Atopic Dermatitis
Conditions
Keywords
Eczema, Monoclonal Antibody
Brief summary
The purpose of this study is to determine the efficacy and safety of a monoclonal antibody, OpSCF, in the treatment of adults with moderate to severe Atopic Dermatitis (Eczema). OpSCF will be compared to a placebo. OpSCF or placebo will be administered every 2 weeks for 14 weeks, and the efficacy will be assessed two weeks later. After that, subjects may choose to enter an Open Label Extension phase in which all subjects will receive OpSCF every 4 weeks for 40 additional weeks.
Interventions
BIOLOGICALOpSCF
Administered SC.
BIOLOGICALPlacebo
Administered SC.
Sponsors
Insmed Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Subject has clinically confirmed diagnosis of active AD. * Subject has at least a 6-month history of AD * Subject is willing to use effective birth control
Exclusion criteria
* Subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study. * Subject has any clinically significant medical condition that would put the subject at undue risk or interfere with interpretation of study results. * Subject has used dupilumab within 26 weeks prior to Day 1. * Subject has used tralokinumab within 12 weeks prior to Day 1. NOTE: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Eczema Area and Severity Index (EASI) at Week 16 | Baseline, Week 16 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Experienced At-Least One Treatment Emergent Adverse Event (TEAE) and Serious Adverse Events (SAEs) | From first dose of study drug up to end of follow-up (up to Week 67) | 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. |
| Percent Change From Baseline in EASI at Weeks 2, 4, 6, 8, 10, 12, and 14 | Baseline, Weeks 2, 4, 6, 8, 10, 12 and 14 | 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. |
| Change From Baseline in EASI at Weeks 2, 4, 6, 8, 10, 12, 14, and 16 | Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, and 16 | 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. |
| Percentage of Participants Achieving At-Least 50% Improvement From Baseline in EASI (EASI50) | At Weeks 2, 4, 6, 8, 10, 12, 14, and 16 | 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. |
| Percentage of Participants Achieving At-Least 75% Improvement From Baseline in EASI (EASI75) | At Weeks 2, 4, 6, 8, 10, 12, 14, and 16 | 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. |
| Percentage of Participants Achieving At-Least 90% Improvement From Baseline in EASI (EASI90) | At Weeks 2, 4, 6, 8, 10, 12, 14, and 16 | 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. |
| Percentage of Participants Achieving At-Least a 2-grade Reduction From Baseline to Clear (0) or Almost Clear (1) in Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) | At Weeks 2, 4, 6, 8, 10, 12, 14, and 16 | 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. |
| Percentage of Participants Achieving At-Least a 2-grade Reduction From Baseline in vIGA-AD | At Weeks 2, 4, 6, 8, 10, 12, 14, and 16 | 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. |
| Change From Baseline in Weekly Average of the Daily Peak Pruritus Numeric Rating Scale (PP-NRS) | Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, and 16 | 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. |
| Percent Change From Baseline in Weekly Average of the Daily PP-NRS | Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, and 16 | 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. |
| Percentage of Participants Achieving At-Least a 4-point Reduction From Baseline in Weekly Average of the Daily PP-NRS | Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, and 16 | 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. |
| Change From Baseline in Body Surface Area (BSA) Involved With Atopic Dermatitis (AD) | Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, and 16 | 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. |
| Percent Change From Baseline in BSA Involved With AD | Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, and 16 | 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. |
| Change From Baseline in Atopic Dermatitis Control Tool (ADCT) at Weeks 2, 4, 8, 12, and 16 | Baseline, Weeks 2, 4, 8,12 and 16 | 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. |
| Change From Baseline in Patient-Oriented Eczema Measure (POEM) at Weeks 2, 4, 8, 12, and 16 | Baseline, Weeks 2, 4, 8,12 and 16 | 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. |
| Change From Baseline in Dermatology Life Quality Index (DLQI) at Weeks 2, 4, 8, 12, and 16 | Baseline, Weeks 2, 4, 8,12 and 16 | 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. |
| Placebo-controlled Period: Serum Concentrations of OpSCF Over Time | Days 15, 29, 43, 57, 85, 99, 102, 106 and 113 | — |
| OLE Period: Serum Concentrations of OpSCF Over Time | Days 141, 169, 197, 225, 253, 281, 309 and 337 | — |
Countries
Canada, United States
Contacts
STUDY_DIRECTORStudy Director
Insmed Incorporated
Participant flow
Recruitment details
Participants took part in this study at multiple investigative sites from 21 November 2023 to 18 August 2025.
Pre-assignment details
A total of 65 participants with atopic dermatitis (AD) were screened, of which 50 participants were enrolled and randomized to receive treatment in this study.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 44.1 years STANDARD_DEVIATION 16.89 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 7 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 31 Participants |
| Sex: Female, Male Female | 25 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 24 | 0 / 24 | 0 / 22 |
| other Total, other adverse events | 6 / 26 | 8 / 24 | 9 / 24 | 4 / 22 |
| serious Total, serious adverse events | 0 / 26 | 0 / 24 | 1 / 24 | 1 / 22 |
Outcome results
None listed