 (n=5,0)	13.08 # positive cells Standard Deviation 7.275	NA # positive cells Standard Deviation NA no observations made
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD3 Dermis lesional day 29 (n=5,0) Change	0.78 # positive cells Standard Deviation 10.054	NA # positive cells Standard Deviation NA no observations made
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD3 Dermis lesional Day 85 (n=10,6) Change	0.46 # positive cells Standard Deviation 5.775	2.24 # positive cells Standard Deviation 13.351
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD3 Dermis lesional Day 140(n=7,4) Change	0.93 # positive cells Standard Deviation 10.179	6.33 # positive cells Standard Deviation 20.884
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD4 Epidermis non lesional Baseline (n=19,10)	0.99 # positive cells Standard Deviation 1.400	1.07 # positive cells Standard Deviation 1.018
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD4 Epidermis non lesional Day 8 (n=19,10)	1.20 # positive cells Standard Deviation 1.428	1.46 # positive cells Standard Deviation 1.639
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD4 Epidermis non lesional Day 8 (n=18,10) Change	0.33 # positive cells Standard Deviation 1.287	0.39 # positive cells Standard Deviation 1.826
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD4 Epidermis non lesional Day 29 (n=4,0)	1.43 # positive cells Standard Deviation 1.144	NA # positive cells Standard Deviation NA no observation made
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD4 Epidermis non lesional Day 29 (n=4,0) change	-0.13 # positive cells Standard Deviation 0.922	NA # positive cells Standard Deviation NA no observations made
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD4 Epidermis non lesional Day 85(n=18,8)	0.69 # positive cells Standard Deviation 1.528	0.44 # positive cells Standard Deviation 0.360
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD4 Epdiermis non lesional Day 85(n=18,8) Change	-0.31 # positive cells Standard Deviation 2.239	-0.49 # positive cells Standard Deviation 0.797
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD4 Epidermis non lesional Day 140(n=17,7)	0.81 # positive cells Standard Deviation 0.742	0.76 # positive cells Standard Deviation 1.355
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD4 Epidermis non lesional Day 140(n=16,7) Change	-0.07 # positive cells Standard Deviation 1.283	-0.04 # positive cells Standard Deviation 1.802
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD4 Epidermis lesional Baseline(n=19,8)	0.95 # positive cells Standard Deviation 1.066	0.91 # positive cells Standard Deviation 1.204
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD4 Epidermis lesional Day 8(n=11,10)	0.63 # positive cells Standard Deviation 0.725	0.90 # positive cells Standard Deviation 0.920
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD4 Epidermis lesional Day 8(n=11,8) Change	-0.46 # positive cells Standard Deviation 1.193	-0.04 # positive cells Standard Deviation 0.680
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD4 Epidermis lesional Day 29(n=5,0)	1.52 # positive cells Standard Deviation 1.927	NA # positive cells Standard Deviation NA no observation made
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD4 Epdiermis lesional Day 29(n=5,0) Change	0.12 # positive cells Standard Deviation 1.726	NA # positive cells Standard Deviation NA no observation made
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD4 Epidermis lesional Day 85(n=10,7)	0.68 # positive cells Standard Deviation 0.691	0.47 # positive cells Standard Deviation 0.432
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD4 Epidermis lesional Day 85(n=10,6) Change	-0.20 # positive cells Standard Deviation 0.847	-0.78 # positive cells Standard Deviation 1.3489
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD4 Epidermis lesional Day 140(n=6,5)	0.03 # positive cells Standard Deviation 0.082	0.84 # positive cells Standard Deviation 0.518
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD4 Epidermis lesional Day 140(n=6,4) Change	-0.61 # positive cells Standard Deviation 1.281	-0.73 # positive cells Standard Deviation 1.473
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD4 Dermis non lesional Baseline(n=19,10)	16.81 # positive cells Standard Deviation 6.868	19.39 # positive cells Standard Deviation 13.966
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD4 Dermis non lesional Day 8(n=19,10)	17.80 # positive cells Standard Deviation 8.144	16.04 # positive cells Standard Deviation 10.590
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD4 Dermis non lesional Day 8(n=18,10) Change	1.21 # positive cells Standard Deviation 9.816	-3.35 # positive cells Standard Deviation 10.063
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD4 Dermis non lesional Day 29(n=4,0) Change	-0.88 # positive cells Standard Deviation 1.928	NA # positive cells Standard Deviation NA no observation made
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD4 Dermis non lesional Day 85(n=18,8) Change	19.33 # positive cells Standard Deviation 7.741	19.21 # positive cells Standard Deviation 10.316
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD4 Dermis non lesional Day 85(n=17,8) Change	1.94 # positive cells Standard Deviation 10.126	-2.32 # positive cells Standard Deviation 9.451
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD4 Dermis non lesional Day 140(n=17,7)	21.14 # positive cells Standard Deviation 11.300	16.90 # positive cells Standard Deviation 10.151
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD4 Dermis non lesional Day 140(n=16,7) Change	3.36 # positive cells Standard Deviation 11.994	-2.01 # positive cells Standard Deviation 13.600
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD4 Dermis lesional baseline(n=19,8)	14.28 # positive cells Standard Deviation 5.351	18.98 # positive cells Standard Deviation 9.361
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD4 Dermis lesional Day 8(n=11,10)	17.84 # positive cells Standard Deviation 10.403	17.74 # positive cells Standard Deviation 9.230
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD4 Dermis lesional Day 8(n=11,8) Change	2.86 # positive cells Standard Deviation 7.576	0.10 # positive cells Standard Deviation 10.085
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD4 Dermis lesional Day 85(n=10,7)	17.20 # positive cells Standard Deviation 6.815	19.80 # positive cells Standard Deviation 12.617
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD4 Dermis lesional Day 85(n=10,6) Change	3.41 # positive cells Standard Deviation 7.859	0.98 # positive cells Standard Deviation 10.706
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD4 Dermis lesional Day 140(n=6,5)	12.81 # positive cells Standard Deviation 10.305	19.80 # positive cells Standard Deviation 12.617
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD4 Dermis lesional Day 140(n=6,4) Change	2.58 # positive cells Standard Deviation 11.073	-0.15 # positive cells Standard Deviation 11.300
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD8 Epidermis non lesional Day 8(n=19,10)	0.40 # positive cells Standard Deviation 0.593	0.20 # positive cells Standard Deviation 0.340
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD8 Epidermis non lesional Day 8(n=18,10) Change	0.24 # positive cells Standard Deviation 0.550	-0.04 # positive cells Standard Deviation 0.532
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD8 Epidermis non lesional Day 85(n=18,8)	0.22 # positive cells Standard Deviation 0.361	0.15 # positive cells Standard Deviation 0.207
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD8 Epidermis non lesional Day 85(n=17,8) Change	0.00 # positive cells Standard Deviation 0.473	-0.13 # positive cells Standard Deviation 0.354
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD8 Epidermis non lesional Day 140(n=17,7)	0.16 # positive cells Standard Deviation 0.215	0.28 # positive cells Standard Deviation 0.351
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD8 Epidermis non lesional Day 140(n=16,7) Change	-0.04 # positive cells Standard Deviation 0.344	-0.01 # positive cells Standard Deviation 0.566
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD8 Epidermis lesional Baseline(n=19,8)	0.34 # positive cells Standard Deviation 0.644	0.14 # positive cells Standard Deviation 0.207
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD8 Epidermis lesional Day 8(n=11,10)	0.43 # positive cells Standard Deviation 0.568	0.08 # positive cells Standard Deviation 0.140
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD8 Epidermis lesional Day 8(n=11,8) Change	0.30 # positive cells Standard Deviation 0.534	-0.11 # positive cells Standard Deviation 0.236
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD8 Epidermis lesional Day 29(n=5,0)	0.20 # positive cells Standard Deviation 0.346	NA # positive cells Standard Deviation NA no observation made
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD8 Epidermis lesional Day 29(n=5,0) Change	0.08 # positive cells Standard Deviation 0.363	NA # positive cells Standard Deviation NA no observation made
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD8 Epidermis lesional Day 85(n=10,7)	0.14 # positive cells Standard Deviation 0.313	0.03 # positive cells Standard Deviation 0.076
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD8 Epidermis lesional Day 85(n=10,6) Change	-0.01 # positive cells Standard Deviation 0.356	-0.15 # positive cells Standard Deviation 0.235
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD8 Epidermis lesional Day 140(n=6,5)	0.03 # positive cells Standard Deviation 0.082	0.33 # positive cells Standard Deviation 0.239
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD8 Epidermis lesional Day 140(n=6,4) Change	-0.53 # positive cells Standard Deviation 1.129	0.18 # positive cells Standard Deviation 0.304
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD8 Dermis non lesional Baseline(n=19,10)	5.74 # positive cells Standard Deviation 3.278	6.59 # positive cells Standard Deviation 3.826
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD8 Dermis non lesional Day 8(n=19,10)	7.10 # positive cells Standard Deviation 5.020	5.50 # positive cells Standard Deviation 3.779
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD8 Dermis non lesional Day 8 (n=18,10) Change	1.19 # positive cells Standard Deviation 4.798	-1.09 # positive cells Standard Deviation 1.374
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD8 Dermis non lesional Day 29(n=4,0)	8.45 # positive cells Standard Deviation 5.369	NA # positive cells Standard Deviation NA no observation made
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD8 Dermis non lesional Day 85 (n=18,8) Change	5.51 # positive cells Standard Deviation 3.725	7.62 # positive cells Standard Deviation 4.288
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD8 Dermis non lesional Day 85 (n=17,8) Change	-0.46 # positive cells Standard Deviation 2.757	0.35 # positive cells Standard Deviation 3.067
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD8 Dermis non lesional Day 140(n=16,7) Change	-1.74 # positive cells Standard Deviation 2.726	-2.65 # positive cells Standard Deviation 1.686
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD8 Dermis lesional Baseline(n=19,8)	5.67 # positive cells Standard Deviation 2.983	4.63 # positive cells Standard Deviation 2.448
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD8 Dermis non lesional Day 8(n=11,10)	7.55 # positive cells Standard Deviation 4.953	6.12 # positive cells Standard Deviation 3.847
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD8 Dermis non lesional Day 8(n=11,8) Change	1.02 # positive cells Standard Deviation 5.174	0.88 # positive cells Standard Deviation 2.679
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD8 Dermis non lesional Day 85(n=10,7)	7.19 # positive cells Standard Deviation 3.022	6.70 # positive cells Standard Deviation 6.690
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD8 Dermis non lesional Day 85(n=10,6) Change	0.98 # positive cells Standard Deviation 3.556	1.48 # positive cells Standard Deviation 6.628
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD8 Dermis non lesional Day 140(n=6,5)	7.73 # positive cells Standard Deviation 6.774	6.37 # positive cells Standard Deviation 10.549
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD8 Dermis non lesional Day 140(n=6,4)	1.87 # positive cells Standard Deviation 7.440	3.57 # positive cells Standard Deviation 10.671
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD117 Epidermis non lesional Baseline (n=19,10)	9.47 # positive cells Standard Deviation 5.070	10.99 # positive cells Standard Deviation 4.498
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD117 Epidermis non lesional Day 8 (n=19,10)	10.29 # positive cells Standard Deviation 4.555	9.68 # positive cells Standard Deviation 3.057
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD117 Epidermis non lesional Day 8 (n=18,10) Chge	0.99 # positive cells Standard Deviation 5.511	-1.31 # positive cells Standard Deviation 2.493
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD117 Epidermis non lesional Day 29 (n=4,0)	12.00 # positive cells Standard Deviation 4.578	NA # positive cells Standard Deviation NA no observationmade
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD117 Epidermis non lesional Day 29 (n=4,0) Chge	1.05 # positive cells Standard Deviation 2.996	NA # positive cells Standard Deviation NA no observation made
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD117 Epidermis non lesional Day 85 (n=18,8)	8.75 # positive cells Standard Deviation 4.492	9.17 # positive cells Standard Deviation 2.550
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD117 Epidermis non lesional Day 85 (n=17,8) Chge	-1.62 # positive cells Standard Deviation 5.338	-1.02 # positive cells Standard Deviation 4.166
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD117 Epidermis non lesional Day 140 (n=17,7)	9.89 # positive cells Standard Deviation 3.427	8.01 # positive cells Standard Deviation 2.744
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD117 Epidermis non lesional Day 140 (n=16,7) Chge	0.023 # positive cells Standard Deviation 3.866	-2.43 # positive cells Standard Deviation 2.234
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD117 Epidermis lesional baseline(n=19,8)	7.64 # positive cells Standard Deviation 3.710	10.18 # positive cells Standard Deviation 3.804
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD117 Epidermis lesional Day 8(n=11,10)	11.25 # positive cells Standard Deviation 5.742	10.84 # positive cells Standard Deviation 3.865
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD117 Epidermis lesional Day 8(n=11,8) Change	2.58 # positive cells Standard Deviation 4.315	1.42 # positive cells Standard Deviation 5.978
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD117 Epidermis lesional Day 29(n=5,0)	14.06 # positive cells Standard Deviation 4.272	NA # positive cells Standard Deviation NA no observation made
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD117 Epidermis lesional Day 29(n=5,0) Change	3.74 # positive cells Standard Deviation 4.844	NA # positive cells Standard Deviation NA no observation made
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD117 Epidermis lesional Day 85(n=10,7)	10.68 # positive cells Standard Deviation 6.160	8.77 # positive cells Standard Deviation 2.606
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD117 Epidermis lesional Day 85(n=10,6) Change	2.10 # positive cells Standard Deviation 5.703	-0.97 # positive cells Standard Deviation 3.885
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD117 Epidermis lesional Day 140(n=6,5)	9.88 # positive cells Standard Deviation 4.399	8.66 # positive cells Standard Deviation 2.136
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD117 Epidermis lesional Day 140(n=6,4) Change	2.41 # positive cells Standard Deviation 3.792	-0.98 # positive cells Standard Deviation 3.444
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD117 Dermis non lesional Baseline (n=19,10)	10.59 # positive cells Standard Deviation 6.616	10.11 # positive cells Standard Deviation 2.910
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD117 Dermis non lesional Day 8 (n=19,10)	12.00 # positive cells Standard Deviation 6.370	9.20 # positive cells Standard Deviation 3.319
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD117 Dermis non lesional Day 8 (n=18,10) Change	1.49 # positive cells Standard Deviation 5.924	-0.91 # positive cells Standard Deviation 3.078
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD117 Dermis lesional Day 8(n=11,8) Change	0.60 # positive cells Standard Deviation 4.374	1.26 # positive cells Standard Deviation 2.890
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD117 Dermis lesional Day 29(n=5,0)	12.42 # positive cells Standard Deviation 5.175	NA # positive cells Standard Deviation NA no observation made
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD117 Dermis lesional Day 29(n=5,0) Change	5.39 # positive cells Standard Deviation 5.412	NA # positive cells Standard Deviation NA no observation made
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD117 Dermis lesional Day 85(n=10,7)	11.07 # positive cells Standard Deviation 6.023	9.51 # positive cells Standard Deviation 2.891
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD117 Dermis lesional Day 85(n=10,6) Change	2.11 # positive cells Standard Deviation 5.917	3.03 # positive cells Standard Deviation 2.659
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD117 Dermis lesional Day 140(n=6,5)	10.92 # positive cells Standard Deviation 6.704	8.87 # positive cells Standard Deviation 4.017
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD117 Dermis lesional Day 140(n=6,4) Change	5.12 # positive cells Standard Deviation 6.410	2.88 # positive cells Standard Deviation 4.907
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit Giemsa Epidermis non lesional Day 8 (n=18,10) Chge	0.00 # positive cells Standard Deviation 0.000	0.00 # positive cells Standard Deviation 0.000
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit Giemsa Epidermis non lesional Day 29 (n=4,0)	0.00 # positive cells Standard Deviation 0.000	NA # positive cells Standard Deviation NA no observation made
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit Giemsa Epidermis non lesional Day 29 (n=4,0) Chge	0.00 # positive cells Standard Deviation 0.000	NA # positive cells Standard Deviation NA no observation made
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit Giemsa Epidermis non lesional Day 85 (n=18,8)	0.00 # positive cells Standard Deviation 0.000	0.00 # positive cells Standard Deviation 0.000
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit Giemsa Epidermis non lesional Day 85 (n=17,8)	0.00 # positive cells Standard Deviation 0.000	0.00 # positive cells Standard Deviation 0.000
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit Giemsa Epidermis non lesional Day 140(n=18,8)	0.00 # positive cells Standard Deviation 0.000	0.00 # positive cells Standard Deviation 0.000
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit Giemsa Epidermis lesional Baseline (n=19,8)	0.00 # positive cells Standard Deviation 0.000	0.03 # positive cells Standard Deviation 0.071
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit Giemsa Epidermis lesional Day 8 (n=11,10)	0.00 # positive cells Standard Deviation 0.000	0.00 # positive cells Standard Deviation 0.000
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit Giemsa Epidermis lesional Day 8 (n=11,8) Chge	0.00 # positive cells Standard Deviation 0.000	-0.03 # positive cells Standard Deviation 0.071
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit Giemsa Epidermis lesional Day 29(n=5,0 )	0.00 # positive cells Standard Deviation 0.000	NA # positive cells Standard Deviation NA no observation made
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit Giemsa Epidermis lesional Day 29(n=5,0 ) Chge	0.00 # positive cells Standard Deviation 0.000	NA # positive cells Standard Deviation NA no observation made
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit Giemsa Epidermis lesional Day 85 (n=10,6)	0.00 # positive cells Standard Deviation 0.000	0.00 # positive cells Standard Deviation 0.000
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit Giemsa Epidermis lesional Day 85 (n=10,5) Chge	0.00 # positive cells Standard Deviation 0.000	-.04 # positive cells Standard Deviation 0.089
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit Giemsa Epidermis lesional Day 140(n=6,5 )	0.00 # positive cells Standard Deviation 0.000	1.00 # positive cells Standard Deviation 2.236
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit Giemsa Epidermis lesional Day 140(n=6,4 ) Chge	0.00 # positive cells Standard Deviation 0.000	1.25 # positive cells Standard Deviation 2.500
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit Giemsa Dermis non lesional Baseline (n=19,10 )	6.91 # positive cells Standard Deviation 4.751	6.80 # positive cells Standard Deviation 8.610
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit Giemsa Dermis non lesional Day 8 (n=19,10 )	5.51 # positive cells Standard Deviation 4.142	4.47 # positive cells Standard Deviation 4.529
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit Giemsa Dermis non lesional Day 8 (n=18,10 ) Chge	-1.33 # positive cells Standard Deviation 5.141	-2.33 # positive cells Standard Deviation 4.750
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit Giemsa Dermis non lesional Day 29 (n=4,0 )	3.88 # positive cells Standard Deviation 1.876	NA # positive cells Standard Deviation NA no observation made
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit Giemsa Dermis non lesional Day 29 (n=4,0 ) Chge	-1.62 # positive cells Standard Deviation 1.811	NA # positive cells Standard Deviation NA no observation made
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit Giemsa Dermis non lesional Day 85 (n=18,8 )	4.75 # positive cells Standard Deviation 3.397	5.28 # positive cells Standard Deviation 4.906
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit Giemsa Dermis non lesional Day 85 (n=17,8 ) Chge	-2.34 # positive cells Standard Deviation 3.618	-2.16 # positive cells Standard Deviation 6.705
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit Giemsa Dermis non lesional Day 140 (n=18,10 )	6.69 # positive cells Standard Deviation 5.409	3.12 # positive cells Standard Deviation 3.120
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit Giemsa Dermis lesional Baseline(n=19,8 )	8.29 # positive cells Standard Deviation 5.189	4.79 # positive cells Standard Deviation 5.931
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit Giemsa Dermis lesional Day 8(n=11,10 )	6.71 # positive cells Standard Deviation 4.309	4.80 # positive cells Standard Deviation 4.512
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit Giemsa Dermis lesional Day 8(n=11,8 ) Chge	-1.75 # positive cells Standard Deviation 6.143	0.18 # positive cells Standard Deviation 3.394
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit Giemsa Dermis lesional Day 29(n=5,0 )	8.09 # positive cells Standard Deviation 11.851	NA # positive cells Standard Deviation NA no observation made
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit Giemsa Dermis lesional Day 29(n=5,0 ) Chge	2.57 # positive cells Standard Deviation 12.812	NA # positive cells Standard Deviation NA no observation made
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit Giemsa Dermis lesional Day 85(n=10,6 )	5.96 # positive cells Standard Deviation 2.589	10.30 # positive cells Standard Deviation 15.647
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit Giemsa Dermis lesional Day 85 (n=10,5 ) Chge	-1.56 # positive cells Standard Deviation 7.155	6.36 # positive cells Standard Deviation 9.563
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit Giemsa Dermis lesional Day 140 (n=6,4 ) Chge	-1.20 # positive cells Standard Deviation 7.929	4.50 # positive cells Standard Deviation 5.073
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit H&E Epidermis non lesional Baseline(n=19,10 )	0.00 # positive cells Standard Deviation 0.000	0.00 # positive cells Standard Deviation 0.000
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit H&E Epidermis non lesional day 8(n=19,10 )	0.00 # positive cells Standard Deviation 0.000	0.00 # positive cells Standard Deviation 0.000
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit H&E Epidermis non lesional Day 8(n=18,10 ) Chge	0.00 # positive cells Standard Deviation 0.000	0.00 # positive cells Standard Deviation 0.000
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit H&E Epidermis non lesional Day 29(n=4,0 )	0.00 # positive cells Standard Deviation 0.000	NA # positive cells Standard Deviation NA no observation made
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit H&E Epidermis non lesional Day 29(n=4,0 ) Chge	0.00 # positive cells Standard Deviation 0.000	NA # positive cells Standard Deviation NA no observation made
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit H&E Epidermis non lesional Day 85(n=17,8 )	0.00 # positive cells Standard Deviation 0.000	0.00 # positive cells Standard Deviation 0.000
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit H&E Epidermis non lesional Day 85(n=16,8 ) Chge	0.00 # positive cells Standard Deviation 0.000	0.00 # positive cells Standard Deviation 0.000
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit H&E Epidermis non lesional Day 140 (n=17,7 )	0.00 # positive cells Standard Deviation 0.000	0.00 # positive cells Standard Deviation 0.000
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit H&E Epidermis non lesional Day 140 (n=16,7 ) Chge	0.00 # positive cells Standard Deviation 0.000	0.00 # positive cells Standard Deviation 0.000
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit H&E Epidermis lesional Baseline(n=19,8 )	0.00 # positive cells Standard Deviation 0.000	0.00 # positive cells Standard Deviation 0.000
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit H&E Epidermis lesional Day 8(n=11,10 )	0.00 # positive cells Standard Deviation 0.000	0.00 # positive cells Standard Deviation 0.000
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit H&E Epidermis lesional Day 8(n=11,8 ) Chge	0.00 # positive cells Standard Deviation 0.000	0.00 # positive cells Standard Deviation 0.000
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit H&E Epidermis lesional Day 29(n=5,0 )	0.00 # positive cells Standard Deviation 0.000	NA # positive cells Standard Deviation NA no observation made
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit H&E Epidermis lesional Day 29(n=5,0 ) Chge	0.00 # positive cells Standard Deviation 0.000	NA # positive cells Standard Deviation NA no observation made
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit H&E Epidermis lesional Day 85(n=10,6 )	0.00 # positive cells Standard Deviation 0.000	0.00 # positive cells Standard Deviation 0.000
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit H&E Epidermis lesional Day 85(n=10,5 ) Chge	0.00 # positive cells Standard Deviation 0.000	0.00 # positive cells Standard Deviation 0.000
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit H&E Epidermis lesional Day 140(n=6,5 )	0.00 # positive cells Standard Deviation 0.000	0.00 # positive cells Standard Deviation 0.000
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit H&E Epidermis lesional Day 140(n=6,4 ) Chge	0.00 # positive cells Standard Deviation 0.000	0.00 # positive cells Standard Deviation 0.000
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit H&E Dermis non lesional Baseline(n=19,10 )	0.00 # positive cells Standard Deviation 0.000	0.00 # positive cells Standard Deviation 0.000
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit H&E Dermis non lesional Day 8(n=19,10 )	0.01 # positive cells Standard Deviation 0.046	0.02 # positive cells Standard Deviation 0.063
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit H&E Dermis non lesional Day 8(n=18,10 ) Chge	0.01 # positive cells Standard Deviation 0.047	0.02 # positive cells Standard Deviation 0.063
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit H&E Dermis non lesional Day 29(n=4,0 )	0.00 # positive cells Standard Deviation 0.000	NA # positive cells Standard Deviation NA no observation made
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit H&E Dermis non lesional Day 85(n=17,8)	0.00 # positive cells Standard Deviation 0.000	0.00 # positive cells Standard Deviation 0.000
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit H&E Dermis non lesional Day 140(n=16,7 ) Chge	0.00 # positive cells Standard Deviation 0.000	0.03 # positive cells Standard Deviation 0.076
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit H&E Dermis lesional Day 8(n=11,10 )	0.05 # positive cells Standard Deviation 0.129	0.00 # positive cells Standard Deviation 0.000
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit H&E Dermis lesional Day 8(n=11,8 ) Chge	0.03 # positive cells Standard Deviation 0.159	-0.03 # positive cells Standard Deviation 0.071
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit H&E Dermis lesional Day 85(n=10,5 ) Chge	0.00 # positive cells Standard Deviation 0.000	0.04 # positive cells Standard Deviation 0.089
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit H&E Dermis lesional Day 140(n=6,5 )	0.00 # positive cells Standard Deviation 0.000	0.00 # positive cells Standard Deviation 0.000
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit H&E Dermis lesional Day 140(n=6,4 ) Chge	0.00 # positive cells Standard Deviation 0.000	0.00 # positive cells Standard Deviation 0.000
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit Tryptase Epidermis non lesional Baseline (n=19,10)	0.00 # positive cells Standard Deviation 0.000	0.00 # positive cells Standard Deviation 0.000
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit Tryptase Epidermis non lesional Day 8 (n=19,10)	0.02 # positive cells Standard Deviation 0.092	0.00 # positive cells Standard Deviation 0.000
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit Tryptase Epidermis non lesional Day 8(n=18,10) Chg	0.02 # positive cells Standard Deviation 0.094	0.00 # positive cells Standard Deviation 0.000
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit Tryptase Epidermis non lesional Day 29 (n=4,0)	0.00 # positive cells Standard Deviation 0.000	NA # positive cells Standard Deviation NA no observation made
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD117 Dermis non lesional Day 29 (n=4,0)	10.08 # positive cells Standard Deviation 2.062	NA # positive cells Standard Deviation NA no observation made
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD117 Dermis non lesional Day 29 (n=4,0) Change	-0.47 # positive cells Standard Deviation 2.968	NA # positive cells Standard Deviation NA no observation made
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD117 Dermis non lesional Day 85 (n=17,8) Change	-0.01 # positive cells Standard Deviation 5.750	0.52 # positive cells Standard Deviation 3.239
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD117 Dermis non lesional Day 140(n=17,7)	12.05 # positive cells Standard Deviation 4.212	7.22 # positive cells Standard Deviation 2.100
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD117 Dermis non lesional Day 140 (n=16,7) Change	0.69 # positive cells Standard Deviation 5.439	-3.79 # positive cells Standard Deviation 2.284
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD117 Dermis lesional Baseline(n=19,8)	9.00 # positive cells Standard Deviation 4.570	7.31 # positive cells Standard Deviation 2.468
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit CD117 Dermis lesional Day 8(n=11,10)	10.15 # positive cells Standard Deviation 6.629	8.08 # positive cells Standard Deviation 2.743

SECONDARY outcome

Timeframe: Baseline through Day 85

Population: All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis.

Outcome measures

Outcome measures
Measure	IGE025 n=20 Participants IGE025 administered subcutaneously every 4 weeks at the study center	Placebo IGE025 n=10 Participants Placebo IGE025 administered subcutaneously every 4 weeks at the study center
Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit Chemokine CCR3 Baseline (n=19,10)	2.9669 ug/mL Standard Deviation 2.31825	3.0394 ug/mL Standard Deviation 2.38102
Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit Chemokine CCR3 Day 2 (n=20, 10)	2.8190 ug/mL Standard Deviation 2.94786	3.3035 ug/mL Standard Deviation 3.52023
Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit Chemokine CCR3 Day 8 (n=20,10)	2.5597 ug/mL Standard Deviation 2.22009	2.2742 ug/mL Standard Deviation 1.58648
Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit Chemokine CCR3 Day 15 (n=19,8)	2.2711 ug/mL Standard Deviation 1.98781	2.0216 ug/mL Standard Deviation 1.46346
Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit Chemokine CCR3 Day 29 (n=20,9)	2.5869 ug/mL Standard Deviation 2.31661	2.2826 ug/mL Standard Deviation 1.56237
Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit Chemokine CCR3 Day 85 (n=17,8)	2.5178 ug/mL Standard Deviation 1.93931	1.8724 ug/mL Standard Deviation 1.16171
Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit Chemokine CCR3 Day 140 (n=18,10)	2.022 ug/mL Standard Deviation 2.44218	2.4060 ug/mL Standard Deviation 1.85351
Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit Chemokine CXCR3/IP-10 Baseline (n=19,10)	0.1020 ug/mL Standard Deviation 0.07807	0.0638 ug/mL Standard Deviation 0.07208
Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit Chemokine CXCR3/IP-10 Day 2 (n=20,9)	0.0836 ug/mL Standard Deviation 0.06630	0.0621 ug/mL Standard Deviation 0.06496
Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit Chemokine CXCR3/IP-10 Day 8 (n=19,8)	0.0910 ug/mL Standard Deviation 0.07704	0.0772 ug/mL Standard Deviation 0.05990
Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit Chemokine CXCR3/IP-10 Day 15 (n=19,7)	0.0883 ug/mL Standard Deviation 0.06303	0.0546 ug/mL Standard Deviation 0.02550
Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit Chemokine CXCR3/IP-10 Day 29 (n=20,9)	0.0881 ug/mL Standard Deviation 0.07624	0.0601 ug/mL Standard Deviation 0.04219
Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit Chemokine CXCR3/IP-10 Day 85 (n=17,8)	0.0714 ug/mL Standard Deviation 0.03079	0.0430 ug/mL Standard Deviation 0.02910
Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit Chemokine CXCR3/IP-10 Day 140 (n=18,9)	0.0864 ug/mL Standard Deviation 0.07319	0.0859 ug/mL Standard Deviation 0.07489
Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit Histamine Baseline (n=19,10)	5.0526 ug/mL Standard Deviation 2.06757	5.2000 ug/mL Standard Deviation 1.13529
Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit Histamine Day 2 (n=20,10)	4.1500 ug/mL Standard Deviation 1.6111	5.0000 ug/mL Standard Deviation 1.76383
Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit Histamine Day 8 (n=20,10)	4.5000 ug/mL Standard Deviation 2.01311	5.4000 ug/mL Standard Deviation 2.01108
Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit Histamine Day 15 (n=19,8)	4.5789 ug/mL Standard Deviation 1.64370	4.7500 ug/mL Standard Deviation 1.83225
Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit Histamine Day 29 (n=20,9)	5.1500 ug/mL Standard Deviation 2.20705	4.7778 ug/mL Standard Deviation 3.38296
Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit Histamine Day 85 (n=17,8)	5.8235 ug/mL Standard Deviation 1.50977	5.0000 ug/mL Standard Deviation 1.30931
Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit Histamine Day 140 (n=18,10)	4.8333 ug/mL Standard Deviation 2.64019	5.7000 ug/mL Standard Deviation 1.76698
Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit Chemokine ICAM-1 Baseline (n=19,10)	0.4858 ug/mL Standard Deviation 0.09955	0.5191 ug/mL Standard Deviation 0.14846
Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit Chemokine ICAM-1 Day 2 (n=20,10)	0.4468 ug/mL Standard Deviation 0.07872	0.4975 ug/mL Standard Deviation 0.14406
Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit Chemokine ICAM-1 Day 8 (n=20,10)	0.4967 ug/mL Standard Deviation 0.12551	0.4728 ug/mL Standard Deviation 0.15713
Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit Chemokine ICAM-1 Day 15 (n=19,8)	0.4788 ug/mL Standard Deviation 0.12577	0.4709 ug/mL Standard Deviation 0.11789
Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit Chemokine ICAM-1 Day 29 (n=20,9)	0.4633 ug/mL Standard Deviation 0.10172	0.4704 ug/mL Standard Deviation 0.11356
Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit Chemokine ICAM-1 Day 85 ( n= 17,8)	0.4314 ug/mL Standard Deviation 0.10424	0.4037 ug/mL Standard Deviation 0.05599
Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit Chemokine ICAM-1 Day 140 ( n=15,10)	0.4314 ug/mL Standard Deviation 0.10921	0.4918 ug/mL Standard Deviation 0.15250

SECONDARY outcome

Timeframe: Baseline through Day 85

Population: All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis.

Fluorescence-activated cell sorting (FACS) is a specialized type of flow cytometry that provides a method for sorting a heterogeneous mixture of biological cells into two or more containers, one cell at a time, based upon the specific light scattering and fluorescent characteristics of each cell. (FACS) provides fast, objective and quantitative recording of fluorescent signals from individual cells as well as physical separation of cells of particular interest. A wide range of fluorophores can be used as labels in flow cytometry. Fluorophores are typically attached to an antibody that recognizes a target feature on or in the cell; they may also be attached to a chemical entity with affinity for the cell membrane or another cellular structure. Each fluorophore has a characteristic peak excitation and emission wavelength.

Outcome measures

Outcome measures
Measure	IGE025 n=20 Participants IGE025 administered subcutaneously every 4 weeks at the study center	Placebo IGE025 n=10 Participants Placebo IGE025 administered subcutaneously every 4 weeks at the study center
Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured as % Out of Leukocytes. Basophils D1 (n=19,10) Units	0.23 % out of leukocytes Standard Deviation 0.132	0.36 % out of leukocytes Standard Deviation 0.482
Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured as % Out of Leukocytes. Basophils D85 (n=7,5) Units	0.47 % out of leukocytes Standard Deviation 0.215	0.40 % out of leukocytes Standard Deviation 0.451
Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured as % Out of Leukocytes. Basophils chge (n=7,5) Units	0.22 % out of leukocytes Standard Deviation 0.268	-0.06 % out of leukocytes Standard Deviation 0.176
Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured as % Out of Leukocytes. CD19+ B cells bound IgE D1 (n=8,8)	4.53 % out of leukocytes Standard Deviation 5.001	15.19 % out of leukocytes Standard Deviation 22.609
Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured as % Out of Leukocytes. CD19+ B cells bound IgE D85(n=5,7)	7.32 % out of leukocytes Standard Deviation 7.579	25.66 % out of leukocytes Standard Deviation 26.485
Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured as % Out of Leukocytes. CD19+ B cells bound IgE chge (n=5,7	1.46 % out of leukocytes Standard Deviation 3.545	12.53 % out of leukocytes Standard Deviation 21.725
Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured as % Out of Leukocytes. CD19+ B cells D1 (n=10,9)	3.57 % out of leukocytes Standard Deviation 2.298	2.5 % out of leukocytes Standard Deviation 1.247
Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured as % Out of Leukocytes. CD19+ B cells D85 (n=7,7)	3.84 % out of leukocytes Standard Deviation 1.595	3.25 % out of leukocytes Standard Deviation 2.007
Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured as % Out of Leukocytes. CD19+ B cells Chge (n=7,7)	0.31 % out of leukocytes Standard Deviation 1.377	0.73 % out of leukocytes Standard Deviation 0.805
Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured as % Out of Leukocytes. Dendritic cells D1 (n=10,7)	0.37 % out of leukocytes Standard Deviation 0.196	0.24 % out of leukocytes Standard Deviation 0.140
Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured as % Out of Leukocytes. Dendritic cells D85 (n=8,5)	0.37 % out of leukocytes Standard Deviation 0.231	0.27 % out of leukocytes Standard Deviation 0.210
Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured as % Out of Leukocytes. Dendritic cells Chge (n=7,5)	0.02 % out of leukocytes Standard Deviation 0.272	-0.02 % out of leukocytes Standard Deviation 0.182

SECONDARY outcome

Timeframe: Baseline through Day 85

Population: All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis.• FACS parameters: FceRI expression on basophils and IgE bound, FceR2 expression on B cells and IgE bound, and FceRI expression on dendritic cells

Outcome measures

Outcome measures
Measure	IGE025 n=20 Participants IGE025 administered subcutaneously every 4 weeks at the study center	Placebo IGE025 n=10 Participants Placebo IGE025 administered subcutaneously every 4 weeks at the study center
Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured in Fluorescence Units. Basophils with FcεR1 exp D1 (n=11,8)	292391 Flourescence units Standard Deviation 135848	312038 Flourescence units Standard Deviation 147037
Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured in Fluorescence Units. Basophils with FcεR1 exp D85 (n=7,5)	79457 Flourescence units Standard Deviation 29333	291000 Flourescence units Standard Deviation 108028
Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured in Fluorescence Units. Basophils with FcεR1 expression Chge (n=6,5)	-243700 Flourescence units Standard Deviation 118883	-38260 Flourescence units Standard Deviation 60085
Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured in Fluorescence Units. Basophils with bound IgE D 1 (n=11,7)	149656 Flourescence units Standard Deviation 112936	236071 Flourescence units Standard Deviation 89043
Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured in Fluorescence Units. Basophils with bound IgE D85 (n=7,5)	9554 Flourescence units Standard Deviation 6214	212620 Flourescence units Standard Deviation 109645
Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured in Fluorescence Units. Basophils with bound IgE Chge (n=6,5)	-178487 Flourescence units Standard Deviation 103456	-12680 Flourescence units Standard Deviation 59998
Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured in Fluorescence Units. CD19+ B cells with FcεR2 exp D1 (n=10,9)	59040 Flourescence units Standard Deviation 42446	59700 Flourescence units Standard Deviation 27171
Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured in Fluorescence Units. CD19+ B cells with FcεR2 exp D85 (n=7,7)	59429 Flourescence units Standard Deviation 55980	49243 Flourescence units Standard Deviation 33460
Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured in Fluorescence Units. CD19+ B cells with FcεR2 exp chge (n=7,7)	12814 Flourescence units Standard Deviation 32631	3986 Flourescence units Standard Deviation 16779
Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured in Fluorescence Units. Dendritic cells with FcεR1 expr D1 (n=10,7)	40880 Flourescence units Standard Deviation 17191	43029 Flourescence units Standard Deviation 12363
Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured in Fluorescence Units. Dendritic cells with FcεR1 expr D85 (n=6,5)	38283 Flourescence units Standard Deviation 5768	36962 Flourescence units Standard Deviation 18562
Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured in Fluorescence Units. Dendritic cells with FcεR1 expr Chge (n=5,5)	-10100 Flourescence units Standard Deviation 16887	-516 Flourescence units Standard Deviation 5925

SECONDARY outcome

Timeframe: Baseline

Population: All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis

The # positive cell values are average of cell numbers derived from counting 5 consecutive microscopic fields. Area counted is 5x 0.196 mm2

Outcome measures

Outcome measures
Measure	IGE025 n=10 Participants IGE025 administered subcutaneously every 4 weeks at the study center	Placebo IGE025 n=30 Participants Placebo IGE025 administered subcutaneously every 4 weeks at the study center
Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set CD11c Epidermis ( n= 10,29)	1.1600 # positive cells Standard Deviation 1.13058	1.1241 # positive cells Standard Deviation 0.92944
Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set CD11c Dermis (n=10,29)	14.6400 # positive cells Standard Deviation 9.31083	19.6207 # positive cells Standard Deviation 9.42260
Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set CD11c All skin layers (n=20,58)	7.9000 # positive cells Standard Deviation 9.45983	10.3724 # positive cells Standard Deviation 11.44855
Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set CD 3 Epidermis (n=10,29)	0.1600 # positive cells Standard Deviation 0.26331	0.4759 # positive cells Standard Deviation 0.82046
Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set Cd 3 Dermis (n=10,29)	10.1600 # positive cells Standard Deviation 9.00311	10.8276 # positive cells Standard Deviation 6.11385
Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set CD 3 All Skin Layers (n=20,58)	5.1600 # positive cells Standard Deviation 8.04634	5.6517 # positive cells Standard Deviation 6.77879
Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set CD 4 Epidermis (n=10,29)	1.0250 # positive cells Standard Deviation 1.75804	1.0207 # positive cells Standard Deviation 1.26297
Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set CD 4 Dermis (n=10,29)	15.7750 # positive cells Standard Deviation 10.06565	17.7000 # positive cells Standard Deviation 9.72481
Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set CD 4 All Skin Layers (n=20,58)	8.4000 # positive cells Standard Deviation 10.33004	9.3603 # positive cells Standard Deviation 10.86324
Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set CD 8 Epidermis (n=10,29)	0.0600 # positive cells Standard Deviation 0.13499	0.2138 # positive cells Standard Deviation 0.34197
Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set CD 8 Dermis (n=10,29)	5.9083 # positive cells Standard Deviation 4.07998	6.0322 # positive cells Standard Deviation 3.43255
Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set CD 8 All Skin Layers (n=20,58)	2.9842 # positive cells Standard Deviation 4.11029	3.1230 # positive cells Standard Deviation 3.80226
Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set CD 117 Epidermis (n=10,29)	10.1600 # positive cells Standard Deviation 3.80386	9.9931 # positive cells Standard Deviation 4.85502
Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set CD 117 Dermis (n=10,29)	8.2200 # positive cells Standard Deviation 2.44849	10.4241 # positive cells Standard Deviation 5.56025
Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set CD 117 All Skin Layers (n=20,58)	9.1900 # positive cells Standard Deviation 3.26865	10.2086 # positive cells Standard Deviation 5.17814
Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set Fc epsilon receptor I Epidermis (n=10,29)	4.9800 # positive cells Standard Deviation 2.02309	6.0776 # positive cells Standard Deviation 3.12906
Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set Fc epsilon receptor I Dermis (n=10,29)	14.2000 # positive cells Standard Deviation 6.76133	19.4500 # positive cells Standard Deviation 8.21582
Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set Fc epsilon receptor I All Skin Layers (n=20,58)	9.5900 # positive cells Standard Deviation 6.77968	12.7638 # positive cells Standard Deviation 9.13548
Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set Giemsa Epidermis (n=10,29)	0.0000 # positive cells Standard Deviation 0.00000	0.0000 # positive cells Standard Deviation 0.00000
Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set Giemsa Dermis (n=10,29)	4.8000 # positive cells Standard Deviation 5.62929	6.8690 # positive cells Standard Deviation 6.19228
Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set Giemsa All Skin Layers (n=20,58)	2.4000 # positive cells Standard Deviation 4.59061	3.4345 # positive cells Standard Deviation 5.55324
Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set Haematoxylin + Eosin Epidermis (n=10,29)	0.0000 # positive cells Standard Deviation 0.00000	0.0000 # positive cells Standard Deviation 0.00000
Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set Haematoxylin + Eosin Dermis (n=10,29)	0.0000 # positive cells Standard Deviation 0.00000	0.0000 # positive cells Standard Deviation 0.00000
Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set Haematoxylin + Eosin All Skin Layers (n=20,58)	0.0000 # positive cells Standard Deviation 0.00000	0.0000 # positive cells Standard Deviation 0.00000
Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set IgE Epidermis (n=10,29)	0.0800 # positive cells Standard Deviation 0.13984	1.0603 # positive cells Standard Deviation 2.30385
Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set IgE Dermis (n=10,29)	8.7600 # positive cells Standard Deviation 5.92231	14.7776 # positive cells Standard Deviation 9.84503
Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set IgE All Skin layers (n=20,58)	4.4200 # positive cells Standard Deviation 6.03739	7.9190 # positive cells Standard Deviation 9.90380
Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set IgE + CD 11c Epidermis (n=10,28)	0.0000 # positive cells Standard Deviation 0.00000	0.0357 # positive cells Standard Deviation 0.12237
Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set IgE + CD 11c Dermis (n=10,29)	0.9150 # positive cells Standard Deviation 1.29401	1.0115 # positive cells Standard Deviation 1.05290
Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set IgE+CD 11c All Layers (n=20,57)	0.4575 # positive cells Standard Deviation 1.00672	0.5322 # positive cells Standard Deviation 0.89651
Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set IgE + Tryptase Epidermis (n=10,28)	0.0000 # positive cells Standard Deviation 0.00000	0.0000 # positive cells Standard Deviation 0.00000
Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set IgE + Tryptase Dermis (n=10,29)	1.3000 # positive cells Standard Deviation 1.01215	0.8713 # positive cells Standard Deviation 0.79919
Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set IgE + Tryptase All Skin Layers (n=20,57)	0.6500 # positive cells Standard Deviation 0.96437	0.4433 # positive cells Standard Deviation 0.71586
Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set Tryptase Epidermis (n=10,29)	0.0000 # positive cells Standard Deviation 0.00000	0.0000 # positive cells Standard Deviation 0.00000
Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set Tryptase Dermis (n=10,29)	6.6400 # positive cells Standard Deviation 3.53371	6.7741 # positive cells Standard Deviation 3.64713
Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set Tryptase All Skin Layers (n=20,58)	3.3200 # positive cells Standard Deviation 4.18539	3.3871 # positive cells Standard Deviation 4.26704

SECONDARY outcome

Timeframe: Baseline through Day 85

Population: PK analysis set which included all subjects who received at least one dose of study drug and had evaluable IGE025 concentrations.

Serum concentrations (ng/mL) of omalizumab by visit after the administration of omalizumab 300 mg every 4 weeks

Outcome measures

Outcome measures
Measure	IGE025 n=20 Participants IGE025 administered subcutaneously every 4 weeks at the study center	Placebo IGE025 Placebo IGE025 administered subcutaneously every 4 weeks at the study center
Serum Levels of Omalizumab Day 1	0.0 ng/mL Standard Deviation 0.00	—
Serum Levels of Omalizumab Day 2	13400 ng/mL Standard Deviation 4690	—
Serum Levels of Omalizumab Day 8	30100 ng/mL Standard Deviation 7800	—
Serum Levels of Omalizumab Day 29	17000 ng/mL Standard Deviation 5500	—
Serum Levels of Omalizumab Day 57	25000 ng/mL Standard Deviation 8640	—
Serum Levels of Omalizumab Day 85	28800 ng/mL Standard Deviation 11400	—

SECONDARY outcome

Timeframe: Baseline through Day 85

Population: All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis.

Outcome measures

Outcome measures
Measure	IGE025 n=20 Participants IGE025 administered subcutaneously every 4 weeks at the study center	Placebo IGE025 n=10 Participants Placebo IGE025 administered subcutaneously every 4 weeks at the study center
Mean (SD) Serum Total IgE Concentration From Baseline by Visit Day 2 Mean (20,10)	1152 ng/mL Standard Deviation 2539	447 ng/mL Standard Deviation 587.5
Mean (SD) Serum Total IgE Concentration From Baseline by Visit Day 1 Mean (n=20,10)	1037 ng/mL Standard Deviation 2474	442 ng/mL Standard Deviation 580.7
Mean (SD) Serum Total IgE Concentration From Baseline by Visit Day 8 Mean (n=20,10)	1970 ng/mL Standard Deviation 2992	449 ng/mL Standard Deviation 593.1
Mean (SD) Serum Total IgE Concentration From Baseline by Visit Day 29 Mean (n=20,9)	2160 ng/mL Standard Deviation 2688	462 ng/mL Standard Deviation 628.7
Mean (SD) Serum Total IgE Concentration From Baseline by Visit Day 57 Mean (n=19,8)	2430 ng/mL Standard Deviation 3343	490 ng/mL Standard Deviation 648.0
Mean (SD) Serum Total IgE Concentration From Baseline by Visit Day 85 Mean (n=17,8)	2222 ng/mL Standard Deviation 2931	475 ng/mL Standard Deviation 616.8

SECONDARY outcome

Timeframe: Baseline through Day 85

Population: All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis.

Outcome measures

Outcome measures
Measure	IGE025 n=20 Participants IGE025 administered subcutaneously every 4 weeks at the study center	Placebo IGE025 n=10 Participants Placebo IGE025 administered subcutaneously every 4 weeks at the study center
Mean (SD) Serum Total IgE % Change From Baseline by Visit Day 85 % Change (n=16,8)	244.8 Percent Change from Baseline Standard Deviation 138.28	-6.9 Percent Change from Baseline Standard Deviation 24.10
Mean (SD) Serum Total IgE % Change From Baseline by Visit Day 2 % Change (n=19,10)	27.1 Percent Change from Baseline Standard Deviation 20.08	0.2 Percent Change from Baseline Standard Deviation 5.13
Mean (SD) Serum Total IgE % Change From Baseline by Visit Day 8 % Change (n=19,10)	174.7 Percent Change from Baseline Standard Deviation 84.93	-1.5 Percent Change from Baseline Standard Deviation 9.13
Mean (SD) Serum Total IgE % Change From Baseline by Visit Day 29 % Change (n=19,9)	247.2 Percent Change from Baseline Standard Deviation 121.81	-4.0 Percent Change from Baseline Standard Deviation 12.17
Mean (SD) Serum Total IgE % Change From Baseline by Visit Day 57 % Change (n=18,8)	247.8 Percent Change from Baseline Standard Deviation 134.10	-4.4 Percent Change from Baseline Standard Deviation 18.59

SECONDARY outcome

Timeframe: Baseline through Day 85

Population: All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis.

Outcome measures

Outcome measures
Measure	IGE025 n=20 Participants IGE025 administered subcutaneously every 4 weeks at the study center	Placebo IGE025 n=10 Participants Placebo IGE025 administered subcutaneously every 4 weeks at the study center
Mean (SD) Serum Free IgE Concentration From Baseline by Visit Day 29 Mean (n=20,9)	41.506 ng/mL Standard Deviation 40.5322	107.881 ng/mL Standard Deviation 60.1708
Mean (SD) Serum Free IgE Concentration From Baseline by Visit Day 57 Mean (n=19,8)	38.502 ng/mL Standard Deviation 39.5567	122.318 ng/mL Standard Deviation 51.1087
Mean (SD) Serum Free IgE Concentration From Baseline by Visit Day 85 Mean (n=17,8)	35.776 ng/mL Standard Deviation 41.5426	120.978 ng/mL Standard Deviation 50.6692
Mean (SD) Serum Free IgE Concentration From Baseline by Visit Day 1 Mean (n=20,10)	1037 ng/mL Standard Deviation 2474	442 ng/mL Standard Deviation 580.69
Mean (SD) Serum Free IgE Concentration From Baseline by Visit Day 2 Mean (n= 20,9)	26.8 ng/mL Standard Deviation 34.27	111.5 ng/mL Standard Deviation 60.75
Mean (SD) Serum Free IgE Concentration From Baseline by Visit Day 8 Mean (n=20,10)	24.306 ng/mL Standard Deviation 29.7698	112.169 ng/mL Standard Deviation 58.6525

SECONDARY outcome

Timeframe: Baseline through Day 85

Population: All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis.

Outcome measures

Outcome measures
Measure	IGE025 n=20 Participants IGE025 administered subcutaneously every 4 weeks at the study center	Placebo IGE025 n=10 Participants Placebo IGE025 administered subcutaneously every 4 weeks at the study center
Mean (SD) Serum Free IgE % Change From Baseline by Visit Day 2 % Change (n=19,9)	-96.166 % change Standard Deviation 2.9216	-60.475 % change Standard Deviation 17.9330
Mean (SD) Serum Free IgE % Change From Baseline by Visit Day 8 % Change (n=20,10)	-96.446 % change Standard Deviation 2.0162	-60.804 % change Standard Deviation 15.8379
Mean (SD) Serum Free IgE % Change From Baseline by Visit Day 29 % Change (n=19,9)	-93.363 % change Standard Deviation 3.5975	-61.456 % change Standard Deviation 17.2340
Mean (SD) Serum Free IgE % Change From Baseline by Visit Day 57 % Change (n=18,8)	-94.460 % change Standard Deviation 3.0681	-61.270 % change Standard Deviation 18.6447
Mean (SD) Serum Free IgE % Change From Baseline by Visit Day 85 % Change (n=16,8)	-94.750 % change Standard Deviation 3.420	-61.906 % change Standard Deviation 17.7819

SECONDARY outcome

Timeframe: Baseline through Day 140

Population: All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis.

Outcome measures

Outcome measures
Measure	IGE025 n=20 Participants IGE025 administered subcutaneously every 4 weeks at the study center	Placebo IGE025 n=10 Participants Placebo IGE025 administered subcutaneously every 4 weeks at the study center
Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit Artemisia vulgaris (Mugwort) Day 140( n=0,1)	NA IU/mL Standard Deviation NA Specific IgE not observed	1.9100 IU/mL Standard Deviation NA one patient only tested positive
Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit Alternaria alternara Baseline (n= 0, 1)	NA IU/mL Standard Deviation NA Specific IgE not observed	0.1360 IU/mL Standard Deviation NA one patient only tested positive
Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit Alternaria alternara Day 140 (n= 0,1)	NA IU/mL Standard Deviation NA Specific IgE not observed	0.1140 IU/mL Standard Deviation NA one patient only tested positive
Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit Artemisia vulgaris (Mugwort) Baseline (n=1,1)	0.2730 IU/mL Standard Deviation NA one patient only tested positive	1.4800 IU/mL Standard Deviation NA one patient only tested positive
Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit Parietaria judaica Day 140 (n=0,1)	0.0000 IU/mL Standard Deviation NA one patient only tested positive	2.0000 IU/mL Standard Deviation NA one patient only tested positive
Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit Cat dander Absolute Change (n = 2,1)	-1.1315 IU/mL Standard Deviation 4.33951	0.2000 IU/mL Standard Deviation NA only 1 observation
Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit Cat dander Basseline (n=3,1)	17.9677 IU/mL Standard Deviation 22.73833	0.6980 IU/mL Standard Deviation NA one patient only tested positive
Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit Cat dander Day 140 (n=2,1)	21.0100 IU/mL Standard Deviation 26.14881	0.8980 IU/mL Standard Deviation NA one patient only tested positive
Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit Common silver Birch Baseline (n=6,3)	12.3640 IU/mL Standard Deviation 19.48667	12.3767 IU/mL Standard Deviation 11.22609
Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit Common silver Birch Day 140 (n=4,3)	4.4890 IU/mL Standard Deviation 6.15938	14.8600 IU/mL Standard Deviation 16.58164
Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit Dog dander Baseline (n=2,1)	26.7720 IU/mL Standard Deviation 37.09199	0.5120 IU/mL Standard Deviation NA one patient only tested positive
Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit Dog dander Day 140 (n=1,1)	50.1000 IU/mL Standard Deviation NA one patient only tested positive	0.6690 IU/mL Standard Deviation NA one patient only tested positive
Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit Dermatophagoides farinae Baseline (n=3,1)	3.3333 IU/mL Standard Deviation 3.39883	0.4340 IU/mL Standard Deviation NA one patient only tested positive
Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit Dermatophagoides farinae Day 140 (n=2,1)	5.3200 IU/mL Standard Deviation 0.89095	0.4970 IU/mL Standard Deviation NA one patient only tested positive
Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit Dermatophagoides pteronyssinus Baseline (n=5,1)	2.1250 IU/mL Standard Deviation 1.46791	0.4550 IU/mL Standard Deviation NA one patient only tested positive
Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit Dermatophagoides pteronyssinus Day 140(n=4,1)	5.2463 IU/mL Standard Deviation 3.72052	0.5170 IU/mL Standard Deviation NA one patient only tested positive
Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit Grey Alder (t2) Baseline (n=4,3)	15.7650 IU/mL Standard Deviation 20.03961	10.9533 IU/mL Standard Deviation 10.92027
Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit Grey Alder (t2) Day 140(n=3,3)	4.4900 IU/mL Standard Deviation 5.16654	13.0533 IU/mL Standard Deviation 15.24029
Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit German Cockroach Baseline (n=4,2)	0.8605 IU/mL Standard Deviation 0.93609	0.4425 IU/mL Standard Deviation 0.62579
Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit German Cockroach Day 140 (n=4,2)	3.0263 IU/mL Standard Deviation 2.87190	0.4705 IU/mL Standard Deviation 0.66539
Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit Hazelnut Baseline (n=3,3)	8.9627 IU/mL Standard Deviation 14.49722	7.3267 IU/mL Standard Deviation 8.28160
Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit Hazelnut Day 140 (n=2,3)	1.4450 IU/mL Standard Deviation 1.50977	8.9927 IU/mL Standard Deviation 10.59244
Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit Olive (black, fresh) Baseline (n=4,1)	0.0890 IU/mL Standard Deviation 0.17800	0.0000 IU/mL Standard Deviation NA one patient only tested positive
Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit Olive (black, fresh) Day 140 (n=3,1)	0.1037 IU/mL Standard Deviation 0.17956	0.0000 IU/mL Standard Deviation NA one patient only tested positive
Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit Platanus acerifolia Baseline (n=1,1)	0.1210 IU/mL Standard Deviation NA one patient only tested positive	3.7100 IU/mL Standard Deviation NA one patient only tested positive
Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit Platanus acerifolia Day 140 (n=0,1)	0.0000 IU/mL Standard Deviation NA one patient only tested positive	4.8300 IU/mL Standard Deviation NA one patient only tested positive
Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit Parietaria judaica Baseline(n=0,1)	0.0000 IU/mL Standard Deviation NA one patient only tested positive	1.4900 IU/mL Standard Deviation NA one patient only tested positive
Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit Staphylococcal enterotoxin A Baseline (n=20,10)	0.7264 IU/mL Standard Deviation 3.07821	0.0741 IU/mL Standard Deviation 0.13580
Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit Staphylococcal enterotoxin A Day 140 (n=18,10)	1.6161 IU/mL Standard Deviation 4.39936	0.1077 IU/mL Standard Deviation 0.15294
Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit Staphylococcal enterotoxin C Baseline (n=20,10)	0.8976 IU/mL Standard Deviation 3.02621	0.1626 IU/mL Standard Deviation 0.27226
Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit Staphylococcal enterotoxin C Day 140 (n=18,10)	2.1089 IU/mL Standard Deviation 4.19834	0.1922 IU/mL Standard Deviation 0.28071
Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit Staphylococcal enterotoxin TSST Baseline (n=20,10)	0.5390 IU/mL Standard Deviation 1.02581	0.1537 IU/mL Standard Deviation 0.23902
Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit Staphylococcal enterotoxin TSST Day 140 (n=18,10)	0.8402 IU/mL Standard Deviation 1.05356	0.1468 IU/mL Standard Deviation 0.22155
Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit Alternaria alternara Absolute Change (n = 0,1)	NA IU/mL Standard Deviation NA Specific IgE not observed	-0.0220 IU/mL Standard Deviation NA only 1 observation
Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit Artemisia vulgaris Absolute Change (n = 0,1)	NA IU/mL Standard Deviation NA Specific IgE not observed	0.4300 IU/mL Standard Deviation NA only 1 observation
Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit Common Silver Birch Absolute Change (n = 4,3)	-10.2145 IU/mL Standard Deviation 26.47094	2.4833 IU/mL Standard Deviation 5.63479
Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit Dog dander Absolute Change (n = 1,1)	-2.9000 IU/mL Standard Deviation NA only 1 observation	0.1570 IU/mL Standard Deviation NA only 1 observation
Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit Dermatophagoides farinae Absolute Change(n=2,1)	3.9350 IU/mL Standard Deviation 1.46371	0.0630 IU/mL Standard Deviation NA only 1 observation
Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit Dermatophagoides pteronyssinus Abs Chge (n=4,1)	3.6800 IU/mL Standard Deviation 3.05938	0.0620 IU/mL Standard Deviation NA only 1 observation
Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit Grey Alder Absolute Change(n=3,3)	-12.6300 IU/mL Standard Deviation 27.47614	2.1000 IU/mL Standard Deviation 4.50900
Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit German Cockroach Absolute Change(n=4,2)	2.1658 IU/mL Standard Deviation 2.03436	0.0280 IU/mL Standard Deviation 0.03960
Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit Hazelnut Absolute Change(n=2,3)	-11.83000 IU/mL Standard Deviation 18.15850	1.6660 IU/mL Standard Deviation 2.47183
Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit Olive (black, fresh) Absolute Change(n=3,1)	-0.0150 IU/mL Standard Deviation 0.02598	0.0000 IU/mL Standard Deviation NA only 1 observation
Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit Platanus acerifolia Absolute Change(n=0,1)	NA IU/mL Standard Deviation NA Specific IgE not observed	1.1200 IU/mL Standard Deviation NA only 1 observation
Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit Parietaria judaica Absolute Change(n=0,1)	NA IU/mL Standard Deviation NA Specific IgE not observed	0.5100 IU/mL Standard Deviation NA only 1 observation
Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit Staphylococcal enterotoxin A Abs chge (n=18,10)	0.8090 IU/mL Standard Deviation 2.63582	0.0336 IU/mL Standard Deviation 0.09116
Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit Staphylococcal enterotoxin C Abs chge (n=18,10)	1.1116 IU/mL Standard Deviation 2.26524	0.0296 IU/mL Standard Deviation 0.06545
Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit Staphylococcal enterotoxin TSST Abs chge(n=18,10)	0.2608 IU/mL Standard Deviation 0.72963	-0.0069 IU/mL Standard Deviation 0.15669

SECONDARY outcome

Timeframe: Baseline, Day 85

Population: Efficacy analysis set which included all randomized patients who received at least one dose of study drug and had post-randomization efficacy data. If the Week 12 value was missing, it was imputed as the last available UAS7 value (LOCF).

Efficacy was assessed by the urticaria activity score (UAS). UAS was completed each morning and evening on a daily basis to record patient symptoms of itch and hives via an electronic diary. The UAS is a composite eDiary-recorded score with numeric severity intensity ratings on a scale of 0-3 (0 = none to 3 = intense/severe) for 1) the number of wheals (hives); and 2) the intensity of the itch. The daily UAS is the average of the morning and evening scores and the UAS7 is the sum of the daily UAS scores over 7 days.UAS7 score: The sum of the daily UAS scores over 7 days. Range: 0-42. If fewer than 7 but at least 4 daily values were non-missing, the remaining values were imputed to be the average. This is equivalent to multiplying the average of the non missing values by 7. UAS7 score: The sum of the daily UAS scores over 7 days. Range: 0-42. A higher score indicates worse disease. A negative change score (Week 12 score minus Baseline score) indicates improvement.

Outcome measures

Outcome measures
Measure	IGE025 n=17 Participants IGE025 administered subcutaneously every 4 weeks at the study center	Placebo IGE025 n=8 Participants Placebo IGE025 administered subcutaneously every 4 weeks at the study center
Change From Baseline in Urticaria Activity Score (UAS7)	-23.1 units on a scale Standard Deviation 12.94 • Interval -28.5 to -17.6	-8.1 units on a scale Standard Deviation 14.45 • Interval -17.8 to 1.5

SECONDARY outcome

Timeframe: Baseline, Day 85

Population: Efficacy analysis set which included all randomized patients who received at least one dose of study drug and had post-randomization efficacy data

The investigator or the person he or she designated and the patient provided scoring of the patient's global assessment of symptoms (urticaria lesions (hives) and pruritus) reflective of the patient's condition over the 12 hours prior to the visit (0 = no symptoms, 1 = mild, 2 = moderate 3 = severe

Outcome measures

Outcome measures
Measure	IGE025 n=17 Participants IGE025 administered subcutaneously every 4 weeks at the study center	Placebo IGE025 n=8 Participants Placebo IGE025 administered subcutaneously every 4 weeks at the study center
Likert Scale-Physician's and Patients In-clinic Global Assessment by Treatment Physicians Baseline (n=17,9)	2.0 score Standard Deviation 0.87	2.2 score Standard Deviation 0.83
Likert Scale-Physician's and Patients In-clinic Global Assessment by Treatment Physicians Week 12, (day 85) (n=17,8)	0.8 score Standard Deviation 1.01	2.0 score Standard Deviation 1.31
Likert Scale-Physician's and Patients In-clinic Global Assessment by Treatment Patients Baseline (n=17,9)	2.4 score Standard Deviation 0.87	2.4 score Standard Deviation 0.53
Likert Scale-Physician's and Patients In-clinic Global Assessment by Treatment Patients Week 12, (day 85) (n=17,8)	0.9 score Standard Deviation 1.05	1.9 score Standard Deviation 0.99

SECONDARY outcome

Timeframe: Day 29 to Day 85

Population: Efficacy analysis set which included all randomized patients who received at least one dose of study drug and had post-randomization efficacy data

Outcome measures

Outcome measures
Measure	IGE025 n=17 Participants IGE025 administered subcutaneously every 4 weeks at the study center	Placebo IGE025 n=8 Participants Placebo IGE025 administered subcutaneously every 4 weeks at the study center
Percentage of Angioedema-free Days Weeks 4 Through 12 by Treatment	90.9 Percentage of days Standard Deviation 22.83 • Interval 87.8 to 94.0	70.5 Percentage of days Standard Deviation 28.50 • Interval 64.9 to 76.1

SECONDARY outcome

Timeframe: Baseline through Day 85

Population: Efficacy analysis set which included all randomized patients who received at least one dose of study drug and had post-randomization efficacy data

The DLQI is a 10-item dermatology-specific health-related quality of life measure. Patients rated their dermatology symptoms as well as the impact of their skin condition on various aspects of their lives. An overall score was calculated as well as for the following domains: Symptoms and Feelings, Daily Activities, Leisure, Work and School, Personal Relationships, Treatment.Negative score shows positive efficacy. Meaning of DLQI Scores 0-1 = no effect at all on patient's life 2-5 = small effect on patient's life 6-10 = moderate effect on patient's life 11-20 = very large effect on patient's life 21-30 = extremely large effect on patient's life. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. The DLQI can also be expressed as a percentage of the maximum possible score of 30.

Outcome measures

Outcome measures
Measure	IGE025 n=16 Participants IGE025 administered subcutaneously every 4 weeks at the study center	Placebo IGE025 n=8 Participants Placebo IGE025 administered subcutaneously every 4 weeks at the study center
Change From Baseline in Dermatology Life Quality Index (DLQI) by Treatment	-10.19 Score Standard Deviation 8.159	-3.13 Score Standard Deviation 7.180

SECONDARY outcome

Timeframe: Baseline and Day 85

Population: Efficacy analysis set which included all randomized patients who received at least one dose of study drug and had post-randomization efficacy data

The Skindex-29 is a validated 29-item instrument to measure the effects of skin disease on patients' quality of life.Results are reported as 3 scale scores (functioning, emotions and symptoms) and a composite score (average scale score). The domain scores and the overall score are expressed on a 100-point scale, with higher scores indicating a lower level of quality of life. The cuttoff values for each category are noted below. Symtoms; 39 mild, 42 moderate,52 severe. Emotions; 24 mild, 35 moderate, 39 severe. Functioning: 21 mild, 32 moderate, 37 severe. Overal Score: 25 mild, 32 moderate, 44 severe.

Outcome measures

Outcome measures
Measure	IGE025 n=16 Participants IGE025 administered subcutaneously every 4 weeks at the study center	Placebo IGE025 n=8 Participants Placebo IGE025 administered subcutaneously every 4 weeks at the study center
Skindex-29 by Treatment Baseline (n= 16,9)	17.98 Score Standard Deviation 7.807	21.67 Score Standard Deviation 9.068
Skindex-29 by Treatment Day 85 (n=16,8)	6.17 Score Standard Deviation 7.119	22.63 Score Standard Deviation 10.276

SECONDARY outcome

Timeframe: Baseline and Day 85

Population: Efficacy analysis set which included all randomized patients who received at least one dose of study drug and had post-randomization efficacy data

The Cu-Q2OL is a 23-item CIU-specific health-related quality of life questionnaire. Patients rated their CIU symptoms and the impact of their CIU on various aspects of their lives. An overall score was calculated as well for the following domains: pruritus, swelling, impact on life activities, sleep problems, limits, and looks. Zero is the minmum score and 100 the maximum score. The higher score correlates to more disease activity.

Outcome measures

Outcome measures
Measure	IGE025 n=17 Participants IGE025 administered subcutaneously every 4 weeks at the study center	Placebo IGE025 n=9 Participants Placebo IGE025 administered subcutaneously every 4 weeks at the study center
Chronic Urticaria Quality of Life Questionnaire (Cu-Q2OL) by Treatment Baseline (n=16,8)	53.71 score Standard Deviation 19.881	59.24 score Standard Deviation 15.350
Chronic Urticaria Quality of Life Questionnaire (Cu-Q2OL) by Treatment Day 85 (n=17,8)	14.51 score Standard Deviation 22.319	53.53 score Standard Deviation 29.817

Adverse Events

IGE025 300mg

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Placebo

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	IGE025 300mg n=20 participants at risk IGE025 administered subcutaneously every 4 weeks at the study center	Placebo n=10 participants at risk Placebo administered subcutaneously every 4 weeks at the study center.
Infections and infestations Upper respiratory tract infection	0.00% 0/20 • 1 year 5 mos	10.0% 1/10 • 1 year 5 mos
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/20 • 1 year 5 mos	10.0% 1/10 • 1 year 5 mos

Other adverse events

Other adverse events
Measure	IGE025 300mg n=20 participants at risk IGE025 administered subcutaneously every 4 weeks at the study center	Placebo n=10 participants at risk Placebo administered subcutaneously every 4 weeks at the study center.
Gastrointestinal disorders Constipation	5.0% 1/20 • 1 year 5 mos	0.00% 0/10 • 1 year 5 mos
Gastrointestinal disorders Tongue pruritus	5.0% 1/20 • 1 year 5 mos	0.00% 0/10 • 1 year 5 mos
Gastrointestinal disorders Toothache	5.0% 1/20 • 1 year 5 mos	0.00% 0/10 • 1 year 5 mos
General disorders Fatigue	5.0% 1/20 • 1 year 5 mos	0.00% 0/10 • 1 year 5 mos
General disorders Injection site pain	5.0% 1/20 • 1 year 5 mos	0.00% 0/10 • 1 year 5 mos
Infections and infestations Bronchitis	5.0% 1/20 • 1 year 5 mos	0.00% 0/10 • 1 year 5 mos
Infections and infestations Influenza	15.0% 3/20 • 1 year 5 mos	20.0% 2/10 • 1 year 5 mos
Infections and infestations Nasopharyngitis	35.0% 7/20 • 1 year 5 mos	30.0% 3/10 • 1 year 5 mos
Infections and infestations Periodontitis	0.00% 0/20 • 1 year 5 mos	10.0% 1/10 • 1 year 5 mos
Infections and infestations Tooth abscess	5.0% 1/20 • 1 year 5 mos	0.00% 0/10 • 1 year 5 mos
Infections and infestations Urinary tract infection	5.0% 1/20 • 1 year 5 mos	0.00% 0/10 • 1 year 5 mos
Injury, poisoning and procedural complications Fractured coccyx	5.0% 1/20 • 1 year 5 mos	0.00% 0/10 • 1 year 5 mos
Investigations Fungal test positive	0.00% 0/20 • 1 year 5 mos	10.0% 1/10 • 1 year 5 mos
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/20 • 1 year 5 mos	10.0% 1/10 • 1 year 5 mos
Musculoskeletal and connective tissue disorders Tenosynovitis	5.0% 1/20 • 1 year 5 mos	0.00% 0/10 • 1 year 5 mos
Nervous system disorders Headache	5.0% 1/20 • 1 year 5 mos	10.0% 1/10 • 1 year 5 mos
Nervous system disorders Syncope	5.0% 1/20 • 1 year 5 mos	0.00% 0/10 • 1 year 5 mos
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/20 • 1 year 5 mos	10.0% 1/10 • 1 year 5 mos
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	5.0% 1/20 • 1 year 5 mos	10.0% 1/10 • 1 year 5 mos
Respiratory, thoracic and mediastinal disorders Pleurisy	5.0% 1/20 • 1 year 5 mos	0.00% 0/10 • 1 year 5 mos
Skin and subcutaneous tissue disorders Alopecia areata	5.0% 1/20 • 1 year 5 mos	0.00% 0/10 • 1 year 5 mos
Skin and subcutaneous tissue disorders Urticaria	15.0% 3/20 • 1 year 5 mos	10.0% 1/10 • 1 year 5 mos
Vascular disorders Haematoma	5.0% 1/20 • 1 year 5 mos	0.00% 0/10 • 1 year 5 mos

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Results disclosure agreements

Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
Publication restrictions are in place

Restriction type: OTHER