Atopic Dermatitis
Conditions
Brief summary
To assess the safety, tolerability and efficacy of CIM331, compared to placebo, in atopic dermatitis patients who are inadequately controlled by or intolerant to topical therapy
Interventions
DRUGnemolizumab (CIM331)
OTHERPlacebo
Sponsors
Chugai Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* ≥18 and ≤65 years of age at the time of consent. * Patients with Atopic Dermatitis * Pruritus visual analogue scale (VAS) ≥50 mm at the screening and baseline visit * Eczema Area and Severity Index (EASI) ≥10 at the screening and baseline visit * static Investigator's Global Assessment (sIGA) score ≥3 at the baseline visit
Exclusion criteria
* Serological evidence of hepatitis B virus or hepatitis C virus infection * Known human immunodeficiency virus infection * Ongoing treatment with specific or non-specific hyposensitization therapy for AD * Treatment with mild or moderately potent topical corticosteroids (TCS) within 1 week prior to randomization * History of infection including skin infection requiring treatment with oral or intravenous (IV) antibiotics, antivirals, or antifungals within 1 week prior to randomization. * Evidence of tuberculosis (TB) infection as defined by a positive purified protein derivative (PPD) and/or positive interferon-gamma release assay. * Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Changes From Baseline in Pruritus Visual Analogue Scale (VAS) at Week 12 | baseline to Week 12 | Percent changes from baseline in pruritus VAS at Week 12. VAS indicates pruritus intensity in the last 24 hours, from 0 (no itch) to 10 (worst imaginable itch). When condition of pruritus improves, percent change from baseline at Week 12 indicates negative value (i.e. the higher the absolute value is, the more the condition improves). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A + Part B, ITT Long Population) | baseline to Week 12 (Part A), up to Week 64 (Part B) | EASI score was used to measure the severity and extent of atopic eczema. The intensity of a representative area of eczema and the approximate percentage affected by eczema were calculated for each of the four body regions: head and neck, upper limbs, trunk, and lower limbs. The sum of the above 4 body region scores was calculated and should be 0 (none) to 72 (severest). When the condition of eczema improves, the percent change from baseline at each timepoint indicates negative value (i.e. the higher the absolute value is, the more the condition improves). |
| Changes From Baseline in SCORing Atopic Dermatitis (SCORAD) (Part A, PP Population) | baseline to Week 12 (Part A) | SCORAD is a clinical tool used to assess the extent and severity of eczema. Area and intensity, were assessed by the Investigator and subjective symptoms were reported by the patient in order to determine an overall score. The score should be 0 to 103: mild \[\<25\], moderate \[25-50\] or severe \[\>50\]). When the condition of eczema improves, the percent change from baseline at each timepoint indicates negative value (i.e. the higher the absolute value is, the more the condition improves). |
| Changes From Baseline in SCORing Atopic Dermatitis (SCORAD) (Part A + Part B, ITT Long Population) | baseline to Week 12 (Part A), up to Week 64 (Part B) | SCORAD is a clinical tool used to assess the extent and severity of eczema. Area and intensity, were assessed by the Investigator and subjective symptoms were reported by the patient in order to determine an overall score. The score should be 0 to 103: mild \[\<25\], moderate \[25-50\] or severe \[\>50\]). When the condition of eczema improves, the percent change from baseline at each timepoint indicates negative value (i.e. the higher the absolute value is, the more the condition improves). |
| Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A, PP Population) | baseline to Week 12 (Part A) | EASI score was used to measure the severity and extent of atopic eczema. The intensity of a representative area of eczema and the approximate percentage affected by eczema were calculated for each of the four body regions: head and neck, upper limbs, trunk, and lower limbs. The sum of the above 4 body region scores was calculated and should be 0 (none) to 72 (severest). When the condition of eczema improves, the percent change from baseline at each timepoint indicates negative value (i.e. the higher the absolute value is, the more the condition improves). |
| Changes From Baseline in Static Investigator's Global Assessment (sIGA) (Part A + Part B, ITT Long Population) | baseline to Week 12 (Part A), up to Week 64 (Part B) | The sIGA consisted of a 6-point severity scale from clear to very severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease and 5 = very severe disease). The sIGA assessed clinical characteristics of erythema, infiltration, papulation, oozing and crusting for the overall severity assessment at the time of evaluation. When the skin condition improves, the change from baseline at each timepoint indicates negative value (i.e. the higher the absolute value is, the more the condition improves). |
| Changes From Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement (Part A, PP Population) | baseline to Week 12 (Part A) | The total BSA affected by AD was assessed as part of SCORAD. The BSA is a measure of the severity of AD, and it is considered to be severe when the rash with strong inflammation is 10 % or more of the total BSA. When the BSA of AD involvement decreases, the change from baseline at each timepoint indicates negative value (i.e. the higher the absolute value is, the more the BSA of AD involvement decreases). |
| Changes From Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement (Part A + Part B, ITT Long Population) | baseline to Week 12 (Part A), up to Week 64 (Part B) | The total BSA affected by AD was assessed as part of SCORAD. The BSA is a measure of the severity of AD, and it is considered to be severe when the rash with strong inflammation is 10 % or more of the total BSA. When the BSA of AD involvement decreases, the change from baseline at each timepoint indicates negative value (i.e. the higher the absolute value is, the more the BSA of AD involvement decreases). |
| Changes From Baseline in Static Investigator's Global Assessment (sIGA) (Part A, PP Population) | baseline to Week 12 (Part A) | The sIGA consisted of a 6-point severity scale from clear to very severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease and 5 = very severe disease). The sIGA assessed clinical characteristics of erythema, infiltration, papulation, oozing and crusting for the overall severity assessment at the time of evaluation. When the skin condition improves, the change from baseline at each timepoint indicates negative value (i.e. the higher the absolute value is, the more the condition improves). |
Countries
United States
Participant flow
Recruitment details
The patients were enrolled at 57 investigational sites in the UK, Germany, Poland, Japan, and the US.
Pre-assignment details
Patient eligibility was assessed during the screening period (Day -28 to Day -8). If all eligibility criteria were met, the patient entered a 7-day run-in period (Day -7 to Day -1) during which all prohibited treatments were discontinued. Baseline assessments were performed until randomization on Day 1.
Participants by arm
| Arm | Count |
|---|---|
| Placebo (Part A) Data from patients randomized to this group in Part A were analyzed.
Placebo-controlled period (Part A) (Day 1 to Week 12):
Patients randomized to this group received placebo subcutaneously every 4 weeks on Day 1, Week 4 and Week 8. | 46 |
| Nemoliozumab (0.1 mg/kg) Q4W (Part A) Data from patients randomized to this group in Part A were analyzed.
Placebo-controlled period (Part A) (Day 1 to Week 12):
Patients randomized to this group received Nemoliozumab (0.1 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8. | 46 |
| Nemoliozumab (0.5 mg/kg) Q4W (Part A) Data from patients randomized to this group in Part A were analyzed.
Placebo-controlled period (Part A) (Day 1 to Week 12):
Patients randomized to this group received Nemoliozumab (0.5 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8. | 45 |
| Nemoliozumab (2.0 mg/kg) Q4W (Part A) Data from patients randomized to this group in Part A were analyzed.
Placebo-controlled period (Part A) (Day 1 to Week 12):
Patients randomized to this group received Nemoliozumab (2.0 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8. | 47 |
| Nemoliozumab (2.0 mg/kg) Q8W (Part A) Data from patients randomized to this group in Part A were analyzed.
Placebo-controlled period (Part A) (Day 1 to Week 12):
Patients randomized to this group received Nemoliozumab (2.0 mg/kg) subcutaneously every 8 weeks on Day 1 and Week 8. | 45 |
| Total | 229 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Active-to-active (Part B) | Adverse Event | 0 | 2 | 0 | 1 | 3 |
| Active-to-active (Part B) | Lack of Efficacy | 0 | 3 | 2 | 0 | 4 |
| Active-to-active (Part B) | Lost to Follow-up | 0 | 0 | 0 | 0 | 1 |
| Active-to-active (Part B) | Others (not classified above reasons) | 0 | 1 | 0 | 1 | 1 |
| Active-to-active (Part B) | Physician Decision | 0 | 0 | 1 | 1 | 0 |
| Active-to-active (Part B) | Pregnancy | 0 | 0 | 0 | 0 | 1 |
| Active-to-active (Part B) | Withdrawal by Subject | 0 | 4 | 7 | 6 | 6 |
| Placebo-controlled (Part A) | Adverse Event | 1 | 5 | 2 | 2 | 4 |
| Placebo-controlled (Part A) | Lack of Efficacy | 3 | 1 | 1 | 2 | 1 |
| Placebo-controlled (Part A) | Lost to Follow-up | 0 | 1 | 0 | 1 | 0 |
| Placebo-controlled (Part A) | Others (not classified above reasons) | 0 | 0 | 0 | 0 | 2 |
| Placebo-controlled (Part A) | Withdrawal by Subject | 5 | 2 | 6 | 2 | 7 |
| Placebo-to-active (Part B) | Adverse Event | 0 | 1 | 0 | 1 | 0 |
| Placebo-to-active (Part B) | Lack of Efficacy | 0 | 0 | 0 | 1 | 0 |
| Placebo-to-active (Part B) | Lost to Follow-up | 0 | 1 | 0 | 0 | 0 |
| Placebo-to-active (Part B) | Protocol Violation | 0 | 0 | 1 | 0 | 0 |
| Placebo-to-active (Part B) | Withdrawal by Subject | 0 | 3 | 4 | 3 | 0 |
Baseline characteristics
| Characteristic | Nemoliozumab (0.1 mg/kg) Q4W (Part A) | Nemoliozumab (0.5 mg/kg) Q4W (Part A) | Nemoliozumab (2.0 mg/kg) Q4W (Part A) | Placebo (Part A) | Nemoliozumab (2.0 mg/kg) Q8W (Part A) | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 33.9 years STANDARD_DEVIATION 10.2 | 33.0 years STANDARD_DEVIATION 11.5 | 33.7 years STANDARD_DEVIATION 12.2 | 35.7 years STANDARD_DEVIATION 13.3 | 34.6 years STANDARD_DEVIATION 13.3 | 34.2 years STANDARD_DEVIATION 12.1 |
| Age, Customized Age Category 20 -< 30 years | 21 Participants | 22 Participants | 20 Participants | 14 Participants | 21 Participants | 98 Participants |
| Age, Customized Age Category < 20 years | 0 Participants | 3 Participants | 1 Participants | 4 Participants | 1 Participants | 9 Participants |
| Age, Customized Age Category 30 -< 40 years | 15 Participants | 7 Participants | 13 Participants | 10 Participants | 7 Participants | 52 Participants |
| Age, Customized Age Category 40 -< 50 years | 4 Participants | 6 Participants | 7 Participants | 8 Participants | 7 Participants | 32 Participants |
| Age, Customized Age Category 50 -< 60 years | 6 Participants | 7 Participants | 4 Participants | 8 Participants | 7 Participants | 32 Participants |
| Age, Customized Age Category > 60 years | 0 Participants | 0 Participants | 2 Participants | 2 Participants | 2 Participants | 6 Participants |
| Body mass index | 25.92 Kilogram per square metre STANDARD_DEVIATION 6.41 | 26.10 Kilogram per square metre STANDARD_DEVIATION 6.66 | 25.08 Kilogram per square metre STANDARD_DEVIATION 5.26 | 26.20 Kilogram per square metre STANDARD_DEVIATION 6.81 | 25.71 Kilogram per square metre STANDARD_DEVIATION 6.47 | 25.80 Kilogram per square metre STANDARD_DEVIATION 6.3 |
| Body Mass Index Category < 25 kg/m^2 | 26 Participants | 23 Participants | 28 Participants | 27 Participants | 23 Participants | 127 Participants |
| Body Mass Index Category >- 25 kg/m^2 | 20 Participants | 22 Participants | 19 Participants | 19 Participants | 22 Participants | 102 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 45 Participants | 44 Participants | 45 Participants | 45 Participants | 44 Participants | 223 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 3 Participants |
| Height | 170.19 Centimetre STANDARD_DEVIATION 10.52 | 167.41 Centimetre STANDARD_DEVIATION 9.44 | 170.04 Centimetre STANDARD_DEVIATION 8.84 | 167.81 Centimetre STANDARD_DEVIATION 8.84 | 167.58 Centimetre STANDARD_DEVIATION 9.63 | 168.62 Centimetre STANDARD_DEVIATION 9.47 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 17 Participants | 11 Participants | 15 Participants | 13 Participants | 14 Participants | 70 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 6 Participants | 1 Participants | 1 Participants | 4 Participants | 15 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 26 Participants | 27 Participants | 30 Participants | 32 Participants | 27 Participants | 142 Participants |
| Sex: Female, Male Female | 21 Participants | 27 Participants | 18 Participants | 23 Participants | 21 Participants | 110 Participants |
| Sex: Female, Male Male | 25 Participants | 18 Participants | 29 Participants | 23 Participants | 24 Participants | 119 Participants |
| Weight | 76.01 Kilogram STANDARD_DEVIATION 22.9 | 73.40 Kilogram STANDARD_DEVIATION 19.98 | 72.51 Kilogram STANDARD_DEVIATION 16.04 | 74.20 Kilogram STANDARD_DEVIATION 21.6 | 72.63 Kilogram STANDARD_DEVIATION 20.96 | 73.75 Kilogram STANDARD_DEVIATION 20.27 |
| Weight Category < 60 kg | 12 Participants | 15 Participants | 11 Participants | 11 Participants | 15 Participants | 64 Participants |
| Weight Category >- 60 kg | 34 Participants | 30 Participants | 36 Participants | 35 Participants | 30 Participants | 165 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 53 | 0 / 53 | 0 / 54 | 0 / 52 | 0 / 52 | 0 / 53 | 0 / 54 | 0 / 52 | 0 / 52 |
| other Total, other adverse events | 27 / 53 | 29 / 53 | 23 / 54 | 27 / 52 | 25 / 52 | 37 / 53 | 35 / 54 | 33 / 52 | 35 / 52 |
| serious Total, serious adverse events | 1 / 53 | 1 / 53 | 0 / 54 | 3 / 52 | 5 / 52 | 3 / 53 | 3 / 54 | 4 / 52 | 9 / 52 |
Outcome results
Primary
Percent Changes From Baseline in Pruritus Visual Analogue Scale (VAS) at Week 12
Percent changes from baseline in pruritus VAS at Week 12. VAS indicates pruritus intensity in the last 24 hours, from 0 (no itch) to 10 (worst imaginable itch). When condition of pruritus improves, percent change from baseline at Week 12 indicates negative value (i.e. the higher the absolute value is, the more the condition improves).
Time frame: baseline to Week 12
Population: The per-protocol (PP) population in Part A was used for the analysis. The PP population was defined as a subset of the intent to treat (ITT) population excluding some of the major protocol violators, patients who were withdrawn before being evaluated for pruritus VAS at Week 8, or those who withdrew prior to receiving two or more study drug administrations. Patients who received the wrong study drug were also excluded from the PP population.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo (Part A) | Percent Changes From Baseline in Pruritus Visual Analogue Scale (VAS) at Week 12 | -20.07 percentage change |
| Nemoliozumab (0.1 mg/kg) Q4W (Part A) | Percent Changes From Baseline in Pruritus Visual Analogue Scale (VAS) at Week 12 | -41.46 percentage change |
| Nemoliozumab (0.5 mg/kg) Q4W (Part A) | Percent Changes From Baseline in Pruritus Visual Analogue Scale (VAS) at Week 12 | -61.24 percentage change |
| Nemoliozumab (2.0 mg/kg) Q4W (Part A) | Percent Changes From Baseline in Pruritus Visual Analogue Scale (VAS) at Week 12 | -60.46 percentage change |
p-value: 0.002795% CI: [-35.25, -7.53]ANCOVA
p-value: <0.000195% CI: [-55.17, -27.15]ANCOVA
p-value: <0.000195% CI: [-54.11, -26.67]ANCOVA
Secondary
Changes From Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement (Part A + Part B, ITT Long Population)
The total BSA affected by AD was assessed as part of SCORAD. The BSA is a measure of the severity of AD, and it is considered to be severe when the rash with strong inflammation is 10 % or more of the total BSA. When the BSA of AD involvement decreases, the change from baseline at each timepoint indicates negative value (i.e. the higher the absolute value is, the more the BSA of AD involvement decreases).
Time frame: baseline to Week 12 (Part A), up to Week 64 (Part B)
Population: The intent to treat (ITT) Long population was used for the analysis. The ITT Long population included patients randomized to Nemoliozumab treatment groups in Part A and patients re-randomized from the placebo group to Nemoliozumab treatment groups, providing they received at least one dose of Nemoliozumab and providing the results of at least one post-dose efficacy assessment was available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (Part A) | Changes From Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement (Part A + Part B, ITT Long Population) | Week 48 | -65.21 percentage change from baseline | Standard Deviation 32.63 |
| Placebo (Part A) | Changes From Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement (Part A + Part B, ITT Long Population) | Week 60 | -60.41 percentage change from baseline | Standard Deviation 37 |
| Placebo (Part A) | Changes From Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement (Part A + Part B, ITT Long Population) | Week 8 | -18.08 percentage change from baseline | Standard Deviation 45.82 |
| Placebo (Part A) | Changes From Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement (Part A + Part B, ITT Long Population) | Week 24 | -48.13 percentage change from baseline | Standard Deviation 39.07 |
| Placebo (Part A) | Changes From Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement (Part A + Part B, ITT Long Population) | Week 64 | -62.54 percentage change from baseline | Standard Deviation 40.92 |
| Placebo (Part A) | Changes From Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement (Part A + Part B, ITT Long Population) | Week 4 | -10.12 percentage change from baseline | Standard Deviation 45.56 |
| Placebo (Part A) | Changes From Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement (Part A + Part B, ITT Long Population) | Week 12 | -24.53 percentage change from baseline | Standard Deviation 49.77 |
| Nemoliozumab (0.1 mg/kg) Q4W (Part A) | Changes From Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement (Part A + Part B, ITT Long Population) | Week 4 | -23.28 percentage change from baseline | Standard Deviation 38.96 |
| Nemoliozumab (0.1 mg/kg) Q4W (Part A) | Changes From Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement (Part A + Part B, ITT Long Population) | Week 24 | -51.41 percentage change from baseline | Standard Deviation 44.1 |
| Nemoliozumab (0.1 mg/kg) Q4W (Part A) | Changes From Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement (Part A + Part B, ITT Long Population) | Week 12 | -25.31 percentage change from baseline | Standard Deviation 63.43 |
| Nemoliozumab (0.1 mg/kg) Q4W (Part A) | Changes From Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement (Part A + Part B, ITT Long Population) | Week 64 | -66.01 percentage change from baseline | Standard Deviation 36.38 |
| Nemoliozumab (0.1 mg/kg) Q4W (Part A) | Changes From Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement (Part A + Part B, ITT Long Population) | Week 8 | -29.58 percentage change from baseline | Standard Deviation 47.13 |
| Nemoliozumab (0.1 mg/kg) Q4W (Part A) | Changes From Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement (Part A + Part B, ITT Long Population) | Week 60 | -70.44 percentage change from baseline | Standard Deviation 35.81 |
| Nemoliozumab (0.1 mg/kg) Q4W (Part A) | Changes From Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement (Part A + Part B, ITT Long Population) | Week 48 | -69.20 percentage change from baseline | Standard Deviation 39.95 |
| Nemoliozumab (0.5 mg/kg) Q4W (Part A) | Changes From Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement (Part A + Part B, ITT Long Population) | Week 12 | -25.91 percentage change from baseline | Standard Deviation 44.4 |
| Nemoliozumab (0.5 mg/kg) Q4W (Part A) | Changes From Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement (Part A + Part B, ITT Long Population) | Week 64 | -63.35 percentage change from baseline | Standard Deviation 40.37 |
| Nemoliozumab (0.5 mg/kg) Q4W (Part A) | Changes From Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement (Part A + Part B, ITT Long Population) | Week 8 | -24.64 percentage change from baseline | Standard Deviation 37.49 |
| Nemoliozumab (0.5 mg/kg) Q4W (Part A) | Changes From Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement (Part A + Part B, ITT Long Population) | Week 4 | -17.98 percentage change from baseline | Standard Deviation 35.12 |
| Nemoliozumab (0.5 mg/kg) Q4W (Part A) | Changes From Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement (Part A + Part B, ITT Long Population) | Week 24 | -40.53 percentage change from baseline | Standard Deviation 42.94 |
| Nemoliozumab (0.5 mg/kg) Q4W (Part A) | Changes From Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement (Part A + Part B, ITT Long Population) | Week 48 | -49.66 percentage change from baseline | Standard Deviation 44.18 |
| Nemoliozumab (0.5 mg/kg) Q4W (Part A) | Changes From Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement (Part A + Part B, ITT Long Population) | Week 60 | -60.99 percentage change from baseline | Standard Deviation 48 |
| Nemoliozumab (2.0 mg/kg) Q4W (Part A) | Changes From Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement (Part A + Part B, ITT Long Population) | Week 8 | -6.66 percentage change from baseline | Standard Deviation 59.4 |
| Nemoliozumab (2.0 mg/kg) Q4W (Part A) | Changes From Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement (Part A + Part B, ITT Long Population) | Week 64 | -60.54 percentage change from baseline | Standard Deviation 55.96 |
| Nemoliozumab (2.0 mg/kg) Q4W (Part A) | Changes From Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement (Part A + Part B, ITT Long Population) | Week 48 | -59.97 percentage change from baseline | Standard Deviation 50.32 |
| Nemoliozumab (2.0 mg/kg) Q4W (Part A) | Changes From Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement (Part A + Part B, ITT Long Population) | Week 4 | -2.79 percentage change from baseline | Standard Deviation 54.12 |
| Nemoliozumab (2.0 mg/kg) Q4W (Part A) | Changes From Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement (Part A + Part B, ITT Long Population) | Week 60 | -58.38 percentage change from baseline | Standard Deviation 44.97 |
| Nemoliozumab (2.0 mg/kg) Q4W (Part A) | Changes From Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement (Part A + Part B, ITT Long Population) | Week 24 | -36.91 percentage change from baseline | Standard Deviation 40.99 |
| Nemoliozumab (2.0 mg/kg) Q4W (Part A) | Changes From Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement (Part A + Part B, ITT Long Population) | Week 12 | -18.56 percentage change from baseline | Standard Deviation 52.3 |
Secondary
Changes From Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement (Part A, PP Population)
The total BSA affected by AD was assessed as part of SCORAD. The BSA is a measure of the severity of AD, and it is considered to be severe when the rash with strong inflammation is 10 % or more of the total BSA. When the BSA of AD involvement decreases, the change from baseline at each timepoint indicates negative value (i.e. the higher the absolute value is, the more the BSA of AD involvement decreases).
Time frame: baseline to Week 12 (Part A)
Population: The per-protocol (PP) population in Part A was used for the analysis. The PP population was defined as a subset of the ITT population excluding some of the major protocol violators , patients who were withdrawn before being evaluated for pruritus VAS at Week 8, or those who withdrew prior to receiving two or more study drug administrations. Patients who received the wrong study drug were also excluded from the PP population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (Part A) | Changes From Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement (Part A, PP Population) | Week 4 | -7.48 percentage change from baseline | Standard Deviation 37.14 |
| Placebo (Part A) | Changes From Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement (Part A, PP Population) | Week 12 | -13.29 percentage change from baseline | Standard Deviation 49.87 |
| Placebo (Part A) | Changes From Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement (Part A, PP Population) | Week 8 | -14.44 percentage change from baseline | Standard Deviation 49.29 |
| Nemoliozumab (0.1 mg/kg) Q4W (Part A) | Changes From Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement (Part A, PP Population) | Week 4 | -12.11 percentage change from baseline | Standard Deviation 43.69 |
| Nemoliozumab (0.1 mg/kg) Q4W (Part A) | Changes From Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement (Part A, PP Population) | Week 12 | -17.54 percentage change from baseline | Standard Deviation 47.16 |
| Nemoliozumab (0.1 mg/kg) Q4W (Part A) | Changes From Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement (Part A, PP Population) | Week 8 | -14.90 percentage change from baseline | Standard Deviation 45.84 |
| Nemoliozumab (0.5 mg/kg) Q4W (Part A) | Changes From Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement (Part A, PP Population) | Week 8 | -27.23 percentage change from baseline | Standard Deviation 47.17 |
| Nemoliozumab (0.5 mg/kg) Q4W (Part A) | Changes From Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement (Part A, PP Population) | Week 4 | -23.49 percentage change from baseline | Standard Deviation 40.93 |
| Nemoliozumab (0.5 mg/kg) Q4W (Part A) | Changes From Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement (Part A, PP Population) | Week 12 | -19.68 percentage change from baseline | Standard Deviation 67.49 |
| Nemoliozumab (2.0 mg/kg) Q4W (Part A) | Changes From Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement (Part A, PP Population) | Week 4 | -18.44 percentage change from baseline | Standard Deviation 35.47 |
| Nemoliozumab (2.0 mg/kg) Q4W (Part A) | Changes From Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement (Part A, PP Population) | Week 12 | -24.36 percentage change from baseline | Standard Deviation 41.84 |
| Nemoliozumab (2.0 mg/kg) Q4W (Part A) | Changes From Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement (Part A, PP Population) | Week 8 | -22.99 percentage change from baseline | Standard Deviation 38.58 |
Secondary
Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A + Part B, ITT Long Population)
EASI score was used to measure the severity and extent of atopic eczema. The intensity of a representative area of eczema and the approximate percentage affected by eczema were calculated for each of the four body regions: head and neck, upper limbs, trunk, and lower limbs. The sum of the above 4 body region scores was calculated and should be 0 (none) to 72 (severest). When the condition of eczema improves, the percent change from baseline at each timepoint indicates negative value (i.e. the higher the absolute value is, the more the condition improves).
Time frame: baseline to Week 12 (Part A), up to Week 64 (Part B)
Population: The intent to treat (ITT) Long population was used for the analysis. The ITT Long population included patients randomized to Nemoliozumab treatment groups in Part A and patients re-randomized from the placebo group to Nemoliozumab treatment groups, providing they received at least one dose of Nemoliozumab and providing the results of at least one post-dose efficacy assessment was available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (Part A) | Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A + Part B, ITT Long Population) | Week 48 | -69.90 percentage change from baseline | Standard Deviation 28.17 |
| Placebo (Part A) | Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A + Part B, ITT Long Population) | Week 8 | -25.13 percentage change from baseline | Standard Deviation 49.82 |
| Placebo (Part A) | Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A + Part B, ITT Long Population) | Week 4 | -25.47 percentage change from baseline | Standard Deviation 42.41 |
| Placebo (Part A) | Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A + Part B, ITT Long Population) | Week 64 | -68.45 percentage change from baseline | Standard Deviation 41.62 |
| Placebo (Part A) | Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A + Part B, ITT Long Population) | Week 24 | -55.83 percentage change from baseline | Standard Deviation 42.25 |
| Placebo (Part A) | Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A + Part B, ITT Long Population) | Week 12 | -35.11 percentage change from baseline | Standard Deviation 47.92 |
| Placebo (Part A) | Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A + Part B, ITT Long Population) | Week 60 | -63.11 percentage change from baseline | Standard Deviation 41.89 |
| Nemoliozumab (0.1 mg/kg) Q4W (Part A) | Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A + Part B, ITT Long Population) | Week 4 | -32.11 percentage change from baseline | Standard Deviation 43.7 |
| Nemoliozumab (0.1 mg/kg) Q4W (Part A) | Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A + Part B, ITT Long Population) | Week 48 | -71.16 percentage change from baseline | Standard Deviation 43.31 |
| Nemoliozumab (0.1 mg/kg) Q4W (Part A) | Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A + Part B, ITT Long Population) | Week 60 | -78.81 percentage change from baseline | Standard Deviation 28.82 |
| Nemoliozumab (0.1 mg/kg) Q4W (Part A) | Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A + Part B, ITT Long Population) | Week 64 | -75.79 percentage change from baseline | Standard Deviation 25.4 |
| Nemoliozumab (0.1 mg/kg) Q4W (Part A) | Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A + Part B, ITT Long Population) | Week 8 | -47.86 percentage change from baseline | Standard Deviation 41.38 |
| Nemoliozumab (0.1 mg/kg) Q4W (Part A) | Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A + Part B, ITT Long Population) | Week 12 | -47.75 percentage change from baseline | Standard Deviation 45.41 |
| Nemoliozumab (0.1 mg/kg) Q4W (Part A) | Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A + Part B, ITT Long Population) | Week 24 | -62.71 percentage change from baseline | Standard Deviation 44.37 |
| Nemoliozumab (0.5 mg/kg) Q4W (Part A) | Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A + Part B, ITT Long Population) | Week 60 | -70.85 percentage change from baseline | Standard Deviation 36.24 |
| Nemoliozumab (0.5 mg/kg) Q4W (Part A) | Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A + Part B, ITT Long Population) | Week 48 | -61.14 percentage change from baseline | Standard Deviation 44.43 |
| Nemoliozumab (0.5 mg/kg) Q4W (Part A) | Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A + Part B, ITT Long Population) | Week 12 | -46.78 percentage change from baseline | Standard Deviation 35.15 |
| Nemoliozumab (0.5 mg/kg) Q4W (Part A) | Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A + Part B, ITT Long Population) | Week 8 | -41.02 percentage change from baseline | Standard Deviation 36.5 |
| Nemoliozumab (0.5 mg/kg) Q4W (Part A) | Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A + Part B, ITT Long Population) | Week 64 | -78.91 percentage change from baseline | Standard Deviation 24.34 |
| Nemoliozumab (0.5 mg/kg) Q4W (Part A) | Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A + Part B, ITT Long Population) | Week 4 | -32.48 percentage change from baseline | Standard Deviation 34.02 |
| Nemoliozumab (0.5 mg/kg) Q4W (Part A) | Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A + Part B, ITT Long Population) | Week 24 | -56.26 percentage change from baseline | Standard Deviation 34.68 |
| Nemoliozumab (2.0 mg/kg) Q4W (Part A) | Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A + Part B, ITT Long Population) | Week 60 | -70.87 percentage change from baseline | Standard Deviation 32.84 |
| Nemoliozumab (2.0 mg/kg) Q4W (Part A) | Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A + Part B, ITT Long Population) | Week 4 | -25.43 percentage change from baseline | Standard Deviation 35.58 |
| Nemoliozumab (2.0 mg/kg) Q4W (Part A) | Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A + Part B, ITT Long Population) | Week 8 | -33.35 percentage change from baseline | Standard Deviation 38 |
| Nemoliozumab (2.0 mg/kg) Q4W (Part A) | Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A + Part B, ITT Long Population) | Week 48 | -74.29 percentage change from baseline | Standard Deviation 33.97 |
| Nemoliozumab (2.0 mg/kg) Q4W (Part A) | Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A + Part B, ITT Long Population) | Week 24 | -51.01 percentage change from baseline | Standard Deviation 37.07 |
| Nemoliozumab (2.0 mg/kg) Q4W (Part A) | Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A + Part B, ITT Long Population) | Week 12 | -42.12 percentage change from baseline | Standard Deviation 40.82 |
| Nemoliozumab (2.0 mg/kg) Q4W (Part A) | Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A + Part B, ITT Long Population) | Week 64 | -69.25 percentage change from baseline | Standard Deviation 43.96 |
Secondary
Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A, PP Population)
EASI score was used to measure the severity and extent of atopic eczema. The intensity of a representative area of eczema and the approximate percentage affected by eczema were calculated for each of the four body regions: head and neck, upper limbs, trunk, and lower limbs. The sum of the above 4 body region scores was calculated and should be 0 (none) to 72 (severest). When the condition of eczema improves, the percent change from baseline at each timepoint indicates negative value (i.e. the higher the absolute value is, the more the condition improves).
Time frame: baseline to Week 12 (Part A)
Population: The per-protocol (PP) population in Part A was used for the analysis. The PP population was defined as a subset of the ITT population excluding some of the major protocol violators , patients who were withdrawn before being evaluated for pruritus VAS at Week 8, or those who withdrew prior to receiving two or more study drug administrations. Patients who received the wrong study drug were also excluded from the PP population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (Part A) | Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A, PP Population) | Week 4 | -12.12 percentage change from baseline | Standard Deviation 40 |
| Placebo (Part A) | Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A, PP Population) | Week 12 | -20.89 percentage change from baseline | Standard Deviation 47.63 |
| Placebo (Part A) | Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A, PP Population) | Week 8 | -21.82 percentage change from baseline | Standard Deviation 47 |
| Nemoliozumab (0.1 mg/kg) Q4W (Part A) | Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A, PP Population) | Week 4 | -26.89 percentage change from baseline | Standard Deviation 44.48 |
| Nemoliozumab (0.1 mg/kg) Q4W (Part A) | Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A, PP Population) | Week 12 | -27.88 percentage change from baseline | Standard Deviation 50.5 |
| Nemoliozumab (0.1 mg/kg) Q4W (Part A) | Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A, PP Population) | Week 8 | -25.17 percentage change from baseline | Standard Deviation 51.79 |
| Nemoliozumab (0.5 mg/kg) Q4W (Part A) | Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A, PP Population) | Week 8 | -46.20 percentage change from baseline | Standard Deviation 42.62 |
| Nemoliozumab (0.5 mg/kg) Q4W (Part A) | Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A, PP Population) | Week 4 | -35.70 percentage change from baseline | Standard Deviation 44.29 |
| Nemoliozumab (0.5 mg/kg) Q4W (Part A) | Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A, PP Population) | Week 12 | -44.57 percentage change from baseline | Standard Deviation 48.21 |
| Nemoliozumab (2.0 mg/kg) Q4W (Part A) | Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A, PP Population) | Week 4 | -33.86 percentage change from baseline | Standard Deviation 34.14 |
| Nemoliozumab (2.0 mg/kg) Q4W (Part A) | Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A, PP Population) | Week 12 | -40.29 percentage change from baseline | Standard Deviation 37.7 |
| Nemoliozumab (2.0 mg/kg) Q4W (Part A) | Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A, PP Population) | Week 8 | -39.89 percentage change from baseline | Standard Deviation 34.43 |
Secondary
Changes From Baseline in SCORing Atopic Dermatitis (SCORAD) (Part A + Part B, ITT Long Population)
SCORAD is a clinical tool used to assess the extent and severity of eczema. Area and intensity, were assessed by the Investigator and subjective symptoms were reported by the patient in order to determine an overall score. The score should be 0 to 103: mild \[\<25\], moderate \[25-50\] or severe \[\>50\]). When the condition of eczema improves, the percent change from baseline at each timepoint indicates negative value (i.e. the higher the absolute value is, the more the condition improves).
Time frame: baseline to Week 12 (Part A), up to Week 64 (Part B)
Population: The intent to treat (ITT) Long population was used for the analysis. The ITT Long population included patients randomized to Nemoliozumab treatment groups in Part A and patients re-randomized from the placebo group to Nemoliozumab treatment groups, providing they received at least one dose of Nemoliozumab and providing the results of at least one post-dose efficacy assessment was available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (Part A) | Changes From Baseline in SCORing Atopic Dermatitis (SCORAD) (Part A + Part B, ITT Long Population) | Week 4 | -27.73 percentage change from baseline | Standard Deviation 23.92 |
| Placebo (Part A) | Changes From Baseline in SCORing Atopic Dermatitis (SCORAD) (Part A + Part B, ITT Long Population) | Week 64 | -56.55 percentage change from baseline | Standard Deviation 28.25 |
| Placebo (Part A) | Changes From Baseline in SCORing Atopic Dermatitis (SCORAD) (Part A + Part B, ITT Long Population) | Week 8 | -29.05 percentage change from baseline | Standard Deviation 27.17 |
| Placebo (Part A) | Changes From Baseline in SCORing Atopic Dermatitis (SCORAD) (Part A + Part B, ITT Long Population) | Week 12 | -36.35 percentage change from baseline | Standard Deviation 22.24 |
| Placebo (Part A) | Changes From Baseline in SCORing Atopic Dermatitis (SCORAD) (Part A + Part B, ITT Long Population) | Week 48 | -55.82 percentage change from baseline | Standard Deviation 24.21 |
| Placebo (Part A) | Changes From Baseline in SCORing Atopic Dermatitis (SCORAD) (Part A + Part B, ITT Long Population) | Week 24 | -48.73 percentage change from baseline | Standard Deviation 27.64 |
| Placebo (Part A) | Changes From Baseline in SCORing Atopic Dermatitis (SCORAD) (Part A + Part B, ITT Long Population) | Week 60 | -55.08 percentage change from baseline | Standard Deviation 24.22 |
| Nemoliozumab (0.1 mg/kg) Q4W (Part A) | Changes From Baseline in SCORing Atopic Dermatitis (SCORAD) (Part A + Part B, ITT Long Population) | Week 12 | -42.22 percentage change from baseline | Standard Deviation 30.72 |
| Nemoliozumab (0.1 mg/kg) Q4W (Part A) | Changes From Baseline in SCORing Atopic Dermatitis (SCORAD) (Part A + Part B, ITT Long Population) | Week 48 | -59.20 percentage change from baseline | Standard Deviation 28.61 |
| Nemoliozumab (0.1 mg/kg) Q4W (Part A) | Changes From Baseline in SCORing Atopic Dermatitis (SCORAD) (Part A + Part B, ITT Long Population) | Week 64 | -64.02 percentage change from baseline | Standard Deviation 27.72 |
| Nemoliozumab (0.1 mg/kg) Q4W (Part A) | Changes From Baseline in SCORing Atopic Dermatitis (SCORAD) (Part A + Part B, ITT Long Population) | Week 4 | -30.30 percentage change from baseline | Standard Deviation 30.39 |
| Nemoliozumab (0.1 mg/kg) Q4W (Part A) | Changes From Baseline in SCORing Atopic Dermatitis (SCORAD) (Part A + Part B, ITT Long Population) | Week 60 | -64.02 percentage change from baseline | Standard Deviation 24.24 |
| Nemoliozumab (0.1 mg/kg) Q4W (Part A) | Changes From Baseline in SCORing Atopic Dermatitis (SCORAD) (Part A + Part B, ITT Long Population) | Week 8 | -36.16 percentage change from baseline | Standard Deviation 28.6 |
| Nemoliozumab (0.1 mg/kg) Q4W (Part A) | Changes From Baseline in SCORing Atopic Dermatitis (SCORAD) (Part A + Part B, ITT Long Population) | Week 24 | -58.15 percentage change from baseline | Standard Deviation 28.15 |
| Nemoliozumab (0.5 mg/kg) Q4W (Part A) | Changes From Baseline in SCORing Atopic Dermatitis (SCORAD) (Part A + Part B, ITT Long Population) | Week 24 | -52.00 percentage change from baseline | Standard Deviation 24.97 |
| Nemoliozumab (0.5 mg/kg) Q4W (Part A) | Changes From Baseline in SCORing Atopic Dermatitis (SCORAD) (Part A + Part B, ITT Long Population) | Week 4 | -28.20 percentage change from baseline | Standard Deviation 22.65 |
| Nemoliozumab (0.5 mg/kg) Q4W (Part A) | Changes From Baseline in SCORing Atopic Dermatitis (SCORAD) (Part A + Part B, ITT Long Population) | Week 48 | -53.82 percentage change from baseline | Standard Deviation 29.98 |
| Nemoliozumab (0.5 mg/kg) Q4W (Part A) | Changes From Baseline in SCORing Atopic Dermatitis (SCORAD) (Part A + Part B, ITT Long Population) | Week 60 | -63.26 percentage change from baseline | Standard Deviation 25.04 |
| Nemoliozumab (0.5 mg/kg) Q4W (Part A) | Changes From Baseline in SCORing Atopic Dermatitis (SCORAD) (Part A + Part B, ITT Long Population) | Week 64 | -66.61 percentage change from baseline | Standard Deviation 19.9 |
| Nemoliozumab (0.5 mg/kg) Q4W (Part A) | Changes From Baseline in SCORing Atopic Dermatitis (SCORAD) (Part A + Part B, ITT Long Population) | Week 8 | -37.52 percentage change from baseline | Standard Deviation 23.34 |
| Nemoliozumab (0.5 mg/kg) Q4W (Part A) | Changes From Baseline in SCORing Atopic Dermatitis (SCORAD) (Part A + Part B, ITT Long Population) | Week 12 | -42.60 percentage change from baseline | Standard Deviation 27.12 |
| Nemoliozumab (2.0 mg/kg) Q4W (Part A) | Changes From Baseline in SCORing Atopic Dermatitis (SCORAD) (Part A + Part B, ITT Long Population) | Week 64 | -63.07 percentage change from baseline | Standard Deviation 27.96 |
| Nemoliozumab (2.0 mg/kg) Q4W (Part A) | Changes From Baseline in SCORing Atopic Dermatitis (SCORAD) (Part A + Part B, ITT Long Population) | Week 60 | -61.03 percentage change from baseline | Standard Deviation 24.27 |
| Nemoliozumab (2.0 mg/kg) Q4W (Part A) | Changes From Baseline in SCORing Atopic Dermatitis (SCORAD) (Part A + Part B, ITT Long Population) | Week 4 | -25.31 percentage change from baseline | Standard Deviation 22.68 |
| Nemoliozumab (2.0 mg/kg) Q4W (Part A) | Changes From Baseline in SCORing Atopic Dermatitis (SCORAD) (Part A + Part B, ITT Long Population) | Week 12 | -41.85 percentage change from baseline | Standard Deviation 20.79 |
| Nemoliozumab (2.0 mg/kg) Q4W (Part A) | Changes From Baseline in SCORing Atopic Dermatitis (SCORAD) (Part A + Part B, ITT Long Population) | Week 48 | -66.15 percentage change from baseline | Standard Deviation 24.43 |
| Nemoliozumab (2.0 mg/kg) Q4W (Part A) | Changes From Baseline in SCORing Atopic Dermatitis (SCORAD) (Part A + Part B, ITT Long Population) | Week 24 | -49.97 percentage change from baseline | Standard Deviation 24.99 |
| Nemoliozumab (2.0 mg/kg) Q4W (Part A) | Changes From Baseline in SCORing Atopic Dermatitis (SCORAD) (Part A + Part B, ITT Long Population) | Week 8 | -31.81 percentage change from baseline | Standard Deviation 28.42 |
Secondary
Changes From Baseline in SCORing Atopic Dermatitis (SCORAD) (Part A, PP Population)
SCORAD is a clinical tool used to assess the extent and severity of eczema. Area and intensity, were assessed by the Investigator and subjective symptoms were reported by the patient in order to determine an overall score. The score should be 0 to 103: mild \[\<25\], moderate \[25-50\] or severe \[\>50\]). When the condition of eczema improves, the percent change from baseline at each timepoint indicates negative value (i.e. the higher the absolute value is, the more the condition improves).
Time frame: baseline to Week 12 (Part A)
Population: The per-protocol (PP) population in Part A was used for the analysis. The PP population was defined as a subset of the ITT population excluding some of the major protocol violators , patients who were withdrawn before being evaluated for pruritus VAS at Week 8, or those who withdrew prior to receiving two or more study drug administrations. Patients who received the wrong study drug were also excluded from the PP population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (Part A) | Changes From Baseline in SCORing Atopic Dermatitis (SCORAD) (Part A, PP Population) | Week 4 | -6.83 percentage change from baseline | Standard Deviation 25.97 |
| Placebo (Part A) | Changes From Baseline in SCORing Atopic Dermatitis (SCORAD) (Part A, PP Population) | Week 12 | -15.97 percentage change from baseline | Standard Deviation 26.99 |
| Placebo (Part A) | Changes From Baseline in SCORing Atopic Dermatitis (SCORAD) (Part A, PP Population) | Week 8 | -17.29 percentage change from baseline | Standard Deviation 30.74 |
| Nemoliozumab (0.1 mg/kg) Q4W (Part A) | Changes From Baseline in SCORing Atopic Dermatitis (SCORAD) (Part A, PP Population) | Week 4 | -29.31 percentage change from baseline | Standard Deviation 23.58 |
| Nemoliozumab (0.1 mg/kg) Q4W (Part A) | Changes From Baseline in SCORing Atopic Dermatitis (SCORAD) (Part A, PP Population) | Week 12 | -27.22 percentage change from baseline | Standard Deviation 25.81 |
| Nemoliozumab (0.1 mg/kg) Q4W (Part A) | Changes From Baseline in SCORing Atopic Dermatitis (SCORAD) (Part A, PP Population) | Week 8 | -26.41 percentage change from baseline | Standard Deviation 26.6 |
| Nemoliozumab (0.5 mg/kg) Q4W (Part A) | Changes From Baseline in SCORing Atopic Dermatitis (SCORAD) (Part A, PP Population) | Week 8 | -36.81 percentage change from baseline | Standard Deviation 29.04 |
| Nemoliozumab (0.5 mg/kg) Q4W (Part A) | Changes From Baseline in SCORing Atopic Dermatitis (SCORAD) (Part A, PP Population) | Week 4 | -34.59 percentage change from baseline | Standard Deviation 29.36 |
| Nemoliozumab (0.5 mg/kg) Q4W (Part A) | Changes From Baseline in SCORing Atopic Dermatitis (SCORAD) (Part A, PP Population) | Week 12 | -39.49 percentage change from baseline | Standard Deviation 32.68 |
| Nemoliozumab (2.0 mg/kg) Q4W (Part A) | Changes From Baseline in SCORing Atopic Dermatitis (SCORAD) (Part A, PP Population) | Week 4 | -29.82 percentage change from baseline | Standard Deviation 21.65 |
| Nemoliozumab (2.0 mg/kg) Q4W (Part A) | Changes From Baseline in SCORing Atopic Dermatitis (SCORAD) (Part A, PP Population) | Week 12 | -38.31 percentage change from baseline | Standard Deviation 28.85 |
| Nemoliozumab (2.0 mg/kg) Q4W (Part A) | Changes From Baseline in SCORing Atopic Dermatitis (SCORAD) (Part A, PP Population) | Week 8 | -34.72 percentage change from baseline | Standard Deviation 24.33 |
Secondary
Changes From Baseline in Static Investigator's Global Assessment (sIGA) (Part A + Part B, ITT Long Population)
The sIGA consisted of a 6-point severity scale from clear to very severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease and 5 = very severe disease). The sIGA assessed clinical characteristics of erythema, infiltration, papulation, oozing and crusting for the overall severity assessment at the time of evaluation. When the skin condition improves, the change from baseline at each timepoint indicates negative value (i.e. the higher the absolute value is, the more the condition improves).
Time frame: baseline to Week 12 (Part A), up to Week 64 (Part B)
Population: The intent to treat (ITT) Long population was used for the analysis. The ITT Long population included patients randomized to Nemoliozumab treatment groups in Part A and patients re-randomized from the placebo group to Nemoliozumab treatment groups, providing they received at least one dose of Nemoliozumab and providing the results of at least one post-dose efficacy assessment was available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (Part A) | Changes From Baseline in Static Investigator's Global Assessment (sIGA) (Part A + Part B, ITT Long Population) | Week 4 | -0.7 change from baseline | Standard Deviation 0.9 |
| Placebo (Part A) | Changes From Baseline in Static Investigator's Global Assessment (sIGA) (Part A + Part B, ITT Long Population) | Week 64 | -1.9 change from baseline | Standard Deviation 1.1 |
| Placebo (Part A) | Changes From Baseline in Static Investigator's Global Assessment (sIGA) (Part A + Part B, ITT Long Population) | Week 12 | -0.9 change from baseline | Standard Deviation 0.9 |
| Placebo (Part A) | Changes From Baseline in Static Investigator's Global Assessment (sIGA) (Part A + Part B, ITT Long Population) | Week 60 | -1.9 change from baseline | Standard Deviation 1 |
| Placebo (Part A) | Changes From Baseline in Static Investigator's Global Assessment (sIGA) (Part A + Part B, ITT Long Population) | Week 24 | -1.5 change from baseline | Standard Deviation 1.1 |
| Placebo (Part A) | Changes From Baseline in Static Investigator's Global Assessment (sIGA) (Part A + Part B, ITT Long Population) | Week 48 | -1.7 change from baseline | Standard Deviation 1.2 |
| Placebo (Part A) | Changes From Baseline in Static Investigator's Global Assessment (sIGA) (Part A + Part B, ITT Long Population) | Week 8 | -0.8 change from baseline | Standard Deviation 1 |
| Nemoliozumab (0.1 mg/kg) Q4W (Part A) | Changes From Baseline in Static Investigator's Global Assessment (sIGA) (Part A + Part B, ITT Long Population) | Week 12 | -1.1 change from baseline | Standard Deviation 1.1 |
| Nemoliozumab (0.1 mg/kg) Q4W (Part A) | Changes From Baseline in Static Investigator's Global Assessment (sIGA) (Part A + Part B, ITT Long Population) | Week 64 | -1.9 change from baseline | Standard Deviation 0.9 |
| Nemoliozumab (0.1 mg/kg) Q4W (Part A) | Changes From Baseline in Static Investigator's Global Assessment (sIGA) (Part A + Part B, ITT Long Population) | Week 8 | -1.0 change from baseline | Standard Deviation 1.2 |
| Nemoliozumab (0.1 mg/kg) Q4W (Part A) | Changes From Baseline in Static Investigator's Global Assessment (sIGA) (Part A + Part B, ITT Long Population) | Week 4 | -0.8 change from baseline | Standard Deviation 0.9 |
| Nemoliozumab (0.1 mg/kg) Q4W (Part A) | Changes From Baseline in Static Investigator's Global Assessment (sIGA) (Part A + Part B, ITT Long Population) | Week 60 | -2.0 change from baseline | Standard Deviation 0.9 |
| Nemoliozumab (0.1 mg/kg) Q4W (Part A) | Changes From Baseline in Static Investigator's Global Assessment (sIGA) (Part A + Part B, ITT Long Population) | Week 24 | -1.7 change from baseline | Standard Deviation 1 |
| Nemoliozumab (0.1 mg/kg) Q4W (Part A) | Changes From Baseline in Static Investigator's Global Assessment (sIGA) (Part A + Part B, ITT Long Population) | Week 48 | -1.8 change from baseline | Standard Deviation 0.8 |
| Nemoliozumab (0.5 mg/kg) Q4W (Part A) | Changes From Baseline in Static Investigator's Global Assessment (sIGA) (Part A + Part B, ITT Long Population) | Week 48 | -1.4 change from baseline | Standard Deviation 1.2 |
| Nemoliozumab (0.5 mg/kg) Q4W (Part A) | Changes From Baseline in Static Investigator's Global Assessment (sIGA) (Part A + Part B, ITT Long Population) | Week 24 | -1.2 change from baseline | Standard Deviation 1 |
| Nemoliozumab (0.5 mg/kg) Q4W (Part A) | Changes From Baseline in Static Investigator's Global Assessment (sIGA) (Part A + Part B, ITT Long Population) | Week 8 | -0.9 change from baseline | Standard Deviation 0.9 |
| Nemoliozumab (0.5 mg/kg) Q4W (Part A) | Changes From Baseline in Static Investigator's Global Assessment (sIGA) (Part A + Part B, ITT Long Population) | Week 64 | -1.7 change from baseline | Standard Deviation 1 |
| Nemoliozumab (0.5 mg/kg) Q4W (Part A) | Changes From Baseline in Static Investigator's Global Assessment (sIGA) (Part A + Part B, ITT Long Population) | Week 60 | -1.7 change from baseline | Standard Deviation 1.1 |
| Nemoliozumab (0.5 mg/kg) Q4W (Part A) | Changes From Baseline in Static Investigator's Global Assessment (sIGA) (Part A + Part B, ITT Long Population) | Week 4 | -0.6 change from baseline | Standard Deviation 0.9 |
| Nemoliozumab (0.5 mg/kg) Q4W (Part A) | Changes From Baseline in Static Investigator's Global Assessment (sIGA) (Part A + Part B, ITT Long Population) | Week 12 | -0.9 change from baseline | Standard Deviation 1 |
| Nemoliozumab (2.0 mg/kg) Q4W (Part A) | Changes From Baseline in Static Investigator's Global Assessment (sIGA) (Part A + Part B, ITT Long Population) | Week 64 | -1.8 change from baseline | Standard Deviation 1.3 |
| Nemoliozumab (2.0 mg/kg) Q4W (Part A) | Changes From Baseline in Static Investigator's Global Assessment (sIGA) (Part A + Part B, ITT Long Population) | Week 4 | -0.4 change from baseline | Standard Deviation 0.8 |
| Nemoliozumab (2.0 mg/kg) Q4W (Part A) | Changes From Baseline in Static Investigator's Global Assessment (sIGA) (Part A + Part B, ITT Long Population) | Week 8 | -0.5 change from baseline | Standard Deviation 0.9 |
| Nemoliozumab (2.0 mg/kg) Q4W (Part A) | Changes From Baseline in Static Investigator's Global Assessment (sIGA) (Part A + Part B, ITT Long Population) | Week 12 | -0.9 change from baseline | Standard Deviation 0.8 |
| Nemoliozumab (2.0 mg/kg) Q4W (Part A) | Changes From Baseline in Static Investigator's Global Assessment (sIGA) (Part A + Part B, ITT Long Population) | Week 24 | -1.2 change from baseline | Standard Deviation 1.1 |
| Nemoliozumab (2.0 mg/kg) Q4W (Part A) | Changes From Baseline in Static Investigator's Global Assessment (sIGA) (Part A + Part B, ITT Long Population) | Week 60 | -1.7 change from baseline | Standard Deviation 1.1 |
| Nemoliozumab (2.0 mg/kg) Q4W (Part A) | Changes From Baseline in Static Investigator's Global Assessment (sIGA) (Part A + Part B, ITT Long Population) | Week 48 | -2.0 change from baseline | Standard Deviation 1.2 |
Secondary
Changes From Baseline in Static Investigator's Global Assessment (sIGA) (Part A, PP Population)
The sIGA consisted of a 6-point severity scale from clear to very severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease and 5 = very severe disease). The sIGA assessed clinical characteristics of erythema, infiltration, papulation, oozing and crusting for the overall severity assessment at the time of evaluation. When the skin condition improves, the change from baseline at each timepoint indicates negative value (i.e. the higher the absolute value is, the more the condition improves).
Time frame: baseline to Week 12 (Part A)
Population: The per-protocol (PP) population in Part A was used for the analysis. The PP population was defined as a subset of the ITT population excluding some of the major protocol violators , patients who were withdrawn before being evaluated for pruritus VAS at Week 8, or those who withdrew prior to receiving two or more study drug administrations. Patients who received the wrong study drug were also excluded from the PP population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (Part A) | Changes From Baseline in Static Investigator's Global Assessment (sIGA) (Part A, PP Population) | Week 4 | -0.2 change from baseline | Standard Deviation 0.8 |
| Placebo (Part A) | Changes From Baseline in Static Investigator's Global Assessment (sIGA) (Part A, PP Population) | Week 12 | -0.3 change from baseline | Standard Deviation 1 |
| Placebo (Part A) | Changes From Baseline in Static Investigator's Global Assessment (sIGA) (Part A, PP Population) | Week 8 | -0.5 change from baseline | Standard Deviation 1.2 |
| Nemoliozumab (0.1 mg/kg) Q4W (Part A) | Changes From Baseline in Static Investigator's Global Assessment (sIGA) (Part A, PP Population) | Week 4 | -0.8 change from baseline | Standard Deviation 0.9 |
| Nemoliozumab (0.1 mg/kg) Q4W (Part A) | Changes From Baseline in Static Investigator's Global Assessment (sIGA) (Part A, PP Population) | Week 12 | -0.7 change from baseline | Standard Deviation 1 |
| Nemoliozumab (0.1 mg/kg) Q4W (Part A) | Changes From Baseline in Static Investigator's Global Assessment (sIGA) (Part A, PP Population) | Week 8 | -0.7 change from baseline | Standard Deviation 1 |
| Nemoliozumab (0.5 mg/kg) Q4W (Part A) | Changes From Baseline in Static Investigator's Global Assessment (sIGA) (Part A, PP Population) | Week 8 | -1.0 change from baseline | Standard Deviation 1.2 |
| Nemoliozumab (0.5 mg/kg) Q4W (Part A) | Changes From Baseline in Static Investigator's Global Assessment (sIGA) (Part A, PP Population) | Week 4 | -0.9 change from baseline | Standard Deviation 0.9 |
| Nemoliozumab (0.5 mg/kg) Q4W (Part A) | Changes From Baseline in Static Investigator's Global Assessment (sIGA) (Part A, PP Population) | Week 12 | -1.0 change from baseline | Standard Deviation 1.1 |
| Nemoliozumab (2.0 mg/kg) Q4W (Part A) | Changes From Baseline in Static Investigator's Global Assessment (sIGA) (Part A, PP Population) | Week 4 | -0.6 change from baseline | Standard Deviation 0.9 |
| Nemoliozumab (2.0 mg/kg) Q4W (Part A) | Changes From Baseline in Static Investigator's Global Assessment (sIGA) (Part A, PP Population) | Week 12 | -0.8 change from baseline | Standard Deviation 1.1 |
| Nemoliozumab (2.0 mg/kg) Q4W (Part A) | Changes From Baseline in Static Investigator's Global Assessment (sIGA) (Part A, PP Population) | Week 8 | -0.8 change from baseline | Standard Deviation 1 |