Phase 2a Study of Efficacy and Safety of OpSCF in Moderate to Severe AD (Atopic Dermatitis)

The EASI quantifies the severity of a participant's AD based on both lesion severity and the % of body surface area (BSA) affected. Severity of clinical signs of AD lesions (erythema [E], induration/papulation[I], excoriation[Ex] & lichenification[L]) was scored separately for each of 4 body regions[head(h), upper extremities(u), trunk(t), lower extremities(l)] on a 4-point scale:0= absent; 1= mild;2= moderate;3= severe. EASI area score was based on % BSA with AD in body region: 0(no involvement), 1(< 10%),2 (10 to <30%), 3(30 to <50%), 4(50 to <70%), 5(70 to <90%) and 6(90 to 100%). The EASI score is obtained as: EASI(A) = 0.1*(Eh+Ih+Exh+Lh)*Ah + 0.2*(Eu+Iu+Exu+Lu)*Au + 0.3*(Et +It+Ext+Lt)*At + 0.4*(El+Il+Exl+Ll)*Al. Total EASI score = 0.0 to 72.0; higher scores indicate greater severity of AD. Here, a negative change from baseline indicates less severity in AD.

An adverse event (AE) was any untoward medical occurrence in participant administered a pharmaceutical product & that does not necessarily have a causal relationship with this treatment. It can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study product, whether or not considered related to the study product. An SAE was any untoward medical occurrence that, at any dose resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization resulted in persistent or significant disability/incapacity & was a congenital anomaly/birth defect. Any AE starting on or after the first dose date will be considered TEAE.

The EASI quantifies the severity of a participant's AD based on both lesion severity and the % of body surface area (BSA) affected. Severity of clinical signs of AD lesions (erythema [E], induration/papulation[I], excoriation[Ex] & lichenification[L]) was scored separately for each of 4 body regions[head(h), upper extremities(u), trunk(t), lower extremities(l)] on a 4-point scale:0= absent; 1= mild;2= moderate;3= severe. EASI area score was based on % BSA with AD in body region: 0(no involvement), 1(< 10%),2 (10 to <30%), 3(30 to <50%), 4(50 to <70%), 5(70 to <90%) and 6(90 to 100%). The EASI score is obtained as: EASI(A) = 0.1*(Eh+Ih+Exh+Lh)*Ah + 0.2*(Eu+Iu+Exu+Lu)*Au + 0.3*(Et +It+Ext+Lt)*At + 0.4*(El+Il+Exl+Ll)*Al. Total EASI score = 0.0 to 72.0; higher scores indicate greater severity of AD. Here, a negative change from baseline indicates less severity in AD.

The EASI quantifies the severity of a participant's AD based on both lesion severity and the % of body surface area (BSA) affected. Severity of clinical signs of AD lesions (erythema [E], induration/papulation[I], excoriation[Ex] & lichenification[L]) was scored separately for each of 4 body regions[head(h), upper extremities(u), trunk(t), lower extremities(l)] on a 4-point scale:0= absent; 1= mild;2= moderate;3= severe. EASI area score was based on % BSA with AD in body region: 0(no involvement), 1(< 10%),2 (10 to <30%), 3(30 to <50%), 4(50 to <70%), 5(70 to <90%) and 6(90 to 100%). The EASI score is obtained as: EASI(A) = 0.1*(Eh+Ih+Exh+Lh)*Ah + 0.2*(Eu+Iu+Exu+Lu)*Au + 0.3*(Et +It+Ext+Lt)*At + 0.4*(El+Il+Exl+Ll)*Al. Total EASI score = 0.0 to 72.0; higher scores indicate greater severity of AD. Here, a negative change from baseline indicates less severity in AD.

The EASI quantifies severity of a participant's AD based on both lesion severity & % of body surface area (BSA) affected. Severity of clinical signs of AD lesions (erythema [E], induration/papulation[I], excoriation[Ex] & lichenification[L]) was scored separately for each of 4 body regions[head(h), upper extremities(u), trunk(t), lower extremities(l)] on a 4-point scale:0=absent; 1=mild; 2=moderate; 3=severe. EASI area score was based on % BSA with AD in body region: 0(no involvement), 1(< 10%),2 (10 to <30%), 3(30 to <50%), 4(50 to <70%), 5(70 to <90%) & 6(90 to 100%). EASI score is obtained as: EASI(A) = 0.1*(Eh+Ih+Exh+Lh)*Ah + 0.2*(Eu+Iu+Exu+Lu)*Au + 0.3*(Et +It+Ext+Lt)*At + 0.4*(El+Il+Exl+Ll)*Al. Total EASI score = 0.0 to 72.0; higher scores indicate greater severity of AD. Here, a negative change from baseline indicates less severity in AD. EASI 50 response was defined as at least a 50% improvement in EASI relative to Baseline. 90% CI was based on exact Clopper-Pearson method.

The EASI quantifies severity of a participant's AD based on both lesion severity & % of body surface area (BSA) affected. Severity of clinical signs of AD lesions (erythema [E], induration/papulation[I], excoriation[Ex] & lichenification[L]) was scored separately for each of 4 body regions[head(h), upper extremities(u), trunk(t), lower extremities(l)] on a 4-point scale:0=absent; 1=mild; 2=moderate; 3=severe. EASI area score was based on % BSA with AD in body region: 0(no involvement), 1(< 10%),2 (10 to <30%), 3(30 to <50%), 4(50 to <70%), 5(70 to <90%) & 6(90 to 100%). EASI score is obtained as: EASI(A) = 0.1*(Eh+Ih+Exh+Lh)*Ah + 0.2*(Eu+Iu+Exu+Lu)*Au + 0.3*(Et +It+Ext+Lt)*At + 0.4*(El+Il+Exl+Ll)*Al. Total EASI score = 0.0 to 72.0; higher scores indicate greater severity of AD. Here, a negative change from baseline indicates less severity in AD. EASI 75 response was defined as at least a 75% improvement in EASI relative to Baseline. 90% CI was based on exact Clopper-Pearson method.

The EASI quantifies severity of a participant's AD based on both lesion severity & % of body surface area (BSA) affected. Severity of clinical signs of AD lesions (erythema [E], induration/papulation[I], excoriation[Ex] & lichenification[L]) was scored separately for each of 4 body regions[head(h), upper extremities(u), trunk(t), lower extremities(l)] on a 4-point scale:0=absent; 1=mild; 2=moderate; 3=severe. EASI area score was based on % BSA with AD in body region: 0(no involvement), 1(< 10%),2 (10 to <30%), 3(30 to <50%), 4(50 to <70%), 5(70 to <90%) & 6(90 to 100%). EASI score is obtained as: EASI(A) = 0.1*(Eh+Ih+Exh+Lh)*Ah + 0.2*(Eu+Iu+Exu+Lu)*Au + 0.3*(Et +It+Ext+Lt)*At + 0.4*(El+Il+Exl+Ll)*Al. Total EASI score = 0.0 to 72.0; higher scores indicate greater severity of AD. Here, a negative change from baseline indicates less severity in AD. EASI 90 response was defined as at least a 90% improvement in EASI relative to Baseline. 90% CI was based on exact Clopper-Pearson method.

The vIGA-AD was assessed by the principal investigator or sub-investigator using the descriptors that best described the overall appearance of the lesions. It is a 5-point morphological assessment of overall disease severity that ranges from 0 to 4, where 0 = Clear; No inflammatory signs of atopic dermatitis 1 = Almost clear; Barely perceptible erythema, barely perceptible induration/papulation, and/or minimal lichenification 2 = Mild; Slight but definite erythema (pink), slight but definite induration/papulation, and/ or slight but definite lichenification 3 = Moderate; Clearly perceptible erythema (dull red), clearly perceptible induration/papulation, and/or clearly perceptible lichenification 4 = Severe; Marked erythema (deep or bright red), marked induration/ papulation, and/or marked lichenification. Percentage of participants who achieved at least a 2-grade reduction from baseline to clear (0) or Almost Clear (1) in vIGA-AD are reported here.

The vIGA-AD was assessed by the principal investigator or sub-investigator using the descriptors that best described the overall appearance of the lesions. It is a 5-point morphological assessment of overall disease severity that ranges from 0 to 4, where 0 = Clear; No inflammatory signs of atopic dermatitis 1 = Almost clear; Barely perceptible erythema, barely perceptible induration/papulation, and/or minimal lichenification 2 = Mild; Slight but definite erythema (pink), slight but definite induration/papulation, and/ or slight but definite lichenification 3 = Moderate; Clearly perceptible erythema (dull red), clearly perceptible induration/papulation, and/or clearly perceptible lichenification 4 = Severe; Marked erythema (deep or bright red), marked induration/ papulation, and/or marked lichenification. The percentage of participants with reduction from baseline of ≥2 grade in vIGA-AD score has been reported.

PP-NRS is based on the Numeric Rating Scale which was used to assess the level of itch the participant was experiencing. The following question was asked to participants: "On a scale of 0 to 10, with 0 = "no itch" and 10 = "worst itch imaginable", how would you rate your itch at the worst moment during the previous 24 hours?" Based on the score provided by participant, the PP-NRS score was assigned. Higher score indicates more severity. A negative change from baseline indicates improvement.

PP-NRS is based on the Numeric Rating Scale which was used to assess the level of itch the participant was experiencing. The following question was asked to participants: "On a scale of 0 to 10, with 0 = "no itch" and 10 = "worst itch imaginable", how would you rate your itch at the worst moment during the previous 24 hours?" Based on the score provided by participant, the PP-NRS score was assigned. Higher score indicates more severity. A negative change from baseline indicates improvement.

PP-NRS is based on the Numeric Rating Scale which was used to assess the level of itch the participant was experiencing. The following question was be asked to participants: "On a scale of 0 to 10, with 0 = "no itch" and 10 = "worst itch imaginable", how would you rate your itch at the worst moment during the previous 24 hours?" Based on the score provided by participant, the PP-NRS score was assigned. Higher score indicates more severity. A negative change from Baseline indicates improvement. The percentage of participants who had at least a 4-point reduction in the NRS score at post-baseline visits has been reported.

The overall BSA affected by AD was evaluated (from 0% to 100%). It was calculated using the palm surface area method. This method states that palmar surface of 1 hand (using the participant's hand and including the fingers) represents 1% of his or her total BSA.

The overall BSA affected by AD was evaluated (from 0% to 100%). It was calculated using the palm surface area method. This method states that palmar surface of 1 hand (using the participant's hand and including the fingers) represents 1% of his or her total BSA.

ADCT questionnaire is a self-assessment comprised of 6 concise questions to evaluate participant's perceptions of AD symptoms and impacts on their life and function over the last week. Each question carries equal weight and is scored from 0 to 4, for a total score ranging between 0 and 24. Higher score indicates higher severity. A negative change from baseline indicates improvement.

POEM is a self-assessment of disease severity using 7 questions asked to participant. A maximum value of 28 can be assigned based on the participant's response to 7 questions scored from 0 to 4, where 0 = No days, 1 = 1-2 days, 2 = 3-4 days, 3 = 5-6 days and 4 = Every day. Higher score indicates high severity. A negative change from baseline indicates improvement.

DLQI is a 10 questions questionnaire to measure how much skin problems have affected a participant's life over the last week. Each question is scored from 0 to 3 (0 = Not at all, 1 = A little, 2 = A lot and 3 = Very much). The DLQI is calculated by summing the score of each question, giving a total score ranging from 0 (not at all) to 30 (very much). The higher the score the more quality of life is impaired. A negative change from baseline indicates improvement in QoL.